Archive for the 'Public Policy' category

FDA Proposes Oversight of Laboratory Developed Tests: Is This Good for Public Health?

Oct 09 2014 :: Published in Public Policy

By Celia Hagan, MPH, Senior Specialist, Public Policy, APHL

It finally happened.

After an extended silence and lack of significant action since their 2010 public meeting on the oversight of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) released their long awaited draft regulatory framework for LDTs. While the official comment period was announced in the Federal Register on October 3, 2014, this isn’t the first time that we’ve seen the outlined framework.

FDA Proposes Oversight of Laboratory Developed Tests: Is This Good for Public Health? | www.aphlblog.org

Just this past July, FDA released a Notice to Congress indicating their intent to move forward with regulation. At the same time, they provided public access to the draft oversight framework. During the 60-day period between July and October, APHL has been hard at work analyzing and interpreting the framework to assess and understand the impact on public health laboratories.

The proposed framework will regulate LDTs in a risk based approach, similar to the way medical devices are currently regulated. Due to growing concerns about the lack of clinical validity, FDA is proposing premarket review requirements to establish these characteristics in LDTs and the establishment of a quality system to assure the finished device will be safe and effective. Laboratories that manufacture or utilize LDTs will be required to notify FDA of their LDT inventory six months after the date of the published final rule. This will allow FDA to classify LDTs into risk categories. The requirement to establish the test’s clinical validity through premarket review will depend on how LDTs fall into these risk categories. While every laboratory will be required to comply with notification and medical adverse reporting no matter what the risk, high risk and moderate risk LDTs will be subject to premarket review requirements. Low risk LDTs will be allowed enforcement discretion with respect to premarket review.  (FDA will classify LDTs into risk classes at a later date.)

FDA is also allowing some enforcement discretion with respect to premarket review for:

APHL strongly supports accurate and quality testing. Public health laboratories exist because they are nimble, prepared, responsive and adaptive; therefore, as FDA gathers feedback on its proposed LDT regulation, APHL will advocate for a framework which will not inhibit the critical services provided by public health laboratories. The innovation and evolution, not to mention the daily activities, of the public health laboratory system relies on an LDT regulatory framework that is not so burdensome that it unintentionally eliminates testing that provides important public health benefits. APHL has engaged FDA’s leadership to communicate the necessity of continuing the services provided by public health laboratories within any LDT regulatory framework. In addition, APHL has educated congressional staff on the critical role of public health laboratories within the public health system.

As the 120-day comment period comes to an end on February 2, 2015, APHL will submit a thoroughly considered and carefully crafted comment to ensure that services provided by public health laboratories continue to improve the public’s health. We encourage others who support public health to voice their interest in maintaining this valuable work.

FDA will host an informational webinar on October 23, 2014, at 2:00 pm EDT. More details can be found on FDA’s website. In addition to the submission of formal comments to regulations.gov, APHL will present at FDA’s public comment meeting in January 2015 (details to be announced at a later date). See you there!

 

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Food Safety Funding Cuts in Action

Jul 25 2014 :: Published in Food Safety, Public Policy

By Michelle Forman, senior media specialist, APHL

Food Safety Funding Cuts in Action | www.aphlblog.org

It seems that our blog post “Could funding cuts to food safety programs make you sick?” on the impact of funding cuts on food safety programs was unintentionally timely. The current nationwide stone fruit recall is a real-life demonstration of the hypothetical situation outlined in our story.

As explained in an article on FoodSafetyNews.com, Australian tests found Listeria on fruit exported from the US. Not tests performed in this country. On December 31, 2012, a valuable and relatively inexpensive federal program called the Microbiological Data Program (MDP) – a program that did 80% of the federal US testing on fruits and vegetables (FDA did the other 20%) at the low price of $5 million per year – was intentionally allowed to lapse by Congress. In the absence of this US program, American consumers were not protected from exposure to the Listeria that might have been on the fruit sold in our markets.

Here’s the quick timeline:

  • July 10 – Australian company discovered Listeria on fruits; the amount of Listeria fell within the tolerance level for Australia, but the FDA has a zero-tolerance policy
  • July 12 – California’s Wawona Packing Co. shut down packing operations and ordered testing by a private laboratory
  • July 17 – Wawona learned from the lab that three pieces of fruit tested positive for Listeria. They decided to order additional testing on other fruits from the same lot. While they waited, they thoroughly cleaned and sanitized their packaging facility.
  • July 21 – The lab reported that tests on additional fruits were negative. Wawona felt confident that entire lots of fruit were not contaminated and there was not a significant risk to the public, but decided to issue a recall anyway.
  • July 22 – Wawona issued a voluntary recall of all fruits packed between July 1 and July 12 (when the company stopped production)

Wawona Packing Co. responded to the information that was sent from Australia quickly and aggressively. They were not required to stop production or issue a recall in the US, but they did. Their response was handled quite well.

The problem here is that a critical program, MDP, could have discovered this contamination sooner. By the time Wawona was able to respond, the potentially contaminated fruit was already in the market and quite likely already consumed. It is safe to assume that MDP would have tested fruit sooner than the Australians simply because of the absence of prolonged international shipping time.

American consumers can be appreciative of the Australians for alerting Wawona to the Listeria contamination in their produce. And we are glad that Wawona responded as quickly as they were able. But there were still 11 days between when the first questionable lot of fruit was shipped and when production was halted. If we want to intercept contaminated produce before it lands on our plates, we need to appropriately fund the local, state and federal programs designed to do so. People may or may not get sick from this fruit, but we don’t want to take that gamble with every recall.

There still have not been any reported cases of Listeria associated with the recalled stone fruits, although it is important to note that Listeria infections can take up to 70 days (yes, 70!) to present symptoms.

 

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Could funding cuts to food safety programs make you sick?

Jul 23 2014 :: Published in Food Safety, Public Policy

By Michelle Forman, senior media specialist, APHL

Could funding cuts to food safety programs make you sick? | www.aphlblog.orgWhen public health works, no one sees it.

That’s a common adage at APHL and is most frequently used when referring to the gross lack of – and ever plummeting – funding for valuable public health programs. But what does it mean? When do we see public health and when does it vanish into the background?

The public health system comprises many areas from healthy eating to smoking cessation to biomonitoring to newborn screening. To answer this question, we’re going to focus on food safety – something that impacts every person in the United States – by following the journey of peanuts as they pass through the food system and into your lunch bag.

(Note: Peanuts were chosen to make a point. They are not inherently risky. As of the original date of this post, there is no current known outbreak associated with peanuts. This journey could feature any food item.)

Our peanuts were grown on a large farm that distributes its harvests for use in many different products.

After being roasted, they are shipped to another facility to be ground into a paste. That paste is then used to make peanut butter for cookies, crackers, ice cream, dog treats and many other products.

In a perfect situation, our peanuts are grown using the safest growing practices; thoroughly roasted to kill pathogens acquired on the farm; processed in facilities that ensure utmost safety and cleanliness in accordance with all food safety guidance provided to them; sent to stores, restaurants and other food service facilities where they will be purchased and consumed by families trusting that they are receiving peanut butter crackers free of Salmonella. Public health has worked in the form of inspectors, guidelines, regulations, sample testing, quality assurance, staff training and public education to ensure that a perfect situation can and will exist most of the time. Although you never saw public health working to prevent you from getting sick, it was there.

Even when all goes right – even when there are not blatant safety oversights along the way – sneaky Salmonella can find its way in. What then?

Our peanuts have picked up Salmonella after roasting (there’s likely no more heating to kill that nasty pathogen) in the processing facility. They are then mixed with more and more peanuts, shipments from other farms, passing through machine after machine, being ground into peanut paste, infecting huge lots of peanuts along the way. Our peanuts are now causing a silent outbreak deep within the processing facility.

The lots of infected peanut paste – soon to be peanut butter – go unsuspected and are sent to the next phase of processing where they will become cookies, crackers, ice cream, dog treats, etc.

Suzy Public loves peanut butter cookies, so she picks up a package during a routine grocery store visit. Two days later, Suzy is very sick.

Vomiting takes a turn to more severe symptoms so Suzy does the right thing and heads to her doctor. In keeping with clinical care guidelines, Suzy’s doctor orders a stool sample which is then sent to a clinical lab where it tests positive for Salmonella. This is obviously important information for Suzy’s doctor who needs to determine the most effective treatment, but it is also important for the public at large, especially for those in her community.

Additional testing at the public health laboratory could link Suzy’s Salmonella to other cases in her area or across the country.

While clinical labs must submit a report alerting epidemiologists of Suzy’s Salmonella, many states don’t require clinical labs to submit isolates (a sample of the Salmonella that made Suzy sick) to the public health lab. The report allows epidemiologists to gather initial exposure information on cases, but identifying potential outbreaks among sporadic cases can be tough without additional information. An isolate allows the public health lab to subtype or get DNA fingerprints from the Salmonella (more on this below), providing greater information and more rapid outbreak detection. So why wouldn’t states require these isolates be submitted? There are likely different reasons for this; one common reason is simply that the states lack resources. Some states can afford to have a courier pick up and deliver those isolates, but not every state is able. It is hard to mandate that the clinical labs handle shipments on their own time and dime. Additionally, some states simply cannot process all of those isolates at their current funding level. Requiring all clinical labs to send those isolates would put an enormous workload on already understaffed public health laboratories.

Once the investigation has been opened, an epidemiologist or public health nurse will contact Suzy Public to begin the investigation to nab the culprit. The first question they will ask Suzy is to list everything she consumed in the week or so prior to getting sick. These interviews allow disease detectives to track patterns in sick individuals’ diets. If everyone ate peanut butter crackers, they can target their investigation.

Could funding cuts to food safety programs make you sick? | www.aphlblog.org

Delays in testing or reporting will delay these disease detectives, and that means Suzy and the others who were made ill may not remember so far back. Even if they do remember and the disease detectives can identify a common food item in their diets, that product may already be off the shelves and in more people’s homes thus exacerbating the outbreak. Additionally, departments of public health face staff shortages that mean overloaded epidemiologists and public health nurses. Their ability to conduct thorough interviews requires ample time – and time is limited when staff are carrying a workload suited for several people.

If that isolate was sent to the public health lab, additional testing is done to confirm Salmonella and to subtype the pathogen. There are over 2,500 subtypes of Salmonella, so the first step in outbreak detection is determining which type has made this individual sick. PFGE testing delves further into the identification of the pathogen by identifying its DNA fingerprint. For example, there could be multiple outbreaks associated with Salmonella Typhimurium at the same time but that doesn’t mean it is the same culprit. Isolating the DNA fingerprints is like a detective pulling fingerprints from a crime scene – when there are multiple offenses committed, fingerprints can link them to the same perpetrator. The DNA fingerprints are then entered into the PulseNet database, a system used to detect clusters nationally. This information is used by epidemiologists to further target their investigation.

But staff shortages in public health laboratories mean not all isolates can be tested, and those that are tested could be delayed. That means less information is making its way into the PulseNet database or it is being entered too late.

Delays or gaps in information make the investigation extremely difficult.

The case of the contaminated peanuts is a complicated one. We know the contaminated peanut butter used to make Suzy’s cookies caused her illness, but identifying those cookies as the source is only the beginning of the investigative process. Was it the flour, sugar, salt, eggs, peanuts, or one or more of the other ingredients that made Suzy sick? And what about the people who were sickened by peanut butter crackers? Or energy bars? Finding the common denominator – and drilling all the way down to where contamination occurred – is very difficult. These complicated investigations can last upwards of a year, but they are being closed without resolution simply because public health departments don’t have the means to keep them open. No resolution means contamination at the processing facility could continue and more people could become ill. It also means the rest of the industry cannot learn from the outbreak and implement changes to improve product safety.

Rapid detection leads to faster recalls of contaminated products. That means fewer people get sick. But our public health system does not have the means to investigate every case of foodborne illness. There are not enough resources to follow up on every cluster.

Without question, more outbreaks would be found if there were sufficient resources to detect and investigate them all. Simply put, funding cuts are ultimately causing more people to get sick.

Advocates continue to work hard to convince decision makers that increasing funding for the public health system is a very good investment in our population. Healthy people are better for every aspect of society. While the advocates are working, public health professionals continue to seek more ways to improve the system with fewer staff and fewer resources. Whole genome sequencing, for example, could provide more information to better understand outbreak clusters, and that could mean less follow up testing which could mean operating with fewer staff. However, implementation of advancements such as whole genome sequencing requires time and money that the system simply does not have.

Every day that you wake up without foodborne illness, thank the public health system. Waking up healthy did not happen without the dedicated men and women working hard to prevent the spread of dangerous bacteria.

When public health works, no one sees it… but it still needs adequate support to continue protecting our health. The disease identification system described above operates on only $40 million annually and is in immediate need of at least an additional $10 million as indicated in the 2015 budget request. To realize significant improvements, CDC funding for food safety should be doubled at a minimum.

Tell Congress that more money is needed for food safety! Follow these two simple steps:

  1. Here is a letter telling Congress that more funding is needed for public health. Complete the information and it will be sent to your elected officials.
  2. Copy the following sentence and paste it into the letter to draw attention to the specific needs for food safety: I am especially concerned with the need for funding to improve our nation’s food safety system. CDC’s food safety office is in immediate need of an additional $10 million as indicated in the 2015 budget request. Without this funding, more Americans will get sick from foodborne illness.

 

 

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Days End; Unending Night?

Mar 18 2014 :: Published in Public Policy

By Peter Kyriacopoulos, senior director of public policy

The federal fiscal year 2014 appropriations process concluded on January 17, 2014, with enactment of the Consolidated Appropriations Act. That bill funded federal government operations for the eight month remainder of fiscal year 2014, which began October 1, 2013 with the shutdown of the federal government and runs through September 30, 2014.

Overall, the 2014 appropriations levels provide some relief for many programs on which the nation’s public health laboratory system depends. Instead of the full $36 billion cut in nondefense discretionary spending – the budget account that funds the Department of Health and Human Services and its agencies like the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) – required by current law, only $14 billion will be cut in 2014.

Days End; Unending Night? | www.aphlblog.org

This $22 billion in “additional” funding has led to $30 million in funding for the CDC Advanced Molecular Detection initiative, an additional $31 million for state and local preparedness, and $9 million more for CDC food safety activities. Most other areas of CDC, HRSA and FDA of interest to the public health laboratory community get level funding, the exception being CDC’s Public Health Workforce which is cut over $11 million – a cut that imperils the APHL fellowship program in the coming year. Funding for the Environmental Protection Agency (EPA) Clean Water and Drinking Water revolving funds are also increased $73 million and $46 million respectively.

While the 2014 funding levels offer some respite, it is transitory as the agreement for spending levels in fiscal year 2015 includes a much smaller reduction is spending cuts of only $9 billion. This also means the amount cut will be $27 billion – or $1 billion more than the amount cut in 2013. Complicating the picture further, $7 billion of the $9 billion in relief is directed to other specific funding needs so that the actual relief from cuts for the rest of nondefense discretionary is closer to only $2 billion. Federal funding in 2015 will be substantially below what was provided in 2013 with the possibility that it will have the effect of a $34 billion cut, and each of the fiscal years 2016 through 2023 will have no relief from the $36 billion that will be cut annually.

One hopes that the impact of these current and projected cuts provide ample evidence on why sequestration and automatic cuts in spending were never intended to become actual policy and are so punitive that they lead to a more inspired and thoughtful resolution of financing federal government operations. If not, the dark forecast will indeed appear as unending night.

  •  SEQUESTRATION!
  • American Taxpayer Relief Act (ATRA)
  • Sequester 2013 Operating Plans
  • CDC funding cut $340 million; PHEP hit hardest at -$34 million
  • HRSA: -$365 million
  • FDA: -$209 million
  • Global Health: -$411 million
  • EPA: -$385 million
  • After Sequester?
  • Fiscal Year 2014
  • House-passed budget – 3/2013 (Congressman Paul Ryan)
    • Continues reduced sequestration funding for nondefense discretionary (NDD);
    • Cancels the reductions in defense and transfers those cuts onto NDD; and
    • Imposes  additional cuts of $700 billion on NDD over the next ten years.
    • Senate-passed budget – 3/2013 (Senator Patty Murray)
      • Eliminates sequestration,
      • Imposes cuts of $145 billion on NDD over next ten years.
      • President’s budget request – 4/2013
        • Eliminates sequestration
        • Imposes cuts of $98 billion on NDD over next ten years, staring 2017
        • CDC takes largest cut of any HHS agency, -$270 million
        • SHUTDOWN!

(Partial)

  • We Have a Deal?!
  • What is That Number?
  • Murray/Ryan Agreement
  • 2014 Appropriations

 

  • WHAT’S NEXT?!
  • What’s Next?
  • Total spending for 2015 is set –
    • $1.013  trillion
    • NDD sequestration for 2015 is set –
      • $27 billion (+$1 billion over 2013; ~+$6 billion)
      • President’s budget for 2015 March 4
        • So what?
        • How Does This End?
        • 2015 funding cuts worse than 2013 – no delays
        • 2016 full $36 billion NDD sequestration
        • Impact of mid-term election results?

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Public Health Labs Lend a Helping Hand During Federal Government Shutdown

Oct 15 2013 :: Published in Food Safety, Infectious Diseases, Public Policy

By APHL staff Stephanie Chester, Senior Specialist, Influenza; Laura Iwig, Senior Specialist, Infectious Diseases; and Jennifer Adams, Lead Specialist, PulseNet Quality Assurance

Public Health Labs Lend a Helping Hand During Federal Government Shutdown | www.aphlblog.org

As the government shutdown continues, we are becoming acutely aware of how the shutdown impacts public health and safety. From delayed testing for drug resistant TB to postponed distribution of quality assessment panels, our public health infrastructure is undeniably weakened without the full support of federal agencies such as CDC and FDA. A skeleton staff is doing their best to maintain critical functions but important surveillance efforts are being put on hold. For example, right now CDC is unable to publish their weekly FluView report which provides critical information about influenza activity to health departments and physicians across the country. Flu surveillance, along with many public health activities, comprises a complex puzzle. Right now this puzzle is broken into many pieces that can’t be linked together to create a complete national picture. The ever-ready and dedicated public health laboratories are stepping into help wherever possible. Despite being already stretched thin and dealing with their own dwindling budgets, efforts by the public health laboratories are filling in important gaps of the surveillance puzzle.  Additionally, these acts by the public health laboratories will help our federal partners get back up to speed faster once the shutdown is lifted.

Influenza Stops for No One

It would be nice if we could ask flu season to hold off for a few weeks, but unfortunately that is not an option. The season officially started on October 1st and positive specimens are already being identified across the country. During a normal season, early flu specimens are sent directly to CDC so they can rapidly determine if the vaccine is a good match for circulating flu types and help determine next year’s vaccine makeup. With the shutdown looming at the end of September, CDC recognized that they would have limited laboratory capacity during the shutdown so an emergency teleconference was scheduled with three states (California, Utah and Wisconsin). As part of an already routine surveillance project, these states were contracted by APHL to perform national surveillance testing on flu specimens after the first few early season specimens were sent to CDC. Fortunately, all three states were ready and willing to accept this unanticipated, influx of early season specimens. As Hugo Guevara of the California Public Health Laboratory explained, “Each year, two months before the official influenza season starts, our group performs quality control. Because of this, we were ready when the first specimens arrived 2 days after our emergency teleconference with CDC and APHL.”

Preparedness efforts such as this do not happen overnight. These contract labs were instituted during the 2009 H1N1 pandemic, and, since their inception, CDC and the labs have put extensive efforts into training so that national surveillance testing is consistent between CDC and the three public health laboratories. Already having this additional capacity and expertise available outside of CDC means that this critical piece of the surveillance system will continue despite the government shutdown. Even though the results of the surveillance testing cannot be processed and shared nationally via FluView until the necessary surveillance staff return to work at CDC, the data and specimens will be readily available for them to analyze and distribute preventing further delays in completing a national picture of influenza activity.

Responding to Rare Disease Outbreaks

In addition to early flu season testing, four public health laboratories have been able to help CDC by being prepared to test for vaccine preventable diseases (VPDs) such as measles, mumps and whooping cough.  The four VPD Reference Centers are trained and experienced in using CDC protocols to test the most common specimen types for nine VPDs.  During the shutdown, public health laboratories have been asked to submit specimens to one of the VPD Reference Centers instead of CDC for testing whenever possible to ensure rapid results, avoiding unnecessary delays in investigating cases and outbreaks of these uncommon diseases.

Foodborne Disease Surveillance

As the shutdown approached, the PulseNet Area Laboratories stepped up to the occasion. Each of the seven Area Laboratories (Massachusetts, Virginia, Michigan, Minnesota, Texas, Utah, and Washington) were willing to help. The PulseNet Area Laboratories exist for this sort of incident: to assist their fellow laboratories with a sudden influx of PFGE testing, data submission and outbreak communication should the need arise. PulseNet laboratorians from across the country submit DNA fingerprints of bacteria from sick patients to CDC. When these fingerprints are matched, investigations may be launched by public health laboratories, CDC, USDA and/or FDA to detect the source of the illness. Without full coverage of the national DNA databases at CDC, national outbreak detection could have been severely hindered. Most of the cluster and outbreak detection and communication would have been up to the public health laboratories possibly without the presence of federal authorities to aid in the investigations. Fortunately the majority of the PulseNet database team and OutbreakNet staff at CDC was brought back to work after seven days of furlough. However, there are still many staff members out and there will be backlog to overcome as government employees return to work. The public health laboratories will play a crucial role assisting CDC with national outbreak detection while employees are playing catch up.

Piecing It All Back Together

While the shutdown is an unfortunate situation and has far reaching effects beyond public health, our federal partners and public health laboratories are doing as much as possible to continue to ensure national public health and safety. These are only a few examples. We extend our appreciation to our partners and public health laboratories for their preparedness efforts over many years that minimize catastrophic effects during emergency events such as this one. This too will provide an opportunity for further growth as we exercise preparedness plans and can institute improvements for the future. Once the federal government reopens, we look forward to seeing the pieces of the puzzle patched back together, getting a full picture of the arriving flu season and having critical federal support for many public health activities.

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What Exactly Does the Shutdown Mean for Public Health?

As we face day three of the federal government shutdown, we are hearing more about the deeply felt impact on our federal partners.  While we can be grateful that local and state public health agencies are still hard at work, the federal portion of the continuum is minimally staffed and operating a bare-minimum of essential programs that ensure the public’s health and safety.  Below are some of the negative effects we are hearing from the Centers for Disease Control and Prevention (CDC), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).

What Exactly Does the Shutdown Mean for Public Health? | www.aphlblog.org

Reference Testing Services Will be Delayed or Absent

CDC provides highly specialized reference testing for rare pathogens and for rare instances of drug resistance. Although CDC will maintain many of these services, the number of staff performing these tests will be greatly reduced. The result will be a delay in delivery of potentially lifesaving test results.

For example, the Division of Tuberculosis Elimination performs sequencing to detect mutations associated with drug resistance to rapidly identify persons with drug resistant TB.  It is the only laboratory in the country that is currently utilizes this method (which provides a high level of detail) for public health investigations.  Delayed results will lead to delays in delivering optimal treatment to patients and mounting an appropriate public health response.

National Disease Surveillance Will Be Weakened

CDC collects data on infectious diseases from all 50 states, local jurisdictions and territories.  The compiled data tracks how diseases are spreading and helps scientists to identify multi-state outbreaks.  One of the best examples of this function is influenza surveillance.  Flu season is upon us; CDC monitors the flu virus strains that are circulating nationally, keeps track of any resistance to drugs, and determines how well this season’s flu shot will work against circulating strains, and sends national alerts to public health professionals when things look out of the ordinary.  It shares the data generated from this activity with state and local health departments, providing them with a “big picture” view of flu activity across the country. Armed with this information, they can prepare effectively for potential outbreaks in their area. But a prolonged government shutdown will reduce the clarity of the big picture view, since less data will be collected.

CDC Support of Local Outbreak Response will be Limited

CDC services like advanced testing and consultation to state and local public health programs facing cases or outbreaks of relatively rare diseases. Because these diseases are so rare, many jurisdictions rely heavily on subject matter expertise at CDC for advice and information when responding. Although CDC’s skeleton crew of staff will do its best to assist, state and local public health departments will be largely on their own when it comes to responding to outbreaks of relatively rare diseases like measles or mumps.

Food Safety Will be Negatively Impacted – More People Could Get Sick

  • If you and others who ate the same food become ill from certain types of foodborne bacteria, you may never know the cause of your illness, as CDC will not be analyzing all of the data submitted, and FDA and USDA will not be following up on those leads to track the source of the illness.  These are necessary steps to ensuring fewer people get sick.
  • CDC will delay assessing the proficiency of state and local laboratories that participate in PulseNet.  This bi-annual assessment may be pushed back for several weeks, even if the shutdown only lasts several days.
  • State and local scientists who want to begin submitting DNA fingerprints to PulseNet will not be allowed to, as CDC certification of new PulseNet participants will be on hold.
  • In normal operating status, state and local food regulators do not have enough resources to properly inspect all retail food establishments and restaurants.  With federal inspection personnel on furlough, even fewer establishments will be inspected to make sure that they are following the regulations.
  • CDC’s IT staff have been furloughed. PulseNet IT staff are not present to aid public health laboratories if they are unable to connect or submit data to the national databases. If the system fails, national outbreak detection could come to a halt. If communication list-serves fail, there are few remaining staff with the know-how to repair these critical national communication tools.

Select Agent Program Has a Delayed Response

Due to the absence of either an FY 2014 appropriation or a Continuing Resolution for HHS and USDA, the Federal Select Agent Program, which oversees the possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products, is not fully staffed and thus unable to provide timely regulatory compliance support to state and local entities. These regulatory gaps could have serious implications for safety and security.

Laboratory Response Network Anticipates Delays

Because the CDC is operating with minimal staff throughout, the Laboratory Response Network, which is the nation’s premier system for responding to potential bioterrorism, chemical terrorism and other public health emergencies, is down to just a few staff with anticipated delays in responding to requests for assistance from state and local public health laboratories and no support for daily reagent shipments.

The larger impact is the lack of federal support for state and local public health. While these state and local agencies continue to conduct routine surveillance and monitor the nation’s health, they rely on their federal counterparts to provide the big picture of disease spread, potential releases of biological threats as well as scientific guidance and methodologies to detect novel threats, like the MERS-coronavirus.

Newborn Screening Laboratory Quality Assessment Delayed

Closing CDC has delayed the fourth quarter assessment of newborn screening laboratory quality. If the delay is extended, then these laboratories will not be able to rely on the assistance of CDC to maintain their compliance with Clinical Laboratory Improvement Amendments, the federal law known as CLIA. Newborn screening depends upon high complexity laboratory operations that are governed by the requirements of CLIA, which include an independent external review to provide quality assurance – and is provided by CDC in the case of newborn screening.

The shutdown will force newborn screening laboratories to seek out non-traditional sources for external review, establish a working relationship with them – possibly at some expense, and pursue activities to meet the CLIA quality assurance requirements. This will not only be inefficient, cumbersome and potentially costly, it will also result in a greater degree of uncertainty because it has never been done.

As CDC’s website details, “The Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences, operates the Newborn Screening Quality Assurance Program (NSQAP). NSQAP is a voluntary, non-regulatory program to help state health departments and their laboratories maintain and enhance the quality of test results. The program is operated in partnership with APHL. The program provides services to more than 85 domestic newborn screening laboratories, 31 manufacturers of diagnostic products, and laboratories in 67 countries. NSQAP has been the only comprehensive source of essential quality assurance services for dried-blood spot testing for more than 33 years.”

The shutdown will add an unnecessary burden and additional complexity to one of the most successful public health programs in the United States.

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Federal Public Health Programs and Employees are Essential Despite Label

Oct 02 2013 :: Published in Food Safety, General, Infectious Diseases, Public Policy

By Scott J. Becker, executive director, APHL

It is day two of the federal government shutdown.

Every day, before I leave for work, I walk our family dog around the neighborhood.  The weather is beautiful today, just as it has been for the last couple weeks.  What’s different about today, however, is that my neighborhood is full of cars on the street and people milling about. It just dawned on me that I live in a nonessential neighborhood.  My neighbors are government employees.

Federal Public Health Programs and Employees are Essential Despite Label | www.aphlblog.org

APHL is headquartered in Montgomery County, Maryland, an ethnically and socioeconomically diverse area; our school system is known for being one of the top in the nation but today it’s known for having children from 70,000 families whose family members’ jobs are considered nonessential and are now furloughed.  Among those furloughed are the security guards who check IDs at the National Institutes of Health (NIH); our nation’s top scientists who are looking for cures for childhood cancer; the researchers doing work on influenza viruses; the food service workers who are usually hard at work by now helping to feed the many employees at the National Institute of Science and Technology (NIST); and the Maternal and Child health specialist at the Health Resources and Services Administration (HRSA) who supports the newborn screening programs in our public health labs.

Despite being given a “nonessential” label, they are all essential to us.

Public health is a local, state and federal continuum where all parts work together to ensure we have a healthy American populace. The public health system can’t work very well – or, I should say, doesn’t work very well – when one part of the system simply isn’t engaged. That’s the situation we face today on the second day of the federal government shutdown. Local public health is still hard at work, state public health is still hard at work, but the federal portion of public health is minimally staffed. If the local or state systems need technical assistance or laboratory support, they are largely on their own.

The federal portion of the continuum is essential.  In some ways you can think of it as the glue that holds the system together.  Public health laboratories and epidemiologists are busy tracking down disease outbreaks all the time. They do a great job in their local or state jurisdictions detecting diseases and other pathogens that can harm us. But it is the role of the federal government – the Centers for Disease Control and Prevention (CDC), in this case – to come up with a national picture of disease outbreaks. It’s the job of the CDC to knit together the mystery of how outbreaks unfold across the country, all with the goal of stopping them as soon as possible so that lives can be saved.

Take a foodborne outbreak for example. On any given day CDC is reviewing up to 30 (and sometimes more) clusters of foodborne illness across the country. We have an incredible system called PulseNet, which is essentially a DNA fingerprinting system for bacteria that cause foodborne outbreaks.  It’s those DNA patterns that are uploaded to a large database at CDC. It is then CDC’s role to review that data and to look for matching patterns across the country so that multistate outbreaks can be detected, the product pulled from market, the outbreak stopped and people can regain their health. What I just described isn’t only CDC’s role, it also involves the FDA. It’s their responsibility to test products that have been implicated in outbreaks and ensure they are pulled from the market. But because of the shutdown, only a skeleton crew of CDC disease investigators and FDA investigators and regulatory specialists are at work.

It’s also the beginning of the annual flu season. Public health laboratories around the country are busy collecting specimens and analyzing them to determine what influenza strains are circulating. That information is then shared with CDC so they can do their job of reviewing the information nationally to determine where flu outbreaks are occurring.  But because of the government shutdown there is no one at CDC able to review these reports.  That means we are likely to see influenza reported in each state but we will not see a national picture. While  that’s not devastating in the short run, if we go a few weeks or longer we will miss out on seeing what’s happening with influenza this year which will impact our knowledge base on what strains might be put into the flu vaccine for next year potentially compromising  the health – and possibly lives – of many.

I could go on and on but my point is really that public health remains an enterprise; as I said above, it is a local, state and federal continuum. The federal role in public health is essential. It is the part that holds together the other pieces and we are less safe when the federal contributions to public health are missing in action.

Congress must act soon; public servants deserve better and the American public deserves better.

 

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The End of Sequestration: Not as Great as it Sounds

Apr 02 2013 :: Published in Public Policy

By Peter Kyriacopoulos, Senior Director, Public PolicyAPHL

Sequestration – or the “automatic cuts” in federal funding – is dead. Long live sequestration! We will no longer go through the drama of the imposition of automatic spending cuts that occurred on March 1, 2013 – but not because Congress and the White House have reached an agreement that suspends sequestration and puts in place a balanced and responsible plan for deficit reduction.

MoneyThe automatic spending cuts feature of the Budget Control Act (BCA) was limited to the fiscal year 2013 funding cycle. In fiscal years 2014 through 2022, the mechanism for achieving the level of cuts required by BCA will instead occur behind the scenes by a reduction in the spending caps for each of those fiscal years. This means that each year the appropriations committees in Congress will have $109 billion less than the amounts they anticipated – and specifically that each year there will be at least $33 billion less for non-defense discretionary accounts, including the one that funds the department of Health and Human Services (including the Centers for Disease Control and Prevention (CDC)). The reduction in funding will vary between $33 billion and $37 billion each year, a cut of about 5.5% to 7% annually. Defense funding will be reduced to a greater extent: $54 billion each year.

The Congress has passed and the President signed into law a funding measure for the remainder of federal fiscal year 2013, and while that action avoided a shut-down of federal governmental operations past March 27, 2013, it maintained the application of the automatic spending cuts – or sequestration – for fiscal year 2013. So this means that federal agencies must now produce plans on how they will address the reduction in spending for their operations.  The reductions – each of which must occur between now and September 30, 2013 – are as follows:

  • CDC: $340 million
  • HRSA: $365 million
  • FDA: $209 million
  • Global Health: $411 million
  •  EPA: $385 million

But wait, there’s more. The House-passed budget resolution for fiscal year 2014, written by Congressman Paul Ryan, not only assumes a continuation of the reduced funding for non-defense discretionary caused by the sequester and its evolution, it also cancels the reductions in defense and transfers those cuts onto non-defense discretionary. That’s just the beginning: In total, the House-passed budget would impose an additional (in addition to sequestration for defense being transferred to non-defense) cut of $700 billion in non-defense discretionary funding over the next ten years. Thankfully, the Senate-passed budget resolution does not follow this extreme path and instead fully replaces the amount lost in the fiscal year 2013 sequester and beyond.

It is extremely unlikely that the considerable differences between the House-passed and Senate-passed budget resolutions for federal fiscal year 2014 can be resolved, and more likely that the House and the Senate will move to considering appropriations bills and other deficit reduction legislation under the direction of their specific budget resolutions – laying the groundwork for irreconcilable differences on those measures. All of which will lead to uncertainty. A rose by any other name most likely will not smell as sweet.

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What We’re Reading — Sequestration Edition

Feb 28 2013 :: Published in Public Policy, What We're Reading

By Peter Kyriacopoulos, Senior Director, Public Policy, APHL

On sequester eve, I recommend the following recent articles for those who would like to know more about the developments in federal funding. It is all but certain that sequestration will occur on March 1, 2013 and these articles describe how we got here, what may happen next, and whether there is a prospect of even greater disruption through a shutdown of the federal government on March 27. Read on!

And here’s the list of the many blog posts I’ve written on these automatic cuts — including one video:

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Sequestration State by State

Feb 25 2013 :: Published in Public Policy

By Peter Kyriacopoulos, Senior Director of Public Policy, APHL

United States of America

The White House has produced individual state fact sheets that provide some additional detail on the state-impact of the automatic spending cuts (or sequestration) that will occur starting on March 1, 2013. Click on the links below to learn more about the potential effects on your state. We will continue to share materials on the impact of the automatic spending cuts as it becomes available.
Alabama | Alaska | Arizona | Arkansas | California | Colorado | Connecticut | Delaware
District of Columbia | Florida | Georgia | Hawaii | Idaho | Illinois | Indiana | Iowa
Kansas | Kentucky | Louisiana | Maine | Maryland | Massachusetts | Michigan | Minnesota
Mississippi | Missouri | Montana | Nebraska | Nevada | New Hampshire | New Jersey
New Mexico | New York | North Carolina | North Dakota | Ohio | Oklahoma | Oregon
Pennsylvania | Rhode IslandSouth Carolina | South Dakota | Tennessee | Texas
Utah | Vermont | Virginia | Washington | West Virginia | Wisconsin | Wyoming

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