Helena Bottemiller | Food Safety News

Tracking Down the Source of Outbreaks: It’s Complicated

Helena Bottemiller — Thu, 15 Aug 2013 05:01:28 +0000

At an FDA lab in Denver, Microbiologist Melissa Nucci preps for testing peanut butter samples for Salmonella. Photo courtesy of FDA’s flickr. With a globalized food supply brought to us by increasingly complex supply chains, foodborne illness outbreaks are notoriously tough to solve. These outbreaks often involve multiple states and dozens of illnesses, which are chronically underreported. They include patients who can’t remember what they ate for lunch last week, and, while food products are often narrowed down to a list of possible culprits, nine times out of 10 we will never know which one was to blame. The outbreaks we hear about – and that Food Safety News reports on – are usually the ones that were solved, meaning federal, state, and local health officials were able to put all the evidence together, pinpoint a food source, and alert the public with an outbreak announcement from the federal Centers for Disease Control and Prevention or maybe even a recall from the U.S. Food and Drug Administration. But an extraordinary amount of work goes into trying to crack these cases, whether the public hears about them or not. That’s where FDA’s elite team of investigators comes in. This cohort – formally known as the Coordinated Outbreak Response and Evaluation Network – has been working tirelessly on foodborne illness outbreaks since the initiative launched two years ago this month. Designed for more rapid response, CORE brings together epidemiologists, microbiologists, veterinarians and other experts, all under the same roof at FDA so they can work together more efficiently and focus solely on outbreaks. In interviews, CORE staff often use terms such as “more efficient,” “better structured,” “more effective,” “faster” and “better organized” to describe the shift to a consolidated team. But one of the biggest changes, according to FDA officials, is that CORE puts a fresh focus on learning from each incident and applying those lessons toward more preventive policies and practices. Before CORE, FDA only had seven or eight people to do outbreak response within the Center for Food Safety and Applied Nutrition, according to microbiologist Elisa Eliot, a 24-year veteran of FDA who now works at CORE. “We didn’t have people out there really evaluating information, looking for outbreaks, and working proactively with CDC. Sometimes we’d get together in a work group, but it wasn’t an ongoing, continuing, day-to-day activity,” Eliot recalls. “We didn’t have the people power to look back and do a lot of the ‘lessons learned’ and come up with preventive, better practices. We were more in the response mode all the time.” CORE, which now has a staff of more than 30 (including contractors), is divided into three parts to help ensure prevention is not lost in the shuffle: Signals and Surveillance, which works closely with CDC to identify any emerging outbreaks that might be linked to an FDA-regulated product; Response, which is comprised of separate teams that coordinate the response efforts on multiple foodborne illness outbreaks; and Post-Response, a team solely dedicated to gleaning what is learned from each outbreak and applying it. Tip of the iceberg In the past two years, CORE has been repeatedly tested with an onslaught of foodborne illness outbreaks, only a fraction of which ever made headlines. “It’s seasonal for us, as outbreaks tend to be,” said Ashley Grant, an epidemiologist for the Signals team. “Right now, we are in the peak of our season, so we probably have about eight to 10 on our plate at any given time in summer and spring months. As we get into the fall and winter, we probably have about five a week.” Between August 2011 and the end of 2012, for example, the CORE Signals team evaluated 211 incidents, 63 of which were transferred to a Response team. During that time frame, however, only 12 outbreaks were announced on the FDA Website. Of all the incidents CORE Signals tracked during that time, 144 were not referred to a Response team. According to FDA, in 22 of those cases, the vehicle turned out not to be an FDA-regulated product (remember that meat, poultry and processed eggs fall under the jurisdiction of the U.S. Department of Agriculture). The agency said that in another 34 cases, “FDA response activities had already been initiated and completed,” which means the case might be handled outside of CORE by the enforcement branch or at the state level. In the remaining 88 cases, the vehicle was not identified. Staying on top of all this is a lot of work. CORE staff are known to work long hours and weekends when they’re assigned to an outbreak that’s particularly tricky. The slow-moving nature of foodborne illness reporting, which suffers from lag times, underreporting and diminishing public health resources at the state and local levels, adds another layer to an already complicated puzzle. “Sometimes, the outbreak has concluded by the time we’re actually getting to the point where we have an idea of what the vehicle might have been,” said Jennifer Beal, an epidemiologist for the Signals team. “In that case, there’s nothing left for the response team to do.” “Other times, the vehicle is never identified and that probably constitutes the bulk of the cases we don’t transfer [to the Response team],” she added. “But for any one of these things, we put in the same amount of effort to try to determine the vehicle.” The team still pours a lot of time and energy into trying to figure out what the cause of a foodborne illness outbreak might have been. When they aren’t successful, they still save the information gathered in case a similar situation arises. According to Gary Weber, a CORE supervisory interdisciplinary specialist in animal science, each and every incident is “pushed as far as this team can take them to find out the linkages.” “They don’t give up easily, that’s for sure,” he added. Frustration over the unexplained

CORE Network Team leaders from left: Jeffrey Brown (Signals and Surveillance Team), Carla Tuite (Response Team), Brett Podoski (Post-Response Team), Pamela LeBlanc (Response Team) and William Lanier (Response Team). Photo courtesy of FDA’s flickr.

When meeting with CORE investigators, the passion they have for their work and for public health is evident, but so is their frustration over the outbreaks that could not be explained, despite intense, lengthy investigations. For Roberta Hammond, a CORE supervisory interdisciplinary scientist, it’s often the multiple-ingredient outbreaks that cause heartbreak — when investigators can narrow the source to a salad mix or a restaurant chain but are unable to take it one step further to figure out which ingredient. Even when they do figure out the vehicle in time, comingling and lot mixing, especially for produce, can complicate things. “Something with a short shelf life is more challenging because there may not be product to sample, or if you do manage to trace it back to the firm or farm or field, it’s not there,” said Pamela LeBlanc, a leader of one of the CORE Response teams. Stelios Viazis, a microbiologist for one of CORE’s response teams, agrees: “That’s the most frustrating.” These are increasingly factors in foodborne illness outbreaks as Americans increase their year-round appetite for fresh and even raw foods from a variety of sources, both domestic and foreign. Looking back at tuna scrape Most consumers have never heard of tuna scrape – it’s tuna meat that has been scraped or mechanically separated from the bone, resulting in a slurry of fish meat – but it is commonly used to make inexpensive sushi. This is a prime example of what foodborne illness investigators call a “stealth ingredient.” Last year, when Salmonella Bareilly and Nchanga infections started cropping up in several states, investigators quickly honed in on sushi, but they were stumped by which ingredient was responsible. The CORE team recalls spending “a lot of time doing an ingredient matrix.” For a while, they thought it might be the hot sauce mixed into spicy tuna rolls, as many people sickened had reported eating them. Investigators pursued the hot sauce, with no luck, and there were many other ingredients to look at: sesame seeds, seaweed paper, rice, mayo or another sauce mixed in with the tuna, or even spices that were added into the mix. As they started investigating tuna scrape, CORE investigators realized there was no common language for invoicing the product – the scrape could be labeled any number of things. Making matters more difficult, many of the restaurants also used Cash and Carry or bought ingredients from sources with no receipts or paper trails. Plenty of businesses linked to the outbreak didn’t know where their tuna product came from. “It wasn’t labeled,” recalls Dr. Kathy Gensheimer, the chief medical officer and director of CORE. “We had someone from the Bronx who just bought this stuff off the back of a pickup truck.” When approached by FDA, many restaurant owners also insisted they only used fresh tuna, not the lower-quality frozen scrape – even when they did – adding yet another layer to the investigation. It ended up taking CORE about a month – bringing nearly 30 extra people into an emergency operations center to work on traceback for three weeks – to definitively link the outbreak to the scrape. Officials had to sort through thousands of pages of documents and map out each complicated supply chain, which are really more like webs. The traceback map from that investigation is a flow chart that looks “like a circuit board,” as FDA spokesman Doug Karas puts it. That outbreak, which ultimately sickened 425 people in 28 states, showed that “with enough resources, you can get to the bottom of anything,” Gensheimer said. “A month may sound like a horrendously long time for people getting sick,” she said, but FDA’s effort paid off in terms of public health. Once a recall was initiated, 58,000 pounds of the contaminated scrape was taken off the market. “That would have made a lot of sushi rolls,” Gensheimer noted, adding that the product showed an unusually high level of contamination. “Just about every sample we were pulling yielded Slamonella Bareilly and Nchanga.” If you assume a sushi roll contained a few ounces per roll of a very contaminated product, FDA’s work likely prevented thousands of diners from eating the Salmonella-ridden pink paste. “I think you can multiply that 500 cases many, many, more times. I think we would have had thousands of cases nationwide, and even internationally, because of course this is a global trade,” Gensheimer said. New focus on prevention During a series of interviews with CORE officials, prevention was a common theme. Investigators repeatedly said one of the best parts about the way CORE is organized is that it dedicates a team to learning from outbreaks and following up on investigators’ recommendations. “Now we really take the time for every single outbreak to figure out: Is there something we could have done better? Even if it’s not us – even if it’s a policy or a practice – that’s just never been done before,” explains Carla Tuite, a leader of one of CORE’s Response teams. CORE’s Post-Response team kicks in right as the outbreak is winding down, regardless of the size or scale of the incident. If investigators ran into roadblocks – perhaps a trading partner wasn’t cooperating, for example – this team follows up on those problems. “It’s the follow-through that takes place that has really made a big impact,” said Kari Irvin, a leader of a Response team. Irvin explained that Post-Response might include follow-up inspections or specific policy recommendations. “If we think it’s a larger industry problem, we might work with an industry association,” said Katherine Vierk, who works on Post-Response for CORE. “[The team] might discuss whether there needs to be additional guidance, or if this issue needs to be considered in an upcoming guidance document.” Vierk said the Post-Response teams also reach out to the people working on rolling out and implementing the Food Safety Modernization Act, the country’s new food safety law. If poor record-keeping was a particularly thorny issue during an investigation, it would be the Post-Response team’s job to give feedback to the FSMA rulemaking experts and tell them what would have been helpful. Or, let’s say that the Response teams didn’t ask for the right records. If that were the case, the Post-Response team would try to figure out a way to improve their internal process. According to Vierk, CORE is expecting to look more toward environmental assessments in the future. “Getting out there to find out the true environmental antecedents, the true reasons why contamination occurred and then exploring ways to get that information back to industry so it doesn’t happen to them,” is a top priority, she said. CORE points to Jensen Farms as a great example of translating knowledge into better practices. What was learned in that Listeria monocytogenes outbreak in late 2011 is now informing preventive practices at the farm level. For produce, FDA puts together PowerPoint presentations based on what CORE has learned from various outbreaks, and those are disseminated through extension agents in different states. That knowledge, according to Vierk, is helping growers learn from others’ mistakes. Before CORE, such prevention efforts were made on an ad hoc basis as people would flag things, but now the agency has dedicated staff to do that work. FDA is also able to prevent more illnesses because CORE gets involved with foodborne illness investigations more quickly now than in years past, giving the agency a better shot at removing contaminated product before it’s consumed. Before CORE was launched, CDC would determine that there was a foodborne illness, and then, once they figured out it might be related to an FDA-regulated product such as cheese or lettuce, “they would literally toss it over like a volleyball net and FDA could then pick up their piece and run with it,” explains Gensheimer, who oversees CORE at FDA. “If you’re sitting there waiting for all that work to be done, the lettuce is long gone or the cheese has been eaten,” she said. “We get involved earlier now,” she added. The Signals team now actively monitors consumer complaints, talks to states, and keeps an eye on PulseNet, CDC’s surveillance network. “Instead of that volleyball-net mentality, we’re all engaged with the states really almost from the get-go. It’s a cobweb interface, it’s constant communication back and forth and hopefully getting us where we need to be more quickly,” Gensheimer said. Cyclospora outbreak rolls on Despite all the focus on improving foodborne illness outbreak response, FDA has come under fire recently for what many consider a painfully slow response to the ongoing Cyclospora outbreak. At last count, 548 people in 19 states have fallen ill with the parasite. In an update issued this week the FDA said, “we are moving quickly to learn as much as possible and prevent additional people from becoming ill.” But food safety experts have questioned why federal officials have still not figured out which product caused all of these illnesses, or even if all the illnesses are related to one another. A few weeks ago, Iowa and Nebraska identified an unnamed salad mix as the source, but both FDA and CDC have continued to say they are pursuing multiple leads, insinuating that the conclusions drawn by those two states are just part of the picture. FDA has since confirmed that the salad mix grown by Taylor Farms de Mexico and served at Olive Garden and Red Lobster restaurants in Iowa and Nebraska is indeed linked to the illnesses in those states, but the question is why haven’t federal officials been able to solve the larger outbreak? David Steigman, an FDA spokesman, declined to answer questions about how many separate supply chains the agency might be investigating because the investigation is still ongoing. “It is not yet clear whether the cases reported from other states are all part of the same outbreak,” Steigman said. Larry Slutsker, director of CDC’s Division of Parasitic Diseases and Malaria, told Food Safety News that part of the problem is that the agency lacks the technology to quickly differentiate which Cyclospora infections are related. “The ability to determine subtypes, also known as strain differentiation, of foodborne pathogens would be an invaluable tool in foodborne outbreaks like this,” he said. “Subtyping supplements epidemiologic and traceback information so we’re better able to tell how cases or clusters of cases may – or may not – be related to each other. Unfortunately, this process is much less well-developed for parasites when compared to bacteria such as Salmonella or E. coli.” FDA said Monday the traceback process for the current Cyclospora outbreak is “labor-intensive and painstaking work” that involves thousands of documents. The agency said it has a 21-person team focused on the outbreak at headquarters, with another 10-person staff working in the field, but there are still no answers as the outbreak rolls toward its eighth week.

Are Chemicals Commonly Used in Poultry Plants Masking Salmonella?

Helena Bottemiller — Thu, 08 Aug 2013 06:56:06 +0000

Food safety experts are scratching their heads after a Washington Post article suggested last week that certain chemicals used in poultry processing might be masking the presence of Salmonella. It’s a scandalous theory that could explain why government data show big reductions in Salmonella rates in poultry plants while human illnesses have held steady – but is it a real concern? According to the Post’s report, the U.S. Department of Agriculture’s Food Safety and Inspection Service is reviewing academic research that shows there “could be a problem.” The article cites a “lengthy PowerPoint presentation that cited research from a USDA scientist and several university scientists” that was presented at FSIS in June. The story says the compound under the most scrutiny is cetylpyridinium chloride (CPC), which is widely used in mouthwash and is a common finishing rinse for poultry to combat disease-causing pathogens. The issue being raised is whether CPC, or other antimicrobials, might stick around in the samples collected for pathogen testing at a high enough concentration to kill the bacteria on the way to the lab, which would give FSIS a false negative test result when the chicken might very well be contaminated. Asked about the concerns raised in the presentation, the USDA’s Food Safety and Inspection Service downplayed the issue, noting that it was not undertaking a formal review, but said officials are taking a look at the information that was presented. The agency said the new information “contributes to a well established dialogue on antimicrobial use in poultry processing” and that it “will take appropriate steps to adjust our policies and procedures if warranted.” One of the scientists cited in the PowerPoint presentation, Catherine Cutter, a food safety professor at Penn State, told Food Safety News she did not know her research on CPC was being mentioned at the meeting and was a bit confused about why her study was referenced because it is 14 years old. She said she conducted the research so long ago that she no longer has her lab notebooks from the study. On top of that, she pointed out that her study was about beef, not poultry, which is an “inherently different process.” For beef, pathogen testing is done by swabbing meat directly, but for chicken, the process requires rinsing the birds and then testing the resulting liquid for bacteria. When the Post quoted Cutter as saying, “This is a valid concern,” she says was talking about her beef research. “[CPC] stuck to everything. It sticks to whatever you put it on,” she said, noting that it has great cleaning capability for hides. “How [the paper] made the leap to chicken, I have no idea.” One of the pieces of research at the heart of the controversy, it seems, was produced by Enviro Tech Chemical, one of the leading manufacturers of peracetic acid, another widely used poultry wash. The company’s research, which they posted online at the end of July also suggests that CPC should be labeled as a food additive if it lingers in product – an argument reminiscent of the controversy over the use of ammonium hydroxide in lean finely textured beef, aka pink slime, last year. The National Chicken Council contends processing aids are not remaining in product or interfering with the pathogen tests. “USDA-approved processing aids by definition have no lasting effect after application,” said Ashley Peterson, NCC’s vice president of scientific and regulatory affairs. “As such, we are confident that testing results are indicative of effective chemistry.” As the Post noted, the presentation in June was made by chemical companies, including Enviro Tech, who make products that compete with CPC, produced by Safe Foods in Arkansas, fueling accusations that these new concerns are really just about trying to undermine a competitor’s product. Mansour Samadpour, president of IEH Laboratories and a leading food testing expert, agrees the controversy is likely a marketing move. “This is a commercial issue,” Samadpour said. “They are making a circular argument. If the wash remains in the sample and is killing the bacteria, it’s also killing bacteria on the bird.” But Jon Howarth, the technical director for Enviro Tech, who was one of the presenters at FSIS in June, argues that the problem is real and says FSIS is concerned about it. Howarth – who co-authored the research in question and whose company has also developed a method for testing CPC concentration in samples – said he was asked to present his findings to FSIS and that he was surprised by just how much interest there was. He said nearly 20 regulators attended and another 30 to 40 called into the meeting, which was scheduled for an hour, but lasted two hours because of the high level of interest in the matter. (Howarth also clarified that someone at FSIS leaked the PowerPoint to the Washington Post and that the company did not share the presentation with the paper.) The reaction from FSIS officials was “very, very good,” he said. “They told me ‘this is very interesting and we’d like you to explore this in more detail’. I was very pleased with FSIS. They said ‘yes, you do raise some points of concern.'” Asked why FSIS downplayed the presentation and their review of the issue, Howarth replied: “Of course they did. They don’t want to scare the public.”

As Frustration Mounts, Rep. DeLauro Seeks Answers on Cyclospora Outbreak Response

Helena Bottemiller — Fri, 02 Aug 2013 08:28:38 +0000

In response to growing frustration and increased media attention surrounding the response to the ongoing Cyclospora outbreak, which has now sickened at least 418 people in 16 states, Rosa DeLauro (D-CT) on Thursday “demanded” answers from federal health officials about why they have not given the public more information. Citing concerns raised by a handful of high-profile food safety experts, DeLauro, a key appropriator, wrote a letter to both the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, pointing out that a full month into the investigation “there is minimal information available to the public on the possible cause(s) of this outbreak from federal agencies.” The cause of the outbreak, it seems, is in dispute. As Food Safety News has reported, state officials in Iowa and Nebraska, which have 146 and 81 cases, respectively, have identified bagged salad mix containing romaine and iceberg lettuce, cabbage, and carrots as the likely culprit, but have offered no more detail on which of the ingredients in the mix, or which company or distributor, might be to blame. Federal health officials and the other states involved have not pinned the outbreak on a source. Both CDC and FDA have said they are still pursuing other leads. “I recognize it’s frustrating when we’re not able to give all the information people want at this point in the outbreak investigation,” said CDC spokeswoman Barbara Reynolds on Wednesday. “However, what we have learned from Iowa and Nebraska gives us a strong lead on a possible source for the outbreak.” FDA spokesman Doug Karas said the agency’s Coordinated Outbreak Response and Evaluation (CORE) Network is “following the strongest leads provided by the states and has prioritized the ingredients of the salad mix identified by Iowa for the traceback investigation, but is following other leads as well.” Karas said the traceback process is “labor intensive and painstaking work, requiring the collection, review and analysis of hundreds and at times thousands of invoices and shipping documents” and noted FDA has dedicated at least 17 staff to working on the outbreak. In her letter to the agencies Thursday, DeLauro requested details and timelines on how exactly the inter-agency investigation has unfolded. She asked for a timeline that includes data and specific dates that “indicated possible associations between the outbreak and particular food products” and details on when such information was shared with states, industry, and the public. “Understandably, investigations of disease outbreaks, including foodborne disease, must be thorough and thoughtful,” wrote DeLauro. “At the same time, the public was left in the dark as an outbreak leaped from 2 cases to nearly 400 and questions around data and information sharing abound.” DeLauro asked why neither Iowa nor Nebraska has released “the brand, producer, or country of origin of the food product associated with the cases within their state.” She also asked whether FDA or CDC consider it acceptable to identify the source of an outbreak and withhold that information and, if so, to provide the rationale and legal justification. If regulators know the source and are “intentionally” withholding that information, wrote DeLauro, it would be “an alarming precedent and incredible disappointment to consumers who expect a transparent federal food safety system that protects the public health.” Cyclospora, a microscopic parasite that can be transferred via contaminated food or water, can cause infection, or cyclosporiasis. Common symptoms include watery diarrhea, loss of appetite, and weight loss, according to CDC, and usually begin about a week after exposure.

USDA: Level of Dioxin in Chile's Chicken Recall Would Not Have Sparked Recall in U.S.

Helena Bottemiller — Wed, 31 Jul 2013 06:06:06 +0000

Nearly 200,000 pounds of Chilean chicken is being recalled in the United States for dioxins only because the levels found violate Chile’s domestic limits, according to federal food safety officials. In other words, the 126,000 pounds of chicken currently being held at the border is there only because Chile recalled it, not because the U.S. Department of Agriculture thinks it’s a public health risk. In fact, when the same dioxin levels are found in U.S. product, it does not spark a domestic recall, according to Dan Engeljohn, Assistant Administrator of the Office of Field Operations at the USDA’s Food Safety and Inspection Service. “Although we would likely not have recalled this same product for that level, we made the determination, based on their decision to recall the product, that it is adulterated,” Engeljohn told Food Safety News. Dioxins are toxic environmental contaminants that are both naturally occurring, from wild fires and volcanic eruptions, but also the result of industrial activities and waste incineration. When FSIS issued a press release over the weekend informing the public about the Chilean recall, the agency did not say at what level dioxins had been found in Chile, only stating that the agency had “determined that the risk to consumers is negligible.” The agency also said it is tracking down some 62,000 pounds of the product that did enter the U.S. Dr. David Goldman, Assistant Administrator for the Office of Public Health Science at FSIS, told Food Safety News on Tuesday that Chilean health authorities found 5.1 picograms per kilogram (pg/kg) in their tests, which he said is only “slightly above” Chile’s maximum residue limit (MRL) of 3.5 pg/kg. The U.S. doesn’t have an MRL for dioxins in meat and poultry products. Instead, FSIS has developed what the agency calls “trigger values.” For chicken, that level is 4 pg/kg, which means that anything found above that would trigger an investigation by the U.S. Food and Drug Administration. The FDA would collect environmental and feed samples for analysis, but there would not be a recall, according to Engeljohn. Instead, health officials would try and pinpoint where the exposure was coming from — be it contaminated feed or a coating on part of the building — and reduce or eliminate it. Every five years FSIS conducts a survey to estimate the levels of dioxins and other toxic pollutants, like PCBs, in meat and poultry products. Since the mid-1990s when the testing began, the levels found have dropped 20 to 80 percent for turkey, chicken and pork, have stayed relatively even for beef, and overall are considered to be safe, according to the 2008 dioxin report. The drop is likely due to tighter controls on dioxin pollution, including restrictions on certain herbicides and a ban on using clay as a binder for certain feeds (the clay was sometimes contaminated with dioxins). The government is in the middle of collecting data for its 2013 report on dioxins in meat and poultry. While the project is still in progress, Dr. Goldman said the preliminary results continue that trend. Asked to respond to the questions raised by Food & Water Watch on Monday, FSIS officials told Food Safety News there was no lag time between the dioxin recall in Chile. Officials were alerted to a potential problem based on preliminary test results on July 17, but did not receive confirmation about the test results or notice about the recall until the day before issuing a notification on Saturday. (The lag time on Chile’s end was likely due to the fact that its test results were confirmed by a lab in the Netherlands, according to FSIS.) The agency also defended not issuing a public health alert or formal recall, saying experts at FSIS have determined there is no significant public health risk based on the levels Chile is reporting. Since there are no MRLs set for dioxins, FSIS determines what will put consumers at risk on a case by case basis. According to the World Health Organization, 90 percent of human exposure to dioxins — linked to cancer, reproductive and development problems, among other ailment — is from food. Animal products, including fish, meat, poultry, and dairy products are the biggest contributors to human dioxin exposure as animals accumulate the compounds, mostly in their fat. The Codex Alimentarius Commission, the UN’s global food standards setting body, has established a provisional tolerable monthly intake (PTMI) of 70 pg/kg per month. “This level is the amount of dioxins that can be ingested over lifetime without detectable health effects,” according to WHO.

Dioxin Chicken Recall Prompts Questions from Food & Water Watch

Helena Bottemiller — Tue, 30 Jul 2013 07:53:42 +0000

Food & Water Watch, a Washington, DC-based advocacy group, said Monday it’s concerned about the way the U.S. Department of Agriculture is regulating meat imports following last weekend’s recall of nearly 200,000 pounds of imported chicken for dioxins — toxic pollutants that can pose a public health risk. On Saturday, the USDA’s Food Safety and Inspection Service issued a public notification announcing that health authorities in Chile had recalled 188,522 pounds of chicken that had been shipped to the United States over concerns about dioxins. According to Google news, the recall was not picked up by any mainstream media outlets — likely because it was released on a Saturday and the agency said the risk to consumers is “negligible.” Food & Water Watch is now calling on FSIS to answer a number of questions about the incident. The group wants to know whether there was lag time between when the agency learned of the Chilean recall and when the press release went out Saturday, and what role FSIS port-of-entry inspection played in identifying the problem. In a release, Food & Water Watch points out that a 2012 FSIS audit of the Chilean meat safety system found Chilean food safety officials were bolstering staff training on dioxin contamination. The group wants to know how long dioxin contamination has been an issue with imported products from that country and why. Considering dioxins are highly toxic, the agency didn’t issue a recall or even a public health alert to “accurately reflect the severity of the problem,” a fact Food & Water Watch finds odd. FSIS said Saturday about 126,082 pounds of the product in question is being held at the border, so it has not entered commerce. “The agency is investigating the distribution of the remaining 62,440, pounds and verifying if additional shipments are involved,” read the announcement. “FSIS may expand the public notification and will take necessary and appropriate action after analyzing updated information received from the government of Chile.” FSIS said it was issuing a public notification to “make the public aware of the situation,” but the agency is not formally announcing a recall because “the establishment most directly associated with producing the adulterated product has recalled product and USDA works with its counterparts to conduct effectiveness checks in U.S. In this case, the Chilean Ministry of Health initiated a recall of this product.” According to the World Health Organization, more than 90 percent of human exposure to dioxins is from food, which is why many countries monitor their food supplies for contamination. Over the past decade there have been multiple large-scale international dioxin recalls, usually stemming from contaminated animal feed. Dioxins occur naturally in the environment from volcanic eruptions and forest fires, but are also the result of industrial processes. The compounds can cause developmental and reproductive problems, according to WHO. FSIS says it conducted an analysis of the Chilean test results and “determined that the risk to consumers is negligible,” but the agency has not announced the levels found. FSIS is continuing to track down where the product was distributed.

FDA Releases Two Major Rules to Boost Oversight of Imported Foods

Helena Bottemiller — Fri, 26 Jul 2013 13:00:26 +0000

Today the U.S. Food and Drug Administration is releasing two long-awaited rules aimed at improving the safety of imported foods, which now make up about 15 percent of the U.S. food supply. The measures, mandated by the Food Safety Modernization Act, will require that importers verify their suppliers are employing prevention-based food safety practices and create a system for certifying third-party auditors. The agency is also extending the comment period for two other key rules, preventive controls and produce safety, another 60 days, beyond the current Sept. 16 deadline, to help stakeholders consider the proposals as a package. The two new proposed regulations — Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors — would be a “huge sea change” for food safety, according to Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine at FDA, because they shift the regulatory system toward prevention, instead of relying heavily on FDA inspectors to catch problems at the border or port of entry. According to FDA, the agency is only able to physically inspect about two percent of all of the food coming into the country. At some points in the year half of fresh fruits and 20 percent of fresh vegetables consumed in the U.S. come from abroad and FDA is eager to hold produce, and all foods, to the same FSMA standards that U.S. producers will soon be held to. The FDA estimates the verification programs alone will cost the food industry between $400 and 500 million annually. In an interview, Taylor noted that many U.S. food importers are already meeting what will be required under the coming Foreign Supplier Verification Program, but the regulations will for the first time clearly define their responsibility. Importers will have to have a plan in place that identifies the potential hazards for each food they’re procuring, they will have to document what is being done to control the hazards, and FDA will have access to those documents. “What’s not present in the current system, even for those doing the right thing, is public accountability,” said Taylor. While foreign supplier verification is likely to get most of the attention, the Accreditation of Third-Party Auditors is also a key change as many in the food community look to improve the integrity and consistency of food safety audits. Under the rule, FDA would recognize accreditation bodies, which could be foreign governments , non-profits, or private companies, to accredit third-party auditors, which can then be used for certifying foreign food facilities and for food, in some cases. According to the agency, importers will not be required to obtain such certifications, but the process might be used by FDA to determine whether to admit a particular imported that might pose a food safety risk. Taylor said the agency hopes that in the future the accreditation system can be adopted more broadly by third-party auditors to “strengthen the integrity of the industry,” which has come under scrutiny in the wake of high-profile foodborne illness outbreaks caused by companies that had recently received exemplary audits. Consumer and industry groups are pleased the proposed regulations are out so the process of implementing FSMA can keep moving. “We are very pleased that implementation of FSMA is moving forward,” said the Grocery Manufacturers Association, in a statement. The group said it looks forward to working with the FDA “by continuing to share our food safety expertise and best practices and by evaluating and commenting on these and future proposed rules.” Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, called the new rules a “huge step forward.” “We’re thrilled that we’ll finally get to read these proposals,” she said. According to Pew, 8 of the 19 multistate foodborne illness outbreaks that have occurred since President Obama signed FSMA into law in January 2011 were linked to imported foods, including mangoes, tuna scrape, cucumbers, and other items. That number includes the current 9-state hepatitis A outbreak linked to pomegranate seeds imported from Turkey that has sickened 153 people, 66 of whom were hospitalized. “The longer it takes to get these rules implemented, the more people will get sick who don’t need to get sick,” Eskin said. When asked why the two new proposed rules took more than a year and a half to clear the White House Office of Management and Budget’s Office of Information and Regulatory Affairs, FDA’s Taylor would not name any particular sticking points. He said the rules are particularly complex and the timeline is “not out of the ordinary.” “What’s been impressive to me is how complicated it gets when you’re designing a new system,” he said. “And then you have to work out the intricacies of how [all the FSMA rules] work together.” Some stakeholders have speculated that the concerns of foreign governments might have had a hand in the long review, as the rules would need to be carefully crafted with trade concerns and the United States’ World Trade Organization obligations in mind. Ben England, former regulatory counsel at FDA and a founding member of FDAimports.com, said he thinks that there is going to be intense push back from the international community on the new proposals. “These regulations are going to be ugly,” said England, who served at FDA for 17 years, but now advises a variety of import clients. While he thinks the idea of foreign supplier verification makes sense, England believes the way Congress outlined the program is problematic because it doesn’t recognize the complexity of the global food system. Many food companies shipping food to the U.S., for example, are sourcing ingredients from all over the world. In that case, it’s very doubtful FDA would be able to regulate so many steps up the supply chain, according to England. “There will be international resistance to FDA reaching their fingers all the way up the supply chain, across multiple supply chains in multiple countries,” he said. Both proposals, which are around 200 pages each, will be posted to the federal register today and stakeholders will be given 120 days to comment on them. Taylor told Food Safety News that the new 60-day extension of the comment period for preventive controls and produce safety, which comes after another extension issued in April, will be the last. As Food Safety News has reported, the implementation of FSMA has been severely behind the schedule mandated by Congress and the FDA is now under court order to publish all rules required by FSMA by mid-2015. This article has been updated to include links to the proposed rules, estimated costs, and inspection numbers.

Government Extends Review of Smithfield-Shuangui Deal

Helena Bottemiller — Thu, 25 Jul 2013 06:01:17 +0000

The U.S. government will extend its review of the proposed sale of Smithfield Foods to Shuanghui International, which would be the largest Chinese takeover of a U.S. company, Smithfield said on Wednesday. The Virginia-based company said the Committee on Foreign Investment in the United States (CFIUS), the interagency group charged with reviewing the national security implications of foreign acquisitions, notified all parties that it will take an additional 45 days to review the deal that was submitted to the panel on June 18. Lawmakers, food safety groups and consumers have expressed concerns about what the sale of the world’s largest pork processor to a Chinese company might mean for food safety, but most experts expect the deal will be approved. Smithfield said both companies expect the transaction to close in the second half of 2013. While being grilled by the Senate Agriculture Committee earlier this month, Smithfield CEO Larry Pope vowed that the sale would have no impact on the quality or safety of Smithfield’s products. “It will be the same old Smithfield, only better,” Pope said. “There should be no noticeable impact in how we do business operationally in America…except we plan to do more of it.” Sens. Debbie Stabenow (D-MI) and Thad Cochran (R-MI), chairwoman and ranking member of the Senate Agriculture Committee, have urged the CFIUS panel, which is led by the Treasury Department and includes most national security-focused agencies, to include the U.S. Department of Agriculture and the U.S. Food and Drug Administration “We believe that our food supply is critical infrastructure that should be included in any reasonable person’s definition of national security,” read a letter signed Stabenow, Cochran, and 13 of their agriculture committee colleagues. “Any CFIUS review of this transaction should look beyond any direct impact on government agencies and operations to the broader issues of food security, food safety, and biosecurity.” Shuangui was embroiled in a high profile food safety scandal in 2011 after a state-run media outlet found the company was selling pork tainted with clenbuterol, a lean- and growth- promoting drug that is widely banned because it is dangerous at low levels in meat products. Pope and others have suggested the company is seeking to improve its food safety reputation by acquiring the expertise and technology that Smithfield Foods has developed and also by using a trusted American brand name. The CFIUS panel responded to the letter but did not comment on the request, noting its review process is confidential. Photo of truck pulling into food bank courtesy of Smithfield Foods, Inc flickr.

Expert: Boston Restaurants Closed for Salmonella Had 'Pitiful' Food Safety Program

Helena Bottemiller — Tue, 23 Jul 2013 06:35:42 +0000

Clover Food Lab, a popular group of restaurants and food trucks in the Boston area that sells locally sourced vegetarian food, had a “really pitiful” food safety program leading up to a local Salmonella outbreak tied to the company, according a leading food safety and restaurant inspection expert. After the Boston Globe reported that the restaurant group was shuttered after being linked to a 12-person Salmonella outbreak and posted the restaurants’ health inspection report online, Food Safety News asked Roy Costa, a veteran food safety trainer and founder of Environ Health Associates consulting firm, to evaluate the report. Costa said Clover appeared to have a “really pitiful” or nonexistent food safety program in place. “It was a shocking operation,” Costa said. “They don’t have a food safety program. Let’s put it that way. They were operating by the seat of their pants.” Clover underwent an inspection on July 12, according to the five-page inspection report, in response to a foodborne illness complaint. Inspectors cited the restaurant for having spoiled cauliflower on hand, for not having “necessary supervision of operation” related to food safety, and for keeping wild rice salad, hummus, pickled onions, boiled eggs and caramelized onions at temperatures between 49 and 55 degrees Fahrenheit — well above the 41 degree threshold that’s considered ideal for hampering the growth of bacteria. The city also docked the company for having open whoopie pies within customer reach (instead of being behind a sneeze guard) and for having open food in a prep sink where it could have been “subject to splash from the hand wash sink.” The report asked the restaurant to “eradicate drain flies,” deal with water on floors and keep a clean walk-in fridge floor, and listed several other violations. “This facility is closed, the food trucks are out of service; no food production at this facility for any retail affiliate or food trucks until further inspection and approved by City of Cambridge Inspection Service [Department],” reads the report. “No food prep, no food receiving, no cooking of any food or beverage items, no CSA [Community Supported Agriculture] pickups, until all violations are corrected and the ISD [Inspection Service Department] approves to reopen.” In case the city wasn’t getting the point across, the report adds: “NO FOOD IN OR OUT.” Costa said Clover is “unfortunately” an entirely preventable but predictable case because they had likely expanded quickly. He said that oftentimes food companies or restaurants that scale up can be victims of their own success if they don’t properly manage their operations and keep food safety front and center. “You have to be prepared for that,” Costa said, of restaurants that get into high production. “It totally got away from them.” The Globe reported that Ayr Muir, Clover’s founder and CEO, is being praised for actively communicating with customers via the company’s blog:

On Clover’s website, Muir, an MIT and Harvard alumnus, promotes his company’s “radically different” way of operating without using preservatives or flavor enhancers, while relying on locally grown, mostly organic ingredients. Those qualities and his transparency in reporting the outbreak on his website appear to have cemented Muir’s bond with his customers, judging by the supportive and forgiving comments on Clover’s website; many promised to keep eating there, while others praised Muir for his honesty.

On Monday, Muir highlighted the effort the company is making to respond to the city’s concerns and prevent any food safety issues in the future in a post on the company’s blog. “Why is that walk-in empty? We threw everything out,” he wrote. “Anything that could have possibly been contaminated. All surfaces sanitized multiple times. Environmental testing, all clean. All new food. All employees screened. New food safety procedures throughout entire company. Why? We want to have absolutely no doubt that our food is going to be delicious and safe.” The post said Clover intends to reopen all restaurants this Wednesday and will be giving out free French fries to celebrate, but noted some of the food trucks may take more time to come back online: “we’re still waiting for all the screening results of employees.” Photo courtesy of flickr Creative Commons.

FDA Expands Outreach to Farmers Concerned About FSMA Rules

Helena Bottemiller — Wed, 17 Jul 2013 06:53:04 +0000

The U.S. Food and Drug Administration on Monday stepped up its outreach to small- and medium-sized growers by launching more resources to help explain the sweeping new food safety rules. The move comes after several news outlets ran stories highlighting farmers’ concerns about the costs of the regulations, which were mandated by Congress in the Food Safety Modernization Act enacted in early 2011. After being extended, the comment period for two major proposed rules — one that would require preventive controls for food manufacturers and one that would mandate safety standards for fresh produce — is open until Sept. 16, but it seems the agency is taking a proactive approach to address some of the issues that are sure to be raised by stakeholders. The FDA on Monday issued a handful of documents under a new “Resources for Farmers” section on its FSMA produce safety rule page and posted an interview with Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, complete with a photo of him on a farm. “We want [farmers] to know that we are committed to developing, with their input, a final rule that prevents illnesses but that also is practical and adaptable to a wide diversity of growing conditions and practices,” said Taylor, in the interview. Sustainable agriculture leaders met in Washington, DC on Monday and Tuesday for a series of meetings focused on FSMA and its implications for small- and medium-sized farmers. The National Sustainable Agriculture Coalition participated in meetings with FDA and USDA, as well as consumer and produce industry stakeholders, to discuss their concerns about the rules. While big produce interests vigorously lobbied against the Tester-Hagan amendment, which NSAC supported, to exempt certain farms from the bulk of FSMA when the legislation was being debated in Congress, the two groups are finding that some of their members have overlapping concerns about the details of the produce safety rule. For example, there has been considerable press coverage of farmers’ concerns, especially coming from tree fruit growers who take particular issue with the proposed water testing provision. Sustainable and conventional agriculture groups share many of the same concerns about the proposed requirements for water. “We are glad that FDA is doing outreach to farmers about the proposed rules, but we continue to have a number of concerns with the proposed rules that need to be addressed for these rules to work for diversified sustainable and organic farmers,” said Ariane Lotti, assistant policy director at NSAC. “We really want to make sure these rules work for all types of supply chains,” added Lotti. “We want to make sure no one is going out of business.”

FDA Proposes Limit for Arsenic in Apple Juice

Helena Bottemiller — Mon, 15 Jul 2013 04:26:28 +0000

The U.S. Food and Drug Administration on Friday proposed a limit for arsenic in apple juice, two years after testing by Dr. Oz and Consumer Reports spurred widespread consumer concern about the presence of the compound in juice products. The Environmental Protection Agency already has an arsenic limit for tap water, but the FDA’s new proposal is the first such federal standard for a food product. The proposed limit, or “action level,” for inorganic arsenic — the harmful form of the chemical that is a known human carcinogen — matches the EPA’s current threshold for inorganic arsenic at 10 parts per billion. Consumer groups and a handful of Democrats ramped up their calls for a federal limit for arsenic in juice after two rounds of testing in 2011 showed arsenic is often found in apple juice and in some cases exceeds the EPA’s limit for drinking water. Consumer Reports’ testing found a full 10 percent of juices tested were over the EPA limit for water. The FDA has maintained that juices are safe to drink, in moderation, like any other food or beverage, but after such high-profile attention to the issue and the special concerns raised about children’s exposure, the agency said it would study the issue and look at setting limits. When asked why it took two years for FDA to move forward, Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine, noted the proposed limit is “based upon a careful risk assessment.” “It takes time to put that together and put it through the proper review,” he said. “It’s important to get it right.” The risk assessment, industry guidance, and draft action level the agency came up with were also reportedly under lengthy review at the Office of Management and Budget’s Office of Information and Regulatory Affairs, an obscure but powerful agency at the White House that has been blamed for the delay of numerous health and safety regulations. The FDA has been monitoring apple juice for arsenic for the past two decades and the overall levels found have been low. New tests have allowed the agency to better distinguish between inorganic arsenic and organic arsenic, which is not considered a public health concern. In the latest round of testing of 94 samples, FDA found that 95 percent were below 10 ppb of total arsenic and 100 percent were below 10 ppb for inorganic arsenic. Consumers Union, the advocacy arm of Consumer Reports, had recommended a 3 ppb limit, but the group still praised FDA’s proposed action level. Dr. Urvashi Rangan, director of consumer safety and sustainability at Consumer Reports, called the move “a reasonable first step in protecting consumers from unnecessary exposure to arsenic.” “It also offers an important enforcement and accountability tool for regulators and a key benchmark for apple juice manufacturers,” said Rangan, who urged parents to moderate their kids’ juice consumption along the guidelines issued by the American Academy of Pediatrics. The physicians group recommends children from one to six years of age not have more than four to six ounces per day. Wenonah Hauter, executive director of Food & Water Watch, said the group was “extremely pleased” with FDA’s announcement and pointed out two-thirds, or about 400 million pounds, of the apple juice consumed by Americans comes from China each year. FDA said it plans to take the 10 ppb level into account when considering taking enforcement action “if it finds a food product exceeds the threshold,” but Taylor told Food Safety News that FDA does not have plans to increase testing on apple juice beyond the agency’s normal sampling. Taylor also noted the agency has not found a significant difference between the levels of arsenic found in imported and domestic juice products. “In terms of public health priorities and fairly limited resources we don’t think it would be justified to significantly ramp up testing,” he said. “But we’ll keep our guard up.” The agency is seeking comments on the proposed action level and risk assessment for the next 60 days. Rice up next Arsenic – which is both naturally occurring and the product of human activities like burning fossil fuels and pesticide use – is likely to continue to be in the spotlight as FDA studies the levels of the compound that can be found in rice, an issue that health groups have also focused on in recent years. Consumer advocates and lawmakers have asked FDA to set limits for arsenic in rice products, but the agency is still in data-analysis mode after testing some 1,200 samples. “We’re coming along,” said Taylor, when asked about FDA’s timeline. “It’s an important project and it’s on our front burner.”

House Clears Portion of Farm Bill with Provision Aimed at Delaying FSMA

Helena Bottemiller — Fri, 12 Jul 2013 07:04:48 +0000

The House took a new approach to passing the long-stalled farm bill on Thursday: it passed a version that included farm programs, but left off the nutrition section, which represents 80 percent of the bill’s price tag. While much of the focus in Washington is on the political implications of splitting the farm bill into two, food safety advocates are concerned because the version that cleared the House could further delay implementation of the Food Safety Modernization Act. A little-known provision in the bill sponsored by Rep. Dan Benishek (R-MI) that was added to the farm bill last month would require the U.S. Food and Drug Administration to conduct a “scientific and economic analysis” of FSMA regulations before they can move forward, a requirement that could further delay regulations that are severely behind the deadlines set by Congress. Benishek, who has tree fruit farmers in his Northern Michigan district, says he wants to make sure FDA is getting the rules right so it doesn’t hinder farmers. Apple, cherry, and other tree fruit growers have been among the most outspoken critics of proposed FSMA regulations for produce safety. The groups are particularly upset about new water testing requirements they view as onerous and unnecessary. Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, thinks Benishek’s amendment could “significantly delay” the rules FDA is working on. “What this provision does is totally undermine the process we have for regulations in this country,” said Eskin, noting that FDA has published regulatory impact reports that include analysis on the costs and benefits of each proposed rule. The bill specifically says FDA may not enforce any of the FSMA regulations until the analyses are published to the federal register, but some in the produce industry think that the requirement might not stall the rules if it becomes law because FDA is already focusing on the science and considering the economic impact. Consumer advocates are hoping that Sens. Tom Harkin (D-IA), Dick Durbin (D-IL), and others who were champions for the sweeping food safety law, will ensure the measure is stripped when the House and Senate reconcile their respective versions in conference. Sen. Harkin took to Twitter Thursday afternoon and said the House had passed “a farm bill that nobody wants,” adding that it “would undermine critical food safety law” while foodborne illness continues to impact 1 in 6 Americans annually. The farm program-only farm bill cleared the House 216 to 208 with no support from Democrats. House Majority Leader Eric Cantor said leadership is in discussions about bringing the nutrition title, which deals with the Supplemental Nutrition Assistance Program, to the floor “sometime in the near feature,” but the path forward for SNAP is not clear. The House version seeks $20 billion in cuts to nutrition assistance over the next 10 years — significantly more than the Senate’s $4 billion scale-back. Senate Agriculture chairwoman Debbie Stabenow (D-MI) said the House’s first phase of the farm bill is “not a real Farm Bill and is an insult to rural America.” She pointed out that splitting the bill in two was “strongly opposed by more than 500 farm, food and conservation groups.” “We will go to conference with the bipartisan, comprehensive Farm Bill that was passed in the Senate,” said Stabenow. Frank Lucas (R-OK), chairman of the House Agriculture Committee — who had made it clear he thought splitting the bill was a bad idea — said the vote was “an important step toward enacting a five-year farm bill this year that gives our farmers and ranchers certainty.” Lucas said he would be continuing conversations with lawmakers in both chambers to find a path “that ultimately gets a farm bill to the President’s desk in the coming months.”

Smithfield CEO Tells Lawmakers Shuanghui Deal Won't Impact Food Safety

Helena Bottemiller — Thu, 11 Jul 2013 05:20:48 +0000

American consumers will not be impacted and the safety of pork products will not diminish if Smithfield Foods is acquired by Shuanghui International, Smithfield’s CEO Larry Pope told the Senate Agriculture Committee at a hearing Wednesday. The assurances come as the proposed $4.7 billion sale, which would be the largest ever Chinese acquisition of an American company, is facing an interagency government review and increased scrutiny on Capitol Hill. Fielding tough questions from lawmakers about the potential downsides of the deal, Pope, who will remain CEO, was upbeat about the acquisition. He said the deal would deliver more American jobs and increase exports. “It will be the same old Smithfield, only better,” he said, noting that pork producers and industry groups are supportive. “There should be no noticeable impact in how we do business operationally in America…except we plan to do more of it.” Pope’s view was backed up by the testimony of Matthew Slaughter, an associate dean at the Tuck School of Business who served on the Council of Economic Advisors to President Bush. Slaughter said the investment and the increased trade with China is exactly what the sluggish economic needs, adding that a smooth transaction would signal that the U.S. is ripe for foreign investment. On the whole, however, the hearing was extremely divided. Committee chairwoman Debbie Stabenow (D-MI) raised concerns about the Chinese meat company gaining access to valuable pork industry technologies that were heavily supported by taxpayer-funded research and seriously questioned the federal government’s process for reviewing such acquisitions. Stabenow and more than a dozen senators from the committee recently asked the Committee on Foreign Investment in the United States (CFIUS), headed by the Treasury Department, to include the U.S. Food and Drug Administration and the U.S. Department of Agriculture in its review of the proposed deal because of the potential threats to food security and public health, but it’s not clear whether that will happen. In a letter to the committee this week, the Treasury did not respond to that request, but noted that its review process is confidential. During the hearing, lawmakers echoed the concerns many consumers have: that the deal will ultimately result in the U.S. importing more food from China in the wake of multiple unsavory and dangerous food scandals. Pope told the committee that the acquisition “will not result in any imports of food into the U.S. from China” and said specifically that China has “no plans” and “no applications in place” seeking permission from the USDA to sell its meat products to U.S. consumers. He also reminded the committee that regardless of who owns the company, it will be under strict scrutiny by the USDA’s Food Safety and Inspection Service, which oversees the safety of all meat, poultry, and processed egg products in the U.S. “We’re going to protect these brands and products and if we don’t the U.S. government will,” he said. “You know how tight those inspection processes are.” Daniel Slane, Commissioner of the U.S.-China Economic and Security Review Commission at the U.S. Chamber of Commerce, told the committee he thinks the long-term implications of the deal are wholly negative. “This is all about control,” said Slane, who argued that giving Shuangui access to technology and intellectual property could end up disadvantaging American producers. Eventually, he said, China can use that knowledge to achieve the same efficiency in their production and undercut U.S. pork exports to the Pacific Rim. “Their endgame is to dominate our markets.” Dr. Usha Haley, a professor for the Robbins Center for Global Business and Strategy at West Virginia Univeristy, was equally critical in her testimony before the committee. “I don’t think shanghai is buying Smithfield for its pork,” said Haley. She believes the deal is about Shuanghui’s access to intellectual property and technology and assuaging local consumers’ food safety concerns by using an American brand. Even if China gobbled up Smithfield’s entire production, she said, it would only account for about 3 percent of the country’s total pork consumption. “China is not seeing this as one acquisition,” she said. “China sees this as a foot in the door.” Haley said she also believes the deal will ultimately impact food safety. In June, she penned an Op-Ed for USA Today arguing against the Smithfield sale. “Shuanghui’s culture exudes outrageous food-safety violations and a history of food adulteration. For example, the company finally shut down a plant after numerous reports that it fed pigs a chemical that sickened humans but enhanced leanness in pork,” she wrote. “Over the past five years, U.S. pork purchases in China rose 155%, one of the few areas in which a trade surplus with China exists. China’s history of forced technology transfer to access markets indicates that other Chinese demands will follow.” Stabenow said she remains concerned about the adequacy of the government’s review process. “I really believe this is a precedent-setting case,” she said. “We need to be thoughtful on behalf of consumers and producers and the broader economy.”

Fast Response May Limit Scope of Listeria Outbreak Linked to Cheese Sold Nationwide

Helena Bottemiller — Wed, 10 Jul 2013 04:58:20 +0000

The rapid detective work that linked a four-state Listeria outbreak — which has killed one person, caused a miscarriage, and hospitalized four others –- to cheese sold nationwide could prevent many illnesses, according to health officials. Dr. Barbara Mahon, deputy chief of the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention, told Food Safety News that Minnesota state health officials played a critical role by quickly detecting a cluster of illnesses. According to Dr. Mahon, the total number of Listeria cases reported to PulseNet, CDC’s national foodborne illness surveillance system, did not rise above normal during the outbreak. Minnesota began an active investigation into two local cases and soon realized there were cases reported in Illinois, Indiana and Ohio that matched the cluster. Once Minnesota contacted CDC, it took just six days to identify the likely cause of the outbreak as Crave Brothers Les Frères cheeses and to take action with a CDC announcement and a nationwide recall. This was a significantly shorter timeline than the average Listeria outbreak investigation, according to Mahon. “Listeria outbreaks can be slow moving and they can continue for a time even after contaminated food is removed from the market,” she said. “We’re very pleased with how well this came together to get product off of shelves as quickly as possible.” CDC does expect more cases will be reported and added to the outbreak, but the official count still stands at five cases in four states. That number includes one reported death of an elderly person in Minnesota and four other hospitalizations, including one woman who suffered a miscarriage. Mary Choi, a spokeswoman for the Minnesota Department of Health, said pinpointing the likely cause of the outbreak was “a collaborative effort” between CDC, the U.S. Food and Drug Administration, the Minnesota Department of Agriculture, and the foodborne epidemiologists from Illinois, Indiana, and Ohio. Choi said testing done by the Minnesota Department of Agriculture found the outbreak strain of Listeria in two samples of Crave Brothers cheese products purchased from two separate retail locations in Minnesota. The soft cheeses in question were sold by Whole Foods in 33 states and the District of Columbia and by Kroger in 20-some states. Dillons, Baker’s, Fred Meyer, Ralphs, QFC and Gerbes retailers also sold the recalled cheese. FDA’s food recall section has a full description of all of the cheeses recalled. Three types of cheese are involved: Les Frères, Petit Frère, and Petit Frère with Truffles cheeses — all made by Crave Brothers Farmstead Cheese Company in Waterloo, Wisconsin. The cheeses were sold under the Whole Foods label. Whole Foods said it has posted signs in its stores to notify consumers. Customers who purchased the product should discard it and bring in their receipt for a full refund. Pregnant women, the elderly, and those with compromised immune systems are particularly at risk for illness after consuming Listeria-contaminated products. Healthy individuals usually do not get sick, but listeriosis can be extremely serious and in some cases fatal. Symptoms can range from high fever, headaches, and abdominal pain to miscarriages and stillbirths among pregnant women. Health officials said the government’s Listeria Initiative also aided the swift response in this particular outbreak. Launched in 2004, the initiative asks state and local health departments to conduct standardized patient interviews as listeriosis cases are reported instead of waiting until after clusters are identified. When clinical pulsed-field gel electrophoresis (PFGE), a type of DNA fingerprinting, results are submitted to PulseNet and a cluster is identified, investigators are able to easily conduct an epidemiological investigation using the patient interviews, which include questions about what foods were consumed the month before they got sick. “The listeria questionnaire was really helpful in solving this outbreak…because it’s a standardized questionnaire, it made it very easy to compare exposures between cases,” said Choi, in an email to Food Safety News. Dr. Mahon at CDC agrees. She said the initiative has helped limit the impact of Listeria outbreaks because the public health response has gotten much faster than it was two decades ago. Even the catastrophic Listeria outbreak tied to Colorado cantaloupes is an example of rapid response. Had the investigation taken another week, or longer, thousands of pounds of potentially contaminated cantaloupes would have remained on the market. “Back in the 80s, these types of investigations took weeks, even months,” said Mahon. “Six days is pretty good. We’re really starting to see this initiative pay off.”

HACCP Validation: A Long Road to Clarification

Helena Bottemiller — Mon, 08 Jul 2013 04:16:10 +0000

While the U.S. Department of Agriculture’s Food Safety and Inspection Service has been requiring meat and poultry plants use Hazard Analysis and Critical Control Point, or HACCP, systems since the late 1990s, the details of how exactly plants validate those systems to ensure they work has been a topic of recent debate and increasingly a focus of the agency. According to FSIS, the initial roll out of HACCP across the industry was focused on making sure all plants had met their basic requirements, but as the years rolled on the agency became concerned about whether small and medium sized plants had designed and documented their systems with enough rigor. In March 2010, FSIS posted an initial draft guidance to help the industry, particularly small and very small plants, comply with the HACCP validation regulations that were already on the books. When FSIS talks about validation, it’s referring to the process of demonstrating that a HACCP system works as it is designed to. There are two parts to validation, according to the agency. The first is making sure you have the right technical or scientific justification that the process can control the particular hazard, whether it is Salmonella or E. coli O157:H7. The second is proving the system can actually do what it is supposed to, that the plan on paper works in practice. This may sound like a straightforward idea, but the agency’s draft guidance set off a firestorm of concern among small and independent plants with few resources to dedicate to regulatory requirements. Of the roughly 6,000 plants FSIS regulates, nearly half of them are very small and another 2,000 are small, while 391 are categorized as large, according to the agency. In June 2010, when FSIS held a public meeting at USDA in Washington, DC to discuss the first draft of the guidance, Administrator Al Almanza told the audience that he had held the document for a while saying, “I knew it was going to have a significant impact across the Agency.” “I am excited about the opportunity to have this public meeting and the additional two meetings because I think that we need to clarify what our position is, and that’s one thing that I think got lost along the way,” said Almanza. FSIS’ position had gotten more than lost. Many in the industry were concerned the guidance was a warning that burdensome testing requirements were coming. Bob Hibbert, a lawyer representing the Eastern Meatpackers Association, summed up the concerns among small and medium sized operations. “What you would hope, after about 15 years or so of HACCP, is that we would all be moving in the direction where this is becoming increasingly known territory, where we have enough experience, enough precedent, enough understanding about what has worked and hasn’t worked to be increasingly useful for people navigating this space,” he said. “Unfortunately, despite the agency’s intentions, I think the current draft is a step backward in that regard.” Hibbert said that people in the field – the ones who matter the most: people working in the plants and FSIS officials enforcing HACCP – were reading the guidance to mean that FSIS would be looking for a lot more tests results. “The message to the establishments now is you’d better test the heck out of everything if you want to avoid problems with enforcement,” said Hibbert. “That’s a problem.” Joe Cloud, co-owner of True and Essential Meats, a very small multi-species plant in the Shenandoah Valley in Virginia, appeared at the meeting after writing to FSIS expressing concerns about how onerous testing requirements could harm his business, which is booming thanks to the growing local food movement. “I’m here today because I do have a concern that FSIS does not necessarily understand the needs and realities of very small plants,” said Cloud. “I’m here to ask that the agency keep in mind the realities of small community-based plants as you proceed,” he said. Over the past three years, the agency has made a concerted effort to clarify the guidance and help smaller plants understand what is expected of them and how to comply. The outreach has included web seminars, public meetings, trainings, and fielding more calls through the small plant help desk, a resource of experts available to answer questions and help plants comply with food safety and labeling requirements. The agency also considered more than 2,000 comments from stakeholders on the first document and worked to address the concerns. In May 2012, FSIS posted a revised draft guidance document and asked for more input. On the second draft, stakeholders logged just 50 comments. “We have finally gotten to a place where the guidance is more understandable and user friendly,” said Daniel Engeljohn, Deputy Assistant Administrator, of FSIS’ Office of Field Operations. “Truly, it’s because we’ve been responsive to the comments. “

FSIS inspector and plant personnel review plant documentation to ensure compliance with a HACCP plan on May 13, 1996. USDA photo by Bob Nichols courtesy of flickr.

“We wrote it so it would be especially helpful for small plants,” said Engeljohn, pointing out that FSIS has included more examples and explanations in the latest draft. FSIS has also charged its Enforcement, Investigations, and Analysis Officers (EIAOs) to be more helpful to plants that need it. “We’re not writing their plans for them,” said Engeljohn, “but answering their questions.” Tony Corbo, a lobbyist for Food & Water Watch, a group often critical of USDA, gives credit to the agency for their work on the guidance. “They’ve made progress in terms of trying to give flexibility to the small guys,” said Corbo. Faith Critzer, a food safety extension specialist and professor at the University of Tennessee agrees that FSIS outreach has been key. “I think they’ve been putting their best foot forward,” she said. “They’ve been working in good faith with industry to make it as easy as it can be.” “I think it’s just as important for small and medium size plants as it is for large,” she added. “It’s just harder for smaller and medium size plants because they don’t have the same resources.” Through the University of Tennessee’s food safety extension program, Critzer works with plants of all sizes to help them improve their food safety practices. The extension pulls scientific literature to help support HACCP plans. They also help processors figure out whether they need to do their own study to back up their practices or whether they can tweak their process. Corbo does remain concerned about how firms can get access to the information they need about validation. In 2011, the National Advisory Committee on Meat and Poultry Inspection (NACMPI) recommended that FSIS support the creation of a consortium of scientists, processors, extension specialists, consumer groups, and trade associations to focus solely on validation. “FSIS doesn’t seem to be interested in doing that,” said Corbo. Plants of all sizes do have resources at their disposal. Agricultural extensions can be invaluable, companies can call the small plant desk, seek out scientific research on their own, or use industry associations and experts – but all of this takes time, and if further study or testing is needed, money. While everyone seems to agree FSIS has made strides in better communicating what they expect, and making the guidance more useful, there is still uncertainty about how it will all work in practice. Critzer said she thinks the FSIS’ validation guidance is on the radar of many small plants, but “it’s not necessarily something they’ve spent a lot of time on.” Three years after the initial public meeting on HACCP validation, Joe Cloud, of True & Essential Meats, told Food Safety News he is still not sure quite what to expect, but he remains concerned about the amount of work that could be required to meet the validation requirements, since his very small plant does not have dedicated scientific staff focused on HACCP like large plants do. “I really don’t know exactly what’s going to be required,” he said. “There are still a lot of unknowns.”

Investigation into Hepatitis A Outbreak Is ‘Very Complicated,’ Says FDA

Helena Bottemiller — Wed, 03 Jul 2013 05:01:50 +0000

Figuring out that pomegranate seeds from Turkey are likely what is responsible for infecting at least 132 people with Hepatitis A was unusually difficult, according to investigators at the U.S. Food and Drug Administration. The ongoing investigation into the outbreak, which spans 8 states, is “very, very complicated,” said Carla Tuite, the lead on the response team handling the outbreak at FDA. Tuite is part of the agency’s Coordinated Outbreak Response and Evaluation (CORE) Network, a multidisciplinary team that works closely with states and the Centers for Disease Control and Prevention to solve foodborne illness outbreaks. “It’s a challenging outbreak due to the type of contaminant,” said Tuite, during a CORE interview with Food Safety News on Tuesday. “It’s unusual to get a virus in a product. When you’re talking about traceback and making sure you have all the right epidemiological information, it can be challenging.” “I think of all the investigations we’ve been on, this is one of the ones that’s been the most challenging we’ve faced,” she added. While public health officials had linked the growing outbreak to Townsend Farms Organic Antioxident Blend, a frozen berry mix, more than a month ago, they had not definitively identified which of the five types of berries in the blend was the culprit. Over the weekend, FDA announced they had traced the problem back to a common lot of pomegranate seeds from Turkey, sold by Goknur Foodstuffs Import Export Trading. The agency said it would detain any further pomegranate seeds from the company at ports of entry. When asked how much product was impacted by the import action, Tuite noted that the situation is still developing, but said it was “a large lot, a large amount of pomegranate seeds that come into the country.” Last week, Scenic Fruit recalled 60,000 packages of pomegranate seeds, which were also imported from Turkey, out of concern they might have been linked to the outbreak. Now, FDA investigators are in overdrive trying to figure out where else the imported pomegranate seeds might have been sold and whether there need to be more recalls. According to Kathleen Gensheimer, the chief medical officer and director of CORE, one of the most challenging factors in this outbreak is the lengthy incubation period for the hepatitis A virus. Once exposed, it can take anywhere from 15 to 50 days to get sick, and people usually do not remember what they ate a month ago, or even a few days ago. Making the situation even more complicated, the implicated berry blend contains five types of berries, which were sourced from different farms in various countries. On the Townsend Farms package it says the berries were from Turkey, Chile, Argentina, and the United States. “No epidemiologic interviews on the part of the patients really could have distinguished whether it was the strawberries, the raspberries, the cherries, the blueberries, or the pomegranates from this frozen blend,” explained Gensheimer. She said FDA honed in on the pomegranate seeds through “very, very tedious, time consuming, and very careful analysis” of all the records provided by Townsend Farms. Through this extensive traceback effort, investigators were able to identify a common lot of that was used in products that had been linked to cases of hepatitis A. Luckily, the pomegranate seeds were the only commonality. “What I compare it to is a 25,000 piece jigsaw puzzle,” said Gensheimer. “When you try to put all these pieces together and have them make sense, it is truly, truly tedious.” The other complicating factor is that it can be tricky to find hepatitis A in food products. “It’s not like Salmonella or an E.coli organism,” explained Gensheimer. “A virus is just different than a bacteria it’s not something you can grow out on a special media.” She said special methods had to be developed by FDA in the early stages of the outbreak to help investigators look for possible contamination. “We’ve yet to identify any positive product,” she said. “I’m not really sure that that represents a lack of contaminated product or a lack of a test that is quite there yet as far as being able to look for evidence of the hepatitis A virus.” While the next steps are not yet clear, FDA is coordinating with Turkey on the matter. “There is strong interest on the part of Turkey – they obviously have some political issues going on at the moment – but in the initial conversations FDA has had with the Turkish government, it’s clear they’re very concerned about this,” Gensheimer said of the current outbreak, noting that the Turkish government said it had sent someone to look into the plant at the center of the issue. FDA spokesman Doug Karas said FDA is communicating with Turkey’s Ministry of Food, Agriculture and Livestock.

FDA to Block Pomegranate Seeds from Turkey; Townsend Recall Expands

Helena Bottemiller — Mon, 01 Jul 2013 04:02:49 +0000

Updated July 30 with expanded recall information: The U.S. Food and Drug Administration said on Saturday it will detain shipments of pomegranate seeds from Turkey as health officials have narrowed the likely cause of a Hepatitis A outbreak that has sickened at least 127 people in 8 states. On Sunday, one of the frozen berry recalls associated with the outbreak expanded. The agency has worked with the Centers for Disease Control and state and local health authorities for several weeks to try and track down the ingredient making people sick. Health officials have now determined that the “most likely vehicle” for the virus appears to be a common shipment of pomegranate seeds from Goknur Foodstuffs Import Export Trading of Turkey that were used by Townsend Farms to make Organic Antioxidant Blend, a mix of frozen berries, sold to Costco and Harris Teeter stores. FDA is now barring Goknur from shipping pomegranate seeds into the United States. It is not clear how much product is impacted, but an FDA official noted that Turkey is a “minor player” compared to countries like India, Iran, China, and Thailand, when it comes to providing pomegranate to the U.S. market. “This outbreak highlights the food safety challenge posed by today’s global food system,” said Michael Taylor, deputy commissioner for foods and veterinary medicine, in a press release over the weekend. “The presence in a single product of multiple ingredients from multiple countries compounds the difficulty of finding the cause of an illness outbreak. The Hepatitis A outbreak shows how we have improved our ability to investigate and respond to outbreaks, but also why we are working to build a food safety system that more effectively prevents them.” The Townsend Farms blend has been linked to the multistate outbreak affecting mostly western states. According to CDC, about half of the reported Hepatitis A cases are in California. Colorado has reported 25 and Arizona 17. Hawaii is reporting 7, New Mexico and Nevada have 5 cases and Utah and Wisconsin have 2 each. The cases reported in Wisconsin, however, resulted from exposure to the product in California, according to health officials. Nearly 60 percent of those sickened are women. The ages in the outbreak range from 2 to 84 and include 6 children under the age of 18. CDC said none of the children had been vaccinated. More than half of those ill required hospitalization. The outbreak strain of hepatitis A virus, belonging to genotype 1B, is rarely seen in the Americas but circulates in North Africa and the Middle East, according to CDC. The outbreak has sparked several large recalls. In early June, Townsend Farms recalled more than 300,000 four pound packages of the frozen berries sold at Costco and then issued another recall of berries sold at Harris Teeter. Last week, Scenic Fruit Company recalled over 60,000 bags of Woodstock Frozen Organic Pomegranate Kernels because their product, imported from Turkey, has the potential to be contaminated with Hepatitis A. On Sunday, FDA announced the Townsend Farms frozen berry recall has been expanded again. The company is now recalling Townsend Farms Organic Antioxidant Blend, 3 lb. bag with UPC 0 78414 40444 8. The codes are located on the back of the package with the words “BEST BY” followed by the code T122114 sequentially through T053115, followed by a letter. All letter designations are included in the voluntary recall, according to the expanded recall announcement. The announcement also said that the epidemiological evidence “does not support an association between the illness outbreak and the four other berry products (raspberry, blueberry, strawberry and dark cherry) in the Frozen Organic Antioxidant blend,” which were also used in other Townsend Farms products, so consumers do not have reason to be concerned about those berries. Townsend Farms said an FDA inspection of the company’s frozen fruit repacking operations has been completed. “The FDA found no evidence linking either the Townsend Farms, Inc.’s repacking facility or any food handler who had possible contact with the product to the source of the illness outbreak,” according to the release. Hepatitis A, a liver disease, can range from mild to severe and can last anywhere from a few weeks to several months. Symptoms usually occur within 15 to 50 days of exposure and include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool. If a person has been exposed to the Hepatitis A virus within two weeks or less, they may be able to prevent the disease by receiving a vaccine. Consumers who may have eaten recalled product or have Hepatitis A symptoms should consult with their healthcare provider or their local health department.

Hepatitis A Cases Rise to 127; FDA Identifies Pomegranate Shipment from Turkey

Helena Bottemiller — Fri, 28 Jun 2013 18:42:49 +0000

The Hepatitis A outbreak linked to frozen mixed berries continues to grow. On Friday, the Centers for Disease Control and Prevention said five more illnesses have been confirmed as part of the outbreak, bringing the total to 127 ill in 8 states, and the U.S. Food and Drug Administration said it thinks it has identified a common shipment of pomegranate seeds from Turkey that may have been to blame. According to CDC, all of the confirmed victims became ill after eating Townsend Farms Organic Anti-oxidant Blend, a frozen berry blend sold across the country in Costco stores. Harris Teeter also sold the now recalled product, but so far no illnesses have been linked to the retailer. Three weeks ago, Townsend Farms Inc. recalled certain lots of the frozen berries linked to the outbreak. This week, Scenic Fruit Company recalled certain lots of Woodstock Frozen Organic Pomegranate Kernels, also thought to be at risk for contamination. Both companies initiating recalls are based in Oregon. “FDA and CDC have determined that the most likely vehicle for the Hepatitis A virus appears to be a common shipment of pomegranate seeds from Turkey used by Scenic Fruit Company to make the recalled Woodstock Frozen Organic Pomegranate Kernels and by Townsend Farms to make the recalled Townsend Farms and Harris Teeter Organic Antioxidant Blend,” FDA said in an update to reporters on Friday. “The FDA reviewed records and determined that the pomegranate seeds from this shipment were the only ingredient common to all of the recalled Townsend Farms and Harris Teeter Organic Antioxidant Blend,” the update added. “FDA will be working with the firms who have distributed pomegranate seeds from this shipment from Turkey to help ensure that all recipients of these seeds are notified.” According to Lynne Terry of the Oregonian, the seeds originally came from Goknur, a fruit company based in Ankara, which shipped them to Purely Pomegranate, Inc., in Dana Point, Calif., according to a letter from Purely Pomegranate to its customers. Purely Pomegranate then resold them. Townsend Farms included the seeds in its Organic Antioxidant Blend, Gaar said. Scenic Fruit Co. in Gresham packaged the frozen seeds for Woodstock Farms in Providence, R.I. under that company’s label, said Ryan Wist, food safety manager for Scenic. The updated case count by state is as follows: Arizona (17), California (64), Colorado (25), Hawaii (7), New Mexico (5), Nevada (5), Utah (2), and Wisconsin (2). [Note: The cases reported from Wisconsin resulted from exposure to the product in California.] Nearly 60 percent of those sickened are women. The ages in the outbreak range from 2 to 84 and include 6 children under the age of 18. CDC said none of the children had been vaccinated. More than half of those ill required hospitalization. The outbreak strain of hepatitis A virus, belonging to genotype 1B, is rarely seen in the Americas but circulates in North Africa and the Middle East, according to CDC. Anyone concerned about exposure should contact their healthcare provider or health department. Consumers exposed to Hepatitis A within the last two weeks may benefit from a vaccine to prevent illness.

With Recent Victories, Movement to Label GMOs Gains Steam

Helena Bottemiller — Thu, 27 Jun 2013 06:08:29 +0000

More than six months after a big defeat in California, the movement to label foods containing genetically modified organisms appears to be picking up steam across the country. In the past three weeks, Connecticut and Maine passed labeling bills, the U.S. Department of Agriculture for the first time approved a non-GMO label claim for meat products, Chipotle began voluntarily labeling menu items containing GMO ingredients online, and, perhaps most notably, the Senate Appropriations Committee voted last week to give the U.S. Food and Drug Administration funding to label genetically modified salmon if the agency approves the fish. These are all small steps compared to what California’s Proposition 37 would have accomplished – since the populous state consumes a significant share of groceries in the United States, some speculated that food giants would have reformulated their products to avoid creating two supply chains – but the string of victories has many in the so-called ‘Right to Know’ movement confident the tide is turning in their favor. “It’s simply a matter of time,” said Scott Faber, who serves as executive director of Just Label It, a national advocacy campaign. Faber, who is vice president of government affairs at the Environmental Working Group, used to be a lobbyist for the Grocery Manufacturers Association, which actively lobbies against mandatory labeling initiatives. Faber believes mandated GMO labeling is inevitable in part because the food industry would prefer federal standards over a patchwork of state laws. “I think companies are starting to realize the fight is worse than the label,” he added, noting that campaigns against labeling can harm consumer confidence in certain companies. Some consumers, for example, who buy brands like Cascadian Farm, Kashi, Horizon Organic, Muir Glen, and Odwalla were outraged last fall after learning the companies’ corporate owners had helped fund the effort to defeat Prop 37. The Grocery Manufacturers Association said in a statement that it remains opposed to “special mandatory labeling for food products containing genetically modified ingredients because these labels could mislead consumers into believing that ingredients from genetically engineered plants are somehow different or unsafe or unhealthy – in clear contradiction of scientific fact.” GMA points out that ingredients derived from GM plants have been widely studied and are considered safe by FDA and groups like the American Medical Association. According to the association, foods with genetically modified ingredients make up 70 to 8o percent of the products on grocery store shelves “because they require fewer pesticides, help foods have a longer shelf life and keep production costs down” which reduces food costs for consumers. The group has been actively engaged in the labeling issue and contributed $2 million to help defeat Prop 37, which ultimately went down 51 to 48 percent. In total, $9.2 million was spent in support of the proposition and $46 million was spent opposing it. In a speech last summer to the American Soybean Association, GMA CEO Pam Bailey said, “Defeating the initative is GMA’s single highest priority this year,” according to an account in the Hagstrom Report. “We have worked with you on what we consider to be valuable technology, but in the past year we have seen an increase in the rhetoric against it.” Bailey said the current movement for labeling is stronger than past attempts. “Social media is feeding this effort and making it more difficult to confront and more powerful,” she said, according to the report.

Map indicating which states have pending GMO labeling bills or upcoming ballot initiatives. Credit: Right to Know.

While momentum may by building for labeling advocates, their recent victories come with significant caveats.

The bills approved in Connecticut and Maine only kick in if other states, including a neighboring state, pass labeling requirements. Vermont’s house passed a bill to require labeling GMOs in May, but the state senate is not expected to take up the same law until next year. Labeling legislation or ballot initiatives have been introduced in 25 other states, but it’s not clear how many states would actually adopt them.

Baylen Linnekin, the executive director of Keep Food Legal, a group that advocates against government involvement in the food arena, said he thinks mandatory labeling is unnecessary and still faces significant challenges going forward. “I would not say it’s inevitable,” said Linnekin, explaining that even if labeling laws succeed at the state level they would be challenged in court. In a recent column for Reason, Linnekin argued the government should stay out of the labeling business: “The truth is that most federal labeling schemes are flawed at best, and often involve conflicts and compromises that rob meaning from the label.” On the other hand, Linnekin applauds the voluntary actions by companies like Whole Foods, which announced earlier this year it will require GMO labeling in its stores by 2018, and McDonalds and Starbucks, which both recently adopted calorie labeling on their menus. The non-GMO label approved by the USDA’s Food Safety and Inspection Service last week – the first GMO-related claim allowed on packages – and Chipotle’s decision to note which foods contain GMOs on their online menu are prime examples of voluntary moves to meet niche consumer demands. According to the New York Times, FSIS approved the label – which can be used on meat, poultry, and liquid eggs from animals fed only non-GMO feed – after three meat companies petitioned for similar claims. The claim will be certified by the Non-GMO Project. Private sector labels to help consumers avoid products containing GM ingredients have taken off in recent years. The Non-GMO Project, the leading third-party certifier in North America for non-GMO claims, said interest in certification has increased four-fold in the past year alone as Prop 37 and the Whole Foods announcement have raised consumer awareness about GMOs. The group now certifies more than 10,000 products. “These days you can walk into a gas station and find Non-GMO verified products,” said Courtney Pineau, assistant director of the project. Despite the explosion in voluntary labeling, advocates want a national law. While there are labeling bills in both chambers, no one expects Congress will approve them anytime soon. In May, the U.S. Senate voted on an amendment by Sen. Bernie Sanders (I-VT) that would have allowed states to label GMOs, but the measure failed by a vote of 71 to 27, and some legal experts say the amendment wasn’t necessary. The closest advocates have come to mandatory, national GMO labeling of any kind, was last week when the Senate Appropriations Committee voted 15 to 14 to give the FDA $150,000 to implement labeling for GM salmon if the agency gives the fish a green light, which it is expected to do. FDA has said it would not require the GM salmon to be labeled, which is consistent with the agency’s policy that GM foods are not materially different from non-GM foods. Some advocates think this decision has driven more consumers to support labeling efforts. A Change.org petition asking FDA to require labeling for the modified salmon garnered nearly 25,000 signatures and consumer campaigns pressured Whole Foods, Trader Joes, Target, Giant Eagle, and 50 other retailers to promise they wont sell the fish even if the FDA approves it. A handful of U.S. lawmakers, mostly from states like Alaska, Washington and Oregon, whose wild salmon fisheries are highly lucrative, have opposed approving the GM salmon and have argued that if the fish is approved it should be labeled as a GMO. The labeling amendment that succeeded in the Senate Appropriations Committee was co-sponsored by Sens. Mark Begich (D-AK) and Lisa Murkowski (R-AK). In the House, Rep. Don Young (R-AK) has made similar attempts at mandating labeling for GM salmon. Colin O’Neil, a regulatory analyst for the Center for Food Safety, an anti-GMO advocacy group, called the amendment “a big step forward for labeling in this country” because clearing the committee is a “huge hurdle.” The bill will next head to the Senate floor. The group said it’s not aware of efforts to strip the Begich-Murkowski amendment from the appropriations bill, but said it would be closely monitoring the legislation when it goes to conference to be reconciled with the House version because “we have not seen something like this get that far before.” Correction: This article originally incorrectly stated that Sen. Sanders amendment would have mandated GMO labeling. It has been corrected to reflect that the amendment would have allowed states to label.

Senators Ask Government to Consider Food Safety When Reviewing Smithfield Deal

Helena Bottemiller — Tue, 25 Jun 2013 05:01:43 +0000

Fifteen U.S. senators from both sides of the aisle are urging the government to consider food safety as they review the proposed sale of Smithfield Foods, America’s largest pork company, to Shuanghui International, China’s largest meat processor. The $4.7 billion deal, which would be the largest Chinese takeover of an American company, will be reviewed by the Committee on Foreign Investment in the United States (CFIUS), an interagency committee chaired by Treasury Secretary Jack Lew that includes 16 agencies, including the Defense Department and the Department of Homeland Security, that reviews foreign investment to ensure national security is not compromised. In a letter to the Treasury last week, the Senators asked Mr. Lew to include the U.S. Department of Agriculture and the U.S. Food and Drug Administration in the review process so that both the food supply and food safety issues can be taken into consideration — the latter is especially of concern to American consumers in the wake of a slew of food safety scandals in China. “We believe that our food supply is critical infrastructure that should be included in any reasonable person’s definition of national security,” read the letter, which was signed by 15 out of 20 senators on the Agriculture Committee. “Any CFIUS review of this transaction should look beyond any direct impact on government agencies and operations to the broader issues of food security, food safety, and biosecurity.” Citing the potential for other foreign acquisitions of American food and agriculture companies, the lawmakers said they have questions about “whether the appropriate authorities are evaluating potential risks and proposing sufficient mitigation measures to protect American interests” and asked CFIUS to consider making USDA one of the lead agencies on the committee. “The United States has the safest, most efficient and reliable food supply in the world,” the letter continued. “It is one of our nation’s great strengths, and we must ensure that it is preserved and protected.” The letter, signed by Agriculture Committee Chairwoman Debbie Stabenow (D-MI), Ranking Member Thad Chochran (R-MS) as well as four other Republicans and nine other Democrats, said the committee would examine how the transiction is reviewed and take a look at how similar transactions should be reviewed in the future. News of the sale of Smithfield Foods, garnered a mixed reaction. Agriculture Secretary Tom Vilsack and several food safety experts, including Bill Marler (publisher of Food Safety News), have pointed out that regardless of ownership Smithfield Foods still falls under jurisdiction of the USDA’s Food Safety and Inspection Service, but others have expressed concerns about whether the acquisition could open the door to unsafe products being imported into the United States. Congresswoman Rosa DeLauro (D-CT) said, “This potential merger raises real food safety concerns that should alarm consumers…We know that Chinese food products have been a threat to public health and that Shuanghui was found to have produced and sold tainted pork. This merger may only make it more difficult to protect the food supply.” On Tuesday, China’s Commerce Ministry Shen Danyang responded to the concerns raised by U.S. lawmakers. “China’s quality management of pork imports and Shuanghui’s purchase of Smithfield are totally unrelated to U.S. food safety,” said Danyang. “We hope the U.S. will treat the merger case fairly and properly.” Danyang noted that China does not ban U.S. pork imports, the country only prohibits the import of pork from pigs raised on ractopamine, a growth promoting drug widely used in the U.S. pork industry. As Food Safety News reported earlier this month, the Shuanghui acquisition raises new questions about the future of the controversial feed additive, which is also used by Canada, Brazil, and others, but banned by the European Union, Russia, and China. This article has been updated to include China’s response.

House Sinks Farm Bill That Could Have Further Delayed FSMA

Helena Bottemiller — Fri, 21 Jun 2013 04:37:33 +0000

Surprising many, the House on Thursday failed to pass its version of the farm bill taking down with it a $20 billion food stamp cuts and a provision that could have further delayed the implementation of Food Safety Modernization Act. Late Wednesday night, the House had agreed by voice vote to add an amendment by Rep. Dan Benishek (R-MI) that would have required the U.S. Food and Drug Administration to conduct “a scientific and economic analysis” of FSMA regulations before they can be rolled out. “I support access to clean, safe, and healthy food, but this proposed rulemaking will have widespread consequences for American family farmers,” said Rep. Benishek on the house floor. “For example, farmers will have to comply with a new set of rules as determined by the FDA when cleaning and storing their equipment–meaning tractors, harvesters, knives, et cetera–so that domesticated animals may be prevented from contaminating them.” Benishek objected to the idea that some farmers in his district might have to “completely redesign” their irrigation systems to meet new water and soil monitoring requirements and complained that the rules might require that farmers inspect each individual piece of fruit for bird feces. “I know that they want to provide clean, safe foods for the American public,” he said. “All specialty crop growers I have met eat the foods that they grow. So my point is that if the FDA estimates that this rule will cost at a minimum $460 million to the industry, why not make sure we’re doing this right?” Food safety and consumer advocates are strongly opposed to the measure, which they say could slow the progress of FSMA, which is already severely behind schedule. “This amendment strikes at the heart of FSMA and undermines the thoughtful work FDA is doing to put in place a prevention-based, science-based, economically sound food safety system,” said Sandra Eskin, director of the Pew Charitable Trust’s food safety campaign. “It will hurt consumers and damage the food industry.” Ray Gilmer, vice president of communications at United Fresh, which represents much of the produce industry, said the group doesn’t believe the amendment would actually delay FSMA implementation because much of the analysis that the measure calls for has already been done. As Food Safety News reported, FDA published a detailed analysis of the costs and benefits of the preventive controls and produce safety rules when they were released in January. The proposals also underwent more than a year of review by the White House Office of Management and Budget. In May, Benishek introduced a separate bill, the Stopping Costly Regulations Against Produce, or the SCRAP Act, which seeks to altogether de-fund the implementation of FSMA produce safety rules. A couple of other food safety-related amendments were tacked onto the bill during debate. Reps. Louise Slaughter (D-NY) and Jared Polis (D-CO) succeeded in adding language to reauthorize funding for the study of Antibiotic Resistant Bacteria through 2018 and Rep. Tony Carenas (D-CA) added a section that would expand food safety education initiatives to include training farm workers on how to identify sources of food contamination and how to decrease contamination events. “The failure by the House leadership, for the second year in a row, to reach consensus on a Food, Farm and Jobs Bill is a tremendous disappointment for all Americans,” said Agriculture Secretary Tom Vilsack in a statement Thursday. “Twice now, the U.S. Senate has done its job and passed balanced, comprehensive legislation with overwhelming bipartisan support.” Vilsack said the lack of bipartisanship on the bill was in large part due to the cuts to the Supplemental Nutrition Assistance Program, commonly known as food stamps, in the House version. “The House version of this bill would have unfairly denied food assistance for millions of struggling families and their children, while failing to achieve needed reforms or critical investments to continue economic growth in rural America,” said Vilsack. Correction: This article originally incorrectly stated that the SCRAP Act was not allowed to be considered as an amendment to the farm bill and has been updated to reflect that it is a stand alone bill.

FDA Won't Set Specific FSMA Deadlines Despite Court Order

Helena Bottemiller — Thu, 20 Jun 2013 07:14:16 +0000

The U.S. Food and Drug Administration and the Center for Food Safety have not been able to come to an agreement on a proposed schedule of Food Safety Modernization Act (FSMA) deadlines despite a court order to do so by May 20.

The order came after CFS sued FDA in August 2012 for missing several statutory deadlines in its implementation of FSMA, the most sweeping update to food safety law in seven decades. The two parties, unable to agree on deadlines as the court ordered, were granted a 20-day extension to June 10 by a U.S. District Court, but ultimately did not submit a joint proposal like they were supposed to. They each submitted their own timelines for the remaining regulations.

FDA’s timeline for each key part of FSMA – including the foreign supplier verification program, preventive controls, produce safety, and other provisions – is longer than CFS’ and it lacks specific dates.

For example, FDA proposed issuing a final rule for produce safety standards by roughly June 2015, but CFS proposed a final deadline of May 1, 2014, which could be extended by up to one year if further analysis is required by the National Environmental Policy Act.

For the foreign supplier verification program, FDA set a deadline for a proposed rule by this summer, without setting a date, while CFS set a deadline of August 31, 2013. For the final rule, FDA set a deadline of summer 2015, while CFS set a deadline of December 31, 2013.

FDA set its own timeline for issuing a proposal for accrediting third party auditors. The agency plans to have a proposed rule out by this summer and a final rule by “roughly” summer 2015. CFS set an August 31, 2013 deadline for a proposed rule and a December 31, 2013 deadline for a final rule.

Consumer advocates said they are dismayed by FDA’s refusal to agree to a shorter timeline for many key food safety rules, many of which are already well passed the statutory deadlines set by Congress.

“The Center for Food Safety’s proposed deadlines are entirely reasonable,” said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest. “FDA needs to get the job done. We’re tired of waiting for regulations and proposals that are long overdue.”

Smith DeWaal said it was “ridiculous,” for example, that FDA was setting a goal of summer 2015 for the foreign supplier verification proposal, especially considering the agency submitted a draft proposal to the White House Office of Management and Budget in November 2011 for review. In FSMA, FDA was directed to write this program no later than one year after the law was enacted in January 2011, so FDA met this requirement and has now been waiting on OMB for nearly a year and a half.

Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America, said that Congress included specific deadlines in the law “for a reason – to ensure timely implementation of the important food safety provisions contained in FSMA.”

“I think CFS’ argument that the implementation period should not be ‘open-ended’ is a valid one,” he said. “Not everything in the process is under FDA’s control, but it is in the best interest of consumers for implementation of FSMA to occur expeditiously. And court-imposed deadlines could help make that happen.”

Senate Panel Approves Bill With FDA Funding Increase; House Begins Farm Bill Debate

Helena Bottemiller — Wed, 19 Jun 2013 07:27:50 +0000

Two key food and agriculture measures inched forward on Capitol Hill on Tuesday. A Senate appropriations subcommittee approved a bill that would increase funding at the U.S. Food and Drug Administration by $53 million for the implementation of the Food Safety Modernization Act (FSMA) and the House kicked off debate on its version of the farm bill. The $20.93 billion appropriations bill, which also covers the U.S. Department of Agriculture, would fund several food and agriculture programs for fiscal year 2014. The legislation would give FDA $2.5 billion in discretionary spending, which the committee noted is $96 million over fiscal year 2013. More than half of that is slated to help the agency roll out and enforce FSMA. Steve Grossman, executive director of the Alliance for a Stronger FDA, a group of industry and consumer groups that lobby for more funding for the agency, lauded the panel for increasing resources at the agency during a tough budgetary time. “The Alliance is very pleased by the Senate subcommittee mark,” said Grossman. “We will continue to work for the largest possible appropriation for the agency, whose responsibilities keep growing every year. We appreciate the recognition that Chairman Pryor and Ranking Member Blunt have given to this reality.” Under the plan, USDA’s Food Safety and Inspection Service would receive just over $1 billion, $7 million below FY 2013. The bill includes full funding for all federal, state and international inspection services, according to a breakdown released by the appropriations committee. USDA’s Agricultural Research Service would get $1.1 billion, which represents a $51 billion boost over FY 13. The measure was approved during a quick subcommittee meeting Tuesday morning and will next be considered by the full appropriations committee. “I’m proud of the bill we’re reporting today,” said Sen. Mark Pryor (D-AR), chair of the subcommittee at the hearing. “We have worked hard to invest these tax dollars into programs that provide direct benefits to our farmers and rural communities and to programs that provide health and safety benefits to all of us.” “Overall some difficult decisions had to be made, but overall I think this is a well balanced bill that allocates funds where they are needed most,” he added. On Tuesday afternoon, the House also began its consideration of its version of the farm bill, just two weeks after the Senate approved its version. While the biggest point of debate is expected to be over the size of the House bill’s cut to the Supplemental Nutrition Assistance Program (SNAP), commonly known as food stamps, it’s also very likely that FSMA and other food safety issues will come up during the debate. During some opening floor statements, Rep. Doc Hastings (R-WA), who represents the Yakima Valley, an extremely productive specialty crop area, expressed concerns about FSMA’s draft produce safety regulations. Hastings said he was particularly concerned about how the regulations would impact tree fruit growers. “I think we can all agree that lettuce and apples are grown in completely different ways,” he said, noting that the former is grown on the ground and the latter in trees. Hastings urged FDA to tailor the regulations to match the risk and the way different crops are grown. House Agriculture Committee chairman Frank Lucas (R-OK) said on the floor that he agreed with Hastings, hinting that FDA may have gone too far “in its zeal to achieve marginal food safety gains.” Nearly 230 amendments have been filed. Among them, an amendment by Rep. Tony Carenas (D-CA) that would expand food safety education initiatives to include training farm workers on how to identify sources of food contamination and how to decrease contamination events and an amendment by Dan Benishek (R-MI) that would requires “a scientific and economic analysis” of FSMA prior to final regulations being enforced. The House is expected to resume consideration of the farm bill and dive into amendments on Wednesday. See Food Safety News in the coming days for more on the discussion. A full round up of amendments that have been filed can be found on the House Rules Committee website here.

House Advances Funding Bill That Bans Horse Slaughter, Gives FDA Small Boost

Helena Bottemiller — Fri, 14 Jun 2013 06:00:21 +0000

The House Appropriations Committee on Thursday approved a $19.45 billion funding bill to support the U.S. Department of Agriculture and the U.S. Food and Drug Administration, among other agencies, for fiscal year 2014. The bill would ban funding for USDA horse slaughter inspection and give FDA a relatively minor boost for food safety — $27 million out of a $4.3 billion budget for the entire agency. The legislation — which is $1.3 billion lower than FY 2013 and $516 million below President Obama’s budget request — would give the USDA’s Food Safety and Inspection Service $999 million, a $31 million decrease over the last fiscal year. The Agricultural Research Service would get $2.5 billion. Under the plan, the FDA would get nearly $2.5 billion in discretionary funding, but including revenue from user fees the agency would see $4.3 billion. “Within this total, food safety activities are increased by $27 million, and drug safety activities are increased by $2.5 million,” according to the appropriations committee. The FDA would also get a $35 million sum to revamp its IT system. The increases are modest in the context of FDA’s expanding food safety authority. The Congressional Budget Office estimated, for example, that FDA would need about $1.4 billion in additional funding over five years just to properly implement the Food Safety Modernization Act (FSMA). “This is a very good bill we put together,” said Rep. Robert Aderholt (R-AL), chairman of the subcommittee on agriculture appropriations, during a full committee markup on Thursday. There were a handful of food safety-related amendments discussed during the meeting. An amendment by Reps. Jim Moran (D-VA) and Bill Young (R-FL) that would prohibit USDA funding for horse slaughter inspection, which would essentially ban the practice in the United States, was approved by voice vote. Animal welfare advocates praised the move, as they argue the practice is inhumane, unnecessary, and presents a health risk because horses are often given drugs that can linger in horsemeat and are harmful to people who consume the meat. Read more coverage on the horse slaughter debate here. Rep. Jack Kingston (R-GA) urged the committee to adopt language asking USDA to move forward on a proposed rule to “modernize poultry inspection.” “Basically we’re trying to keep up with technology,” said Kingston, discussing the merits of the long-running HACCP-based Inspection Models Project. Kingston noted that USDA has been using the pilot extensively for 10 years but has yet to finalize a rule to expand the program. “This would improve the science,” said Kingston during markup. His amendment urging USDA to move forward was adopted on a voice vote over concerns raised by Rep. Sam Farr (D-CA) and Rosa DeLauro (D-CT). DeLauro said during markup that she and her colleagues still have several questions about the program, especially about how it would impact food and worker safety, in large part because the rule allows plants to speed up their line speeds. She asked the committee to wait on asking USDA to move forward until the results of National Institute of Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) studies were completed. Rep. Kingston also introduced an amendment aimed at preventing “bureaucratic overreach” to ensure FDA was not planning to extend FSMA authority over raw grains and oil seeds, which don’t have a record of food safety issues. “All I’m trying to do is make sure FDA stays in the lane its already traveling in,” he said during the meeting. Subcommittee ranking member Farr objected and said he thought the amendment was aimed at a non-problem. “I don’t think your amendment does anything,” he said. Kingston noted that he did not support FSMA because he believes it is unnecessary and duplicative and then withdrew the proposal and said he’d work with his colleagues on the matter. DeLauro was also unsuccessful with her amendment seeking to strip language from the appropriations bill that would delay implementation of country of origin labeling for meat and poultry products. “This could delay a rule for up to two years,” she said. The congresswoman noted that seafood, produce, and other items indicate their country of origin on the labeling and so she argued that consumers had a right to know where their meat and poultry originated as well. Subcommittee chair Aderholt noted that Canada and Mexico have geared up to retaliate against the the latest version of USDA’s rule, because they believe it fails to meet the United State’s obligation under the World Trade Organization. DeLauro, who expressed strong disagreement and noted that 90 percent of consumers support country of origin labeling for meats, withdrew her amendment, acknowledging that she didn’t have the support to pass it. Public health advocates said Thursday they were pleased the appropriations bill also contains report language directing FDA to spend $7.8 million on the National Microbial Resistance Monitoring System and to come up with a data collection approach that can be used to “assess the effectiveness of policies to curb antibiotic resistance.” The report language directs FDA to finalize its Guidance #213 by Jan. 1, 2014 and then to make specific annual reports on the progress of the removal of growth promotion claims on certain medically important antibiotics. The legislation, which cleared the full appropriations committee by voice vote, will next be considered by the full House, where it will likely be subject to many amendments.

Senate Approves Farm Bill Without Major Food Safety Amendments

Helena Bottemiller — Tue, 11 Jun 2013 05:31:37 +0000

The Senate approved a farm bill on Monday evening 66 to 27. The legislation, which has a $955 billion price tag over the next decade, would end direct payments to farmers and boost subsidized crop insurance, but the bill did not include major food safety amendments, including Sen. John McCain’s provision to repeal the controversial catfish inspection program at the U.S. Department of Agriculture. In an op-ed late last week, McCain said that for three weeks he and Sen. Jeanne Shaheen (D-NH) had asked for a vote on their amendment to scrap the “absurd Catfish Office,” which has yet to inspect any catfish, but “despite repeated requests” the chair and ranking member of the Agriculture Committee, Sens. Debbie Stabenow (D-MI) and Thad Cochran (R-MS), blocked a vote. Southern state lawmakers succeeded in getting a provision in the 2008 farm bill to move catfish from under the jurisdiction of the U.S. Food and Drug Administration to USDA to help protect domestic catfish farmers from the flood of cheap foreign imports, but the move has been bogged down in the details and politics. Despite having already spent about $20 million on the initiative, USDA has not yet implemented catfish inspection, five years later. A spokesman for FSIS told Food Safety News that the agency currently has a “core staff” of four people working on “further policy development in anticipation of potential implementation of the catfish inspection program,” but since developing a proposed rule in 2011 the Office of Catfish Inspection has been folded into other program areas. The Government Accountability Office has repeatedly called the program a waste of taxpayer dollars because it is “duplicative” and because it would focus on Salmonella, which is not an issue with catfish, and not illegal drug residues, which could be a real concern. “They want you to think Americans have been eating unsafe foreign catfish (it’s just catfish, of course) even though the FDA, the CDC, and the USDA itself say that’s untrue. Out of the 1.8 billion catfish enjoyed by Americans each year, only two illnesses are reported on average,” wrote McCain for Politico last week. “I obviously support maintaining a safe food supply,” added McCain. “But seafood inspections already fall under FDA’s jurisdiction, which requires foreign catfish farms to follow the same food-safety standards as domestic farms. Unless catfish have suddenly sprouted legs, USDA should stick to meat, poultry and egg inspections.” FDA has also been called out by GAO for having inadequate oversight over imported seafood in general — an increasingly critical issue as nearly 90 percent of seafood consumed in the U.S. is now imported. The Senate had voted for an amendment to scrap the program last summer, the last time it considered a version of the farm bill, but no such vote was held this time around. The House Agriculture Committee recently voted to repeal the inspection scheme, but it is not clear whether the language will make it into law. There are other significant food safety-related amendments that were left out of the farm bill, along with a large heap of amendments that were not allowed to be considered by Senate leadership. Senator Angus King (I-ME) had offered two amendments that addressed concerns about the Food Safety Modernization Act, and these two provisions were among the 120 or so amendments “not allowed onto the bill,” according to Crystal Canney, a spokesperson for Sen. King. King teamed up with Sen. Jon Tester (D-MT) — an organic farmer who succeeded in carving out a major exemption for small farmers during the FSMA debate in 2010 — to introduce an amendment that would narrow the definition of the so-called Tester-Hagan amendment so that only FSMA-regulated food would count toward a farm’s $500,000 sales threshold. Supporters of the measure point out that if, for example, a farm grows mostly soybeans or alfalfa, but also operates a very small CSA it would fall under FSMA if the farm had total revenue of $500,000, even if if the vast majority of the income came from a commodity not covered by FSMA. King also introduced an amendment that would require FDA to conduct a “comprehensive study” of the impact of food safety rules on local food distribution before enforcing new measures. Another amendment, the Stopping Costly Regulations Against Produce (SCRAP) Act, by Sens. Mike Crapo (R-ID) and James Risch (R-ID) would have blocked FDA from moving forward on the proposed on-farm produce safety rules. None of these amendments received a vote and were not attached to the final bill. The Center for Science in the Public Interest opposed the measures. “At their worst, these amendments effectively repeal parts of FSMA and wipe out consumer protections put in place,” said David Plunket, a staff attorney for CSPI. Sen. Crapo’s office said their amendment is “an effort to prevent potentially devastating regulatory burdens from being placed on U.S. farmers.” Congressman Benishek (R-MI) is seeking to add the SCRAP Act to the House farm bill, which is expected to move forward this month. The Senate bill did include a few food safety related provisions, which Food Safety News outlined last month. The legislation directs the government to conduct a study within one year to determine “whether offering policies that provide coverage for specialty crops from food safety contamination issues will benefit agricultural producers.” The legislation requests the study evaluate different plans that could provide protection for production or revenue during food safety disasters like health advisories, outbreaks, or recalls that might hurt business.

Weak Food Safety Culture Led to XL Foods Recall, Review Finds

Helena Bottemiller — Fri, 07 Jun 2013 05:02:21 +0000

Company and Canadian Food Inspection Authority (CFIA) staff at XL Foods had a lax approach to food safety leading up to the massive beef recall last fall, according to an independent review released by the Canadian government. The report also found that XL Foods was not prepared to execute the recall – which was the largest in Canadian history and extended into the United States – because the company had never conducted any mock recalls “on a scale that remotely mimicked a real event.” The recall for E. coli O157:H7 contamination, which was ultimately linked to 18 illness in Canada, was reviewed by a panel of three people appointed by the Governor in Council. The panel spent several weeks interviewing inspectors, plant workers, and others to determine what exactly happened before, during, and after the recall and was asked to make recommendations. “We found that responsibilities towards food safety programs were not always met – by both plant staff and CFIA officials on site,” according to the report. “We found a relaxed attitude towards applying mandatory procedures – clearly outlined in some documents, less so in others. Again, a shortcoming shared by both plant and CFIA staff.” The panel said the Brooks, Alberta plant had a “weak” food safety culture that was shared by both plant management and CFIA staff, but overall the panel believes the Canadian meat inspection system can work if “players across both the food safety and supply spectrum” work together as partners. One of the many issues flagged in the report was that XL Foods and CFIA officials in the plant were not analyzing testing results to identify high event periods (HEPs), or periods where pathogen tests are exceeding a set certain threshold. “It is the Panel’s view that, had XL Foods Inc. analyzed its E. coli O157:H7 sampling data and responded appropriately to HEPs in late August, the contaminated shipments would likely have been contained and not left the plant,” reads the report. The U.S. Department of Agriculture’s Food Safety and Inspection Service is credited with helping to flag the contamination in the report. In early September, CFIA had found E. coli O157:H7 in raw beef trimmings in a processing plant in Calgary – the beef was from XL Foods. On the same day, FSIS notified CFIA saying they had a positive test result from XL Foods trimmings exported to the United States. Because CFIA initially determined the contaminated product was not in the marketplace, it took several days for the recall to take shape after multiple expansions. Eventually about 8 million pounds of beef was recalled, according to the report. This represents “at minimum” 12,000 head of cattle. The report noted that the system likely did prevent many illnesses because the recall was sparked by testing and not in response to an outbreak. “It must be said that, while this E. coli O157:H7 contamination of beef products from the Brooks plant resulted in 18 people becoming sick, the beef recall was triggered well before any cases of human illness had been reported. This is important because, had it been launched only after illnesses were reported and contaminated products still in retail distribution, it is very likely that more consumers would have purchased and consumed product, resulting in even more illnesses.” The lengthy report, which includes a wide variety of policy recommendations, can be found here.

Health Professionals Ask Obama to Take Stronger Action on Antibiotics in Ag

Helena Bottemiller — Wed, 05 Jun 2013 06:25:04 +0000

Citing the growing threat from antibiotic resistant infections, nearly 800 health care professionals signed onto a letter sent to the Obama administration on Tuesday urging more limits on antibiotics used in food animal production. “Current patterns of antibiotic use in agriculture not only increase the risk of antibiotic-resistant infections in people but also support an agricultural system that harms public and environmental health,” said Ted Schettler, MD, the science director for the Science and Environmental Health Network and an adviser for Health Care Without Harm, one of the groups backing the letter, along with the Pew Charitable Trusts and Healthy Food Action. In their letter addressed to 1600 Pennsyvlania Avenue, the advocates urge the president to “move forward with stalled U.S. Food and Drug Administration actions to reduce the overuse and misuse of antibiotics in food animal production.” The groups want the FDA to strengthen and finalize the voluntary guidelines the agency has been working on and also move forward on withdrawal of the “unsafe uses of antibiotics.” “We also ask your administration to publicly report better data on livestock antibiotic sales to inform the public health community about emerging disease threats and to monitor the success of federal policies,” the letter read. “Given the rapid rate at which many antibiotics are becoming ineffective for treating human disease and the limited number of new antibiotics in development, the FDA should take bold steps to rein in overuse and misuse,” the groups wrote. Robert Gould, MD, President of the San Francisco Bay Area Physicians for Social Responsibility, added: “The antibiotic resistance crisis is growing worse each day. Physicians are seeing more and more patients with antibiotic resistant infections in hospitals, and we are cleaning up our own act by curbing our own overuse of antibiotics in clinical practice. But this is not enough. We now recognize that feeding healthy animals antibiotics contributes enormously to this problem. As health professionals fundamentally concerned with the health of our patients, we urge President Obama to demonstrate his leadership on this issue by joining our demand that the livestock industry and the FDA promptly correct this serious threat to public health.”

Smithfield Sale Raises New Questions About the Future of Ractopamine

Helena Bottemiller — Tue, 04 Jun 2013 07:07:38 +0000

The sale of Smithfield Foods, the United States’ largest pork producer, to Shuanghui International, China’s largest meat company, raises new questions about the future of ractopamine, a controversial growth-promoting drug that is widely used in U.S. pork production and has long been the subject of trade disputes. As a report by the Food & Environment Network and NBC News explained last week, the U.S. Food and Drug Administration approved ractopamine, a beta-agonist, more than a decade ago to improve the rate at which animals convert to feed to lean meat. Two dozen other countries, including Canada and Brazil, have also approved the additive for livestock production, but China, Russia, the European Union and several other countries question its safety and refuse to accept meat from animals raised on the drug. With export sales lagging, the U.S. pork industry has started scaling back use of the drug to gain greater access to China and Russia – two major export markets that have recently demanded that incoming meat be certified ractopamine-free. After converting its third slaughter plant to process only pigs not fed the additive, Smithfield Foods announced last month that it would be 50 percent ractopamine-free by June 1. According to the report in NBC News, industry experts say the long-running trade fight may have been a factor in the Smithfield deal, as China seeks to gain more access to pork:

“This is probably a direct result of the ractopamine issue,” said John Saunders, CEO of Where Food Comes From, a third party auditing company that helps companies verify marketing claims. IMI Global, Inc., a division of Where Food Comes From, has applied for a USDA verified process that would certify pork and beef as coming from animals not fed ractopamine or zilpaterol, another beta-agonist widely used in cattle. Under a similar program, the company already verifies that U.S. meat headed for the European Union meets their import requirements, which prohibit growth promoters of any kind. U.S. trade officials would not comment on when a certification program might be approved, but many in the industry expect it eventually will beview it as inevitable. “We’ve had conversations with a majority of beef and pork packers about their path forward on this issue,” said Saunders. “They’re all engaged in conversations about this.”

David Warner a spokesperson for the National Pork Producers Council would not comment on the Smithfield acquisition, but said it is not clear the deal changes the dynamics of the international dispute over the drug. “I don’t know that it changes anything, really,” said Warner. “As far as I know China is not relaxing its restrictions on ractopamine.” The U.S. government initially refused to meet China and Russia’s recent demands for ractopamine-free certification because trade officials believe the restrictions are unwarranted and not based on science. Russia responded by shutting down its market to U.S. beef, pork, and turkey in February. According to the report by FERN, “While China has continued to accept U.S. pork as long as companies assure it is ractopamine-free, but the Chinese government has stepped up residue testing in recent months and recently demanded third-party certification to verify the additive is avoided. According to the U.S. Meat Export Federation, U.S. Department of Agriculture officials have requested a meeting in Moscow June 17 to present Russian officials with a government-verified program to meet Russia’s demands.” While few consumers are aware of ractopamine’s use in meat production, the additive has for years been a source of conflict between countries that ban its use it, including the EU, and those that use it, including the U.S., which is aggressively pushing for greater access to markets for agricultural products. The EU has sharply questioned the science backing the drug. China says it’s worried about the higher levels of drug residues that can be found in pig organs, which are part of a traditional Chinese diet, and Russia claims the drug could pose health risks. U.S. trade officials say opposition to ractopamine is purely political. “The proof that has been presented does not satisfy us,” said Gennady Onishchenko, Russia’s chief public health official, in February. “It does not stand up to criticism in terms of the methodology and the time over which the drug’s application was analyzed, and it does not answer the question regarding the drug’s accumulation in a human body.” After several years of infighting, the Codex Alimentarius Commission, a U.N. food standards setting body, last summer agreed to an international standard for the level of ractopamine residues considered safe in meat products, but trade disputes have continued. The USDA is urging Russia and others to accept the Codex residue standard, which allows ractopamine at or below 10 parts per billion in muscle meat. USDA’s Food Safety and Inspection Service does limited testing for ractopamine residues domestically. In 2011, the most recent year data was reported, 298 samples were screened for the drug; one was positive but below FDA’s safety standard. Consumer Reports did its own testing of 240 samples last year and found 20 percent were positive for the drug, but the levels did not exceed 5 ppb, far below the Codex limit as well as the FDA’s, which is 50 ppb for pork meat. U.S. officials say they have asked for but have not received any scientific justification from Russia or China to support their zero tolerance policies. Colleen Parr Dekker, a spokesperson for Elanco, the manufacturer of ractopamine, said the company is concerned about the broad impact a move away from beta-agonists could have on corn demand and the environment, since livestock would need more to produce the same amount of meat. Global AgriTrends, an industry analyst group, estimates that without the beta-agonists used by the vast majority of beef and pork producers, the meat industry would need to use 91 million more bushels of corn, worth more than $600 million. “Trade is clearly very important to our customers globally,” said Parr Dekker. “That’s why the adoption of a global human safety standard for food from animals fed ractopamine by the United Nations food safety standards body (Codex) was so important. It is disappointing that we do see a few countries not honoring those global standards.” With such a Codex standard in place, the United States could challenge the restrictions at the World Trade Organization. As the report noted, in the U.S., some consumer advocates are worried that amid all the trade scuffles over the feed additive, the majority of ractopamine-free pork will be shipped abroad and not be an option for domestic consumers. “Americans aren’t getting the ractopamine-free pork,” said Elisabeth Holmes, a staff attorney for the Center for Food Safety, which has petitioned the FDA to reevaluate the drug’s impact on human health and animal welfare and lower the trace residue levels that the agency considers safe in meat products. “Smithfield’s announcement of going 50 percent ractopamine-free was clearly to benefit its share price days before the Chinese buyout, not to protect consumers.” In their petition to FDA, the Center for Food Safety and the Animal Legal Defense Fund cited a 2012 report by The Food & Environment Reporting Network/NBC News report that found ractopamine had been linked to more reported adverse drug experiences in more pigs than any other veterinary drug. Reports from producers commonly cited hyperactivity, trouble walking, and death. The FDA said the reports do not establish the drug caused the adverse health effects and maintains ractopamine is a safe and effective compound for food animal protection. According to Jim Herlihy, a spokesperson for the U.S. Meat Export Federation, much of the ractopamine-free pork now produced is actually sold domestically because the U.S. does not export whole hog carcasses, but instead just ships certain cuts that can be sold at a higher price abroad, like organ meats, feet, ears, and tails. “The majority of muscle cuts remain in the U.S., while more than 90 percent of certain cuts, primarily variety meat, go to export markets,” said Herlihy. “As the percentage of U.S. pork production that is ractopamine-free changes, so does the availability of that product to the U.S. market. This doesn’t address the scientific fact of whether ractopamine is safe when properly used in animal agriculture, which the FDA and Codex say it is, just the question of the availability of product.”

Putting Food Traceability at Consumers' Fingertips

Helena Bottemiller — Tue, 28 May 2013 06:20:13 +0000

Imagine that you’re in the produce section at the grocery store. You pick up a container of leafy greens with a QR (quick response) code on the label and you pull out your smart phone. The camera on the device instantly reads the code and tells you exactly where and how the greens were grown, when they were harvested, and who owns the farm. Your phone also recommends recipes and gives you the option of automatically adding the other ingredients you need to your digital shopping list. You decide to buy the greens. You take them home and put them in the fridge. The next day, you get a text message alert: “The product you purchased has been recalled. Throw it away and click here for a full refund.” You toss the greens and breathe a sigh of relief. This is not the future of food traceability, this is what is possible today and what shoppers will increasingly be able to do with any item in the grocery store. As supply chains have gotten more complex and foodborne illness outbreaks continue to take a toll, many food companies have sought to improve traceability, or their ability to rapidly track products from field to customer. Right now most traceability is at the case-level, which means codes are used to track food products in bulk, but once companies have the ability to track product, and capture key data along the way, they can take this one step further and make information available to consumers at the item-level.

The Food Safety News traceability series is sponsored by Infor.

Giving consumers access to more information via QR codes on individual packages can be win-win. Shoppers like that they can trace their food to the source and it gives food manufacturers and growers a way to interface with their end consumers. There are clear marketing benefits—brands can use certain apps to collect feedback from shoppers, connect via social media, up sell, or offer coupons –but the food safety benefits are also significant. “Ideally, at the consumer-level they will be able to scan the code and up pops a picture of the farmer, recipes, and all the things you want them to have,” said Bill Dewey, of Taylor Shellfish Farms in Washington state, who chairs the Interstate Shellfish Sanitation Conference’s traceability committee. “And then appropriate health officials could use a password to see even more details about the product, including HACCP records.” YottaMark, Inc., whose food traceability platform, HarvestMark, has so far made five billion fresh food items traceable for companies like Driscoll’s Berries and Coleman Natural, has seen the public health benefit of consumer-level traceability first hand. “The sophisticated companies are combining marketing and food safety,” said Elliott Grant, chief technology officer and founder of YottaMark. Several of the company’s customers have been through recalls since gaining full supply chain traceability and have been able to limit the damage. During one recall of leafy greens, 15 percent of consumers who looked up the product using HarvestMark did indeed have recalled greens and were able to take action. In the wake of food safety incidents, companies can also utilize their connection to the consumers affected or inconvenienced to rebuild trust by sharing detailed information or even offering free product. “We want to create end consumer confidence. It’s also about bouncing back,” said Christian Hutter, of Junction Solutions, a technology company that has a traceability platform called CLEARthru, which aims to be more interactive with shoppers. With consumers seeking more and more information about where their food comes from, there is now a flurry of consumer-level traceability initiatives. Last summer, Top 10 Produce, a company that specializes in traceability solutions for small and independent farms, received a $100,000 small business innovation research grant from the U.S. Department of Agriculture to study how independent growers can benefit from a mobile commerce platform to sell source-verified food. The grant also pays for more growers to get their own QR code. In an effort to bounce back from the devastating Gulf oil spill and differentiate from the flood of seafood imports, the Gulf States Marine Fisheries Commission has launched “Gulf Seafood Trace,” a voluntary program using Trace Register, a traceability company based in Seattle. The program allows consumers to trace the fish back to where it was caught and get food safety information. Applegate, the fast-growing natural and organic meat company, has what they call “barn codes” that allow consumers to look up their package of meat and find videos about the farmer that raised the turkeys for their lunchmeat. HarvestMark recently conducted a major fresh food traceability pilot project with a major retailer in China that included adding QR labels to individual food products and noting they could be traced back to the farm. “By all measures, it’s a wild success,” said Grant, the founder of YottaMark, Inc. “Sales doubled for these products because there is such paranoia.” Taylor Shellfish plans to pilot QR tags for oysters at its retail shop in Seattle. When customers order a variety oysters on the half shell, the tags, printed on laminated paper, will be stuck in the ice behind each one. Diners will be able to scan the codes and get information about where each oyster is from. “Today, if you’re lucky wait staff might draw on a napkin to indicate where they came from,” said Dewey. Where Food Comes From, a leading third party certification company that verifies many of Whole Foods marketing standards, now has a retail focused “source verified” program that also uses a QR code. The company has a form on its website so consumers can easily request that their grocery stores carry Where Food Comes From approved products. Hutter, of CLEARthru, predicts that, while future traceability regulations might help push the ball forward, ultimately consumer demand will drive widespread adoption. “We know consumers are going to demand better information in real time,” he said. Consumers interested in scanning food to trace it back to the source should start by downloading a QR scanner in their smartphone app store.

Merrigan Expresses Worry About FSMA's Impact on Agriculture

Helena Bottemiller — Fri, 24 May 2013 05:25:44 +0000

Kathleen Merrigan, who recently left her role as Deputy Secretary of Agriculture at the U.S. Department of Agriculture, said this week she is concerned about the negative impact the Food Safety Modernization Act could have on small- and medium-sized farms. According to a report by AgriPulse, Merrigan made the remarks at CropLife America’s National Policy Conference in Washington, D.C. on Wednesday. She told the audience that the FSMA regulations being developed have “the potential to transform, disrupt, improve and potentially destroy some operations.” “It’s really big,” she said. “It could really change agriculture and certain parts of our industry more than you realize.” “No one gets a pass on food safety, but sometimes I worry about the bureaucracy not always being as creative as they might be in achieving the same level of food safety at small and medium size operations,” she said. Merrigan made the comments after telling the audience that she believes the push for labeling GMOs is “not going to go away.” She was also asked why she decided to leave USDA. According to the report, “Merrigan did not answer directly but said there has been ‘a mass exodus of deputies across the federal government. We’re a big club. I do believe it’s the hardest job in the federal government. There’s a lot of pressure there.'”

As Canada Moves Forward, Rule to Label Mechanicallly Tenderized Meat in U.S. Still Stuck at OMB

Helena Bottemiller — Wed, 22 May 2013 05:01:49 +0000

A U.S. Department of Agriculture proposal to require labeling for mechanically tenderized meats, which can be risky if pathogens are pushed into the cut beyond the exterior and the meat is not thoroughly cooked, has now been under review at the White House Office of Management Budget for eight months, far exceeding the 90-day limit the agency is supposed to adhere to. Consumer advocates, who have been calling for labeling for several years, are especially frustrated by the delay with the news that Canada will start mandating labeling in the next two months. While there are no exact figures, USDA estimates that every month somewhere in the neighborhood of 50 million pounds of beef is tenderized, a process that utilizes needles or blades to pierce intact steaks and roasts to make them tender for consumers. While the government recommends consumers cook mechanically tenderized, or non-intact meat, to a higher internal temperature than intact steaks (160 degrees versus 145), there is no requirement to label products so consumers can tell the difference between them. Mechanically tenderized beef products have been linked to five E. coli O157:H7 outbreaks in the past decade, according the Centers for Disease Control and Prevention, including a 21-state outbreak that sparked a large recall on Christmas eve in 2009. In those outbreaks, 174 people fell ill and four died, but most health experts assume those stats don’t capture the full health impact as foodborne illnesses are chronically underreported and usually not successfully linked to a source. “We believe this is an important public health issue,” said Pat Buck, director of outreach and education for the Center for Foodborne Illness Research and Prevention. “We’re not happy that it has not made it out of OMB. We hope it will move forward.” Buck, who became a food safety advocate after losing her grandson Kevin Kowalcyk to a severe E. coli O157:H7 infection in 2001, said the rule is especially imperative as the United States approaches another grilling season so that consumers know to cook tenderized steaks to a higher temperature, as is recommended for ground beef products. “We are now going into our fifth grilling since we began asking for labeling,” she said. “It should have happened a long time ago.” It’s not clear what is causing the lengthy review on the proposed rule, which the OMB’s Office of Information and Regulatory Affairs (OIRA) lists as not economically significant (other economically significant regulations have undergone lengthy reviews at OIRA, which is charged with weighing the costs and benefits of federal agency actions). Inquiries about the delay were not returned by OMB or USDA’s Food Safety and Inspection Service. According to White House meeting records, the American Meat Institute met with OIRA staff in March about the proposed rule, the details of which are unknown to stakeholders. Mark Dopp, AMI’s senior vice president of regulatory affairs, said the meeting was to discuss a recently released abstract on the proposal. The abstract posted on the government’s regulatory dashboard said that FSIS is proposing to require the term “mechanically tenderized” on the labels of raw or partially cooked needle or blade tenderized beef products, including products that are injected with marinade or other solutions, unless these products are going to be fully cooked before heading to customers. According to the outline, FSIS is also “proposing to require that labels of raw and partially cooked needle or blade tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions that inform consumers that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are thoroughly cooked.” FSIS estimates that labeling mechanically tenderized products would cost the industry about $3.6 million and would save between 191 and 239 illnesses, thereby saving between $627,000 and $784,000 in medical costs each year. “We expressed our concerns that the abstract’s characterization of the proposed rule includes a labeling recommendation that is too broad,” said Dopp, when asked about AMI’s meeting with OIRA. “We believe any label should have a distinct purpose and benefit and be something consumers will act on. At this point we have not seen the proposal nor do we know when OMB will issue the proposal. However, we look forward to reviewing it and offering our comments at the appropriate time.” Carol Tucker-Foreman, distinguished policy fellow at the Consumer Federation of America, said the problem is that while Washington delays ordinary consumers have no way of knowing if the steak they are buying and cooking is intact or not and, with a sputtering economy and high unemployment, many consumers are buying cheaper products, which are often tenderized. “The steaks we’re talking about are not the ones being served at the Palm. The steaks we’re talking about are the ones ordinary folks are buying,”said Tucker-Foreman. “Maybe the folks who work at OMB make too much money, but that should not mean that ordinary folks are the ones put at risk.” “Labeling can help consumers protect themselves and their families. We hope OMB finishes its review so the rule can be finalized soon,” said Ami Gadhia, senior policy counsel at Consumers Union, the advocacy arm of Consumer Reports. Consumer Reports, which has over 7 million subscribers, featured mechanically tenderized meat and the potential risks in its June issue. James Marsden, a food safety professor at Kansas State University, weighed into the debate on the industry trade publication Meatingplace this week. “This isn’t the first time the issue has been raised in the popular press and until the issue is addressed, it won’t go away,” wrote Marsden. He believes there are two options for the industry: label the products so consumers know to cook them to 160 degrees, which may not be the “most desirable solution,” or add an intervention to to reduce the risk of contamination before tenderizing products to significantly reduce the chance that pathogens can be translocated to the center of cuts. “It’s up to the industry to decide whether to wait for a regulation that dictates labeling and cooking requirements or to invest in technologies that eliminate the problem before mechanically tenderized products ever reach consumers,” he said.