Wednesday, February 1, 2012

Revisiting Third Party Food Safety Audits

Once again third party audits take heat for an outbreak, in this case, the Listeria outbreak in Jenson Farms Cantaloupes.. In the USA Today, two viewpoints are presented. Both present valid points, but there is more that can be said. Third party food safety audits provide a snapshot evaluation of the food safety system of an organization and give an assessment of whether that facility is following that food safety system. One important limitation is that audits, as currently completed, are not as good at determining the validity of that system, in other words, how well that system is actually working to make safe food. An astute auditor can see signs that the plan is valid through results of pathogen testing, through the process parameters that are set up, but there are factors that limit this.
  •  Auditors often cover a broad range of facilities and process types (even within the same commodity) and so it is difficult to have an in depth understanding of every process in every facility an auditor visits. They will not have the vast knowledge of a given pathogen as compared to a PhD who has studied that pathogen for years.
  • Audits are often one day in duration, so there is little time to get into the nuts and bolts of the process. Audits will look at the broad systems that are in place and make sure they are being followed (such as GMP’s, supplier control, pest control, HACCP), but to look at the validity of a process can take days, especially when there is the lack of support documentation such as pathogen testing.
  •  In most cases, auditors are not conducting microbiological analysis of the environment or of the finished product. They may look at results that are on file, but they themselves are not swabbing surfaces or pulling product from the end of the line and sending to a qualified laboratory. As was seen in the PCA case, a company may only show select results from a less reputable laboratory. So to what degree can an auditor, in a day or so, evaluate the laboratory being used, the methods that laboratory is using, and the sampling scheme used by the plant?
  •  Auditors will count, in part, that the facility actually knows what it is doing. If a facility has been processing cantaloupes for years, it is easy to make the assumption they must have some clue of what they are doing. They can question why a change was made, in this case the change in process, but to make a call on the safety of that change is more difficult.
  •  Companies being audited do want to pass the audit. Their business depends on it. When they hire an auditor, it is less likely they will put themselves in a position to fail….and that may mean hiring someone they know who will not put them through the ringer. Indeed, this a conflict of interest. But this practice of having the supplier pay for their own audit was started years ago by the purchasing companies requiring the audits. To get out of paying for audits of every supplier, they had the idea to make the supplier pay for the audit. Sure, the customer company provides a list of audit firms or auditors from which the supplier can choose, but still, the supplier still hires that person.
Because of these limitations associated with third party audits, they are not a guarantee of product safety. Rather, they are just a part of the entire food safety system that a company uses to ensure safe food. If a company uses the fact that they passed an audit as sole reason for why they believe their food is safe, then that company probably does not have true food safety systems in place. The goal of the audit for the food company is to assess their systems and provide feedback on where improvement is needed. Each aspect of the audit is there for a reason, so food companies need to embrace the intent of the requirement, not just to throw something in place to pass the audit.
While there has been a ratcheting up of requirements through GFSI (SQF and BRC) on both what is required in audits and what is required for someone to be a qualified auditor, some of these issues still exist. Even with government based inspection, there are similar shortcomings. Audits are an important part of our food safety system, whether internal, second party, third party , or government, but the responsibility for food safety ultimately falls on the company producing the food. Food companies must use these audits as guideposts for continual improvement. Employees, managers, and just as importantly, executive management must thoroughly understand their process and product. They must challenge themselves, with the help of auditors, to ensure their food safety system has addressed all possible food safety hazards.
by Martin Bucknavage 12/1/12

Editorial: Food safety auditors too tied to industry
USA Today 1/24/12
The first hints of trouble came last Sept. 2. Trackers who watch for outbreaks of dangerous diseases noticed that seven people in Colorado had come down with listeriosis, a potentially fatal food-borne illness. Within two weeks, federal authorities had tracked the culprit — contaminated cantaloupe — to Jensen Farms, a small Colorado grower.
By November, people in 28 states had fallen ill. By the time federal authorities declared the outbreak over in December, 146 people had been stricken, including a woman who had a miscarriage, and 30 were dead.
You'd think that the deadliest food-borne outbreak in nearly 90 years would change the way business is done in the produce industry. No such luck.
The first line of defense remains independent auditors hired by food producers to monitor their performance, much as companies hire outside auditors to certify their financial statements. But just six days before the Colorado outbreak, Jensen's auditor gave the company stellar ratings.
The system has an inherent conflict of interest: While retailers generally require audits before buying from a supplier, the suppliers often hire and pay the auditors who evaluate them. It's like authors hiring their own book reviewers.
A similarly flawed system contributed to the nation's 2008 financial meltdown. Credit-rating agencies, which are supposed to objectively rate the risk of debt securities for investors, gave AAA ratings to bundles of toxic mortgages. Guess who hired and paid them? The sellers of the shaky securities. At least toxic mortgage debt can't kill. Listeria can.
Primus Labs audited sanitation practices at Jensen's packing house immediately before the outbreak and gave the company a 96% rating. The Food and Drug Administration later cited problems — including the facility's design and flawed sanitizing procedures — as potentially contributing to the contamination. Primus also gave passing grades to 98.7% of those it reviewed in 2010, according to a House Energy and Commerce Committee report released this month.
In 2009, another major auditing firm, AIB International, gave the Peanut Corp. of America a "superior rating" at its Texas plant even as it was churning out salmonella-tainted peanut paste. PCA'S products ultimately sickened 600 people and might have killed as many as nine.
If retailers paid for audits, as a few do, there'd be more incentive for impartial audits. Retailers could also demand that auditors be assigned randomly to jobs from a pool. That, too, would reduce the conflicts.
Outbreaks of food-borne illness have prompted change in the past, but only when industries have stepped up to take responsibility. After contaminated spinach sickened scores of people in 2006, producers agreed to make leafy greens less vulnerable to bacteria. In 2004, after a salmonella outbreak in almonds, California growers researched a pasteurization process to make their products safer.
As government shrinks, more of the nation's food supply will depend on private audits. They won't provide much comfort as long as auditors are evaluating the folks who pay their bill.
Opposing view: Food safety is more than about audits
By Bob Whitaker
 USA Today
Food safety has always been the highest priority for the people who grow, ship and sell our nation's fresh fruits and vegetables. Recognizing there is no one solution, we take a holistic approach to food safety, constantly strengthening best practices, identifying knowledge gaps, creating new guidance on growing, handling and processing, and developing new "field to fork" training programs.
While the industry is constantly in search of new ideas to enhance the safety of our products, the concept of creating a system led by industry to randomly choose third-party auditors is flawed.
If objectivity is the concern, consider that audits are only one tool in a comprehensive food safety program. It is already standard industry practice to rotate auditors to avoid potential familiarity issues. In some cases, it's the buyer who actually chooses a grower's auditing firm.
The concerns about objectivity also assume that the only goal of the grower paying for the audit is to achieve a passing grade. Nothing could be further from the truth. Audits, like other current safeguards, are one tool among many used to ensure the safety of our fresh produce. Further, audit results are routinely used to improve food safety performance.
Everyone has a role in food safety. Rather than debate the merits of a single approach, let's broaden the dialogue and work in partnership with industry, consumers and the government to set the framework to create more effective food safety solutions not only for today, but also tomorrow.
The produce industry's commitment to protecting public health and building consumer trust influences every decision made from farm to table. The industry has been, and will continue, taking aggressive action to chart a course to ensure a better future for produce safety. While we recognize that audits are a critical part of a food safety program, they are but one piece of that commitment.
Bob Whitaker is the chief science and technology officer for the Produce Marketing Association.
Food facility audits largely ignore FDA guidance
By MARY CLARE JALONICK, Associated Press–15 hours ago
WASHINGTON (AP) — Congressional investigators looking into an outbreak of listeria in cantaloupe linked to 30 deaths last year found that third-party auditors who gave Colorado's Jensen Farms a "superior" rating just before the outbreak largely ignored government guidance on food safety.
A bipartisan report released Tuesday by the House Energy and Commerce Committee quotes a representative of an auditing company that graded the facility two months before the outbreak as saying audits are not intended to help clients improve food safety standards. Retailers often rely on such audits to make sure food they buy is safe.
Democrats on the panel asked the Food and Drug Administration to crack down on such third-party auditors, who often are the only outside entities to inspect food facilities. A food safety law signed last year will boost FDA inspections of such facilities, but money to carry out those inspections is not guaranteed from Congress.
"Weaknesses in third-party auditors represent a significant gap in the food safety system," the Democrats said. Republicans on the committee signed the report but did not echo the Democratic call for more oversight.
The FDA currently does not regulate third-party auditors. The food safety law requires the agency to improve third-party audits of food facilities abroad that export to the United States, but does not address domestic audits.
Siobhan Delancey, spokeswoman for the FDA, said in a statement that new standards under the law enacted last year will still go a long way toward improving food safety.
"There are a number of elements of the proposed rule that, had Jensen Farms been in compliance, would have significantly reduced the risk of that outbreak occurring," she said.
 The congressional report notes that Primus Labs, the auditor hired by Holly, Colo.-based Jensen Farms, is one of the nation's largest food facility auditors. The company told the committee that the vast majority of the thousands of audits it completes each year receive passing grades — 98.7 percent in 2010, 97.5 percent in 2009 and 98.1 percent in 2008.
The president of the company, Robert Stovicek, told the investigators that Primus Labs would be "a rogue element if they tried to pick winners and losers" and that the company does not have the expertise to determine which practices should be pushed by industry. A subcontractor who audited the cantaloupe farm told the committee that auditors dock points if a facility is not following specific FDA regulations but do not account for the agency's many guidances on how best to keep food safe.
 The outbreak of listeria in cantaloupe this fall was the deadliest outbreak of foodborne illness in 25 years. Thirty people died, 146 people were sickened and one woman suffered a miscarriage after eating the tainted cantaloupe, according to the federal Centers for Disease Control and Prevention.
The FDA said in October that pools of dirty water on the floor and old, hard-to-clean equipment at Jensen Farms probably were to blame. Government investigators found several positive samples of listeria bacteria on equipment in the Jensen Farms packing facility and on fruit that had been held there. The farm also had stopped using antibacterial washes and did not "pre-cool" cantaloupes off the fields to reduce bacteria growth, the FDA said.
 The Republican-led committee declined to hold a hearing on the outbreak but released the bipartisan report — including summaries of interviews with the FDA, the owners of the farm and the auditors — instead. The report noted that many in the food industry have required better audits since the cantaloupe outbreak, and did not call for the FDA to step up action. Democrats, who had called for a hearing on the matter, wrote the separate letter to the agency after the report was released asking for stricter oversight.
Bill Marler, a food safety lawyer who is suing Jensen Farms on behalf of several of the victims, said government inspectors should be present at food facilities more often.
 "The present audit system is fraught with conflicts and is designed not to find safety problems, but to keep food — regardless of quality — flowing from farm to fork," he said.
Colorado listeria probe by Congress points many fingers
Posted: 01/10/2012 01:24:29 PM MST
Updated: 01/10/2012 05:34:57 PM MST

Read The Denver Post's Terms of Use of its content:
A Congressional committee investigating deaths from the Colorado cantaloupe listeria outbreak points fingers at Jensen Farms, third-party auditors, and lax FDA regulations on sanitation.
Democrats on the House Energy and Commerce Committee, including Rep. Diana DeGette of Denver, also asked the FDA to step up regulation of outside auditors, who they say bring numerous "conflicts of interest" to the food safety system.
The U.S. House Committee on Energy and Commerce staff report echoes the FDA in pointing to key changes in the Jensen Farms packing process that launched the outbreak, which killed 30 people.
In testimony from the Jensen brothers, though, the farm said it was taking advice from an auditor meant to reassure grocery stores on safe growing conditions. Eric and Ryan Jensen told the committee that the farm had also been visited many times by its much larger distributor, Frontera Produce, and no one had faulted their new packing system.
The report highlights a switch to a pass-through washing system that used fresh water but no chlorine to kill bacteria. Jensen had used a chlorine bath system in 2010, but changed it for 2011 and also bought used potato-harvesting equipment later deemed inappropriate for melons.
The staff also questioned the auditors, Bio Food Safety, which were hired as a subcontractor by Primus Labs of California. Jensen received high marks in both its 2010 and 2011 audits; the 2011 audit, just before harvesting began, noted the change to a non-chlorine wash but did not ask Jensen to address it.
Bio Food Safety told committee staffers that the audit was a checklist-style audit, and that there is no set FDA regulation requiring chlorine sanitation for melons. The FDA has said it has guidelines encouraging a sanitary wash, but they are not codified in regulations.
The Jensens, Frontera and the auditors face numerous lawsuits from families of the dead and dozens more made ill by listeria. The FDA and federal prosecutors have also said they reserve the right to add penalties to their investigation of the case, possibly through criminal charges using laws in food safety acts.

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