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,MD20852). All comments should be identified with the docket number FDA-2012-N-0430. Comment is due by July 10, 2012.

For more information about the Leavitt Partners Center for Food Safety click here.

Does rapid pathogen testing help or hurt?

With foods and ingredients moving across continents, the global nature of our food supply means that foodborne illness associated with a particular product can present at low levels throughout the United States or the world. PulseNet facilitates the identification of potentially related cases of foodborne illness, and the power of that technique—based on methodology that is now more than 20 years old—has been a game changer in the world of outbreak investigations. It looks like the game is about to change again.

In my position as Panel Manager for the USDA NIFA Small Business Innovative Research program, I’ve seen numerous proposals seeking funds to advance the development of rapid methods for the detection of foodborne pathogens. The benefits are obvious: the more quickly you can identify if a food is contaminated, the more quickly actions can be taken to ensure that the food does not reach consumers. However, the theme of the “Culture Independent Diagnostics Forum” meeting held in Atlanta, GA, in late April cast a bleaker vision of a world where rapid methods increase in prevalence—at the expense of culture-dependent methods that feed systems like PulseNet.

The roughly 150 attendees at a recent APHL/CDC/CSTE sponsored meeting on the topic of “culture independent diagnostics” were predominately those from the public health and clinical laboratories. Speakers painted a picture illustrating that the reliance on rapid clinical methods to confirm the diagnosis of illness in a patient meant that the longer, more laborious (and seemingly duplicative) confirmatory tests that yielded a culture would be abandoned. Without this culture—the spot on the plate—tests like Pulsed Field Gel Electrophoresis that yield the molecular fingerprints fed to PulseNet would cease to exist, and several suggested that we would revert to conducting investigations the way they were conducted 50 years ago.

In the past six years, PulseNet has identified outbreaks associated with 15 foods that had never before been associated with outbreaks. Perhaps some members of the food industry reminisce about the days that their products were considered “low risk” and yearn for the inability to definitively link pathogens in the environment, food, animals, and people. I sincerely hope that with the focus on prevention, industry would welcome the knowledge and insight gained by better understanding how different strains and serovars of pathogens move through the environment so they can better defend their food against contamination.

My observation is that these “culture independent” rapid methods are further developed in the clinical community compared to food applications where matrices and inhibitors present many challenges. This is unfortunate, since the food industry could benefit from such advances. While testing cannot assure that all products are safe, testing is an important step in verifying the effectiveness of preventive controls. Given that several foods associated with outbreaks are also highly perishable, it would be advantageous to be able to quickly test foods rather than expending precious shelf life time waiting for laboratory results. Often, a “presumptive” positive is enough to warrant the disposition of the product, and last week we reported that a “presumptive positive” of a regulatory sample is enough for FSIS to initiate a traceback investigation. Some food companies may have the resources to conduct follow up tests in the event of a positive finding, to better understand the issue, but this is the exception, not the norm. On the clinical side, in many cases, upon finding a positive rapid test, clinical labs will not follow up with a “reflex culture” (a secondary, culture-based test) because they will not be reimbursed by insurance companies for their effort.

There is a potential conflict in testing between the food world and the clinical world.  While the food industry would benefit from more rapid methods, enabling tests to be conducted by less skilled staff than conventional food microbiology, it was pointed out that if tests become too easy to use in the clinical environment, the results of a test conducted in a doctor’s office may not be submitted to public health agencies. Clearly, outbreaks can’t be identified if data aren’t fed into the system.  So what may be an advantage in the food world could have a negative impact on public health in the clinical world, regarding outbreak identification, yet could still provide good individual patient management.

There are concerns about the validity and interpretation of results of culture-independent methods by the food industry. Many Critical Control Points kill pathogens, and there is concern that some test methods may detect viable as well as non-viable organisms. Some could argue that there is value in knowing that the product initially contained pathogens, so that controls could be moved further upstream to prevent an initial contamination, but from the regulatory perspective, only a food containing viable pathogens able to cause illness are of concern.

Unfortunately, none of the companies who manufacture these tests presented their perspectives. However, after one panel discussion, a manufacturer did ask the obvious question: “As clinicians and public health professionals, what is desired in a test kit? Do you want differentiation down to a strain/serotype level, or do you want multiplexing?” There wasn’t a clear answer, as most presenters seemed content to continue the status quo in collecting cultures.

How would the food industry respond to this question? Are the needs different? Should the conversation that occurred within the public health community also take place jointly with the food industry? I would suggest that it should, given that there was but one food industry member present at the meeting. Reinforcement from the food community about the value of being able to differentiate strains of pathogens, which may rule you “in” or “out” of an investigation, should be voiced. If suddenly we only tested for “Salmonella” without a serotype or PFGE pattern, would we even be able to tell if there was an outbreak?  If there was a marked uptick in cases of salmonellosis, how would you know who was a part of the outbreak compared to the baseline? Given the high number of cases of salmonellosis annually, how would you know who to collect food histories from? If you went the route of testing food and found some that were positive for Salmonella, how would you know if it was associated with an outbreak?  How many products, brands, and industries could be damaged?  While it’s great to develop a rapid test so that a doctor rapidly knows “yes, it’s Salmonella” or a food company can make a quick decision about the safety of a product, many of these tests currently provide no big-picture information for the control of what might be an outbreak.

If there is a move toward culture-independent methods, does this mean the end of PulseNet or some next generation of PulseNet? I can’t imagine that will happen (although questions were raised regarding the “next generation” of PulseNet and the potential to rely on newer methods). However, we do need to think through the unintended consequences of advances in this area. Given the great ingenuity often demonstrated in how these methods work, I am confident that by raising awareness of the issue, we’ll find a workable solution. I hope that in “round 2” of this discussion, all stakeholders — public health and clinical communities, food industry members, test kit developers, and others — convene to discuss how we can work together to ensure that we use the best technology possible to prevent foodborne illness.

David Muhlestein — Analyst at Leavitt Partners — describes and compares the reasons why health insurance exchanges will be disruptive to our current way of delivering health insurance.

The Patient Protection and Affordable Care Act (ACA), considered the most important piece of federal health care legislation since the creation of Medicare and Medicaid[i], has been hailed both as a necessary start to reforming the American health care system[ii] and an unconstitutional overreach of federal powers[iii].  While it does address many aspects of the health care delivery system from quality reporting improvements[iv]  to issues of fraud and abuse[v], lost in the political debate is that the ACA’s core focus is on the American insurance and payment system[vi] with multiple proposed health payment reforms[vii].  Among the many changes to how health care is purchased, one stands out as having the greatest possibility of disrupting the current status quo: health insurance exchanges.

Health insurance exchanges under the ACA[viii] are, at the most basic level, state-run markets where individuals and small businesses can purchase health insurance.  While individual health insurance has long been available on the open market, exchanges are different: they are artificial marketplaces where qualifying insurance plans will compete under monitored conditions to sell insurance directly to consumers who will purchase plans with government-furnished subsidies.

To understand why an exchange’s artificial marketplace is important, it is helpful to compare them to another artificial marketplace: iTunes.  When digital music first arrived on the Internet consumers had few reliable choices to purchase their favorite songs.  A simple search for sites to download MP3s would lead to countless options, but consumers were uncertain about the quality of the recordings, reliability of the service and legality of the content.  When Apple introduced the iTunes market, it remedied each of these concerns; it provided a large selection of high-quality, licensed music with reliable servers and a user-friendly interface.  Most importantly, the popular music player, the iPod, was designed to integrate with iTunes which led to a critical mass of users, eventually making iTunes the largest music vendor in the country[ix].  Record companies now must compete on the iTunes market to access their target audience.

Virtual marketplaces for health insurance have long existed, but they have some serious shortcomings.  These online portals are primarily brokerages[x] for multiple insurers with widely varying plans designed by the individual insurers, each with different coverage, co-pays, deductibles, networks and exclusions.  After trying to evaluate the different plans, consumers are additionally subject to an evaluation by the insurance companies of their medical history in a process known as medical underwriting.  Only after reviewing the health history of the applicant will the insurance companies decide whether to offer the insurance and, if so, at what price.  Additionally, with less than ten percent of the non-elderly insured purchasing insurance individually[xi], there is considerable price variation[xii] as insurance companies simply do not aggressively compete in the individual market[xiii].

Exchanges will overcome many of these problems by eliminating medical underwriting, standardizing plan offerings and increasing competition.  Under the ACA, insurers will be unable to deny coverage or even evaluate individual health histories other than age, tobacco use and geography[xiv], which will limit price discrimination.  Further, all health plans on the exchanges will be required to cover certain “essential health benefits” [xv] with consistent tiers – bronze, silver, gold and platinum – with defined levels of cost sharing[xvi].  This will limit product differentiation based on exclusions and exceptions hidden in the fine print, meaning plans on the same tier offered by different insurers will be more like fungible goods with comparable coverage and cost sharing.  Consumers, then, will be able to make an apples-to-apples comparison of health plans and make educated coverage decisions influenced by price. As consumers are generally price sensitive when purchasing insurance[xvii], insures will be forced to compete on price to attract new enrollees, disrupting the current model based on medical underwriting.

For health insurance exchanges to function properly, though, there must be encouragement for both consumers and insurance carriers to enter and compete in the market.  This is accomplished with the use of federal subsidies for individuals who earn less than 400% of the federal poverty level and tax credits for small employers, both of which can only be spent through the insurance exchanges.  Even without an individual mandate to purchase health insurance, millions are still expected to move to the exchanges to gain access to these subsidies[xviii].  The Congressional Budget Office estimates that by 2021, over $800 billion in subsidies and tax credits[xix] will be spent in the exchanges which will drive insurance companies to more aggressively compete in this space for those funds, ultimately leading to increased consumer-focused price competition among insurance providers.

Major challenges remain, though, in implementing exchanges.  Most importantly, if the prohibition on medical underwriting or the federal subsidies are repealed, insurers will not have a strong incentive to compete in the exchanges without aggressively pricing based on past medical history, making the exchanges function like current online insurance brokerages with their attendant problems.  There also remains the difficulty in establishing these exchanges as some states are politically opposed to creating them[xx] and there is uncertainty whether a federal exchange, which could be implemented in place of a state exchange, will be adequately funded[xxi].  Finally, there is a risk that consumers will simply choose to not purchase health insurance on the exchanges for unknown reasons.  If consumers are not persuaded to use the subsidies on the exchanges, there will not be the critical mass of potential customers to drive the insurers to the exchanges so that meaningful price competition can occur.

Health insurance exchanges are not the sole solution to reform the American health care insurance industry, let alone the health care system.  They do, though, offer the promise of fundamentally shifting how insurance is bought and sold by commoditizing plans and enabling consumers to make more informed, price-based decisions.   Encouraging the growth and adoption of health insurance exchanges offers the best short-term opportunity to encourage price competition among sellers, ultimately leading to lower health care costs for all.

Last week, USDA’s Food Safety and Inspection Service (FSIS) 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 last week 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 received. 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.

For more information about the Leavitt Partners Center for Food Safety click here.

Although 2012 initiatives are still on hold, plans continue to be made for FDA’s future strategies and activities – and means of funding them. Initial FY 2013 appropriations bills are being put forth by Congressional committees and the Agency itself has published a strategic plan for 2012-2016, making “best use of the tools and resources Congress has given us.”

The Budget

Last Thursday (April 26), the Senate Appropriations Committee approved a fiscal year 2013 Agriculture Appropriations Bill providing $2.524 billion for the FDA. This is a $22 million increase including $12.5 million specifically for implementation of the Food Safety Modernization Act (FSMA).

According to opening statements by committee Chairman Daniel Inouye, the funding level takes into consideration the federal government’s responsibilities to protect public health and safety, especially in the areas of food, drugs, medical devices and biologics. The bill does not provide funds that would cover the cost for the proposed user feesthat have yet to be authorized.

In addition, the bill provides $1.001 billion for USDA’s Food Safety and Inspection Service, which includes an increase above the budget request for federal inspection activities and the full funding requested for state and international inspection activities. Overall, however, the agriculture bill is $50 million below the amount requested by the administration. The measures now go to the full Senate for consideration, then, if approved, to the House.

While the $22M is certainly better for FDA than a zero increase or worse, that level of increase is still, in effect, a reduction in overall budget that is available for programs such as FSMA. The cost of living increases and inflation will more than account for $22M, and thus the FDA is on a diminished budget. As we have said before, this will impact enforcement and inspections but will have less impact on the development of regulations, because the former are expensive and the latter are relatively inexpensive.

The Strategy

While awaiting word on its future funding, FDA is continuing to issue reports, with the latest being its Foods and Veterinary Medicine (FVM) Strategic Plan for 2012-2016. The plan covers all activities within the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) and supported by the Office of Regulatory Affairs (ORA).

In the opening letter of the strategic plan, which outlines seven strategic program goals with key objectives, and nearly 100 specific initiatives, Deputy Commissioner for Foods Michael Taylor stated, “We know that success depends in part on the availability of resources, especially to implement FSMA, but we think that mission clarity for ourselves and our stakeholders regarding what we’re trying to achieve and how are crucial and necessary first steps.”

In addition to an overarching strategy to improve effectiveness and efficiency across all levels, the strategic priorities of the FVM Program include the following seven goals and key objectives of each:

Program Goals and Objectives

1. Establish science-based preventive control standards across the food chain including science-based regulation and clear direction to industry.
2. Achieve high rates of compliance with preventive control standards domestically and internationally through improved intelligence, standard-compliance inspections, preventive control assurance for imports, implementation of enforcement tools, and federal, state and local collaboration on these efforts.
3. Strengthen scientific leadership, capacity, and partnership to support public health and animal health decision making by establishing and implementing centralized measurement, improved information sharing, strengthening mission-critical science capabilities, and cultivating expert institutional knowledge.
4. Provide accurate and useful information so consumers can choose a healthier diet and reduce the risk of chronic disease and obesity through updates to the Nutrition Facts label, menu/vending machine labeling regulation, improved consumer us of nutrition information.
5. Encourage food product reformulation and safe production of dietary supplements through reduced sodium and trans fats in foods and improved dietary supplement safety.
6. Improve detection of and response to foodborne outbreaks and contamination incidents through innovative technologies and processes for detection and investigation, enhanced implementation and response strategies of the Reportable Food Registry (RFR), and effective risk communication.
7. Advance animal drug safety and effectiveness by increased access to safe and effective animal drugs, reduced availability of substandard and illegal drugs, and fostering of the judicious use of medically important antibiotics in food animals to minimize antimicrobial resistance.

The strategies and objectives took into consideration the internal and public comment on the September 2011 draft version,Taylor’s letter stated, adding that comment can still be made and elements modified, as warranted. However, the Agency is committed to “the central underlying theme of the plan, which is our duty to make the best use of the tools and resources Congress has given us to protect and promote the public health.”

As written, the plan covers many of the critical needs on which FDA should focus and is not that dissimilar from previous plans articulated by the food teams at FDA. The reality, however, is that translating plans into actionable change can be very difficult especially in a budget-constrained environment. My view of complex plans such as the one discussed above is the criticality of setting priorities and building accountability.  Without that, plans sit on shelves and output is minimal. Currently the food industry and consumers are anxious to get clarity on the new regulations, and while plans are good, the reality and priority has to be pushing forward on the myriad of new regulatory requirements, so that we can all understand what the road into the future looks like.

For more information about the Leavitt Partners Center for Food Safety click here.

With FDA rule-making stalled out as proposed FSMA regulation appears stuck on the desks of OMB, the Agency has been issuing reports on global and domestic data and strategy. Two of the most recent reports are updates on the two-year-old Reportable Food Registry and a Global Engagement strategy which again denotes the FDA’s focus on imported products.

The Reportable Food Registry
Increase the speed with which reports are investigated and appropriate action taken, including removing reportable foods from commerce when necessary;On September 8, 2009, the Reportable Food Registry was opened as an electronic portal for early detection of potential public health risks. While noting that, with only two years of data, it would be premature to make meaningful statements about trends or patterns, the Agency has stated that the data are helping to speed identification and investigation of potential health hazards in human food, animal food/feed (including pet food). With 2240 reportable entries in the first year and now 882 during the second year (September 8, 2010, to September 7, 2011), the data have helped FDA to:

Prior to joining Leavitt Partners, I was working for the state of Utah helping to plan and build a web site that would allow small business employees to search for and select a health insurance plan that met their needs and the needs of their families. This web site would ultimately become the Utah Health Exchange.  My background is in web development and e-commerce, so building data-driven web sites is something I had experience with. Little did I know then what I was getting myself into and what challenges lay ahead.

The first challenge was an extremely small operational and IT budget.  I had originally estimated an IT build budget of around $1.5 million.  However, Utah legislators wanted a private sector solution and to their credit did not want the UHE to become a bloated and unwieldy government project.  As a result, there would only be about two hundred thousand dollars ($200,000) to use for the IT build. The next challenge was an equally daunting time frame of nine months to get the UHE up and running.  Enabling legislation that encapsulated and defined the business rules of the UHE passed in March 2009 and the UHE had to facilitate enrollment by August of that same year.

I had managed much smaller IT projects with much larger budgets.  Needless to say, from my perspective this project initially looked nearly impossible and I thought this would be the shortest-lived project of my career.  However, you know what they say, “desperation leads to inspiration.”

In an effort to educate and provide consumers with information about the UHE, the first objective was to find a web developer to design the Utah Health Exchange web site.  Considering the small budget, an inexpensive solution had to be found.  I placed a help wanted ad with the local colleges around the state and a student responded, who ironically was facing his own challenges. When asked if one thousand dollars would be enough to design the web site, he almost fell over with excitement. I still feel a little guilty about that arrangement.

The next objective was to secure vendors to build the core functions of the UHE (enrollment, plan comparison, carrier interfaces, premium aggregation, etc.).  It would have been nearly impossible for any vendor to have developed the UHE core functions from the ground up in only nine months.  Again, considering the small budget and timeframe, we would have to leverage existing technologies available in the private sector.  Any vendor would be risking a lot to accept this project considering the budget or lack thereof. However, two health reform minded vendors (bswift and HealthEquity) responded to the technology RFPs and were ultimately chosen to build the UHE.  To their credit these vendors chose to be visionary by taking on a project of this magnitude.

Another challenge the UHE faced was carrier integration and policy consensus on how enrollment and eligibility would be facilitated.  In order to mitigate any potential problems, I proposed doing a limited launch to test the technology and to limit any exposure to technical, outreach, or other issues that could have potentially brought the UHE to its knees.

All the members of the Utah Health System Reform Task Force were forward thinking and with overwhelming collaboration, creativity, and vision from stakeholders from across the state, the Utah Health Exchange successfully launched on time and on budget.

The limited launch proved to be a success with only a few minor technical glitches that were resolved in a matter of hours.  There were some policy issues regarding group risk assessment and premiums but these issues were quickly resolved. The limited launch also provided some great lessons learned from a technical, policy, and outreach perspective.  The user experience from the limited launch was used to make improvements to the UHE for the full launch that took place in August 2010.  Additionally, the individuals that are running and managing the UHE today are making significant improvements to all aspects of the Utah Health Exchange.  They are, to their credit, also managing the UHE with a very conservative operational budget and with no grant funding.

Today the Utah Health Exchange continues to grow month after month and has enrolled thousands of individuals that did not have any health insurance prior to enrolling in the UHE.

The success of the Utah Health Exchange is a result of the many individuals from across the state of Utah who were willing to think outside of the box. If there is one takeaway from this story, it is that collaboration and a little bit of creativity and vision can produce some amazing results.

This week’s newsletter examines how two unrelated issues: FDA moving forward with reinspection fees, and the recent announcement around changes in the use of antibiotics on farms—illustrate how FDA is using its available tools to send some strong signals to the food industry.  The issuance of the guidance on antibiotic use calls into question the effective difference between regulation and guidance, the impact of each on the industry and the repercussions if not followed.

In one action, FDA began adding a section to Warning Letters declaring its authority to assess and collect fees to cover its costs for re-inspections and detailing the conditions under which it could assess those fees. As found in Warning Letters as far back as February 14, in a letter to  Ginsberg’s Institutional Foods, and as recent as April 2, in a letter to Lucky Taco, FDA wrote:

“Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.”

As I stated in a previous newsletter, “Get Ready to Pay New Registration Fees,” this is an authority that FDA already has but so far has not used. At that time, I also stated that it was currently unclear exactly when this would start and how it would be implemented. It seems that FDA has decided to start and is finding a way to implement it. As a reminder this could cost some serious cash with an hourly rate of $224 for domestic reinspection and $335 for foreign reinspection. So if you find yourself in this situation following a 483, focus on making sure you address the issues in a way that will enable any reinspection to be targeted and swift.

In another action, FDA issued a guidance document and proposed regulation on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.  The new strategy was announced by Deputy Commissioner for Foods Michael Taylor, as a strategy to “phase out production uses [e.g., to promote growth or improve feed efficiency] of medically important antimicrobials and provide that they be used only for targeted, FDA-approved animal health purposes under the supervision of a veterinarian.”

The guidance focused on two principles which, on the surface, seem innocent enough, but in reality will have massive impact on the food industry and subsequently likely on the cost of certain food products.

Principle 1: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

Because they pose a public health risk, FDA believes the use of the antimicrobial drugs for production purposes represents an injudicious use. Thus, veterinary involvement in the decision-making process is important to assuring appropriate use.

My interpretation of this first principle is that very few antibiotics will be allowed to be used for food production unless there is a health benefit to the animal. This will likely rule out their use as pure growth promoters and it will be up to some smart people to demonstrate that there are health benefits associated with the use of some of the current antibiotics in food production.

Principle 2: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation. Most feed-use antimicrobial drugs are currently approved for over-the-counter (OTC) use. In this new guidance, FDA is recommending that drug sponsors voluntarily change the status of the drugs from OTC to Veterinary Feed Directive (VFD) status for medicated feed products and to prescription status for medicated drinking water products.

My view of the second principle is that it will effectively remove the ability of a farmer to buy antibiotics for feed over the counter and will place a veterinarian between the farmer and the drugs.

InTaylor’s announcement explaining the strategy to limit rather than ban the use of the antimicrobials, he said:

“I know there will be those who question why we have not taken mandatory action to ban production uses of antimicrobials. The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change drug by drug, and labeled use by labeled use. Working together is how we will get good results in a timely manner.”

Taylor’s perspective is correct: it is much easier and faster for FDA to publish guidance than to work through the regulatory process.  While guidance is just that and not a regulatory requirement, industry that ignores guidance does so at their peril.  In a previous newsletter, “BPA Passes FDA Safety Check,” I also noted thatTaylor seemed to be (rightly) passing on some of the onus for the delayed publication of FSMA rulings to the OMB on whose desk the pile is pending. Perhaps rather than simply accepting the inherent governmental lags, FDA has decided to work around the regulatory process to move forward its initiatives.

In the case of the antimicrobials, FDA is giving the animal and veterinary communities the opportunity to “voluntarily” limit the use of the drugs to targeted, FDA-approved animal health uses under the supervision of a veterinarian rather than the general production uses for which the drugs had been being used.

While giving the industries some free rein, however, Taylor backs it up with consequences should the phase out not occur within a three-year time frame: “If progress is not what we expected, we will consider further action as warranted in accordance with existing provisions of the FD&C for addressing matters related to the safety of approved new animal drugs.”

As someone who spent time treating patients with a variety of infectious diseases, I am well aware of the dangers of antibiotic-resistant microbes and believe we have to do all we can to limit the growing threat of antibiotic resistance.  Certainly some studies have indicated that limiting the use of antibiotics in food production will temper the development of antibiotic resistance but so will better control of the use of antibiotics in human medicine.  But the key message here is around the fact that the guidance should not be seen as a light tap but as a major game changer for the food industry.

What do these actions tell us?

FDA may issue its industry declarations in a variety of ways for a variety of reasons. But whether published in a guidance document, warning letter or regulation, you should take all rulings and “recommendations” to heart, and know that there could be long-term repercussions should you choose to ignore them.

In fact, it seems that FDA is beginning to take matters into its own hands, seeking ways to move food safety actions forward despite the standard “cumbersome regulatory process.” The fact that we are seeing FSMA stalled will force FDA to move forward in other ways, and while the “bar” for the publication of guidance is certainly present, that bar is not nearly as high as it is for a regulation.  But the impact on the food industry may be minimally different. So should we expect more impactful guidance in the coming months?  Probably!

For more information about the Leavitt Partners Center for Food Safety click here.

]]> http://leavittpartnersblog.com/2012/04/reinspection-fees-are-starting-to-kick-in/feed/ 0 http://leavittpartnersblog.com/2012/04/are-one-of-your-ingredients-or-products-imported-what-more-should-the-fda-be-doing/?utm_source=rss&utm_medium=rss&utm_campaign=are-one-of-your-ingredients-or-products-imported-what-more-should-the-fda-be-doing http://leavittpartnersblog.com/2012/04/are-one-of-your-ingredients-or-products-imported-what-more-should-the-fda-be-doing/#comments Thu, 12 Apr 2012 18:26:16 +0000 David Acheson http://leavittpartnersblog.com/?p=3701  

You may have noticed that many of our recent newsletters have focused on Imported Foods. Despite the fact that many products carry the “Made in USA” designation, in reality many ingredients are sourced from outside of the United States. In this day and age, very few foods are made that can claim every ingredient as being sourced in the U.S. It has become a global economy and, just as was recently evidenced by the current investigation into the China-sourced chicken jerky used in pet foods, that global economy brings with it numerous challenges.

One of the greatest challenges to any U.S.food manufacturer, retailer or food service operation is controlling the risk around sourcing products from developing countries. In some cases, ingredients are only available from these countries; in other cases, decisions are based on cost or other factors.  Regardless of the impetus, one issue that manufacturers should be aware of is the state of the food and regulatory systems of the country from which they choose to import product.

It was just such a query by which FDA commissioned a study by the Institute of Medicine (IOM) to identify the state of food and medical regulatory systems in developing countries and design a strategy to strengthen these systems. The results of that study were recently released in the report “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” developed by the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries.

The 360-page report identified the most pressing problems facing food and medical product regulators in developing countries, outlined a strategy to guide investments in regulatory capacity, and made five international and eight domestic recommendations for specific actions that could be taken to improve global product safety and public health.

Although FDA is an accepted “gold-standard regulatory agency,” the report stated, the Agency cannot act alone. Rather, to help improve the capacity of its counterpart agencies in emerging economies, it must gain international cooperation, develop ways to make the most of its extensive expertise and limited resources, rebalance programs to give more attention to foreign producers and suppliers, and lead by example in the use of international standards.

The nine most common problems that the committee identified in developing-country product-safety systems included issues in adherence to international standards, supply chain control, infrastructure deficits, a strong legal foundation, government regulatory staffing, agency-scattered or duplicative responsibilities and limited authority, poor surveillance systems, poor communication within and between regulating agencies and with industry, and a lack of prioritizing of product safety.

After analyzing these nine main gaps, the committee developed a strategy to bridge them. Emphasizing public health, market incentives, risk-based investments, and international coordination, the strategy included the following recommendations in the report:

International Recommendations

1. International and intergovernmental investment in strengthening the capacity of regulatory systems in developing countries. This includes U.S. work with interested countries to add it to the G20 agenda, and international organization assistance for developing-country participation at international harmonization and standardization meetings, particularly focused toward scientist participation. (3 – 5 years)
2. Open and regular dialogue between emerging economies, national regulatory authorities, regulated industry, and industry associations to exchange expert scientific and technical information before policies are written and after they are implemented. Government cannot shoulder the burden alone, rather a robust regulatory system depends on input from industry and academia. In some counties this will require a cultural shift. (3 – 5 years)
3. Convening of a technical working group on sharing inspection reports by countries with stringent regulatory agencies. The long-term goal is to establish a system for mutual recognition of inspection reports. (18 months) In time, regulatory authorities in emerging economies would also be able to contribute.
4. Defining of a protocol for sharing of internal inspection results among industry associations. After agreeing on methods, regularly share their results. (3 years)
5. Technical support by USAID, FDA, CDC, and USDA (directly and through WHO and FAO) for strengthening surveillance systems in developing countries – including development of surveillance tools, surveillance protocols and training. (5 years)

U.S. Domestic Recommendations

1. FDA use of enterprise risk management to inform its inspection, training, regulatory cooperation and surveillance efforts. Applying to the entire operation, it should incorporate set criteria, such as country or manufacture or production, volume and type of product, facility inspection history, and trends or data shared from other regulatory authorities.
2. FDA development of an information and informatics strategy for risk-based analysis, monitoring performance metrics, and movement toward paperless systems. Propose an internationally standardized vocabulary, minimum collection dataset and frequency of data collection. (3 to 5 years). Have a paperless system in the next decade.
3. FDA training of regulators in developing countries. Workforce training and professional development through a regulatory science and policy curriculum. Broadening the scope of FDA University to educate FDA staff on international compliance with its regulations (3 to 5 years), and training international regulators and developing an apprenticeship program (10 years).
4. U.S. policy makers integration of food and medical product safety objectives into their international economic development, trade, harmonization, and public health work, with FDA leading the development and adoption of international and harmonized standards for food and medical products.
5. Application of FDA’s one-up, one-back food track and trace requirements to medical through a multi-sector, international, public workshop.
6. FDA and USDA implementation of programs to encourage business and academia innovation that can be used in poor countries for low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain. (2 years)
7. FDA incentives for importers that meet U.S. regulatory standards, such as the FDA Secure Supply Chain pilot program that rewards firms that trace their products from manufacture to entry into theU.S. If the pilot is successful, it should be expanded to a greater number of importers and food.
8. U.S. government agency strengthening of the ability of those harmed by unsafe food and medical products to hold foreign producers and importers liable in civil lawsuits. (10 years)

In an ideal world there is little negative to say about these recommendations. But we don’t live in an ideal world, and the FDA does not have the resources to implement domestic policy, let alone significantly expand on the international front. While the Agency has clearly signaled its focus on imported foods, and FSMA certainly emphasizes that as a priority, there is a limit on what can be achieved in the IOM’s targeted 3-5 year time frame. The purpose of the report was to focus on ways to improve the regulatory systems in other countries, and this is certainly an important way of enhancing the safety of imported food, but it is no easy and not quick. So what, if any, is the message in this report to industry?  I think there are at least two relevant ones:

• First, if you import either finished product or ingredients, spend some time understanding the regulatory process in the countries you import from – that will provide risk insight that can help you target your resources to protect your Brand.
• Second, FDA now has some clear “instructions” from the IOM, and industry consortia can step up to the plate to take some of this work on with FDA. A consortium approach allows the FDA to become involved and can be focused in areas of direct concern to the private sector. Creating industry/regulatory partnerships is not done enough but when done well can be of immense benefit to both parties, and there is now an opportunity to pick one or two of the IOM recommendations and build a joint approach to a global challenge.

Questions to Consider

• How important do you think it is for FDA to spend resources on these types of issues?
• Which of the IOM recommendations, if implemented, would have the greatest positive impact on the global food industry?
• Which recommendation do you think is the most important for food safety?
• Do you think there will be any impact of these types of recommendations on your brand, either in the short or long term?

For more information about the Leavitt Partners Center for Food Safety click here.

In health care some progress is being made to move from a culture of fixing health problems after they occur toward disease and accident prevention but there is still a long journey ahead. Misaligned incentives and cultural barriers impede progress. These types of barriers are not new but have been conquered by bold pioneers in the past. During the 19^th century 25% of women who delivered babies in hospitals died of infection spread primarily by bacteria carried on the unclean hands of caregivers. Handwashing advocates including people as notable as Louis Pasteur were ridiculed for their views. In 1910 thirty physicians sent a petition to the Mayor of New York protesting a hygiene program being taught by a fellow physician to child care providers in New York. Their argument was, “it was ruining medical practice by…keeping babies well.” Today of course handwashing has become a cultural norm. Hand sanitizers are carried in hand bags, found at checkout stands in grocery stores and retail outlets and throughout health care facilities. The CDC states that “Handwashing is the single most important means of preventing the spread of infection.”

As absurd as arguments against handwashing sound today, the obstacles to overcome the epidemic of obesity and other public health concerns that are contributing to the health care crisis we face today are even more daunting. We do not have a century to correct these problems. About one third of U.S. adults and 17% of children are obese contributing to myriad preventable health conditions and related costs. Since 1980, obesity prevalence among children and adolescents has almost tripled. It is common knowledge that obesity is directly linked to higher risk of coronary heart disease, diabetes, cancers, stroke and other costly health problems and yet the incidence of obesity continues to climb. Bold pioneers are needed today. Employers, payers and policy makers have the social and economic influence to begin creating incentives for cultural shifts toward more healthy lifestyles. Providers, technology and pharmaceutical companies can improve the tools to help achieve better individual and population health.

Some of the breakthroughs we are looking for may be simpler than one may expect. Researchers have discovered pockets of people living in varied regions of the world whose lifestyles lead to substantially longer lives and better health when compared to the general population in the U.S. A study lead by Dan Buettner, author of “Blue Zones” found some common characteristics among populations of people who live on average a decade longer and with appreciably fewer health problems than their counterparts. One of the premises of this research is that 25% of how long we live is determined by genes and the other 75% is determined by our lifestyles and everyday choices. Mr. Buettner and his team found that physical activity, proper nutrition, having a sense of purpose and belonging, managing stress, making family a priority, and being surrounded by people with healthy values were among the key ingredients to the health and longevity secret sauce discovered by these people. Certainly these are not the only factors contributing to the health of these populations but if factors like these and others play an important role in an individual’s health how can they become a part of our culture in the places we work and in the communities where we live.

My dad often reminded me of Benjamin Franklin’s adage that “an ounce of prevention is worth a pound of cure”. It seems that this timeless advice is as relevant today in addressing the health care crisis we face as it was for me when I was doing dry wall with my dad or when it originated with Benjamin Franklin in 1736.