The Food Safety Modernization Act and the struggle to give FDA additional power

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

On January 4, 2011 President Obama signed the Food Safety Modernization Act (FSMA) into law.  The culmination of years of work by advocates, victims of foodborne illness and their families, and the regulated food industry, FSMA was seen as a game changer.  It gave FDA new power to regulate food safety.  Most importantly, once fully implemented, FSMA was designed to transform FDA from an agency whose primary mission is response to foodborne illness to one working proactively to prevent these outbreaks from occurring at all.

An essential part of establishing this new paradigm is a series of proposed rules, four of which were scheduled to be released in January 2012.  As January passed, followed by February, then spring, summer, and fall, the clamoring from advocates and the industry for the release of the rules grew louder and louder.  Finally, in January 2013, a year later, two of the four rules were released. These two rules address produce safety and preventive controls in processed food.

Earlier this week FDA released an additional set of documents that can help to explain some of the reasons for the long delay.  These documents show that the two rules were held up at OMB (the agency that must review all agency rulemaking), where extensive changes were made to their content.  Most notably, OMB removed requirements for environmental and end-product pathogen testing as well as a proposed supplier approval verification program.

While what remains is still an improvement over the existing system, it is far weaker than what FDA had initially proposed.  There are likely many reasons why these changes were made, but these considerations will matter very little to the parents of a child whose foodborne illness could have been prevented by one of the nixed measures.

 

Protesters call foul on new poultry inspection rules

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

On Monday, I joined the American Federation of Government Employees (AFGE), the Consumer Federation of America (CFA), Food & Water Watch (FWW) and the Government Accountability Project (GAP) in front of USDA to protest proposed changes to poultry slaughter.

Currently, USDA inspectors from the Food Safety and Inspection Service (FSIS) monitor every plant in the United States that slaughters poultry. They inspect slaughtered animals to ensure that only wholesome product is entering commerce. In a few poultry plants, a new model project called the HACCP-Based Inspection Models Project (or HIMP for short) has changed this model. In HIMP plants, some government inspectors have been replaced with plant employees. The government now proposes to expand this model so that all poultry plants will have the option to participate.

NCL is concerned about several aspects of this proposed rule, which is why we joined Monday’s protest. As part of the proposed changes, plants would be allowed to increase their line speeds to up to 175 birds per minute, or close to three birds per second.

Our first concern is that the new program will negatively impact food safety. With fewer government inspectors on the line, ensuring food safety will be left up to the plant employees. Unfortunately, the proposed rule does not mandate training for these employees. This means that well-trained government inspectors will be replaced with plant employees who may have varying levels of expertise, depending on the level of investment each plant chooses to make. This is not a recipe for uniform, consistent food safety outcomes.

Additionally, NCL is concerned about the impact of increased line speeds on worker safety. We are concerned that with lines moving ever faster, workers may be at increased risk for injury. While the proposed rule includes a study on worker safety, NCL feels that it is important to understand the impact on workers before changes are widely enacted, not after.

It was with these concerns in mind I joined AFGE, CFA, FWW, and GAP to protest the proposed changes. The fact that we were joined by dozens of inspectors speaks to the importance of this issue. We hope that USDA will hear our message and change their approach to updating poultry inspection. In this instance, the proposed changes are extreme and more research is needed on the efficacy of HIMP before we can think about expanding it to all plants.

Animal and consumer activists join egg producers in fight for better treatment of hens

It is often said that Washington can make for strange bedfellows. A great case in point is the recent agreement between The Humane Society of the United States and the United Egg Producers to improve the treatment of the nation’s 280 million egg-laying hens by supporting H.R. 3798.  The legislation would modernize the egg industry by phasing in larger, enriched colony cages that would improve hen health by allowing for natural hen behavior such as turning and nesting. What’s the consumer angle? Studies show that stressed hens have higher rates of diseases such as Salmonella and Campylobacter, illnesses that are passed through their eggs and on to consumers.

The bill also has a food labeling component that would require egg produces to include information on whether packaged eggs come from  hens that were housed in battery cages, enriched cages, or cage-free. To learn more about the consumer choice and safety implications of improving hen health, read NCL Executive Director Sally Greenberg’s guest blog over at the Humane Society’s Animals & Politics Blog!

Just Label It! Americans have the right to know what’s in their food

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

Here at NCL we believe that consumers have a basic right to know what is in their food.  Knowing what’s in your food means you can make informed choices about what to eat and what to avoid, a right that is fundamental. Unfortunately, this still isn’t possible in some cases.

Enter genetically engineered (GE) foods. Some see GE foods as “frankenfoods,” a dangerous scientific development that can put our health at risk.  Others see GE foods as the only answer to feeding a growing world population.  Regardless of where you stand on the issue, most people agree about one thing; People have the right to decide whether or not they eat GE foods.

NCL agrees with the 93% of American consumers who say that they want genetically engineered foods to be labeled. The right to choose what you and your family put in your bodies is a basic one. Without labels, it’s impossible to avoid genetically engineered foods unless you eat only organic foods, which not every family wants or can afford to do. Labels would allow consumers to make informed choices about whether or not to feed their family a certain food.  Nearly 50 countries, including the European Union, Australia, Brazil, and China, already have law mandating the labeling of GE foods.

NCL has joined with more than 450 other organizations as part of the Just Label It campaign to urge the U.S. Food and Drug Administration to mandate the labeling of GE foods. The campaign has issued a petition urging the U.S. Food and Drug Administration (FDA) to require that all genetically engineered foods be clearly labeled. So far, more than 600,000 people have signed on to the petition.

If you believe that consumers have the right to both know what is in their food and choose what they consume, add your signature to the Just Label It petition and urge the FDA to mandate labeling of GE foods!

Strong food safety regulations are common sense

Teresa Green recently joined The National Consumers League as the Linda Golodner Food Safety and Nutrition Fellow.  In her role, Teresa deals with a broad array of food issues including food labeling, truth in advertising, alcohol, child nutrition, food fraud and food safety. 

By Teresa Green, Linda Golodner Food Safety and Nutrition Fellow

In the midst of a serious outbreak of Listeria, which has killed at least 13 people and left more than 70 others seriously ill, Presidential candidate Michele Bachmann visited a meat packing plant and called for fewer government regulations on the food industry. “We want to have safety,” Ms. Bachmann said, “but at the same time we want to have some common sense.”  When it comes to foodborne illnesses, safety and common sense is often the same thing: government oversight helps ensure a safer food supply.

The Centers for Disease Control and Prevention (CDC) estimates that every, year roughly 48 million people, or 1 in 6 Americans, contract foodborne illnesses. Of those who get sick, 128,000 will be hospitalized and over 3,000 will die.  And for those who get better, foodborne illnesses can be far more than a stomach ache; they often result in long term health consequences, such as arthritis and kidney failure.

While some in the industry claim that regulations stifle growth, a powerful argument at a time when many Americans are struggling to find work, the truth is much more complicated. The cost of food recalls is high, averaging around $5 million. The resulting loss of consumer confidence in a brand can be equally devastating, not just to the brand in question, but to the whole food industry. Strict food safety rules will never create a perfect system, but they can ensure that as few outbreaks as possible occur.

Enter the FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011. In the face of a globalized and increasingly technological food supply, FSMA provides a much-needed modernization of the food safety system in this country by shifting the emphasis away from responding to foodborne illness outbreaks. It does this by focusing on enhanced partnerships, import safety, prevention, and inspections, compliance and response. This means that the FDA will have greater authority to force a company to issue a recall and will be better able to trace an outbreak back to its source.

FSMA is good news for American consumers. When it is fully implemented, we will have a new food safety system that focuses on the prevention of, rather than the response to, foodborne pathogens.  This approach will mean a safer food supply and, as a result, fewer sick Americans.  Sounds like common sense to me.

Consumer concerns emerge with yet another food illness outbreak

By Alex Schneider, NCL Public Policy Intern

Last Wednesday, at the request of the US Department of Agriculture (USDA), food manufacturer Cargill announced a massive recall of 36 million pounds of ground turkey due to possible contamination from Salmonella.  Already, a 65-year-old Northern Carolina woman died due to the outbreak, and 77 people have reported falling ill, with one-third ending up in the hospital.  The outbreak has highlighted two consumer concerns related to detection of Salmonella and the use of antibiotics in the food supply.

The need for new testing procedures for salmonella

As reported by CBS News, after the first illness was reported in March and the first signs of an outbreak appeared in May, investigators were able to determine a link between Cargill ground turkey and the outbreak in July.  Inevitably, consumers, industry observers and the media will question why the recall was announced five months after the first reported illness.

The Center for Science in the Public Interest (CSPI) sent a petition to the USDA in May that would have declared four strains of Salmonella to be ‘adulterants.’  The four are – Salmonella Newport, Salmonella Hadar, Salmonella Typhimurium and the strain present in the current outbreak, Salmonella Heidelberg –and  have all been the cause of serious food illness outbreaks.

Under this classification, testing before the product goes to market would be required to identify potential contaminants, as is currently required in testing meat for E. coli O157:H7.  The classification would also mean that selling products with these strains of Salmonella would be illegal, the goal being to stop contaminated meat from ever reaching the marketplace.

Concerns over livestock antibiotics

The second big concern is that Salmonella Heidelberg is resistant to several antibiotics, including ampicillin, streptomycin and tetracycline, as described in a report by NPR.  Today, farmers use 29 million pounds of antibiotics, or four times those prescribed to humans, to get animals to grow more efficiently before their entrance into the food market.

The side effect – antibiotic resistant strains of bacteria  – poses considerable risks, as evidenced by this most recent outbreak of Salmonella.  Although alternative antibiotics exist to treat people who do get sick, this problem has the potential to get worse.  As the Food and Drug Administration has stated, medically important antibiotics should be avoided in the food industry.

NCL strongly supports the CSPI petition calling for a “test and hold” program for the four strains of Salmonella before meats are shipped out to consumers and make people sick, or even worse, kill them. NCL also calls upon the FDA to prohibit the use of medically important antibiotics in animal feed because of the very problem we see with Salmonella Heidelberg,  it’s resistant to treatment by specific antibiotics.

Unsanitary shipping pallets posing threats to food safety?

By Courtney Brein, Linda Golodner Food Safety and Nutrition Fellow

As the Linda Golodner Food Safety and Nutrition Fellow at the National Consumers League, I work on a wide range of food safety and nutrition issues. While, on the food safety front, the topics on which I focus run the gamut, ultimately, they all share a common purpose: improving the safety of the food that American consumers purchase, serve, and eat.

Due in part to a string of recent foodborne illness outbreaks, and in part to an administration that has chosen to prioritize improving food safety, the environment is ripe for making significant changes to – and expansions upon – the mechanisms currently in place for protecting our food supply. More than a year ago, President Obama created a White House Food Safety Working Group co-chaired by Secretary of Health and Human Services (HHS) Kathleen Sebelius and Secretary of Agriculture Tom Vilsack. The group has recommended a public health focused approach to food safety that prioritizes prevention and strengthens surveillance and enforcement, among other measures. On the Congressional front, FDA food safety modernization legislation passed in the House last summer and is slated to come to the Senate floor soon. The United States Department of Agriculture (USDA) recently set new performance standards for Salmonella and Campylobacter in young chickens and turkeys, in an effort to help prevent tens of thousands of illnesses every year. To help consumers stay up-to-date on recalls and other food safety issues, HHS and USDA launched www.foodsafety.gov last September. The list goes on.

Central to the creation of an effective food safety system is the assurance that measures are in place to protect products at every step of the way along the path from “farm to fork,” as the saying goes. While regulations and inspections help to ensure the safety of food grown on farms and produced in factories, and consumer education helps to reduce cross-contamination and unsafe cooking practices in the home, the area in between – the transportation of food from production to purchase point – remains largely overlooked and under-regulated.

Several months ago, NCL Executive Director Sally Greenberg and I began to wonder what role, if any, the pallets used to transport food might potentially play in the contamination of the food supply. Our first tip-off was McNeil’s recall of Tylenol and several other products this past December and January. The company linked the moldy, musty odor – and the unpleasant side-effects it caused in many individuals who consumed the products – to the wood pallets that were stored in the area where these products were made. According to McNeil, when a chemical used to treat the pallets started to break down, another chemical called TBA formed in the air and contaminated the products. When we realized that these pallets were, at least generally speaking, the same as the ones stacked behind many grocery stores, we started to wonder why the shipping platforms that transport food were being stored outside, and if there were any regulations governing the use of pallets.

Our research revealed that pallets are, in fact, more or less overlooked in the regulatory sphere. We decided to conduct exploratory testing of the pallets used to transport food, to determine whether the issue warranted a call for FDA’s consideration. We’ve been at this a long time – NCL first drew attention to potentially harmful products in 1904, when NCL volunteers staffing a booth at the 1904 St. Louis World’s Fair demonstrated to fairgoers that canned green beans touted by food processors as a labor-saving home product were adulterated with green dye. More than 100 years later, we continue this work; this past December, the League called on the FDA to investigate a “sweetened dried cranberry” product that our commissioned lab tests found to be mostly sugar, and made of cranberry skins rather than whole cranberries as advertised.

For this investigation, we tested pallets in the Miami/Tampa area and in Houston. We located a highly regarded lab that gave us strict instructions on taking samples and shipping them back, which we followed to the letter. Many of the pallets I saw – and tested – were really dirty, sullied with items ranging from bird droppings to fish scales. They were stored outside, exposed to the elements, and easily accessible to rodents, insects, and birds. I became intimately familiar with these shipping platforms – both wood and plastic – and the precise, methodical way in which one takes samples to send to a lab. In all, we took samples from 35 plastic pallets and 35 wood pallets in each metropolitan area, totaling 140 samples. We had no idea what our results would be.

As it turned out, our findings were significant – and alarming. The lab found E. coli on 10 percent of the 70 wood pallets we tested, and on 1.4 percent of the 70 plastic pallets. The lab report also revealed the presence of Listeria on 2.9 percent of the wood pallets, half of which further tested positive for Listeria monocytogenes. None of the plastic pallets tested positive for Listeria. High aerobic plate counts, which reflect unsanitary conditions of the pallets, were found on both types of pallets, with approximately one third of the wood pallets and one fifth of the plastic pallets showing the high counts.

While our exploratory testing included only a small number of pallets, we think it gives some indication that the sanitation and safety of the pallets used to transport food in the U.S. deserve a closer examination. This past Tuesday, therefore, the League sent a letter to FDA Commissioner Margaret Hamburg, sharing our findings, urging the agency to do its own testing, and calling on FDA to set standards that will help to ensure that pallets are cleaned and stored properly, thus minimizing the possibility that they will be implicated in the spread of foodborne illness. Additionally, we videotaped our testing – check it out.

Foodborne illness victims lobby Washington for passage of food safety reform legislation

By Courtney Brein, Linda Golodner Food Safety and Nutrition Fellow

Today, as part of the Make Our Food Safe coalition’s coordinated events this week, 45 foodborne illness victims and their family members are meeting with senators from their 23 home states to advocate for the passage of FDA food safety reform legislation,  S. 510.

The Senate Committee on Health, Education, Labor & Pensions unanimously passed this bipartisan piece of legislation in November 2009. Now, in order to make food safety reform a reality, the Senate must bring the bill to the floor for a vote as soon as possible. In July, the House overwhelmingly passed H.R. 2749, its version of the FDA food safety reform, which does even more to strengthen the food safety system than does the Senate bill.

For the individuals who traveled from across the country to urge their senators to act, the pending legislation is highly personal. At a dinner following the advocates’ training session yesterday afternoon – an event that both first-time and seasoned advocates attended, to prepare for their legislative visits and share their stories – I had the opportunity to speak at length with a number of the incredible people with whom senators are currently meeting. Their stories are heartbreaking.

The woman to my right, a vivacious stay-at-home mom from Virginia, told me all about the various athletic pursuits of her ten-year-old twins, children she felt particularly lucky to have in her life. In her fifth or sixth month of pregnancy, she contracted listeriosis from a contaminated food product, an infection that spread to her unborn babies and sent her into early labor. The twins faced severe medical complications and an extensive hospitalization. Thankfully, both mother and children recovered. Across the table sat two girls, chatting with each other and the group alternately: a 12-year-old who contracted E. coli O157:H7 during the 2006 spinach outbreak, fell deathly ill, and recovered to become a seasoned advocate; and a college senior visiting Washington, DC to lobby for the first time after spending a week in the hospital last year fighting illness caused by contaminated Nestle Toll House chocolate chip cookie dough.

What none of these incredible individuals mentioned over our pasta or bread pudding were the medical consequences that remain for many who suffer from foodborne illness: life-changing conditions such as paralysis, kidney failure, seizures, and hearing impairments. Furthermore, these survivors are the “lucky” ones. Another advocate, a soft-spoken dad from Tennessee, came to DC. on behalf of his six-year-old son who passed away from foodborne illness in 2004. With the pain that comes from the loss of a child clearly written on his face, he said to me, “He got sick, and two weeks later he was gone.”

As the brave advocates will underscore to their senators today, no one should have to suffer, or watch a loved one suffer, as a result of something as necessary and basic as eating. Many of the individuals in the room came to DC this week – and return again and again – to speak for those who cannot speak for themselves: parents and grandparents, children and grandchildren, whose lives were cut short by eating contaminated commonplace foods such as peanut butter or spinach.

In addition to the human face of foodborne illness, this week the Make Our Food Safe Coalition has drawn attention to the economic consequences of foodborne illness outbreaks. Utilizing data from a new report that places the cost of foodborne illness in the United States at 152 billion dollars annually, Make Our Food Safe has created an interactive, online map that enables users to explore the costs of foodborne illness state by state. Both the report and the map underscore the financial consequences of a food safety system that does not adequately protect the public from contaminated products.

On Tuesday, HELP Committee Chair Senator Tom Harkin (D-IA) stated that, if all goes according to plan, food safety legislation is likely to reach the President’s desk by May. It is the hope of the National Consumers League, the Make Our Food Safe Coalition, and the victim advocates on the Hill today that our efforts this week will rededicate the Senate to vote on the FDA Food Safety Modernization Act, S. 510, and move food safety reform one step further towards becoming a reality.

Food Safety Tips for Independence Day Picnicking

Holidays are often busy times for people spending time with families and friends. With sunshine, good company, and fireworks to come, food safety might not be the first thing on your mind, but when picnicking and barbecuing it can be challenging to keep your food safe.  Here are a few tips on how to keep your food free from harmful bacteria that cause foodborne illnesses:

• Keep hot foods hot and cold foods cold.  At outdoor temperatures, harmful bacteria grow rapidly.
• Never save leftovers.  Discard anything left over.
• Discard prepared food if it has been at room temperature for more than 2 hours.

For more detailed information on keeping food safe while picnicking, check out these links on “Safe Picnicking and Grilling”  and “Safety on Your Picnic.”

If you’re going camping this weekend, here is a handy checklist to make sure you’re remembering everything you need to have a safe and enjoyable adventure.

Have a safe and enjoyable Independence Day!

Food Safety Bill Goes to House Floor

by Amos Budde, NCL Policy Intern

Once again, news from Capitol Hill:  The House Energy and Commerce committee held a full committee markup on the Food and Safety Enhancement Act yesterday, and it was unanimously adopted and to be sent to the House for a full vote.  Each year, 76 million Americans suffer foodborne illnesses; 5,000 die.  After the recent food scares and recalls of peanut butter, spinach, beef, berries, pet food, tomato products, and more, restoring confidence in the safety of our food supply has finally become a priority in Congress.  This bill aims to fix the gaps in our regulatory system, so that consumers can be sure that their food is safe to eat.

The Food Safety Enhancement Act gives the Food and Drug Administration (FDA) much-needed regulatory authority in a variety of areas, including:

• Registering food facilities – All food producers in the US must register with the FDA and pay a $500 registration fee that will fund the new safety measures.

• More inspections – “High risk” food facilities will be inspected every 6 – 18 months.  Many of these facilities are currently inspected only once per decade!

• Electronic traceability – Food producers must have a “trace back” and “trace forward” system to track of where food is coming from and going to.

• Giving the FDA more enforcement bite – The bill substantially increases fines for noncompliance with safety legislation.

• Mandatory recalls – The FDA did not have the authority to do so previously; with the passage of this bill, they will.

The FDA will now be better able to detect problems when they arise and then respond more quickly and effectively.  Follow this link for a more in-depth look at the bill’s contents.

The most encouraging thing about this new approach is that stakeholders from all sides of the debate are coming together to support this bill.  Both Democrats and Republicans in the committee shared personal stories about how food poisoning or other illnesses had affected their own lives and those of their constituents.  Agricultural corporations and organizations like the Grocery Manufacturers of America recognize that food safety concerns were costing industries hundreds of millions of dollars each time a recall was required.

To build consensus and get broad support, the legislation failed to address some important issues, such as the extensive use of human antibiotics in livestock.  Rep. Jan Schakowsky (D-IL) offered an amendment on this issue, and while Committee Chair Henry Waxman (D-CA) said he sympathized with Schakowsky, he noted that the issue was not being addressed because it was too controversial.

In what will certainly be a contentious year for the Energy and Commerce Committee, (it has to produce both the Climate Change and Health Care Reform legislation) it seemed like the members were enjoying yesterday’s bipartisanship.  As long as this bill remains free of deal-breakers, it should soon become law.