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Senate Passes $1.1-Trillion Funding Package

Late Saturday night, the U.S. Senate passed a $ 1.1-trillion spending package to fund most of the federal government for the rest of the fiscal year. The vote count on the so-called “cromnibus” was a bipartisan 56-40.

On Thursday, President Barack Obama stated he would sign the bill despite the administration’s objections to certain riders and disappointment that the bill will only fund the Department of Homeland Security through Feb. 27, 2015.

To remind you how the bill will affect food safety, here’s Food Safety News’ overview from Friday:

A little more than $ 1.016 billion is allocated to USDA’s Food Safety and Inspection Service (FSIS) in the cromnibus — a compromise between the $ 1.005 billion and the $ 1.023 billion called for by the House and Senate agriculture appropriations bills, respectively.

The bill provides almost $ 2.6 billion in discretionary funding for the Food and Drug Administration, including $ 903 million for the Center for Food Safety and Applied Nutrition and $ 147 million for the Center for Veterinary Medicine. This includes an increase of $ 27.5 million over 2014 enacted funding levels for food-safety activities, which is at least $ 2.5 million more than the House and Senate had added in their original agriculture appropriations.

It maintains provisions to prevent funding for inspections of horse slaughter plants and prevent poultry processed in China from being used in the National School Lunch Program, School Breakfast Program, Child and Adult Care Food Program and Summer Food Service Program.

The cromnibus also directs FSIS, in conjunction with other USDA agencies and FDA, “to support developing technologies that will provide rapid, portable, and facile screening of food fish species at port sites and wholesale and retail centers” in order to counter economic fraud and improve the safety of the country’s seafood supply.

And USDA and the U.S. Trade Representative will be required to make recommendations to Congress by May 1 on changes that must be made to bring country-of-origin labeling (COOL) for beef, pork and poultry into compliance with World Trade Organization obligations.

Under a different division of the bill, the Centers for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases will be allocated $ 353 million in discretionary appropriations — nearly $ 48 million of which goes toward food safety.

An increase of $ 8 million for food safety is for advancing diagnostic capabilities using DNA technology and enhancing surveillance, detection and prevention efforts at the state and local level.

Food Safety News

Foodborne Illness Victims Request Additional FSMA Funding

Victims of foodborne illness and their families are urging Congress to appropriate additional funding for implementation of the Food Safety Modernization Act (FSMA).

Several Congress members and plenty of food safety advocates have written to the leaders of the House and Senate appropriations committees this year asking that they increase FSMA funding in the next federal budget.

The authors of the latest letter are 75 people in 34 states who fell ill from eating contaminated food and their relatives who refer to themselves as “the names behind the statistics.”

Geoff Soza of Encinitas, CA signed the letter and supports FDA’s efforts to finalize strong food safety regulations because he nearly died from an infection of Hepatitis A in 2013 after eating contaminated frozen berries.

An email his wife of 30 years wrote to their daughter at the time described him as “Gagging, retching, burning to the touch, aching and lacking even the energy to sit up. He lay lifeless on the hospital bed, his face and eyes bright yellow. He has refused to eat for 48 hours.” There was the possibility he would need his gall bladder removed or a liver transplant.

Even after he left the hospital, Soza says, it was four months before he felt healthy again.

It’s important for him to do anything he can “to prevent things like this from happening again to anybody” and that victim stories can have a stronger impact on effecting change, he told Food Safety News.

“We should have better food safety rules,” Soza said. “The country thinks pretty highly of itself, but if we can’t take care of our population, we’re lacking, no matter what else we do.”

The House and Senate agriculture appropriations bills for FY2015 included an increase of as much as $ 25 million for FDA food safety activities. When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $ 580 million to fund the expanded food safety activities. FDA has since revised that estimate to between $ 400 and $ 450 million.

Soza and the other victims who signed the letter, sent to to Reps. Harold Rogers (R-KY) and Nita Lowey (D-NY) and to Senators Barbara Mikulski (D-MD) and Richard Shelby (R-AL) Monday, requested that an additional $ 300 million be allocated to FDA over the next two years.

“As Congress continues to consider funding for Food and Drug Administration’s (FDA) food safety budget, we hope you will keep in mind the estimated 48 million Americans who are sickened annually by foodborne illness,” they wrote.

Food Safety News

Public Health Groups Ask Congress For More FSMA Funding

On Wednesday, the first day of the new federal fiscal year, 16 public health organizations wrote to the heads of the House and Senate Appropriations committees urging Congress to add $ 50 million to the Food and Drug Administration’s budget so the agency can fully implement the Food Safety Modernization Act (FSMA).

“FDA estimates that it needs an additional $ 300 million over the next two to three years to fully implement FSMA,” wrote the organizations, which include the Pew Charitable Trusts, the American Public Health Association, the American Academy of Pediatrics and the Infectious Diseases Society of America.

“As you complete your work on Agriculture Appropriations legislation for FY2015, we strongly urge you to more robustly fund this vital national priority by providing at least $ 50 million in additional resources for the FDA’s efforts to implement FSMA in the year ahead,” they stated.

In August, Representatives Rosa DeLauro (D-CT) and Sam Farr (D-CA) called on the Office of Management and Budget and the Department of Health and Human Services to request “much higher budget authority” for FSMA implementation in the president’s FY 2016 budget rather than continuing to consider user fees as a funding source.

Congress passed a Continuing Resolution in September that funds the federal government at current levels until Dec. 11.

Food Safety News

Could Funding Cuts to Food Safety Programs Make You Sick?

(This blog post by Michelle Forman was published July 23, 2014, at APHL’s LabLog.com and is reposted here with permission.)

When 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: They are 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, and 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.orgDelays 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 more than 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 that 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, at a minimum, be doubled.

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.

Food Safety News

Senate Vote on Agriculture Funding Bill Delayed Twice by Partisan Wrangling

The $ 180-billion “minibus” package of appropriations bills to fund agriculture and other government programs for fiscal 2015 was pulled from the Senate floor Thursday afternoon by Senate Majority Leader Harry Reid (D-NV) after his attempt failed to require 60 votes to adopt any amendments.

Minority Leader Mitch McConnell (R-KY) objected to the so-called “supermajority” requirement and is also opposed to the administration’s plan to limit carbon emissions from coal plants, which was originally scheduled to come to the Senate floor Thursday as part of the Department of Energy budget.

McConnell is up for reelection this year and comes from a major coal-producing state, and Reid and his Democratic colleagues were trying to head off a potentially successful move on McConnell’s part to force a negative vote on the new emissions rules. Reid also canceled a separate committee vote Thursday on energy and water projects.

“Not only do we not get votes on the floor, we don’t get votes in committee either,” McConnell was quoting as saying on the Senate floor. “When do we start legislating again? What’s happened to the United States Senate?”

While Senate Appropriations Committee Chairwoman Barbara Mikulski (D-MD) expressed disappointment in the second vote postponement this week on the funding package, she indicated that she hoped for a resolution in the near future, perhaps next week. Mikulski had made the call Wednesday night to delay a floor vote on the massive spending bill for similar reasons as those behind Reid’s action on Thursday.

Highlights of the Senate funding bill include $ 1.023 billion for the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), which is $ 12 million above the FY 2014 level; $ 1.139 billion for the Agricultural Research Service ($ 17 million above FY 2014); $ 2.588 billion for the Food and Drug Administration (FDA), which is $ 36 million above FY 2014 (this amount also includes $ 23 million for implementation of the Food Safety Modernization Act), and $ 1.5 million for the Department of Health and Human Services (HHS) Office of Inspector General to “increase oversight of the programs and operations at the FDA.”

The House of Representatives has debated but still not passed a funding measure for either USDA or FDA, which is part of HHS. Republican House members were reportedly in disarray after the June 10 primary defeat of Majority Leader Eric Canton (R-VA), but his successor, Rep. Kevin McCarthy (R-CA), was elected Thursday, so the path toward a House vote may have cleared.

Food Safety News

Food Safety Advocates Plead for More FSMA Funding

As Congress goes about determining agency funding levels for fiscal year 2015, public health groups are urging members of the House and Senate appropriations subcommittees on agriculture to provide increased funding to the Food and Drug Administration to support implementation of the Food Safety Modernization Act (FSMA).

“We are writing to underscore the fact that … the agency needs a substantial increase in funding to make the promise of a safe food supply a reality,” said the letter addressed to U.S. Reps. Robert Aderholt (R-AL) and Sam Farr (D-CA) and U.S. Sens. Mark Pryor (D-AR) and Roy Blunt (R-MO).

The coalition of groups included the Center for Foodborne Illness, Research & Prevention, the Center for Science in the Public Interest, the Consumer Federation of America, the Consumers Union, Food & Water Watch, the National Consumers League, The Pew Charitable Trusts and STOP Foodborne Illness.

At a hearing before the House Energy and Commerce Committee in February, Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, stated that the agency has sufficient resources to issue the final FSMA rules, but not to put them into action.

“We will continue efforts to make the best use of the resources we have, but simply put, we cannot achieve FDA’s vision of a modern food safety system and a safer food supply without a significant increase in resources,” he said.

Funding is needed for importer oversight, developing partnerships with state and local agencies, retraining inspectors and providing technical assistance to small growers and processors, Taylor said.

Although the president’s FY 2015 budget included a $ 263-million increase for FDA “to implement regulatory action,” the majority of that funding was proposed to come from industry fees.

Those fees are unlikely to go into effect, but the “need for a substantial increase in its food safety funding is no less critical now that it must be provided through appropriations,” the coalition wrote.

The groups warn that the progress FDA has made with FSMA will be cut short if additional resources are not provided.

“Your action in the FY2015 funding bill is pivotal to the ultimate success of a law that is a priority for the American public,” the public health advocates told committee members.

Food Safety News

Experts Debate Whether Food Safety Funding is Adequate

At the National Food Policy Conference in Washington, D.C., this week, a panel of experts discussed the impact of funding deficits on food programs.

Martin Delgado, staff director of the House Appropriations Subcommittee for six years, spoke about how sequestration – the automatic across-the-board budget cuts in effect for most of 2013 – impacted the U.S. Food and Drug Administration and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). He argued against the concept that FDA’s food safety work is not fully funded.

“We gave FDA an extra $ 40 million for food safety activities,” Delgado said. “When their budget came out for FY 2015, if you look at the numbers, they’ve only spent $ 7 million.”

He went on to say that, “There’s this notion out there that the Congress isn’t funding FDA or food safety-related activities at the level that people say it should be. I would say maybe that’s true, maybe it isn’t, but we know that, of the resources we’ve given them, they’re still trying to wrap their hands around what they should do with it.”

And, referring to the fact that the first major FSMA rule won’t be finalized until the FY 2016 budget, Delgado asked, “Why does FDA need money to implement FSMA when we don’t even know what FSMA is yet?”

However, other panelists countered that FDA needs more funding.

Included in the FY 2015 budget was a $ 263-million increase for FDA “to implement regulatory action.” Of the increase, $ 24 million was in budget authority, with an additional $ 229 million in proposed new users fees, which appear unlikely to go into effect.

When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $ 580 million to fund the expanded food safety activities. FDA has since revised that estimate to between $ 400 and $ 450 million.

“When you are looking at what they’re saying they need versus what they’ve gotten, it’s going to make it very difficult to implement,” said Barbara Kowalcyk, CEO and director of research for the Center for Foodborne Illness Research & Prevention. “From my perspective, FSMA is largely an unfunded mandate, and that’s going to … impact how successful it’s going to be.”

The American Frozen Food Institute’s (AFFI) director of government affairs, Kelly Pike Poulsen, also made the argument for more funding to fully implement FSMA.

However, she noted, user fees should not be on the table.

“If FDA does not receive additional funds, FSMA implementation, we do believe, may suffer,” Poulsen said. “We do believe that, with appropriate focus and prioritization, the FSMA rules can be implemented without placing additional financial burdens on the food and beverage industry.”

Her argument was that, unlike user fees tied to a faster review process for new drug applications, food companies wouldn’t derive a direct benefit.

Donna Garren, vice president of AFFI’s regulatory and technical affairs department, chimed in from the audience, calling user fees “an additional tax without an additional benefit.”

And, despite multiple requests for how the additional revenue from such fees would be spent, “They have no plan,” Garren said.

While FDA Commissioner Margaret Hamburg refers to “working with industry” on user fees, Poulsen said FDA is not actually giving industry “enough of a plan.”

Kowalcyk also addressed the consequences of a lack of funding for FSIS and the U.S. Centers for Disease Control and Prevention’s Food Safety Office.

FSIS’ budget declined by $ 9 million in the FY 2015 budget, but “80 percent … goes to salaries and benefits, another 15 percent goes to travel for inspections and investigations,” she said. “It’s a pretty lean budget. If you’re cutting money from FSIS’ budget, you’re cutting positions.”

Kowalcyk referenced the equivalency granted to China for poultry processing and wondered, in an increasingly global food supply, “How are we then going to be able to address the import issue?” in the face of budget cuts.

“That’s just one example of many where it’s going to be difficult for us to keep up,” she said.

CDC is often overlooked when it comes to funding food safety programs, Kowalcyk said, but “epidemiology really drives prevention and risk-based decision-making.”

CDC’s food safety budget in 2014 was $ 40 million. “Half of that went to the states and $ 15 million of that went to competitive grants,” Kowalcyk said.

She added that funding for research is important both for new innovations and for developing the next generation of the food safety workforce who are trained by researchers at academic institutions.

The FY 2015 request proposes an additional $ 10 million for CDC’s food safety work, but when asked about the prospect of additional money for food safety research in light of a budget with only minimal increases, Kowalcyk said she’s not optimistic.

Food Safety News