Dr. David Acheson | Food Safety News

Will FSMA Make a Difference?

Dr. David Acheson — Tue, 06 Oct 2015 05:01:42 +0000

To answer the question of whether the Food Safety Modernization Act (FSMA) will make a difference, I want to take a look historically at why FSMA ever got passed by Congress. To do this, I have to wind the clock back almost 10 years. The only thing that got FSMA through Congress — and those who remember back to the end of 2010 will recall it was only by a squeak that it got through — was an unlikely alliance of stakeholders. So what created that alliance? There were three major events that drove FSMA. The first was in 2006 with the large E. coli O157:H7 outbreak linked to spinach. This event drove the produce industry to push for regulatory change. I remember getting calls in 2006 from the produce industry almost pleading with FDA to set regulatory standards for growers of fresh produce. The second event was in 2007, with the deliberate contamination of wheat gluten with melamine, which resulted in a lot of sick and dead pets. This event really got the attention of the Bush administration due to three factors: It was deliberate, it was in imported food, and it involved China. The third event was, of course, the 2008-09 outbreak involving the Peanut Corporation of America, which, as we all know, has now resulted in some major jail time for those found guilty. What these three events did was to cause the food industry — both growers and manufacturers, along with consumers, Congress and regulators — to all pull together in 2009 and 2010 and push for a set of regulatory standards to which the industry could be held accountable. Back in 2007, when melamine hit, I had the fortune to lead a group at FDA tasked with writing the Food Protection Plan. This was a three-pronged approach to food safety that would shift FDA from a reactive organization to a prevention-focused agency. Our approach for this plan was to concentrate on risk-based preventive controls, targeted risk-based inspections and rapid response. The plan also requested a number of new regulatory authorities around preventive controls and imports that would allow FDA to follow through on this new plan. In my view, this was important policy and regulatory thinking at FDA that paved the way for FSMA from a FDA perspective. So fast-forward to 2015, and we have FDA with a host of new authorities and an agency publishing new and major rules related to many aspects of food safety. These new rules will literally impact hundreds of thousands of entities globally when one considers all seven new rules due out in the coming months and in the early part of 2016. My view is that the stakeholders who supported the passage of FSMA still believe it is both needed and a good idea. But, as with all new regulatory authorities, the devil is in the details, and there are some devils buried in FSMA for sure. Some stakeholders are really not happy — they feel that they are being over-regulated and that there will be no benefit to public health with some aspects of FSMA. Why? Because FDA had to essentially write a one-size-fits-all set of rules and the food industry is anything but one size. So how should FDA proceed in a way that will have that positive public health impact that we all want and which, let’s not forget, was the original driver for the passage of FSMA in the first place? My answer is: with a major dose of enforcement discretion. FDA always has the capacity to use discretion when it comes to enforcing regulations. What is really important is that, in the FSMA regulations, we have a clear regulatory bar that applies to high-risk entities. But it also applies to low-risk entities. Thus, FDA now has the authority to make a difference. However, the agency needs to focus its efforts where they will get the biggest bang for the buck. And, since the bucks are in very short supply, that approach is all the more important. All FDA-registered facilities now have to have preventive controls in place. Some, such as seafood and juice facilities, will stick to the old HACCP approach, while others will have to embrace the more comprehensive and risk-based HARPC approach. That is a good thing since it will raise the standards for those who are somewhat asleep at the switch when it comes to food safety. What I hope FDA will do is to focus its inspectors on those facilities that are not up to speed on food safety in ways that create real risks for public health. FDA has the power to make a lot of people miserable, and the agency shouldn’t do that. FDA can demand to see food safety plans and all the records that go with it. This gives the agency a lot of power to dig very deeply into a facility’s food safety system. The reality is that the regulatory bar is now set with the publication of two new preventive control rules for human and animal foods. Whether these rules drive toward an improvement in public health will be heavily dependent on how FDA acts. FDA has a major shortage of funds, and I want them to have more, but that is unlikely to happen in the short term. So FDA must focus its new authorities on food companies that really do represent a risk to public health. At the same time, I hope that FDA recognizes that it has three roles to play. The first is to set the bar to make the food industry accountable to good preventive controls — the agency has done that with the new rules. The second is to provide the tools for the food industry to understand what it needs to do to meet that new standard — there is a lot more needed here. The third is to hold accountable the parts of the food industry that create public health risks. This latter point is critical and I worry that, without good governance, we will see FDA wielding a new and very large stick that will create resentment and anger and, unfortunately, not result in the public health gains that this is all about. So will FSMA make a difference? The answer is that it will if we manage all these moving parts correctly. The ball is very much in FDA’s court, and while writing the rules was difficult, what will be really tough for the agency will be enforcing them in a way that will drive down foodborne illness and not simply drive up the number of 483s and warning letters. (To sign up for a free subscription to Food Safety News, click here.)

Can a Top-Level Federal Food Safety Assessment Really Be Accurate?

Dr. David Acheson — Tue, 17 Feb 2015 06:02:57 +0000

(This opinion piece by Dr. David Acheson was published here on Feb. 14, 2015, and is reposted with his permission.) Historically, FDA and FSIS have not been really cooperative when it comes to food safety: Each agency has a separate funding stream and is under separate departments, and, in a variety of ways, they are inherently competitive. While this may seem like a platform statement for a missive on a single food safety agency, that is not what this article is about. Recently, the GAO issued a report on Federal Food Safety Oversight which, at least in principle, set out to explore how to better manage overall food safety oversight. In general, the report may have the right idea on its “findings” that broad-based, centralized collaboration between FDA and FSIS would provide for a more unified food safety system. As I was a part of this process, I know that GAO spoke with people with personal experience of federal food safety dysfunction. However, the final report appears to have focused more on using the strategic planning reports of the parent departments — Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) — as the basis of a food safety collaboration assessment. As stated in the report’s summary section, What GAO Found, in their strategic and performance planning reports, “HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts. In addition, they do not include several relevant crosscutting efforts, such as the National Antimicrobial Resistance Monitoring Systems.” Does it really take a GAO report to figure that out?! The original mission of this report as stated to me was solid — GAO was looking at ways to improve overall collaboration and integration of food safety at a federal level. There is no question that we certainly need that. But the issue we see is that the report seems to be fairly useless in that it is not really assessing the interagency collaboration as much it is assessing the quality of the strategic reports. Just because an activity is not specifically detailed in the strategic plans doesn’t mean these don’t exist — GAO acknowledges this itself in noting NARMS (above). Since there are a number of areas in which the agencies have collaborated, such as NARMS, PulseNet, Whole Genome Sequencing, etc. (as we detail below), what is the point of writing a 46-page report on what is, or isn’t, detailed in the departmental strategic plan? Wouldn’t the time have been better spent and the report more useful if it actually assessed the agencies’ collaboration? HHS has 11 operating divisions, including eight health and three human services agencies, each of which then includes a variety of offices and centers whose responsibilities are further divided. For example, FDA itself is responsible not only for food safety, but also for medical products, tobacco, veterinary medicine, and global regulations. So to expect a department to write a strategic plan that details every initiative that every division, center and office operating has taken — and to assess the actions of a single center [e.g., the Center for Food Safety and Applied Nutrition (CFSAN) of FDA of HHS] based on that general report seems to be an exercise in futility and, to be blunt, a waste of time. The same is true for USDA, which has seven agencies, under which FSIS is just one of 18 services. To take it a step further, the report also stated, “In 2011, GAO recommended that the Office of Management and Budget (OMB), in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not acted on that recommendation.” So now we are going even further upward in the hierarchy for responsibility, but as we saw so many times with the FSMA rules, OMB has so many responsibilities that a FDA-initiated action can sit on its desk for months awaiting approval. So again, assessing CFSAN and FSIS collaboration by OMB lack of movement is unfair at best. Now this is not to say that the agencies shouldn’t have a strategic plan, nor that GAO shouldn’t assess it. We just don’t believe that developing a “Federal Food Safety Oversight” report from these upper level (HHS/USDA) strategic documents is really all that helpful. Concluding that food safety collaboration is poor and “Additional Actions Needed to Improve Planning and Collaboration” (as the report is titled) is an accurate assessment of our food safety system is undoubtedly correct — but we knew that going in. What is key is how to improve the system. In actuality, there are numerous areas in which FSIS and FDA, along with the Centers for Disease Control and Prevention (CDC), are collaborating, so it can be done. The examples below are, for the most part, science-based, but where the systems fall apart is alignments on policy and oversight. Yet, we should acknowledge some good collaborative efforts, just a few of which are:

National Antimicrobial Resistance Monitoring System: FDA, FSIS, CDC collaboration in a national public health surveillance system that tracks changes in the antimicrobial susceptibility of certain enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the U.S.
Interagency Food Safety Analytics Collaboration: FDA, FSIS, CDC collaboration to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use. Projects and studies aim to identify foods that are important sources of illnesses. The current focus of IFSAC’s activities is foodborne illness source attribution, defined as the process of estimating the most common food sources responsible for specific foodborne illnesses.
PulseNet: FDA, FSIS, CDC collaboration to connect cases of foodborne illness to potential outbreaks and find immediate (such as a food recall) and long-term (such as a new production practice) solutions to the problems that cause outbreaks.
Whole Genome Sequencing: FDA, FSIS, CDC and NIH collaboration designed to showcase the capacity to revolutionize foodborne disease tracking through such goals as further development and rollout of the open database, GenomeTrakr, a pathogen detection network which would store genomic data of bacteria that have been responsible for foodborne illnesses outbreaks around the world.
Food Defense: FSIS/FDA participation in interagency discussions and reviews of the FSMA food defense tools to continue federal partnership on food defense and help ensure continued FSIS-FDA consistency in food defense principles.

Perhaps there are more awaiting approval at the upper levels of HHS, USDA or OMB? We also see it as no great revelation that, as GAO asserts, “a government-wide performance plan for food safety is necessary.” But we would take that a step further to say that perhaps it is a single, united, government-wide food safety agency that is needed, and GAO has supported that assertion in the past. A single FDA/USDA that is responsible for all food safety, reports up to the same department, and has the same Congressional mandates. Then collaboration would truly be enabled. Then we could truly make system-wide improvements in food safety. However, we should not forget the critical importance of other agencies involved in food safety (e.g., EPA) that are listed in the GAO report. These, too, have to be part of the total collaborative effort, as do both state and local regulatory bodies. Fundamentally, no one wants to give up turf or power, and to date there has not been a big enough disaster to drive change from either the White House or Congress. As with all things food safety, it is sad to say that it will take a major disaster that will likely involve the loss of life for some of these fundamental organizational issues to get addressed in a meaningful way.

Prolonged Procrastination on Petitions Compounds Agencies’ Problems

Dr. David Acheson — Tue, 17 Jun 2014 05:02:08 +0000

(This blog post by Dr. David Acheson was published June 12, 2014, on The Acheson Group blog and is republished here with his permission.) On May 25, 2011, the Center for Science in the Public Interest (CSPI) petitioned USDA to declare certain strains of antibiotic-resistant (ABR) Salmonella in ground meat and poultry to be adulterants. Three years later, USDA has not yet responded. Sound familiar? It becomes even more familiar-sounding with the news that CSPI has sued USDA for “unreasonable delay” in responding to the petition. As CSPI states in its suit, “more than three years after CSPI’s petition, FSIS has neither granted nor denied the petition, and it has taken no action to declare ABR Salmonella an adulterant. Therefore, to protect public safety and prevent needless death and injury, CSPI seeks a declaration that defendants have acted unlawfully by withholding action on CSPI’s petition and an order requiring defendants to act thereon.” Precedent has already been set by the success of similar unreasonable delay suits, such as that filed by CSPI against FDA for lack of response to a petition for the revocation of approval of non-therapeutic use of antibiotics in animal production, as well as that of the Center for Food Safety (CFS) and the Center for Environmental Health against FDA over delayed publication of FSMA rules, and CFS suing FDA over the 1997 Generally Recognized As Safe (GRAS) proposal for its failure to follow rulemaking requirements and finalize the regulation. Unfortunately, through their prolonged procrastination without explanation, the agencies are bringing the lawsuits down on themselves — not to mention the activist angst, consumer controversy, and federal frustration that preceded the lawsuits. The agencies can claim lack of resources, and there’s no question that that is at issue. However, as is often the case in any aspect of business or life, the procrastination and lack of action has caused further burning of resources than if issues were addressed as they came to light. In fact, the problem seems to often be more a lack of decision-making and communication than simply of inaction. The Salmonella issue is exactly that, and likely comes down to no one at USDA wanting to be responsible for making the decision. If the agency were to accept the CSPI request and declare specific types of Salmonella to be an adulterant, it would make the consumer group happy, but USDA would have an awful lot of work to do in setting new rules, levels, oversight, etc., and it would certainly not make the industry happy. If it were to reject the request, it would be depicted by CSPI as not being protective of public health. But if USDA were to let the petition languish — as it did — then no decision would have to be made, no pushback would occur from either consumers or the industry, and life, thus, would not get overly complex. Except it now has, and the agency will need to expend further resources not only to answer the original petition, but also to answer the lawsuit. Additionally, with CSPI alleging that USDA “is failing to protect the public from dangerous antibiotic-resistant strains of Salmonella in ground meat and poultry” through its inaction, the agency has not avoided the negative fallout, and, with media coverage of the lawsuit by everyone from Reuters to NBCNews to foodpoisoningbulletin.com, it has certainly not evaded the publicity. As for the lawsuit against FDA for FSMA delays: We understand FDA’s inability to meet the original congressional timeline, as we see it as having been unrealistic. But couldn’t FDA had communicated this back at the beginning, explaining why it was unrealistic and proposing an alternative timeline? Additionally, a better direction of resources throughout the process could potentially have kept the development of the rules moving at a better pace, kept the lawsuit at bay, and not brought on the additional expenditure of resources for the lawsuit — although we do recognize that a big part of the FSMA delay in the early years was not of FDA’s making. With such precedents being set, what’s next? There are plenty of hot topics for which unreasonable delay could be cited:

GMO labeling is a highly controversial topic. With draft guidance pending since 2001, the issue is now being taken over by the states, to the consternation of industry. (See our April newsletter GMO Labeling: Consumer Right or Wrong.)
The Egg Safety Rule passed in 2010 took a full decade to enact, and Sanitary Transport, which has now reached the proposed rule stage through FSMA, dates back to 1990, with accountability vacillating between the Department of Transportation and FDA and finally landing on FDA in 2005 with no action until recently.
Nutrition Facts labeling is a discussion in and of itself, but suffice it to say here that once something has languished unchanged for more than 20 years — as have these standards — why issue FDA’s Proposed Changes to the Nutrition Facts Label in 2014 when USDA’s five-year dietary guidelines are due to be issued in 2015, with the potential of causing new changes?

I don’t question that FDA needs more resources, but it can become difficult for any agency to validate its need for further resources when there exist all too many examples of inefficient handling of those it has. But, as I look at these lawsuits, I have to say the game has changed. Gone are the days when an agency received a petition, especially from a consumer organization, and the optimal course of action was to do nothing. Inaction today will buy you a greater resource burn down the road, along with media attacks and cries of inefficiency and inappropriate public health priorities. So it seems to me that, moving forward, food safety agencies need to respond to petitions in a timely way, even if that is to say, “No, because we need more data,” and then kick it back. But at least there will have been a response, which has to be better than where we are today.

Are All Salmonella Created Equal?

Dr. David Acheson — Fri, 07 Mar 2014 06:03:10 +0000

With each passing poultry-associated Salmonella outbreak over the past few years, there has been an increased focus on this pathogen and its control. Along with that is an increasing use of the term “virulent.” But what does “virulent” really mean, and should we worry about some strains being more virulent than others? Does evading mitigation in processing make a pathogen “more virulent,” as some seem to indicate? Does the fact that a strain is antibiotic-resistant define it as more virulent? As we look at how the term “virulent” is being used by the public health community, regulators, consumer groups and others – often extending beyond the molecular and clinical definition – what impact will this have on food processors and future policy measures? To understand the conundrum, we need to first understand what we mean by virulent and ensure that everyone is using the same definition. Right now, we’re not all on the same page. As defined in relation to pathogens by the Miriam Webster Medline dictionary, virulent means “able to overcome bodily defense mechanisms.” Or, in simpler terms, able to make you sick. Overcoming bodily defense mechanisms is different than overcoming food industry or consumer mitigations (such as high pressure or cooking). It’s different than resisting clinical treatments (such as antibiotics). But recent statements equating virulence with antibiotic resistance, or suggesting that resistance to heat results in increased virulence, begins to blur these issues together. This has caused confusion and could lead some down the wrong path to finding a solution that reduces illness. Now, to get a little techier, what makes a strain of bacteria more or less virulent (or able to make you sick) begins with its genetic makeup. Genes encode proteins and proteins can result in clinical effects. A good example is that an E. coli strain that makes Shiga toxins (like O157:H7) is generally more virulent than the same bacteria that does not make Shiga toxins. Strains can evolve to become more virulent, swapping genes and whole chunks of DNA (sometimes referred to as pathogenicity islands) and other genetic components that enhance the ability of the strain to survive through the digestive tract and bypass or fool the human’s immune response. What does not make a strain more virulent is resistance to processing, or its ability to evade mitigation. To explain, say a chicken carcass has 10 strains of Salmonella. Say further that, after processing, one strain was able to evade all processing controls and remain on the chicken. To say that just because it is there it will make someone sick is not a foregone conclusion. Salmonella Kentucky is commonly found on chicken, but it’s rarely associated with illness. With that said, one has to ask why certain strains tend to hang around on chicken more than others. And is their ability to “stick” to poultry somehow associated with the likelihood they will cause illness? So far, the connection has not been made, but we can’t rule it out. Another question that often emerges is whether Salmonella strains that are resistant to antibiotics are more likely to make you sick. The jury is still out on that one, but the reason a strain becomes resistant to antibiotics is because it picks up new genes. Sometimes groups of genes move together, so it is possible that, when a Salmonella strain acquires an antibiotic resistance gene, it also picks up some new gene at the same time that confers a greater ability to cause infection – e.g., more virulent. What is important with regard to antibiotic resistance is that, if a person does get sick and needs antibiotics, it is important for the patient that the antibiotic prescribed by the physician will work. If the Salmonella are resistant to antibiotics, that may not always be the case. Why some strains of Salmonella are more likely to make some people sick than others goes back to the techy molecular biology research. But, at least so far, science doesn’t support a blanket statement that virulent strains are more likely to be resistant to antibiotics than less-virulent strains. We could do a lot more for human health by better understanding which strains are more likely to make people sick, finding out why, and finding ways to prevent that. If it’s because they are truly more virulent (more likely to make people sick, all else being equal), then do we go down the road of pinpointing efforts in the food industry against those worst offenders? Have some strains of Salmonella figured out a way to avoid current mitigations? Do we change our mitigations (developing new rinses, new processing methods, changing recommended cooking temperatures, etc.)? The approach to protecting public health – and industry’s role in doing this – could be very different depending on that root cause. Today we have the challenge that we simply don’t have answers to all these questions. Only by getting answers can we better control risk both in plants and with regard to public health. We need to ensure we have answers before any new regulatory policy is put in place. But, at this stage of the game with Salmonella, my instincts are that they are not all created equal. However, can we afford to ignore some strains vs. other strains from a public health perspective in humans? Not yet.

Determining the “High Risk Foods”: Another Analysis Sees Things Differently

Dr. David Acheson — Mon, 08 Apr 2013 07:01:31 +0000

The numbers say that the most outbreaks and illnesses are attributable to produce, but, in reality, fruits and vegetables are really quite safe. How can this be? A new report from the Center for Science in the Public Interest (CSPI) takes a look at the number of cases of foodborne illness relative to the amount eaten. That is, when foodborne illnesses are considered together with consumption rates, meats, poultry, and seafood are far more likely to cause illness than produce. Thus, although CSPI agrees with the basic numbers in CDC’s 2012 report (Attribution of Foodborne Illnesses, Hospitalizations, and Deaths to Food Commodities by using Outbreak Data, United States, 1998–2008) which put the spotlight on produce as causing the most cases of foodborne illness, it did not draw the same conclusions. In the white paper, Outbreak Alert! 2001‐2010 A Review of Foodborne Illness in America, published in March, CSPI analyzed 4,229 foodborne disease outbreaks occurring between 2001 and 2010, as identified by CDC and other sources. However, the difference between the CSPI and CDC report was that CSPI took the numbers a step further. When analyzed “pound-for-pound” with the amount of each type of food consumed by Americans, seafood rose to the top as the most hazardous food, followed by poultry products – two products for which HACCP is already required. With this extended analysis, the CSPI report backs up the assertions we made in our February 7 newsletter when the CDC report came out (From Farm to Consumer: Where is the Real Risk for High-Risk Foods and How Does FSMA Fit In?). As we stated, and asked, then: “With its statement that ‘more illnesses were attributed to leafy vegetables (22%) than to any other commodity,’ the CDC report puts the spotlight heavily on produce and its on-farm production. … But does it really deserve that spotlight? “ We don’t want to undermine any industry efforts in raising the level of safety for produce–or any other foods. We just want to ensure that produce is not getting undue blame or focus to the detriment of other foods that need just as much – or more – of that focus. The report also went another step further to analyze the locations most often associated with outbreaks. Although occurrences in restaurants and private homes impacted the fewest number of people per outbreak, the number of outbreaks were the greatest in these two locations, and contributed to the greatest number of illnesses. The number of illnesses associated with restaurant outbreaks (32,919) were, in fact, almost three times greater than that of any other single location–with private homes coming in second (12,666). Again, while we don’t want to take the food safety onus off the food manufacturing industry, it is important that food safety be considered at further steps of the chain where the food is handled and served, rather than blindly placing blame on the manufacturer or farm, and thus putting the majority of the “regulatory eggs” into those baskets. It’s currently impossible to determine how many outbreaks are due to cross contamination, poor employee hygiene, temperature abuse, etc., and these considerations can have great bearing on the foods associated with outbreaks. Taking produce as an example again: if lettuce is chopped on a cutting board that wasn’t properly cleaned after raw chicken was on it, is it fair to incriminate lettuce as the cause of salmonellosis? It’s these kinds of issues that make what seems like straightforward data analysis not so straightforward, and makes discerning the truly high risk foods very difficult. A further interpretation of the CSPI data is that cross contamination in food service or home environments or inadequate food preparation such as cooking, is, in fact, the major contributor of foodborne illness in the U.S. today. CSPI’s paper was based on the 4,229 outbreaks between 2001-2010 that were reported by public health officials with both an identified pathogen and contaminated food; the database was largely compiled from CDC’s Foodborne Outbreak Online Database (FOOD). While conceding that the 106,635 cases of foodborne illness caused by these outbreaks are only a small fraction of total foodborne illnesses, CSPI stated that they represent those outbreaks that provide the most useful information for attribution analysis. The CSPI study also found a decline in complete reporting between 2001 and 2010 with 54 to 68% of all outbreaks reported annually to CDC lacking necessary information, such as the contaminated food or contaminant. It conjectures that this may be due to recession-reduced budgets for public health departments at the end of the decade, with influenza pandemics and post-9/11 bioterrorism investments possibly diverting attention away from foodborne illness investigations. Clearly, if we don’t have complete information about the agent causing the illness and the food vehicle, we can’t put measures in place to prevent issues in the future. Better traceability may help, but there are many factors at play and issues to be addressed in order to ensure that the public health community can be more successful in “solving” outbreak investigations. While the CSPI and CDC analyses are incredibly useful, they provide an incomplete picture of foodborne illness outbreaks due to the limited availability of data. We sincerely applaud the work of CSPI, its robust approach to the analyses in this report, and its ongoing work as a consumer organization. We see the variations in the conclusions between the CSPI and CDC reports as, in fact, showing the difficulty of trying to discern which food is problematic, and which are or should be designated as “high risk.” It will be interesting to see how FDA slices and dices outbreak and other data to determine what foods receive the “high risk” designation. Although emphasizing the responsibility of the consumer in food safety is often an unpopular message, it is one that is still very important. Vast resources have been spent by the manufacturing industry on food safety with a concomitant regulatory focus. Clearly, we should not back down on that focus, but perhaps it is time to turn our attention closer to the consumer and take on the tough challenge of behavior change at that end of the supply chain. We should not confuse the “don’t blame the consumer” message with the “we all have a responsibility to keep food safe” message. No one, from farm to fork, irrespective of size, can abdicate from that responsibility of doing their part to keep food safe and expect others to do ALL the work for them. This article originally appeared on the Leavitt Partners’ Food Safety blog April 4, 2013.

Third-Party Audits – Their Crucial Role in Moving Forward With FSMA and Food Safety

Dr. David Acheson — Tue, 27 Nov 2012 06:32:36 +0000

I recently had the honor of speaking at the 2012 Safe Quality Food International Conference in Cincinnati on the topic of the crucial role of third-party audits in moving forward with FSMA and food safety. In the talk, I spent time looking at what is working well with third-party audit systems, and where some of the vulnerabilities are. Based on reflections from giving that talk, I thought I would share some of what I see as the key points in this week’s newsletter. At this point in time, the use of third-party audits has potential to be a massive success or a dismal failure depending on the outcome of the continued momentum to build a robust system. Currently there are at least three forces in play in the third-party audit world, each of which is interrelated. Specifically, these three areas are:

The private sector drivers with expanding use of third-party audit systems under the umbrella of the Global Food Safety Initiative (GFSI);
The impact of the requirements in FSMA around using third-party audits in relation to imported foods;
The impact of the recent report from the Government Accountability Office (GAO) on this issue.

As we consider some of the pressure points in the third-party audit system, one of the vulnerabilities that I think is important is the recognition that the audit is always a “snap shot in time” exercise. This then raises the question – whether you are the recipient of a third-party audit or the person who doing that audit: Why is the audit being undertaken? Is it to protect your brand, so you really want the auditor to find the gaps in your system? Or is it to safeguard against the likelihood of litigation or share that risk with someone else if something goes wrong? Or, is it simply to generate the required certificate to allow you to sell your products? It may even be some combination of the above, but in my view the way to both receive and execute an audit is the first one – you really want to find out where the holes are in your system and fix them. Then when you get your certificate, don’t relax! Keep up the pressure, fix the problems, look for continuous improvement and make that “snap shot” assessment into a “movie” of continuous improvement. As we consider third-party audits, there are two words that signify success to me: that is, having a system that is trustworthy and rigorous. That is what will make it a success for the regulators and the private sector. As we look at the role that U.S.food regulators have played in the evolution of the third-party audit system, it was the melamine episode in 2007 that focused attention on this issue for FDA. Melamine and melamine by-product contamination of wheat gluten drove FDA to recognize that the systems around import safety needed a radical rethink. This 2007 event drove the opening of several FDA offices overseas (China, Latin America, India, Europe, etc.), as well as the 2008 Shrimp Pilot and many of the specific sections in FSMA. The Shrimp Pilot was FDA’s first foray into the third-party audit space with the intent of figuring out if the Agency could use third-party audits and what some of the challenges around such a program would be. The pilot answered those questions, and, while the answers were not all that some would have liked, they were encouraging enough for FDA to proceed and include the use of third-party audits as an important part of import controls in FSMA. The final version of FSMA included at least two key sections that will specifically leverage third-party audits: Section 303, giving FDA the authority to require certificates (issued by third-party auditors) for high risk foods, and Section 302, the Voluntary Qualified Importer Program (VQIP). So if FDA is going to use information from third-party audits to address these two sections, who will be considered an appropriate third-party auditing body? The language in FSMA provides quite a list of potential third-party auditors including:

Foreign governments
An agency of a foreign government
Any other third-party, as the Secretary determines appropriate
A single individual
Audit agents employed or used by third-party auditors to help conduct consultative and regulatory audits.

When it comes to foreign governments, FDA must audit the food safety programs, systems, and standards of the government or agency to determine the capability of ensuring that “they meet the requirements of this Act with respect to food manufactured, processed, packed, or held for import into the United States.” When it comes to private entities, FDA must use an accreditation body, which can be FDA itself if the Agency so chooses. However, I think it is both more likely and more sensible if the FDA uses an outside party as the accreditor. Either way the accreditation body needs to perform reviews and audits of the training and qualifications of audit agents and review the internal systems of the auditing body to determine that each entity “has systems and standards in use to ensure that such entity or food meets the requirements of this Act.” Thus FDA is setting a high bar, as it should, because there are certainly organizations waiting in the wings to point out that when the “fox guards the henhouse” the system does not adequately protect the U.S. consumer. Again, this goes back to the systems being both rigorous and trustworthy. Increasing Rigor and Trust of GFSI Systems The importance of rigor and trust is not unique to FSMA-related, third-party audit activities. These attributes are also critical for the success of GFSI and the various schemes under the GFSI umbrella. As we look at the GFSI systems, there are some things that are working well and some things that are not working so well. One attribute of GFSI continues to be its concept of “once audited, accepted everywhere.” While for some, this has meant a reduction in outside audits, it is certainly not the case in all situations. Other attributes are its establishment of a process for robust standards that can adapt to any changes that new FSMA regulations may require, the program’s movement from being retail centric into the manufacturing and ingredient supplier space, and its expansion into a global system. When considering aspects of GFSI that have room for improvement, I see a clear need for more well-trained auditors. I urge GFSI, and all the schemes under GFSI, to embark on the development of third-party-audit training programs through established educational institutions, such as universities. There are many bright, capable individuals who could establish a career in this space. Such a career could be based on a robust education and training program coupled with mentored, hands-on training, and ongoing oversight of audit execution to reinforce both rigor and trust. Recognizing that the life of an auditor is a life on the road, such a career path can evolve from third-party auditor to in-house food-company QA manager and back to third-party auditor. We need to establish a career track in this space that is desirable, fun, and lucrative. Finally, there is a need for proactive public relations activity. Third-party audit systems continue to take media hits with little robust defensive response – this can and should be addressed. The purpose of an audit, and the inherent limitations associated with audits need to be communicated. I mentioned in the opening portion the impact of a new GAO study. This study assessed the capability of FDA to meet the FSMA mandate for third-party audit programs and essentially concluded that the Agency could not meet the mandate. GAO appeared to urge FDA to consider using the USDA/FSIS model of equivalency rather than the more robust system proposed in FSMA. If FDA were to go down that road it would undermine the use of private third-party audit systems in relation to FDA-regulatory activity. Personally I don’t think equivalency is workable for FDA due to the breadth and variability of FDA-regulated foods. FDA is not required to follow GAO’s recommendations, but these recommendations sow a seed of doubt into the system, and part of that doubt creates a vulnerability around private third-party audits. If FDA chooses to make it easier for foreign governments to issue the required certificates for high-risk foods and VQIP, then that will undermine the role that private third-party audits would play As we move into the next four years of the Obama administration, all those involved in third-party audit systems need to recognize that we are at a fork in the road. We have the option of rapid global expansion and broader recognition of such systems by regulators, or the option of a private sector-centric system that is on a slow trajectory to optimization. The choice is ours. I advocate for the former. Let’s drive this hard, and prove that the system can be both rigorous and trustworthy. This will require energy and leadership as well as resources, but the potential losses from not going down that fork far outweigh the costs of the alternate pathway of mediocrity that the regulators cannot trust. As a final word – if you are being audited, use that information to improve your systems, and don’t relax when the auditors leave but build from their input. If you are an auditor, it is essential to recognize the importance of your role and its increasing responsibility, but also to leverage the potential opportunities that are coming. This article originally appeared on Leavitt Partners’ Food Safety blog November 14, 2012.

A Call to Industry: Educate the Media to Educate the Consumer

Dr. David Acheson — Wed, 31 Oct 2012 05:03:51 +0000

Pink Slime vs. lean, finely textured beef. Photos of rats with tumors vs. scientists disputing study methods. Conventionally grown produce vs. local and/or organically grown. Each has been the subject of media “attention.” And as the inaccuracies in the statements reveal, articles on each have too often been published without true understanding, knowledge or representation of the complete facts. This may be due to media jumping on a story in order to break it first, as put forth by FoodQualityNews.com (Flawed GM cancer study highlights flawed media approach), or it may be that reporters simply did not have enough knowledge – or desire – to dig further into complete facts. Or it may simply be a matter of economics: Whether you are a newspaper publisher, a TV executive, a web news provider – or a town crier from days of old, your job is to get people to hear what you say; read what you write simply because that keeps the revenue stream flowing. If that means putting out a bit of hype now and again, well so be it. It’s always been done that way, and I don’t see any major change coming around the bend. So, what does this mean to you? Plenty. The Impact of the Media First is the impact of the media – with media having a much wider definition than it did even just a few years ago, as illustrated by the well-known story – and results – of the “pink slime” debacle. Although she was not the originator of the term, it was a mother’s blog posting of a petition to stop the use of “pink slime” in schools (with an incorrect photo) that led to viral publication by both mainstream and social mediathat led to the eventual closing of the majority of BPI plants. A controversy that may be a bit less well-known, but is bound to resonate in the GMO industry for a long time, is the recent publication of the French study “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” published in Food and Chemical Toxicology – but now declaimed as flawed. According to the highlights listed in the article: “Female mortality was 2–3 times increased mostly due to large mammary tumors and disabled pituitary. Males had liver congestions, necrosis, severe kidney nephropathies and large palpable tumors.” Although a Google search now brings up more articles refuting the study than accepting it, the initial headlines focused on the study’s “findings” that the genetically modified corn caused tumors in rats—and there were plenty of photos to “prove” it. This case was somewhat extreme in that there was little opportunity for an opposing viewpoint in the initial publication, because a media outlet wanting to receive the pre-embargo copy of the study (enabling quick publication when the embargo was lifted), had to agree to not to speak with any independent experts during the embargo. To add to this, not only were the study’s sample sizes exceptionally small and the rats used in the experiment predisposed to tumors, but the scientists would not release data on the methodologies used—a standard in scientific research. However, few of the initial articles focused on any of these shortcomings. Since that first publication, numerous articles disputing the study have come out, including Monsanto’s response, stating in part: “This study does not meet minimum acceptable standards for this type of scientific research, the findings are not supported by the data presented, and the conclusions are not relevant for the purpose of safety assessment. … There is no plausible mechanism for the results reported with genetically modified maize, and the results are inconsistent with an extensive body of experience and scientific study.” But … How many consumers saw the first front-page articles, then never read the less sensational questioning of the study? And … How many GMO opponents are using statements from the study in their promotion? Many did so immediately, and the study is likely to continue to be cited even once the furor over its authenticity or flaws dies down. These brief examples raise two important issues. The first is our need to educate the media and the second is to have a plan ready as part of crisis preparation to address inappropriate messages around your products or your brand. Our Need to Educate The food industry has a need and responsibility to take a hand in proactively educating the media in order to educate the consumer. As noted by the viral nature of the mother’s “pink slime” blog (and resulting 258,874 petition signers), the challenge of our world today is the fact that it is a great deal more difficult to define media than it was in the past when one knew the town crier by name, had one local newspaper, or three TV stations. Today, we not only have innumerable cable and satellite TV stations, we have uncountable online websites, news pages and blogs that are written by degreed scientists to agenda-driven espousers – and everyone in between. And all are doing whatever they can to get the public’s eye. Which means we have no control. Or do we? It is not an easy task to draw attention to reason in place of sensationalism, but we can fight back. In fact, BPI is doing just that with its lawsuit against ABC News. Irrespective of the outcome of this lawsuit it has brought public attention to the other side of the story, and shown that it is not going to accept the media’s right to publish without potential consequence. And, at least in this case, its publication of reason has gotten attention: a Google search on BPI ABC brought up almost 6.5 million hits, with at least the first 20 pages being articles on the lawsuit. While some may argue that such a response simply brings the original negative back to consumers’ minds, given the BPI plants that were closed and jobs that were lost; given the persistent anti-GMO marketing efforts; and given, even, the public’s lack of understanding of the nutrition of organic vs. conventionally grown or the food safety of local vs. large-scale farming – Can industry afford to not fight back? Or, more pragmatically, can we afford to not take the proactive approach and supplant misinformation before it takes hold? My personal experience with the media is that many in the media strive for an accurate and appropriate story. This cadre of solid food reporters should be encouraged and helped to achieve their goal of appropriate reporting. To this end, the industry could more actively reach out to these key players and help them understand aspects of the food industry when things are going well and before we are all in crisis mode. When it comes to being prepared as an organization, this is part of good crisis management planning. Be ready with your talking points and experts for when the need arises. Track social media constantly and consider using a team of “Mommy Bloggers” who will be honest in their opinion but are familiar with your products, your philosophy and your goals of constantly producing safe foods. Today we have to be more vigilant and more aware of media than ever. The power of the media to destroy a brand should never be underestimated, and it is time to recognize this. So establish allegiances, ensure your programs are robust, and manage the media before they manage you. This post originally appeared October 18, 2012 on the Leavitt Partners’ Food Safety blog.

FSMA Delay Spurs Curious Partnerships and Regulation Pleas

Dr. David Acheson — Tue, 11 Sep 2012 08:59:02 +0000

In an industry traditionally anxious to be self policing and oppose regulation, the tide has turned. The first evidence of this was in 2006 after the large E. coli O157:H7 outbreak linked to spinach, when the produce industry was seriously requesting that the U.S. Food and Drug Administration develop regulations around fresh produce. Since then, we have seen repeated outbreaks and recalls in which whole commodities have suffered (such as peanuts, pistachios, tomatoes, cantaloupes and now mangoes). Many of these post-2006 situations drove the desire to update the food safety regulations and, thus, had an impact on both the content of the 2011 Food Safety Modernization Act and the desire by the food industry to make the new regulations a reality. As the delays with FSMA-proposed rules have continued through 2012 and now move into the ninth month, we have continued to see pressure from the industry in conjunction with consumer groups literally begging for regulation. In the most recent action, a joint lawsuit was filed against the FDA last week by the Center for Food Safety (CFS) and the Center for Environmental Health. The suit is “an action for declaratory and injunctive relief regarding the failure by [FDA] to promulgate final regulations by mandatory deadlines contained in the FDA Food Safety and Modernization Act (FSMA).” Stating that “FDA has missed not one, not two, but seven critical deadlines, and counting,” the suit affirms that regulations have been submitted to the Office of Management and Budget (OMB) where they are awaiting approval. However, it adds, “FDA has authority to promulgate the regulations without OMB approval” and seeks “to require FDA to immediately promulgate the FSMA regulations … and enforce self-executing sections of FSMA even without finalized regulations.” While the Centers may be the first to bring a case against FDA for FSMA delay, they are far from the first to call for action. The joint lawsuit is, in fact, simply the latest in what the Washington Post called a “united front by this unusual alliance” – that is, consumer advocates joining with industry groups. In May, the Grocery Manufacturers Association and Pew Health Group co-wrote a letter to FDA regarding the delay, and since that time letters have descended on Washington from a variety of camps, such as that from the Peanut and Tree Nut Processors Association and the Snack Food Association among others. Is it a Failing of the Current Administration? In the CFS statement on the lawsuit, Executive Director Andrew Kimbrell said, “If the Obama Administration has lost the political will to make FSMA a reality, we’re here to help them find it.” The Washington Post article notes the hold-up as especially puzzling due to the president’s previous enthusiastic endorsement of the legislation. And with OMB reporting directly to the president, current endorsement – or command – directly from the boss would certainly have an impact on the prioritization of FSMA review and approval. Or Would a Romney Administration Be Any Different? However, we can only conjecture whether there would be a difference if a Romney administration were to take over after the November election. With no mention of food safety made at the Republican National Convention, there is little indication that there would be much more attention paid to FSMA. But without movement being made on the current front, perhaps a change of administration would speed things up? … or slow it down? We will speculate more on this in a future newsletter. It would certainly be progress were we to see any focus by either victor once the over-arching focus on campaigning is in the past. A Time-Consuming Process While the industry can’t be faulted for taking action to get the rules implemented, response to the current lawsuit (along with the ongoing FDA time needed to respond to the letters) is one more thing that will burn FDA’s already extremely limited resources. And consumer group assertion that on-time passage would have prevented any of the recent recalls and outbreaks is simply wishful thinking. Getting the rules out is merely the first step in a very long road. As detailed in a previous newsletter section “FDA’s Rulemaking Process,” FDA must first publish a notice of the proposed rule or an interim final rule, then allow a period for public comment – generally 30 to 120 days. FDA must then consider any revisions based on comments prior to publishing the final rule, then there is typically up to one year allowed for implementation for large businesses and often three years for small businesses. From our experience, the food industry is falling into three general camps: The most forward-leaning companies are already moving forward with FSMA preventive control preparation. This is partly because these companies want to be ahead and partly because much of FSMA preventive control requirements make a lot of sense for protecting a company’s brand. The second group is the “wait and see” group – those who simply don’t want to take FSMA seriously until they have to; and the third group are those who simply have not seen FSMA coming and happily have their heads in the sand – for now. Obviously having the proposed rules out will be helpful, but, as noted above and frequently in past (Leavitt Partner’s Food Safety) newsletters, prevention is an area that industry can and should be implementing regardless of such regulation. Finally, all the recent noise pushing for the FSMA rules to be published will likely have zero impact on either OMB or FDA. It will waste resources and creates a false impression that proposed rules published today will prevent outbreaks next week. This process takes time, and I have every reason to believe that the FSMA rules will be published under either the current or a future administration – so sit tight and focus on building good preventive controls. Because while being in compliance is important to business continuity, robust preventive controls are important to business survival. David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was originally posted September 6, 2012 on the Leavitt Partners Food Safety blog.

Should the Microbiological Data Program Be Saved?

Dr. David Acheson — Fri, 27 Jul 2012 01:59:02 +0000

After nearly being chopped from existence, the USDA’s Microbiological Data Program (MDP) has been saved for the remainder of 2012. However its future existence is questionable. MDP is a national foodborne pathogen monitoring program implemented in 2001. Through cooperation with State agriculture departments and other federal agencies, MDP manages the collection, analysis, data entry and reporting of foodborne pathogens on selected agricultural commodities at the retail level. At issue for MDP are its operation and funding. That is, although it is housed by the USDA, many, including USDA Secretary Tom Vilsack and the United Fresh Produce Association (UFPA), are publicly stating that it should be operated by the FDA. However, just as USDA does not have the $4 million funding for the program, neither does FDA–nor has FDA requested responsibility for it or have the resources to take on its operation, particularly as the Agency continues to work to roll out FSMA (if OMB would ever move the provisions off its desk). As explained in an article in The Produce News last week, “The Obama administration did not request funding for MDP…. Neither the House nor the Senate bills include funding, but the measures have yet to gain final approval.” MDP was designed to provide monitoring data on pathogenic E. coli (STEC), E. coli 0157:H7, Listeria monocytogenes, and Salmonella spp in selected fruits and vegetables at retail. It collects samples from 11 participating states, representing about 50 percent of the nation’s population and all regions of the country. Collaborating with CDC, MDP communicates immediately any pathogens isolated from MDP samples. The MDP program is one of those federal programs that has a tendency to polarize opinions. In short, the industry hates it and consumer organizations love it. So why the polarity and what is a reasonable middle ground? The first problem with the program is that oftentimes by the time a positive is found, the product is not only in the market place but likely consumed or close to its expiration date – so there is little to no direct public health protection following detection of a positive sample. Second, the tracking/supplier data around that produce is often not robust, so it can be a major challenge to determine which lot numbers to recall or which farms/processors are implicated. Thus recalls get broad and FDA has little data to go on to explore the original source of the problem. So is there a good side to this program? It is currently the only program that provides a glimpse of the prevalence of key microbial agents in high-risk fresh produce, so from that perspective, it provides good information. If the sampling were done at the correct place in the supply chain with the correct data by the correct Agency with appropriate funding, it could be both a public health win and tolerable for the produce industry. So what does this Utopian MDP program look like that will allow it to continue to provide useful information? How about something like the following: – Hold product while MDP conducts tests to eliminate consumer exposure to any positive samples. – Ensure that when a sample is taken, the product tracking information is complete to allow FDA to narrow down the source quickly. – Put the program under the Agency that has responsibility for produce – FDA. – Fund the program so that it can operate quickly and efficiently. While FDA is not eager to take on the program, it has acknowledged its value to the Reportable Food Registry (RFR). The FDA released its second annual report on the RFR in April (covering the September 2010-September 2011 reporting period). As reported in an April 23 article in The Packer, the FDA said part of the reason that there was an increase in produce primary reports was because of alerts from the MDP. According to the FDA report, “While this information is intended to determine the effectiveness of procedures to reduce or eliminate harmful microorganisms, the results of MDP tests are shared with RFR responsible parties who may be required to submit the information to the (registry).” While supporting a testing program by FDA that is “scientifically accurate and effective in monitoring and protecting public health,” UFPA has, however, also urged the elimination of the MDP. According to an AP report, it wants the private sector to do more of its own testing, saying that MDP has cost growers millions in produce recalls and unfairly targeted farmers who aren’t responsible for contaminating the food, since testing at the retail level means that contamination could have occurred at any prior point in distribution. Like many federal programs, if the MDP program was redesigned with input from the food industry, in this case the produce sector, it could be a lot more effective, less costly to the industry and provide better data. But maybe I am being too logical! —– Note: This has article has been corrected. The article originally stated that MDP samples at the retail level when in fact the program pulls samples at produce distribution centers.There are a few exceptions: MDP allows states to collect at retail level when the product is not available at the distribution level and it is bagged or in a sealed container. David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was originally posted July 26, 2012 on the Leavitt Partners Food Safety blog.

FSMA Related Import Programs Taking Shape

Dr. David Acheson — Wed, 20 Jun 2012 01:59:02 +0000

Everyone with even a cursory interest in FSMA continues to ask, “So when are the four key proposed rules (Produce Safety Standards, Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Program) going to be published?” I have to confess right up front that I don’t have any better idea of the right answer to that question than you do. However, despite the lack of clarity on release dates, there have been a couple of instances recently when representatives from FDA have talked about the imported programs. Thus we felt it would be helpful to share what we have heard. Our belief is that a combination of the economic impacts and the potential impact on international trade are at least two of the main issues that have needed further attention, resulting in the publication delays. Once the rules are formally published, which several of our government contacts are continuing to indicate should happen soon, FDA will schedule public hearings in Washington D.C.; Chicago, Ill.;Oakland,Calif.; and overseas at locations yet to be named. The public hearings will be held approximately 30 days after the rules post to the Federal Register. One key question is what will happen on July 3rd when the preventive control rules are due to go into effect? At least in theory, registered firms will have to be compliant with new rules that are not yet final (or possibly even released by that date). The answer from FDA is “enforcement discretion.” While this term is a bit non-specific, I believe it will mean that FDA will continue business as usual and focus on the areas that they currently have rules around, such as seafood, juice, LACF, etc. But this looming date clearly makes everyone just a little nervous. Turning now to the import provisions, as previously reported, FSMA’s Foreign Supplier Verification Program (FSVP) and Voluntary Qualified Importer Program (VQIP) are two provisions of key interest to non-U.S. suppliers and importers. For one thing, the definition of “importer” differs between the FSVP, for which importer is defined as the owner or consignee at the time of entry, and the VQIP, for which it is listed as the person who causes the importation of the product. Moving forward with FSMA, FDA expects that an importer will be defined ultimately is the importer of record whether within theU.S. or overseas. While VQIP, by its very name, is a voluntary program, an importer’s participation will have a positive impact on their FDA’s PREDICT score. This risk-based screening system for imports is a composite of several factors, including a broker’s rating. A better score means facilitated entry into the United States and thus there is likely to be a significant incentive to become part of the VQIP. Criteria for participation FDA is currently working with U.S. Customs to ensure a harmonized approach to entry. Based on what we have heard recently, our understanding is that, in order to participate in VQIP, an importer must: – Be validated as Tier II of Custom’s CTPAT program. FDA understands that this may exclude some commodities, thus how VQIP will ultimately be related to CTPAT is not yet known. use paperless filers/brokers and import documents through ITACS. – Be in compliance with all provisions of the FSVP – yet to be released. If a product is on import alert, an importer will not be eligible to have shipments of those products participate in VQIP, however, the importer may apply to participate for other foods. (Seafood will be exempt from preventive control requirements since HACCP is already mandatory for the industry. However, there may be other elements of the FSVP that the seafood industry and importer may need to implement such as record keeping requirements). – Be an importer of record with an importer ID and have one year’s worth of history on file with FDA (e.g., an established importer). – Be in good standing with the federal agencies in the U.S.and not subject to an FDA action. In addition, the supplier of the product must be certified by a third-party auditor who is accredited by FDA. This program, however, has not yet been established; it is estimated that details will be released 2-3 weeks after the information on FSVP is released. The Process and Benefits To apply for the program, importers will need to submit a letter of intent to apply, after which the first formal step in VQIP participation is an application process. (We have no insight yet on exactly what that process will look like). The second step is verification. FDA needs to verify that the information contained in the application is true and that the stated processes are being followed. Although these are still being finalized, there are benefits to application and verification in this voluntary program. At the applicant level, there would be a reduction in inspection so that the likelihood of products being stopped is decreased. If a product is stopped for inspection and testing, those who have applied for VQIP will receive expedited processing and laboratory analysis. Upon FDA’s verification that the processes described in the application are being implemented, the importer is accepted into the program. At that point, shipments would seldom be stopped, sampling would generally be collected only for cause, and processing and lab analysis would be expedited. At both levels, the applicant would receive adjusted risk scores. Although criteria for revocation or suspension of VQIP status is also not yet finalized, areas under consideration appear to be situations in which the applicant is no longer compliant with any of the criteria for application (above), applicable fees are not paid within 60 days, or any application, or entry information is found to be falsified. Fees FDA is authorized to collect user fees to cover the cost for FDA to build and administer the program. The fees have not yet been determined, nor has the “start” time for the fees (e.g., when you submit a letter of intent, after the application is submitted, etc.). It is likely that there will be both an application fee and then an annual fee thereafter, but we have not seen anything specific in this regard. Whether fees will be based on the number of products being imported is also still not known. In addition, if an applicant is refused participation in the VQIP, the user fee is not likely to be refunded. Timing Even once the rules are published, there are several things that need to happen before the VQIP can be fully implemented. First, there will be some time allotted for firms to meet the requirements of the FSVP. (FSMA states an effective date of January 2013 which does not seem realistic at this point.) Next, there will be a few weeks before details will be published on the third-party certification program for the auditing of overseas suppliers. Again, it will take some time for the program to become operational. Then, user fees must be established and published six months prior to collection. With all these factors, FDA predicted that VQIP could become operational in October 2014 (The FSMA due date was July 2012.) Of course, with so many unknowns, it is impossible to say with certainty when the program will launch. Overall the VQIP is shaping up to be a very important program for anyone who is importing finished products or ingredients, or is relying on such products for their business. Many details are missing but we are now seeing the general shape of this program and all indicants suggest it is a program to watch and be part of, because it will allow FDA regulated food products to move across the border much faster than for those not part of VQIP. FDA Budget Update While FDA continues to attempt to move forward with FSMA implementation, it is looking as though it may receive no additional funding for the coming year. Under the 2013 House Agriculture Appropriations bill, the FDA would receive a budget cut of $16.3 million. This comes after an April Senate bill that, as we reported then, would give FDA a $22 million increase, with $12.5 million specifically appropriated for FSMA implementation. The final appropriation will need to be passed by the full House and Senate. So FSMA continues to be an unfunded mandate for FDA and there is no sign this is going to change any time soon. ——————– David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was originally posted June 7, 2012 on the Leavitt Partners Food Safety blog.

Today: Walmart, Kroger, Primus. Tomorrow: You?

Dr. David Acheson — Sun, 10 Jun 2012 01:59:02 +0000

Last week, Jensen Farms, the grower of the cantaloupe implicated in the Listeria outbreak of 2011, filed for bankruptcy. Prominently listed in the filing were lawsuits associated with the outbreak, from which 146 people were sickened and 36 died. According to the Denver Post, Jensen’s attorney said the filing should free up millions of dollars in insurance and other funds.

Foodborne illness attorney Bill Marler has filed at least 11 lawsuits and is representing almost 40 families or persons said to have been sickened or killed because of the contaminated cantaloupe. According to an article in Marler-published Food Safety News, the bankruptcy filing means that his clients

“can move on to file lawsuits against companies further down the supply chain: Frontera Produce, the cantaloupe distributor; retailers such as Walmart and Kroger; and Primus Labs, the third-party auditor whose subcontractor, Bio-Food Safety, gave Jensen Farms facilities a ‘superior’ inspection rating just six days before the outbreak began.”

“Bankruptcy of Jensen Farms was a necessary prerequisite to allowing families of those who died and those who were injured to seek compensation against Frontera, Primus, suppliers and retailers,” Marler said.

If Mr. Marler is successful in bringing and winning these cases, it is telling us that someone as distant from the farm as the retailer is highly vulnerable to being sued if a farmer’s product makes someone sick and that farm then declares bankruptcy. If you sell adulterated food – or have some role in handling, distributing, or maybe even transporting anywhere along the food chain of that adulterated food, you would be liable to some extent – regardless of the cause or origination of the contamination.

What does this mean to you and the industry?

We are back to that old issue of controlling risk in the supply chain. It is becoming increasingly important that you spend time assessing and addressing risk across your product line supply chains. As we’ve seen in recent outbreaks, it is not enough to focus on historical incidents – cantaloupe was not known to carry Listeria; raw egg has long been a factor in Salmonella outbreaks, but it was likely the cookie dough flour that caused that 2011E.coli O157:H7 outbreak.

Risk assessment is not only critical for consumer and brand protection, it is a key aspect of the preventive provisions of FSMA. In fact, the pending rule, Hazard Analysis and Risk-Based Preventive Controls (Section 103) focuses directly on this area. As we stated in a previous newsletter, preventive controls should be tied to preventing foodborne illness, not just decreasing product contamination.

The vulnerability of not knowing and validating your entire supply chain is becoming more evident. One forward, one back may still be law for product tracking, but back to the farm is fast becoming the legal definition of responsibility. And without continuing the barrage against third-party auditors too heavily, it is a responsibility that processors and retailers are becoming leery of outsourcing, especially for high-risk products. And should these companies decide to conduct all their own supplier assessments and audits because they no longer trust outsourced audits, it could force food-industry consolidation and will fly in the face of robust programs like GFSI. I would like to bet that a Kroger or a Walmart would rather conduct 50 audits of large farms than be forced to audit 500 small farms. It is a potential that does not bode well for small suppliers, and could literally cut them out of the loop for many retailers.

In addition, whether or not such potential would come to fruition, supply chain management is specifically listed as an area for which risk-based preventive controls are required by the Food Safety Modernization Act (FSMA). As noted in a previous newsletter on FSMA key provisions, as part of its food safety plan, a facility may be required to document sanitation procedures, a recall plan, a food allergen control program, supplier verification activities, and environmental sampling testing.

In a late 2011 speech, FDA Deputy Commissioner for Foods Michael R. Taylor discussed the need for partnerships across the food sector. While his primary message was focused on the globalized food supply chain, the message is just as applicable to management of your entire supply chain: No matter where we call home, what language we speak, or culture or economy we follow, we are connected through the global marketplace, and that, as well as the implementation of the U.S. Food Safety Modernization Act, make it more critical than ever before that everyone–foreign and domestic–work together as partners in food safety.

The tough reality today is that if you aren’t partnering with, assessing, and validating every supplier all the way back to the farm; if you aren’t assessing and addressing risk of all the ingredients and products your purchase, process, or sell – instead of the companies being named in today’s headlines, tomorrow’s name on the foodborne-illness lawsuit could be yours. This situation creates massive economic pressures on a system that is built on low margins and thus will be a force toward vertical integration and consolidation which is exactly what someU.S.consumers are pushing hard against. Somewhere in this mix there is a balance, but as with Mr. Marler’s cases noted above, not without a lot of pain along the way.

—————-
David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was originally posted June 7, 2012 in the Leavitt Partners blog, Food Safety.

Facility Profiling: A Benefit or Putting Food Makers in the Cross Hairs?

Dr. David Acheson — Tue, 29 May 2012 01:59:07 +0000

FDA would like food/feed facilities to voluntarily submit additional profile information through the Food Facility Registration Module – and wants to know what you think.

In a Federal Register Notice, FDA announced the opportunity for public comment on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and new electronic form (FDA 3797).

The voluntary profile information is intended to help FDA determine whether a firm is high-risk or non-high-risk, and, from that, determine the frequency at which the firm would be inspected. Additionally, FDA noted that submission would benefit a food facility by enabling FDA to prepare for an inspection in advance “through interaction with better-informed investigators and potentially reduced inspection time.”

Firms will be offered the opportunity to complete or update a food/feed facility profile after electronic registration with FDA and anytime they access the Food Facility Registration Module. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States may also submit or update information at any time through a direct URL (to be provided by FDA).

The proposed information, to be submitted in English only, includes:

• the facility type (e.g., manufacturer/processor, repacker/ packer, or warehouse/holding facility);

• the products and hazards (e.g., biological, physical, chemical) and preventive control measures associated with those products, where either there is a regulation in place requiring identification of hazards and preventive control measures (e.g., seafood and juice), or the firm, as a matter of its own business practices, voluntarily identifies hazards and implements preventive control measures;

• other facility information (such as food safety training, facility size, operational schedule, and number of employees).

Assuming that approximately half the registering firms will choose to provide profile information, FDA estimates annual submission of 6,780 domestic and 11,685 foreign firms. Information submission is estimated to take about 15 minutes by an average domestic facility and 45 minutes by a foreign facility (taking into account a potential lack of fluency in English.)

In 2011, the Food Safety Modernization Act (Section 102) added to the mandated food facility information, requiring that registrations contain the facility/U.S. agent contact e-mail address and an assurance that FDA would be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

FSMA also added a renewal clause, requiring that all facilities renew their registrations between Oct. 1 and Dec. 31 of each even-numbered year, beginning this year. With comments on the voluntary profile submission proposal due by July 10, its timing is undoubtedly due to this upcoming renewal period.

While the request and voluntary aspect of the proposal seems fairly straight forward, it does bring to mind a few questions, specifically that since the form is voluntary, how will the information be evaluated? Will it move a facility that supplies information to a better spot – ostensibly penalizing those who do not fill it out? Or might a facility put itself in the cross hairs based on its responses?

Will the input data be electronically analyzed or will a person review it? Because the forms include the naming of hazards and preventive controls, it seems that it must be subject to some sort of human evaluation – which raises a few more questions in and of itself, including the availability of resources to do so.

And, while FDA states that it expects only half of those registering to complete the profile information, does it actually see the voluntary aspect as a precursor or trial to mandated submission of profile information?

Comment can be submitted electronically or by mail (Division of Dockets Management/HFA-305, Food and Drug Administration,5630 Fishers Lane, Rm. 1061, Rockville,MD 20852). All comments should be identified with the docket number FDA-2012-N-0430. Comment is due by July 10, 2012.

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David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was riginally posted May 24, 2012 in the Leavitt Partners blog, Food Safety.

Regulatory Leapfrog is Underway

Dr. David Acheson — Mon, 14 May 2012 01:59:07 +0000

USDA’s Food Safety and Inspection Service (FSIS) has announced a series of prevention-based food safety policy measures, including a final rule designed to make FSIS aware of adulterated or misbranded food in the supply chain that is similar to FDA’s Reportable Food Registry; a proposed rule for earlier, more expansive traceback for E. coli; and a draft guidance on validating HACCP systems.

FSIS published an advance copy of the Final Rule entitled “Requirements for Official Establishments to Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall Procedures, and Document Certain Hazard Analysis and Critical Control Points System Plan Reassessments.” The rule implements three provisions included in the 2008 Farm Bill and requires establishments to:

– notify FSIS within 24 hours that a meat or poultry product that could be subject to Class I, II or III recall has been shipped into commerce.

– prepare and maintain written recall procedures.

– document each reassessment of their HACCP plan.

The notification requirements show some similarity to FDA’s Reportable Food Registry (RFR), however they clearly go much further in terms of what needs to be reported to FSIS. Also FSIS chose to implement a completely different system with facilities directed to notify, that is – make a phone call to – the appropriate District Office within 24 hours of “learning or determining that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has happened.” As with many rules the precise interpretation of “reason to believe” is significant. Would this mean that a presumptive positive is a reason to believe?

In contrast, the RFR (discussed in a previous newsletter) requires FDA-regulated food facilities to report when there is “reasonable probability” that an article of food will cause serious adverse health consequences – a Class I situation. Additionally, the report is to be submitted through the electronic RFR portal as soon as practicable, but in no case later than 24 hours after determining that an article of food is a reportable food.

Although FSIS received comment suggestions to follow the standard established by RFR, or to incorporate a de minimis standard (that is, the determining of a risk level that is too small to be concerned with). FSIS chose to maintain its standard of reporting of any adulteration or misbranding stating, “If the Agency adopted the RFR standard or a similar de minimis standard, establishments may not be required to notify FSIS about product that could trigger a Class II or Class III recall.” While this is certainly true it is most assuredly “leaping” over the current FDA RFR requirements in terms of regulatory stringency.

As such, the rule assesses the public health concern or hazard presented by a product then classifies the concern as:

Class I – a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death;

Class II – a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product; or

Class III – a situation where the use of the product will not cause adverse health consequences.

A further point to note is that the recall class definitions between FSIS and FDA are different, and this new rule will require the reporting of situations in which “the use of the product will not cause adverse health consequences.”

Additionally, FSIS noted that because the notification requirement is a preventive measure that will allow FSIS to determine more quickly whether a recall action is necessary (including detention and seizure of product by FSIS), the rule requires establishments to report all product that is believed to be adulterated or misbranded.

While the rule is similar to the RFR in that establishments are to report within 24 hours, USDA’s original proposed rule (published March 2010) gave establishments 48 hours to report, however after receiving comments that that may be too long, the Agency concluded “because notification can be made with a phone call, 24 hours is an appropriate time in which to expect official establishments that have shipped or received, or have reason to believe that they have shipped or received, adulterated or misbranded product, to notify the appropriate District Office of that situation.”

Additional provisions of the rule are that:

USDA establishments must provide all available information about the “destination” of adulterated or misbranded product. This rule does not create a duty to seek out new information; however, if establishments have additional information about the destination of adulterated or misbranded product beyond their direct consignees, they must provide it to the Agency.

Establishments are not required to submit their recall procedures to FSIS. They must, however, make the written recall procedures available for copying.

Existing large establishments will have six months from the date of publication of this final rule to implement it and prepare recall plans. Small and very small establishments will have one year.

The Agency is amending 9 CFR part 304.3 and 9 CFR part 381.22 to require that before being granted federal inspection, an establishment must have developed written recall procedures as required by part 418 of Title 9, Chapter III chapter.

Agreeing with comments that the documenting of HACCP reassessments is beneficial, FSIS is requiring that establishments document each reassessment of the HACCP plan and the reasons for any changes or for not changing. For annual reassessments, however, if no changes are deemed necessary, documentation is not needed.

While both USDA and FDA are focusing efforts and regulations on prevention, more coordination between the two could make life easier for those who must report to both. The addition of FSIS’ new notification requirement, which has no alignment with FDA’s RFR has, once again, created duplication of obligation for those who process or manufacturer products that include both FDA- and USDA-regulated ingredients. And with different reporting standards between the two, it seems to be moving the industry backward in documentation rather than forward.

E. coli and HACCP

The other two areas in which USDA also issued new policy are:

Earlier, more expansive traceback. FSIS is proposing a new procedure to be implemented when federal or state sampling finds raw beef presumptive positive for Escherichia coli (E. coli) O157:H7. The proposed procedure means that FSIS will no longer wait for a confirmed positive; rather when presumptivepositive test results in its routine sampling indicate E. coli O157:H7 contamination, it will move quickly to identify the supplier of the product and any processors who received contaminated product from the supplier, once confirmation is re
ceived. It is expected that this change will reduce response time by 24 to 48 hours.As a commentary on this policy, it is interesting given the June start date for testing of six other serotypes of Shiga Toxin Producing E. coli (STEC) this policy change only appears to impact O157:H7 which appears to be a bit of a disconnect between FSIS policies.

Draft Guidance for HACCP Validation: The guidance defines the steps that are necessary to validate one’s HACCP systems, that is, to establish that the HACCP systems will work as designed to control the food safety hazards that they confront. The draft guidance document is available for comment.Historically, FSIS moved ahead of FDA in terms of preventive control requirements in the mid 90′s with the meat and poultry HACCP requirements. The signing of FSMA in 2011 moved FDA back out in front in terms of preventive control requirements, but we are now seeing FSIS snatch back the lead in certain key areas, namely what food companies are required to report in terms of adulterated or misbranded product, as well as early reaction to presumptive-positive testing results. While the food industry clearly understand the need to prevent problems, not just react to them, it would make life a whole lot less confusing if FDA and FSIS were consistent in their approaches – even allowing for statutory differences.

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David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This article was first published May 11, 2012 on the Leavitt Partners Food Safety blog

Recalls and Warning Letters Still High in 2011

Dr. David Acheson — Mon, 26 Mar 2012 01:59:02 +0000

As many will remember 2009 and 2010 showed a fairly dramatic increase in recalls compared with the two years prior to that. Of note 2009/10 was marked by a few very large recalls due to Salmonella contaminated peanut products and Salmonella in hydrolysed vegetable protein.

Now that the data are in for 2011 we have compared the trends in 2011 with that of the previous year (Figure 1). This is particularly relevant given that FDA has recently released their current thinking on how to categorize a domestic facility as “high risk.” Class I recalls are a prime data source that informs the “known safety risks of the food”, which is a key factor in determing whether a facility is considered “high risk” or not which drives the frequency of inspection.

The first thing to note with regard to 2011 recalls is that the total number were about the same as in 2010 (Figure 1) so the trend of increased recalls since 2009 has been maintained into 2011. What is different however between 2010 and 2011 are the agents that triggered recalls.

The single biggest factor leading to a recall in 2010 was Salmonella, accounting for 43 percent of the recalls, with allergens coming in second with 31 percent and Listeria third with 12 percent. In contrast, in 2011 there were about half as many recalls due to Salmonella (21 percent) but more recalls due to allergens (43 percent) and a slight increase in recalls due to Listeria (18 percent). Yet overall these three groups still accounted for the vast majority of recalls, accounting for 86 percent of the recalls in 2010 and 82 percent of the recalls in 2011.

Some would look at the high level of recalls and question if it means that food safety systems are failing? My view is that recalls actually indicate that important parts of the system are working. Recalls are never good but on the other hand illness linked to product that is not recalled is even worse. As programs like the Reportable Food Registry continue to gain traction we are likely to continue to see high numbers of recalls. Similarily as epidemiologists continue to get better at linking food with illness that too will drive recalls. Finally, as the data above indicate, controlling Salmonella, Listeria and allergens are critical parts of avoiding recalls. While some situations leading to recalls are clearly processing failures we are seeing more and more instances where the problem has not be a processing failure but a failure to control the environment, once again emphasizing the importance of environmental sanitation and monitoring.

Like recalls the trend in recent years has been for FDA to issue more warning letters and as can be seen from Figure 2 this trend has continued to rise into 2011. The FDA uses a Warning Letter when it “finds that a manufacturer has significantly violated FDA regulations” as a way to inform the recipient. There is a request from the FDA for the company to plan corrective actions that the FDA will monitor to ensure the problem is resolved. Many times Warning Letters are the result of findings from an FDA inspection.

Compared to 2010, there was a 52 percent increase in food related warning letters in 2011. There was a 155 percent increase in Warning Letters overall (including food and all other FDA regulated products) from the FDA in 2011 from the prior year. As FDA increases their inspections of high-risk facilities, and as the expectations with respect to food safety increase, we can expect that FDA will continue to use warning letters to send “strong messages” to regulated firms.

If one looks at which types of industry are getting the most warning letters it clearly falls on the seafood industry who get the most, with that sector receiving about one third of the warning letters in 2011. Seafood HACCP Warning Letters were the most frequently issued by FDA, with almost twice as many issued in 2011 compared with 2010. Concerns around Current Good Manufacturing Process (CGMP) for manufacturing, packing, or holding human food resulted in the second most commonly used warning letter by the FDA, making up about a quarter of the total food related warnings. Illegal drug residues was another major focus for warning letters.

Warning letters are activley publicized by FDA and will continue to be used as an enforcement tool. As FDA starts to focus on risk based inspection strategies, and the collecting of reinspection fees, food companies are going to want to do all in their power to avoid warning letters as well as 483s, which will likely herald closer FDA scrutiny as well as potential financial consequences. Paying close attention to preventive control systems is the best way to meet this goal.

This information and more can be found at the links below:

FDA.gov – Warning Letters

FDA.gov – Safety Recalls

FDA enforcement statistic summary

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David Acheson, MD, is a former U.S. Food and Drug Administration Associate Commissioner for Foods and is now Managing Director for Foods and Import Safety at the Leavitt Partners consulting firm. “Recalls and Warning Letters Still High in 2011” was originally posted March 23, 2012 on the Leavitt Partners bog. Reposted with permission.

Serious Questions About Third-Party Audits

Dr. David Acheson — Wed, 25 Jan 2012 01:59:01 +0000

On Jan. 10, 2012, a Congressional House report was issued on the government’s investigation into the cantaloupe Listeria outbreak. The report provided some very interesting findings and lessons not only for and about Jensen Farms but for and about the industry as a whole.

Conducted by the Congressional Committee on Energy and Commerce, the investigation included a review of documents from and interviews with FDA; Jensen Farms; its distributor, Frontera Produce; and its third-party auditor, Primus Labs. And it was the information obtained from and about the audits that was highlighted as of most significant issue – and concern – in the report. The report was accompanied by a Letter from the Committee to FDA Commissioner Margaret Hamburg that further emphasized concern around the use of third-party auditors. The letter to Commissioner Hamburg stated:

“We urge you to review closely the information uncovered during our investigation. In particular, the investigation identified significant problems with the third-party inspection system used by growers and distributors … FDA officials identified “serious design flaws” in the processing technique used at Jensen Farms and “poor sanitary design of the facility itself” as the causes of the contamination, and they indicated that “everything that was found wrong was addressed in FDA guidance” published in 2009. Yet these flawed facility designs and processing techniques were both recommended by and rated as “superior” by the third-party auditor of Jensen Farms.

This finding revealed two major industry problem areas:

1. Failures in the industry’s auditing system

As the letter states “The auditing failed in the case of the recent Listeria outbreak.” These failures are itemized as the auditors:

– missing or failing to prioritize important food safety deficiencies

– lacking any regulatory authority and not reporting identified problems to any regulatory authority

– not ensuring that identified problems were resolved

– providing advance notice of site visits

– spending only a short period of time on-site

– multiple conflicts of interest

In defense, Jerry Walzel, the president of Bio Food Safety, Inc., the subcontractor hired by Primus Labs to conduct the Jensen Farms audit, stated that consistent with Primus Labs policy – the audits only deducted from the score if a method or technique was inconsistent with FDA regulations; they did not deduct from the score if FDA guidance was not being followed – which brings up the second major issue.

2. The perception of guidance vs. regulation

The auditors’ findings were not based on the practices of the best farms and failed to ensure that the producer met FDA guidance.

I don’t believe that Walzel’s additional statement that “guidelines are opinions … regulations are law” is indicative of the perception and practices followed by the industry and/or its auditors. But if that is a view, the consequence will herald the end of self-policing and ensure that all GMPs and guidance documents become regulation.

The issue of what to do about FDA guidance vs. regulations is not new. The fact that “one does not have to follow guidance” is true in a literal sense. But from a practical perspective, any company that does not follow FDA guidance is, quite frankly, looking for trouble. In fact, whether or not this is indicative of majority perception, the fact remains that it was unfortunately stated as defense in an outbreak that sickened 146 people in 28 states, killed 30, and caused a miscarriage; that an official of a leading auditing agency told the committee that his company “did not consider FDA guidance when conducting audits;” and that a processor with “serious design flaws” passed its audit with a 96 percent and no deficiencies noted or corrective action stated. Aside from the human tragedy associated with this outbreak, this report and the accompanying letter are another black eye for third-party audit systems. This is a sad reflection of a system that has much to add to food safety and public health. If not to assure food safety, what is the purpose of third-party audits on which so much of the industry depends?

Additionally, each of the Jensen Farm or third-party audit failures noted by the committee raises further question, the answers of which will impact the entire industry. For example, in noting the auditors’ failure to report problems to regulatory authorities, the question to be asked is – If you are in a food plant and see an obvious Class I hazard, do you have an obligation to report it? Although FSMA Section 307, Accreditation of Third-Party Auditors, states that the results of a regulatory third-party audit are to determine if the facility can be certified, while the results of a consultative audit “are for internal purposes only,” does the consultative auditor still hold a legal responsibility to report Class I hazards to FDA? This is a question to which there does not yet appear to be a clear answer, but has wide ranging implications if the answer is “yes.”

It is through FSMA that Congress expects FDA to fix these failures. As the letter explains, FSMA requires that FDA establish an accreditation system and model auditing standards for third-party audits of imported foods. However, the standards are expected to influence domestic audits as well, and the committee suggested that “FDA consider developing a voluntary model program for domestic auditors that could become the standard of care for third-party auditing programs in the United States.”

We have to hope that the details will be clearly and comprehensively specified when the regulatory language of the section is published. And we should all hope that, for the sake of the food industry and the consumer, that the setting of robust standards for these foreign audits – and auditors, will put third-party audits in a good light and not become a source of constant criticism and doubt. There are already some robust third-party audit programs, but those who are looking for problems don’t differentiate the good from the bad, and thus Congressional focus, such as happened recently, is nothing but damaging to a system that has great capacity to protect both brands and public health.

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Dr. David Acheson, former FDA Associate Commission for Foods, is Managing Director for Food and Import Safety at Leavitt Partners LLC. ” Investigation of Cantaloupe Listeria Outbreak Has Congress Asking Serious Questions Around Third Party Audits” first appeared on the Leavitt Partners blog Jan. 19, 2012.

Cuts in Public Health Preparedness Could Hurt Food Industry

Dr. David Acheson — Wed, 18 Jan 2012 01:59:01 +0000

Although preparedness for public health emergencies had been on an upward climb in the U.S. over the last decade, some of our most elementary capabilities are experiencing cuts in every state across the country. This includes the ability to identify and contain outbreaks, provide vaccines and medications during emergencies, and treat people during mass traumas.

So says the ninth annual, “Ready or Not 2011: Protecting The Public’s Health From Diseases, Disasters, and Bioterrorism,” issued by Trust for America’s Health, a non-profit, non-partisan organization dedicated to preventing epidemics to protect people, and Robert Wood Foundation, devoted to improving American’s health and health care.

While this may appear like less oversight and regulatory presence for the food industry and, thus, a blessing in disguise, the overall consequences for the industry are not good. The general finding of the report is that federal and state budget cuts have put public health preparedness at risk. Although the focus is on general health initiatives, the relevance to preparedness and response in potential foodborne outbreaks or bioterrorist threats to the food chain can’t be ignored.

In fact, every one of the report’s key findings has such relevance:

1. 51 cities — in 40 states — are at risk for elimination of Cities Readiness Initiative funds, which support the ability to rapidly distribute and administer vaccinations and medications during emergencies.

2. All 10 state labs with “Level 1” chemical threat testing status are at risk for losing top level capabilities, which could leave the U.S. Centers for Disease Control (CDC) with the only public health lab in the country with full chemical testing capabilities.

Food Industry Relevance: If there were to be a deliberate attack on the food supply, these reductions could have a grave impact on response readiness, impacting the federal and state governments’ abilities to assist the industry in its food defense efforts.

3. 24 states are at risk of losing expert epidemiology support, which has supplemented state and local gaps in the past.

Food Industry Relevance: A loss of such support would also have an impact on the availability to investigate foodborne illness outbreaks, again reducing assistance and response capabilities.

4. Academic preparedness research and training centers are at risk due to budget cuts.

Food Industry Relevance: Anything that erodes such research and training strains the preparedness for food-related issues as well.

5. Potential cuts to the National Center for Environmental Health (NCEH) mean the ability for the U.S. Centers for Disease Control and Prevention (CDC) to mount a comprehensive response to nuclear detonation, radiological attacks, chemical attacks and natural disasters is at risk.

Food Industry Relevance: NCEH also plays an important role in retail food safety work. Such an impact on the end of the food supply chain has a direct impact on the consumer that food safety and defense are designed to protect. A quick look at the NCEH web site demonstrates their role in food safety.

6. 40 states and Washington, D.C. cut their state public health budgets — 29 states cut their budgets for a second year in a row, 15 for three years in a row.

7. 41 states had cuts in state and local preparedness support through the Public Health Emergency and Preparedness (PHEP) grants from FY 2010 to FY 2011.

8. All 50 states and Washington, D.C. had cuts in the Hospital Preparedness Program (HPP) from FY 2010 to FY 2011.

Food Industry Relevance: These general cuts directly affect the ability for the state response to any foodborne outbreak.

As mentioned, some in the food industry may see such cuts as a good thing, reducing federal and state ability to conduct inspections and thus decreasing the chance of finding problems in a plant.

However, when an outbreak starts, the earlier a potential foodborne illness problem can be found, the more likely it will be able to be contained, and the less potential impact it will have on the food company’s brand and litigation risk.

If we were to even focus only on the impact to the food company, it has to be said that while the illness or death of even one or two consumers is bad for business, an outbreak that sickens hundreds or kills tens of people will be many times worse. Focusing back on the consumer, not only are any deaths a horrible thing, but as discussed in a previous newsletter, “Challenges of State Partnerships Reflect Needed Focus for Food Safety and Consumer Confidence,” consumer confidence in food safety is already at a low; any increase in outbreaks will only make it worse, and, regardless of budget cuts, serve to force an increase in federal and state focus.

The inclination to drop one’s guard when inspections are at a low can be related to the inclination to speed when one knows that budget cuts have reduced a city’s ability to keep patrol officers on the highway. Everything is fine, until that high speed leads to a multi-car pile-up.

From a public health perspective, the key findings of this report should be seen as a warning trend. Should such cuts and reduction continue and spread, it could have a significant impact on the entire food industry.

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Dr. David Acheson, former FDA Associate Commission for Foods, is Managing Director for Food and Import Safety at Leavitt Partners LLC. “Cuts in Funding for Public Health Preparedness Likely to Have Negative Impact on the Food Industry” first appeared on the Leavitt Partners blog Jan. 11, 2012.