Food Safety News
Victims of the outbreak, which began in mid-February, include six children and three adults, according to the Civil Beat. Four of the victims – one adult and three children – have been hospitalized. The three children were treated for hemolytic uremic syndrome (HUS), a potentially fatal complication of E. coli infection that causes kidney failure.
One child remains in the hospital but is recovering. All but one of those sickened live on the island. The non-resident was visiting from Canada, reported the Hawaii Department of Health Disease Investigation Branch, which sent out a warning letter to Oahu healthcare providers last week.
Health officials say they have yet to pinpoint the source of the bacteria. The people who were infected belong to different families and live in different places around the island.
“We’ve been doing the investigation but as of right now, there has not been any identifiable commonality among the cases,” said Michele Nakata, chief of the DOH’s Disease Investigation Branch, reported Civil Beat. “They didn’t participate in the same kinds of activities. They didn’t eat the same types of food items. And they didn’t go to the same restaurants or anything like that. So it’s been fairly complicated.”
In the meantime, DOH recommends that consumers use safe food handling practices in order to avoid infection.
Michael Bulger, a graduate student in New York University’s Food Studies Program, is seeking input from produce growers on the Food Safety Modernization Act rules for a research project that could be used to advocate on behalf of farmers.
Bulger has launched a survey and is encouraging all produce growers, especially small and midsize operations, to participate. The survey takes 10 minutes and all responses are anonymous.
“I hope to find out more about produce farmers’ attitudes, levels of awareness of proposed rules, and readiness to meet new standards,” said Bulger, who is trying to get more farmer responses this week.
“If I can collect a sizable number of responses, I hope to analyze the data based on farm size (as measured by income) and/or marketing channels.”
Bulger hopes his research can shed some light on whether farmers are ready for the coming rules and which size operations anticipate having the most difficulty.
As operators of food establishments look towards controlling costs, sometimes the decisions they make directly impact food safety. When sales go south, so does health and sanitation. In my years in the food service industry, this is what I have observed:
Reducing Labor Hours: Cutting staff has been a tactic used since the beginning of time. Unfortunately when this is done too aggressively, it can become a detriment. Expecting employees to unreasonably multi-task will not only affect morale, it will also hurt customer service. In some circumstances, individuals who care about food safety and try to do the right thing (like properly clean and sanitize a deli slicer) will often become the victim of getting their hours trimmed in revenge as a consequence of taking too much time.
Elimination of Training or Certification Programs: Having just one employee as a certified food handler in an operation where hundreds may be responsible for serving food is just not enough. More often than not, training gets kicked to the curb when it comes to cutbacks. It scares me when someone thinks cooking raw chicken to an internal temperature of 128 degrees F is justified; 165 degrees F for 15 seconds is what the FDA suggests.
Sick Employees Preparing or Serving Food: Some operators will just settle for a warm body, regardless of whether the person is infected with one of the “Big 5” pathogens. People who have Norovirus, Hepatitis A, Shigella, Salmonella or E. Coli, or are showing symptoms of foodborne illness such as diarrhea or vomiting, should not be handling food. I understand that people need to work to support their families; however there are other options besides risking a foodborne illness outbreak.
Neglecting Equipment or Facilities Maintenance: Does the price of a thermometer, getting table mounted cutting boards re-surfaced or eliminating the pest control company make sense? Some food establishments pinch pennies in areas where they cannot afford to. If you have mice in your establishment because of a lack of sanitation and they are caught on film by a customer and aired on the five o’clock news, how do you expect to increase sales with such negative publicity?
Purchasing Cheap Food Products From Unapproved Sources: Rolling raw bottom feeding fish from a local polluted river into sushi is not suggested. Neither is knowingly selling peanuts contaminated with Salmonella. Need I say more?
Rolling the dice with food safety will eventually catch up to habitual offenders. With the CDC estimating that 1 in 6 Americans contract a foodborne illness each year, the odds are high. Profits and managing the bottom line should never risk the consumer’s health. Unfortunately, this lesson often gets learned a little too late.
Bills to protect animal agriculture facilities from outsiders seeking to document what goes on in these establishments were killed by legislatures in New Hampshire, Wyoming and New Mexico, but remain very much alive in a half dozen other states.
By about this time last year, Iowa, Utah and Missouri had voted to turn these so-called ag-gag bills into state laws. The purpose of such legislation is to curb or block animal welfare investigations by making it a crime to take pictures or make videos of animal abuse without permission of the owner.
- Banning taking a photo or video of a factory farm without permission,
- Essentially making it a crime for an investigator to get work at a factory farm, or
- Requiring mandatory reporting with impossibly short timelines so that no pattern of abuse can be documented.
Bills with those provisions are moving in Indiana, Arkansas and possibly in Tennessee. Indiana Senate Bill (SB) 373 has already cleared the upper chamber and appears likely to get a floor vote in the Hoosier State’s general assembly before its scheduled April 27 adjournment.
The powerful Indiana Farm Bureau is pushing the bill. Its “Hoosier Ag” news site says the bill “skillfully walks the line between privacy and the protection of animals.”
“Videos of animal abuse can be taken and submitted to law enforcement authorities within 48 hours with no penalty, Hoosier Ag says. “This allows for the disclosure of real abuse to the people who can do something about it.”
In Arkansas, SB 13, also requiring prompt reporting of animal abuse, was cleared for a floor vote with a “do pass” recommendation by the Senate Judiciary Committee with an amendment making owners responsible for the costs of care for seized animals.
The Arkansas Legislature does not adjourn until sometime in May. SB 13, which limits animal cruelty investigations to law enforcement, is still in the Judiciary Committee and won’t be heard until at least April 2.
The Tennessee “ag-gag” bill, SB 1248, was recommended for passage by the Agriculture and Natural Resources Committee, but has yet to get the same green light from the Judiciary Committee. A companion bill in the House, HB1191, might get the first floor vote.
The Nebraska Unicameral heard Legislative Bill 204 on March 14, and has not yet moved it out of the Judiciary Committee. Nebraska’s non-partisan lawmakers don’t go home until June.
Both Pennsylvania and California, which have virtually year-round Legislatures, have pending “ag-gag” bills. Support by the California Cattlemen’s Association for Assembly Bill 343 caught the attention Wednesday of editorial writers at the Los Angeles Times.
“A California Assembly bill that would require anyone who videotapes, photographs or records incidents of animal cruelty to turn over the evidence to authorities within 48 hours—or be charged with an infraction of the law—sounds like a tough new measure to crack down on abuse. It’s not,” the LA Times said.
“In realty, its one of a crop of disturbing “ag-gag” bills being introduced across the country,” says the editorial. “Although AB 343 is not as bad as some others that ban outright recording and videotaping at animal facilities, it would effectively hamper animal welfare undercover investigators and employee whistle-blowers who are collecting information on a systematic animal cruelty at meatpacking plants, slaughterhouses, livestock ranchers and farms.”
The LA editorial writers said AB 343 needs to be “…put out of its misery and killed quickly in committee.”
Food Safety News examines the potential impact of the U.S. Food and Drug Administration’s newly proposed produce rules, mandated by the Food Safety Modernization Act of 2011.
Part of the Food Safety Modernization Act, which has the goal of reducing the incidence of foodborne illness in the U.S., is an update to requirements for produce farmers that codifies accountability for food safety at the farm level.
While the U.S. Food and Drug Administration already has inspection authority over farms, FSMA will widen the agency’s jurisdiction. FDA’s proposed produce safety standards, released in January, provide a new regulatory scheme for farmers to comply with, but includes exemptions for certain types of farms.
The rules attempt to reduce foodborne pathogens on produce by focusing on sources of contamination, including water sources, biological soil amendments, wild and domesticated animals, workers in the fields, equipment, buildings, and harvesting and packing.
The proposed rules begin by listing the farms that are partially exempted from FSMA regulation. Those categories include:
- Farms that grow “certain specified produce commodities that are rarely consumed raw.” Examples of these crops include, but are not limited to: asparagus, beets, black-eyed peas, kale, figs, lentils, okra, rhubarb, sweet potatoes, turnips and yams. To clarify, if a producer grows kale, or any of the other listed crops, that producer is not regulated under the proposed rules.
- Farms that grow “produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity.”
- Farms that grow “produce that receives commercial processing that adequately reduces the presence of microorganisms (e.g. a “kill step”) as long as certain documentation is kept.”
- Farms “that have an average annual value of food sold during the previous three-year period of $25,000 or less.”
There are also a qualified exemption and modified requirements for farms that meet two requirements:
- The farm must have food sales averaging less than $500,000 per year during the last three years; and
- The farm’s sales to qualified end-users must exceed sales to others. A qualified end-user is either: a) the consumer of the food, or b) a restaurant or retail food establishment that is located in the same state as the farm or not more than 275 miles away.
The farms that sell most of their produce to qualified end-users, and do not exceed $500,000 in sales, must include a label on their produce with the complete business name and address. Also, this exemption can be withdrawn during an investigation into a foodborne illness outbreak.
Qualified end-users are people who consume the produce and restaurants.
Earlier this month, Food Safety News reported on some of the comments from stakeholders regarding the proposed rules. Recently, FSN spoke to Ariane Lotti, assistant policy director at the National Sustainable Agriculture Coalition, to get NSAC’s perspective on how the rules may impact farmers.
“Our approach to these rules is we want to ensure a safe food supply and thriving family farms,” Lotti said. “So what we’ve asked ourselves is, ‘How do you construct scale-appropriate regulations so that you can meet those two goals?’”
Along with the proposed rules for growing, harvesting and packing produce, FDA released proposed rules on good manufacturing practices and preventive controls in processing facilities.
Farms are required to comply with the produce regulations if the farm is a mixed-type facility that conducts certain types of processing onsite. Under the preventive controls regulations, processing facilities (including those found on farms) will have to implement HACCP-type procedures into their processing.
The proposed rules list activities that would fit the definition of manufacturing or processing, including washing, trimming of outer leaves, removing stems and husks, sifting, filtering, threshing, shelling, cooling, packaging, mixing, coating, stickering/labeling, drying, sorting/grading, cutting, coring, chopping or slicing, etc.
Examples of “on farm” activities that would not be subject to the additional processing regulations include harvesting, packing food “grown, raised or consumed on that farm or another farm under the same ownership,” or holding.
When a farmer conducts any activity that would change the produce into a “processed food,” the off-farm regulations would likely apply.
“We are in the process of analyzing the rules right now, but a number of things are clear,” Lotti said. “One is that around some of the key issues for farmers in the proposed rules, there is a lack of clarity. It’s unclear what could happen on farms that would trigger that processing definition and how those two rules would interact with a farmer on the ground.”
The comment period for stakeholders ends on May 16, 2013. If the proposed rules are finalized as written, here are some of the rules farmers will have to comply with on the farm:
Agricultural Water Sources
The proposed rules lay out a hierarchy of safe water irrigation sources, with water from a public source at the top of the list, and surface water such as ponds and streams that are susceptible to runoff at the bottom. Ground water from deep aquifers and water pumped from shallow wells are in between.
The lower a water source is on that list, the more the farmer will be required to test the water for E. coli contamination. The proposed rules set different thresholds for generic E. coli testing results depending on the intended use of the water.
If a high level of E. coli is present in the water, it must be treated before applying it to crops. If a farmer uses water that must be tested, the farmer must also keep good records of all testing.
“Farms, through these proposed rules, are being asked to ensure the quality of the water coming onto their farms, which is an enormous burden,” Lotti said. “We anticipate that it will be a significant cost, both in terms of the testing and infrastructure improvements, and also in terms of the farmer’s time.”
The rules offer an alternative mechanism for farmers to be in compliance without having to follow the testing and record keeping standards. To do so, farmers would have to provide scientific research that shows that the water controls or soil amendment controls in place are as protective to public health as what the rules would require.
“Record keeping certainly carries with it somewhat of a burden,” FDA Director of Produce Safety Samir Assar said in an interview with Food Safety News. “We tried to minimize the record keeping burden as much as possible.”
Biological Soil Amendments
The proposed rules also discuss the application of manure and compost to crops as fertilizer, and the regulations relating to those practices. Specifically targeting the use of animal waste as a soil amendment, the proposed rule discusses treated and untreated animal waste.
Untreated animal waste must be applied in a way that prevents any contact with produce, and any application of untreated animal waste must be at least nine months before harvest.
“What we’re finding in our review of the biological soil amendments part of the rule, and what we’re finding in the scientific literature that we are reviewing is that the literature on manure and on the time it takes to kill pathogens on manure is varied and inconclusive,” Lotti said. “It’s not clear from our analysis of the rules and the process that we are going through to analyze scientific literature how FDA came up with that interval.”
For treated manure or compost, restrictions on use are minimal if the farmer complies with certain time and temperature controls in the treatment process.
Farmers also have to be cognizant of cross-contamination while transporting or applying animal waste. The rules provide guidance for keeping tools and equipment clean after touching untreated manure.
Wild and Domesticated Animals
Of all the new regulations proposed under the Act, those governing animals on the farm may be the most difficult for farmers to follow. Grazing animals in the field, working animals, pets and wild animals are all discussed as potential sources of E. coli or Salmonella.
The proposed rules would require a farmer to follow certain requirements if there is a “reasonable probability that animals will contaminate covered produce.”
For working animals, such as draft horses, the rules do not prohibit their use, but they do suggest creating and using segregated “horse paths” that would presumably be next to the rows of produce.
The rules recommend monitoring for wild animals before and during the growing season, but do not require farmers to exclude wild animals. The rules also make it clear that farmers should not disrupt animal habitat or remove endangered species from their farms.
If a farmer suspects a pet or a wild animal has gone into the field, they must wait a “suitable time period” based on relevant factors before harvesting the produce in the field. The rules state the time period does not need to be nine months (the waiting period used when applying untreated manure), but does not specify what a “suitable time period” would be.
The rules do not require documentation of these events, but if an outbreak were to be traced back to a particular farm, FDA would likely ask for evidence of compliance in the form of documentation.
Harvesting, Packing and Holding
The proposed rules offer guidance on handling of produce while harvesting, packing and holding it on the farm.
Food packing materials must be cleanable or single-use, and must be unlikely to support bacterial growth. This regulation may require farmers to purchase new equipment if the containers used during harvest are not easily cleaned.
Farmers are prohibited from distributing produce that drops to the ground before harvest. The rules state that “dropped produce” is more susceptible to bacterial growth. This standard doesn’t apply if produce, such as tree nuts, is dropped to the ground as part of the harvesting practice.
It is unclear if a farmer will be prohibited from selling apples that have accidentally spilled on the ground.
Equipment, Buildings and Sanitation
Some of the new FSMA regulations are a reaction to recent foodborne illness outbreaks. One of the factors listed as a possible source of Listeria contamination in the Jensen Farms cantaloupe outbreak was a retrofitted potato cleaner used to clean cantaloupes.
The rules require all equipment to be easily accessible for cleaning. Also, any seams on surfaces where produce would come into contact with pathogens would need to be bonded or maintained to prevent bacterial growth.
Bathrooms and wash stations will also be required, and farmers will have to keep those areas clean. Bathrooms must be situated away from the produce to avoid contamination.
Compliance, Enforcement and Education
The rules point out that FDA has authority to inspect farms and initiate enforcement actions when needed. It also admits that FDA has limited resources for conducting inspections and enforcement.
In the face of this reality, FDA will conduct its inspections on a risk-based system using past outbreaks and other relevant information to determine which farms will be targeted.
“We are looking at all of the mechanisms that are out there that we can utilize or look at to better focus our inspection resources,” Assar said. “That’s all being worked out right now.”
FDA will also provide education and technical assistance to help facilitate the implementation of the new regulations.
“We are also concerned about the lack of training,” Lotti said. “If they’re going to bring farmers and small businesses in compliance with the rules, while there are later compliance dates for small businesses, there’s this whole aspect of training that is almost absent from the rules.”
“When we talk about training, we talk about building capacity at the farm level and at the processing facility level, so that farms and small businesses can follow good food safety practices and continue to grow and run their businesses and essentially respond to consumer demand for local and healthy and fresh food.”
Assar said that FDA will rely on three specific efforts to provide information and training to help farmers implement the new regulations, including the Produce Safety Alliance at Cornell University, a call center that would offer assistance and information and an updated version of FDA’s and USDA’s Good Agricultural Practices guidance.
“Cornell has had years and years of experience in developing produce safety curriculum and delivering safety curriculum,” Assar said. We have set up this cooperative agreement to set up standardized curriculum across the board.”
FDA may also consider funding non-profit organizations that intend to work with farmers to make it easier for them to transition into compliance, according to Assar. However, FSMA does not specifically authorize any funds for such programs.
“At this point we are evaluating our resources and looking for ways to implement the Food Safety Modernization Act to the fullest extent, achieving this vision of overall compliance,” Assar told Food Safety News.
Impact on growing local food systems?
Farms that process food from other separately owned farms could also be considered a mixed-type facility, which would mean that they’d need to comply with the preventive controls rules in addition to the produce rules. Food hubs, CSA programs and farmer cooperatives often use a centralized location to combine produce from multiple and separately-owned farms.
If you’re packing somebody else’s produce, then you may be a facility that is required to register,” Assar said.
“A farmer that aggregates someone else’s product or includes someone else’s product in their CSA box comes under the rules,” Lotti said. “And that is going to be a big problem for local and regional food systems. It’s an area we will certainly be commenting on.”
FDA does not see it as a barrier for the growth of local food systems, according to Assar.
“We regard it as an opportunity to achieve overall accountability for enhancing the safety of fresh produce.” he said.
Publix Super Markets issued a voluntary recall of a fruit and grain salad sold at its stores Tuesday because the product may be contaminated with Listeria monocytogenes.
The company is recalling certain lots of its Publix brand Deli Tri Fruit and Grain Salad, produced by Allison’s Gourmet Kitchens, and distributed to stores in Alabama, Florida, Georgia, South Carolina and Tennessee.
Product subject to the recall is sold in 12-ounce containers marked with UPC # 41415-39662. Affected items have use by dates of 4/5/2013, 4/14/2013 or 4/17/2013.
Consumers who purchased the recalled salads can return them to their point of purchase for a full refund, announced the company.
No illnesses have been associated with this product to date, according to Publix.
When it comes to dairy production, Montana is not even among the top 30 states, but it may soon be selling the most dangerous raw milk in America. Only four people in the vast state will be responsible for regulating the raw milk supply there, and there won’t be much in the way of rules.
Missoula Republican Champ Edmunds, who is exploring a run for the U.S. Senate in 2014 against Democrat Max Baucus, has succeeded in getting his “small herd exemption” bill through the Montana House of Representatives on a stunning 96-to-3 vote.
State Rep. Edmunds may be taking a page from Montana’s other U.S. Senator, Democrat Jon Tester, who made advocacy for small farms his hallmark.
As the primary sponsor of House Bill 574, Edmunds may be trumping Tester by creating a “Big Sky” size loophole in Montana’s dairy laws.
Here’s just some of what the 16-page bill includes:
- A “small herd” exemption for dairy herds of fewer than 15 lactating cows, 30 lactating goats, or 30 lactating sheep.
- It allows these “small herd” dairies to sell unpasteurized or raw milk directly to the public.
- The “small herd” exemption not only covers licensing, but also sanitation, quality and labeling. (There is a permit for the exemption that in turn allows the sale of raw milk and raw milk products for human consumption.)
- Testing is limited and the standard set is “wholesomeness.” As originally drafted, the bill included testing for bacteria, coliform and somatic cells, and set numerical standards that had to be met. Those specific requirements were axed before final passage.
- The powers of the Montana Department of Livestock to supervise sanitary conditions and to write rules and collect fees were also all eliminated. Later the bill allow the department to do some sampling and testing routinely done at other dairy production facilities. It does allow the department to require “small herd” record keeping.
- Liability for all illnesses and deaths caused by raw milk or raw milk products in Montana is transferred to the consumer, who under the bill “assumes inherent risks in consuming milk or milk products that are not pasteurized, whether those risks are known or unknown, and is legally responsible for all injury or death to the person and for all damages to the person’s property that result from the inherent risks in the consumption of raw milk or milk products.”
- The bill also says it is NOT the duty of Montana state government to see that raw milk is free from the inherent risks so long as it comes from a “small herd” permit holder.
- Facilities operating under a “small herd” permit are not to be considered a “manufactured dairy products” plant or factory.
Raw milk or raw milk products sold under the bill would require a warning label. The required language is: “Warning—This product contains unpasteurized milk, also known as raw milk.” Edmunds was not available for comment on the bill, which has now gone over to the Montana Senate, which continues in session until April 27.
Safe raw milk sales are difficult because time and distance increase the risks. States like Wisconsin and Indiana that have looked at how unpasteurized milk might be sold more safely have concluded that hefty regulatory schemes would be required.
With HB 574, Montana will be taking a very different route that disregards findings by the federal Centers for Disease Control and Prevention (CDC) in Atlanta that say raw milk is 150 times more likely to cause an outbreak of disease than pasteurized milk or that it is the most likely food to put someone in the hospital.
While not in the top 30, Montana’s dairy industry is concerned about the Edmunds bill.
“We have a dairy industry in the state of Montana, and it’s something that we all bust our butts to make a living at,” dairy farmer Jeff Lewis told the Missoulian newspaper. “The biggest issue I see with the bill is it would completely undermine the dairy industry. It doesn’t put us on an even playing field.”
A “fiscal note” on the bill by the Governor’s Office of Budget and Program Planning says the exemption will cost Montana almost $300,000 a year. It says there will be four sanitarians statewide to check on exempted producers.
Edmunds is a veteran of the U.S. Navy’s Submarine Service who moved to Montana in 1997. He then earned a bachelor’s degree in business administration, accounting and finance from the University of Montana. He is ciurrently a mortgage banker in Missoula.
The U.S. Food and Drug Administration this week launched an updated Q&A section to included detailed areas on the two recently introduced food safety rules – on preventive controls and produce safety.
The Frequently Asked Questions (FAQ) section offers stakeholders detail on questions ranging from “Why is this law needed?” to “Will there be a fee associated with FDA inspections?”
This general Food Safety Modernization Act Q&A page gets into several areas that will be of interest to the food producers large and small – looking at fees, inspections, compliance, and recalls, among other things.
According to the FAQ section, FDA still has some details to sort out. For example, the agency has not hashed out what constitutes a “high-risk” food yet.
With the latest update to the page, FDA offers two new much more detailed attempts at answering stakeholder questions for what has been laid out in the two proposed rules. In a 43-page document the agency has presented Frequently asked Questions and Answers on the preventive controls rule. In a 15-page document, the agency answers detailed questions on the produce safety rule.
In a draft guidance for industry published in the Federal Register, the U.S. Food and Drug Administration listed the types of fish that have been found to harbor ciguatoxins, including two species of lionfish that had not previously been named as a potential CFP threat.
Ciguatoxins are produced by an algae that grows in coral reefs and are found in the highest concentrations in the muscle tissue, organs, and fat of tropical or subtropical predatory reef fish, according to the Florida Department of Health.
CFP is usually characterized by nausea, vomiting, diarrhea and neurological symptoms including tingling of the lips and extremities and a reversal of one’s sensation of hot and cold. These neurological symptoms can last for years after exposure to the toxin.
Ciguatoxins cause more illnesses worldwide than any other marine toxin in the world, and are most common in large predatory fish in the Caribbean Sea, the South Pacific Ocean, the Indian Ocean and the Gulf of Mexico.
In its draft guidance, FDA refers fish processors to its Fish and Fishery Products Hazards and Controls Guidance, also known as The Guide, for a list of the fish that may carry dangerous levels of ciguatoxins. These include certain species of barracuda, grouper, scamp, amberjack, snapper, hind, hogfish, jobfish, pompano, jacks and trevally, wrasse, mackerel, tang, moray eels and parrotfish, according to The Guide.
With its new guidance, FDA has added two species of lionfish (Pterois volitans and Pterois miles) to those that may pose a CFP threat.
“We have also found CFP toxins in lionfish (Pterois volitans and Pterois miles) collected in waters surrounding the U.S. Virgin Islands,” says the agency in the document. “However, as of January 2013, there have been no reports of CFP illnesses associated with the consumption of lionfish.”
FDA urges primary seafood processors to be aware of potential ciguatoxin risks associated with fish they are purchasing from harvesters.
The agency’s HACCP guidelines for fish call for species from at-risk areas to be discarded.
Cooking fish does not kill ciguatoxins, which are heat stable and odor free, and there is no known cure for CFP. Therefore the best way to avoid CFP is to be aware of any ciguatoxin risk in the areas from which a fish is harvested.
“[CFP] occurrence is sporadic in reef areas, so you have to rely on local knowledge of areas that have a history of problems.” said Ken Gall, a seafood technology specialist for the New York Sea Grant at Cornell University Extension in an emailed statement to Food Safety News last month.
FDA is accepting comments on its draft guidance on fish associated with ciguatoxins through May 27.
Professor Hugh Pennington, best known for his independent inquiry into the 2005 E. coli outbreak in Wales involving school children, is again stirring the food safety pot from his emeritus post at the University of Aberdeen in Scotland. With Europe moving from one food-related scandal to another, Pennington has been doing one media interview after another, making news with each one.
As one of the world’s top food safety experts, it was Pennington who Wales turned to to investigate its largest E. coli O157:H7 outbreak ever (and the second largest in the United Kingdom). More than 150 people, most of them children, were infected in the Wales outbreak, and 31 were hospitalized. One child, 5-year-old Mason Jones, died as a result of his infection. Jones became the face of the tragedy.
Pennington’s inquiry in Wales led to the criminal prosecution that sent the butcher who supplied the schools to prison.
On Europe’s recent scandal involving the substitution of horse meat for beef, Pennington has had a lot to say. First, he says horse meat is safer than beef because it does not contain E. coli. ”There are no E. coli cases associated with horse meat, though there are around 1,000 cases linked to cattle in the UK each year,” Pennington said.
He suggests that people have been overreacting to the scandal, and says most people could not tell beef from horse in a taste test. Pennington says horse is “bog standard red meat.” He acknowledges that residues of the horse pain killer known as “bute” are a “theoretical risk,” but says somebody would have to eat “tons” of horse burgers before there would be any harm.
Pennington says Europe needs to legitimize horse meat trade to prevent the type of scandal currently being investigated throughout the continent.
Pennington also told British media that meat is generally safer to eat than leafy green salads. Meat, he says, undergoes a more rigorous regulatory process with more quality control checks. Bagged salads go through a chemical wash to kill bugs, but Pennington says the process does not get them all.
“You can only make vegetables safe by cooking and you can’t obviously do that with salad,” Pennington says. “You could irradiate it — but that would be a ‘no, no’ with the public. You just can’t be absolutely sure that the bagged salad you are buying, which has been put through a chemical wash to kill the bugs, is actually free of them.”
He encourages consumers to wash bagged salads because food pathogens including cryptosporidium, Salmonella and Listeria can be riding along on the vegetables.
Finally, the Scottish investigation into pre-packaged sandwiches, which found bacteria in 4 out of 48 samples, does not concern Pennington that much because spoilage is harmful and it stinks. The investigation by 20 local environmental health departments also found another 9 samples of pre-packaged sandwiches that were “borderline.”
“The bacteria found in these sandwiches, while not harmful, make them very unpleasant to eat,”Pennington says. He says the problem may be in the refrigerated storage or sandwich makers are getting the shelf life wrong.
Our founding fathers, white maleness aside, did get a few things right. One of them was the concept of “separation of powers,” which ensures a system of checks and balances among the three branches of government: executive, legislative, and judicial. But a dangerous provision snuck into the budget bill passed last week in Congress upends that system.
Without any hearings on the matter, the Senate included language that would require the U.S. Department of Agriculture to essentially ignore any court ruling that would otherwise halt the planting of new genetically engineered crops. Here is how Capital Press explains it:
The rider pertains to transgenic crops that have been deregulated by the USDA but then had that approval overturned by a judge — a scenario that has occurred with genetically engineered alfalfa and sugar beets.
In such a situation, the agency “shall” immediately issue permits or a partial deregulation order that would temporarily allow farmers to continue growing and selling the crop until USDA is done re-evaluating its environmental effects, according to the rider.
Why is this such a big deal? The court system is often our last hope, with Congress, the White House, and regulatory agencies deep inside industry’s pocket. Several legal challenges have resulted in court decisions overturning USDA’s approval of new GMO crops, for example, sugar beets.
So the biotech industry, unable to make its case to a judge, figured why not just rewrite the Constitution instead, with the help of a Democratic Senate led by Senator Barbara Mikulski, chair of the Senate Agriculture Committee. Despite Montana Senator Jon Tester’s best attempts to stop the so-called biotech rider, the measure was pushed through. (Industry had tried to get a similar measure passed more than once last year.) Tester minced no words in an article in yesterday’s POLITICO about this and other industry power grabs such as weakening small farmer protections:
These provisions are giveaways, pure and simple, and will be a boon worth millions of dollars to a handful of the biggest corporations in this country. They deserve no place in this bill. We simply have got to do better on both policy and process.
If President Obama signs the budget deal with this provision, it could have long-lasting and serious consequences. This list of pending petitions to USDA to approve genetically engineered crops includes new versions of corn, soybean, canola, and cotton. Once these crops get planted, it will be too late to do much about it. That’s why groups such as the Center for Food Safety file lawsuits when USDA turns a blind eye to the potentially harmful environmental consequences of these unique crops.
Here is how Andrew Kimbrell, executive director of the Center for Food Safety described the situation:
In this hidden backroom deal, Senator Mikulski turned her back on consumer, environmental, and farmer protection in favor of corporate welfare for biotech companies such as Monsanto. This abuse of power is not the kind of leadership the public has come to expect from Senator Mikulski or the Democrat Majority in the Senate.
The biotech industry, with the help of Congress, is attempting an end-run of the judicial system. Since judges can’t get be bought off, just go to your friends in Congress instead.
Unfortunately, most of the mainstream media has not picked up on this unprecedented Big Biotech power grab, and in the case of NPR, has even spread misinformation about the rider’s effects:
But a closer look at the language of the provision suggests it may not be granting the USDA any powers it doesn’t already have.
“It’s not clear that this provision radically changes the powers USDA has under the law,” Greg Jaffe, director of the Biotechnology Project at the Center for Science in the Public Interest, tells The Salt.
This interpretation was echoed, unsurprisingly, by the biotech industry, in Capital Express:
“It doesn’t require the USDA to do anything it wouldn’t otherwise have the authority to do,” said Karen Batra, communications director for the Biotechnology Industry Organization. “The language is there to protect farmers who have already made planting decisions.”
But as Kimbrell of the Center for Food Safety explains, the new language makes what is currently discretionary or optional on USDA’s part mandatory, a huge difference:
The word “shall” forces the USDA to continue allowing biotech crop cultivation even if its commercialization was overturned. They’ve taken away the discretion of the secretary of agriculture. Its real not-so-hidden purpose is to take away the ability to effectively vacate the approval of a crop that’s been approved illegally.
If there is any good news, it’s that the continuing resolution the provision hitched a ride on is only valid for six months. But industry seems confident it can make the workaround permanent. Likely what will follow is a protracted court battle over the policy’s constitutionality; remember that whole separation of powers thing? Still, any such legal challenge will likely take years to be resolved. Even USDA thinks the provision is unconstititional. Secretary Vilsack’s office told POLITICO that he has asked the Office of General Council to review the language, “As it appears to pre-empt judicial review of a deregulatory action which may make the provision unenforceable.”
Meanwhile, the grassroots movement continues to grow to demand labeling of foods containing genetically engineered ingredients. While important, we cannot let labeling distract us from pro-biotech policies at the other end of production. The fewer GMO crops that are allowed to be planted in the first place, the fewer end products containing GMOs.
But it’s not too late. You can still demand that President Obama refuse to sign the budget bill into law unless the biotech rider (aka Monsanto Protection Act) is removed. Food Democracy Now! has already gathered more than 175,000 signatures demanding Obama do the right thing. From that organization’s action alert:
By sneaking Section 735 into a federal appropriations bills, Monsanto has successfully planted a dangerous provision in U.S. law that strips judges of their constitutional mandate to protect American’s health and the environment while opening up the floodgates for the planting of new, untested genetically engineered crops.
Even if their new GMO crops are ultimately proven to be harmful to human health or the environment, Section 735 allows them to be planted the minute the USDA approves them!
Even more alarming, currently 13 new crops are awaiting approval at the USDA and AquaBounty’s GMO salmon is on the verge of being approved by the FDA. This new provision opens the door wide open for these approvals.
If the biotech industry can so easily override our court system, which is our last resort in stopping these dangerous crops from being planted, we will have no place left to turn. And Monsanto will have completed its hostile takeover of the U.S. government.
Take action now by calling and emailing the White House here.
The best of the data crunchers are saying it’s a whole lot safer to eat food in America now than it was at the beginning of the last decade. But you still may want to be careful if you’re dining out at a restaurant, or eating at a prison cafeteria.
Food safety risks are the subjects of two new reports from respected and reliable sources: the U.S. Centers for Disease Control and Prevention (CDC) and the consumer watchdog Center for Science in the Public Interest (CSPI).
In the Jan. 25, 2013 edition of its Morbidity and Mortality Weekly Report (MMWR), CDC published an analysis of data on foodborne illness outbreaks between 2009 and 2010, as Food Safety News reported that month.
Now, in its Outbreak Alert! 2001-2010, CSPI examines a decade of outbreaks, revealing a downward trend, with the most dramatic drops coming in seafood, poultry and beef products.
The bottom line in each of the reports is remarkably similar. CDC says, “The number of foodborne disease outbreaks reported in 2009 and 2010 declined 32 percent compared with the preceding five years.”
CSPI says the incidence of foodborne illness outbreaks was down by more than 40 percent over the decade.
Prior to 2011, CDC said foodborne illness in the U.S. sickened 72 million people annually. Then two years ago, that figure was cut to 48 million. Is it now being cut again?
Not exactly. Authors of the CDC study say,”Because of changes in the surveillance system implemented in 2009, comparisons with preceding years should be made with caution.” CDC is now using what it calls the National Outbreak Reporting System (NORS), which features online data entry.
“Despite progress made by the (food) industry and by food safety regulators, contaminated food is still causing too many illnesses, visits to the emergency room, and deaths,” said CSPI’s Caroline Smith DeWaal, food safety director for the Washington D.C.-based nonprofit, in a statement.
“Yet state and local health departments and federal food safety programs always seem to be on the chopping block,” she said. “Those financial pressures not only threaten the progress we’ve made on food safety, but threaten our very understanding of which foods and which pathogens are making people sick.”
One problem in trying to determine trends in foodborne illnesses, according to CSPI, is that such events are “notoriously underreported” because most people do not seek medical treatment for food poisoning. A full outbreak investigation is one in which both the responsible pathogen and the responsible food source are identified. CSPI reports that during the 10-year period it studied, the number of outbreaks that were fully investigated decreased from 46 percent in 2001 to 33 percent in 2010.
As for restaurants, CSPI found there are roughly two and half times more illnesses caused by foodborne illnesses picked up by dining at restaurants than by eating at home.
And while the number of prison outbreaks is relatively small, the number of illnesses caused by these outbreaks is high.
Restaurants were involved in 1,786 outbreaks during the decade, events associated with at least 32,919 illnesses. Private residences were involved in 922 outbreaks resulting in 12,666 illnesses. By comparison, just 77 prison outbreaks sickened 10,660.
Another 1,229 outbreaks occurred in multiple locations —schools, jobsites, catered events, etc.—and were responsible for at least 42,301 illnesses.
Some of CSPI’s other findings include:
- Some of the decline in the number of outbreaks is due to inadequate investigations, leading to fewer fully investigated events.
- Foods regulated by the U.S. Food and Drug Administration (FDA) were responsible for twice as many fully investigated outbreaks as those regulated by the U.S.Department of Agriculture.
- Dairy and produce outbreak levels remained relatively unchanged, while most of the declines came in seafood, beef, pork and poultry,
- Pound for pound, seafood remains the most risky food, followed by poultry, produce and dairy.
- The most common contaminant/vehicle pairing is Salmonella in poultry.
Chicken nuggets and other meat products have been recalled by Greek health authorities after being found to contain horsemeat, the UK’s Meat Trades Journal reported Monday.
The Hellenic Food Safety Authority (EFET) said in a statement that the fraud was discovered via laboratory testing, but so far the first eight results for phenylbutazone, a drug commonly administered to horses that is harmful to humans, have all been negative.
Horse DNA was detected at various levels in a variety of products, including soutsouki (more than 25 percent horsemeat), chicken nuggets (between 10 and 25 percent), pre cooked frozen burgers (more than 50 percent) and frankfurter sausage (between 10 and 25 percent).
See meatinfo.co.uk for a full list of recently recalled products.
The recall became widely known on Monday, just as an editorial by Bloomberg News on how the recent horsemeat scandals are an example of the weaknesses in the global food chain was being circulated.
“The horse-meat storm that broke over Europe two months ago has been in one respect a tempest in a horseshoe, because it posed no threat to human health,” read the editorial. “That’s not a minor caveat in an industry where, in the United States alone, tainted food kills 3,000 people each year and sickens 48 million. The horse-meat substitution has struck a nerve, however, as people wonder what else they’re eating that isn’t what they think it is.”
Pulling on one end of the rope in favor of raw milk and raw milk products — as long as strict standards are followed in producing it — is the National Farmers Union, often described as a “populist” organization with a focus on “family-size” farms.
Pulling on the other end of the rope in flat-out opposition to the sale of raw milk and raw milk products is the American Farm Bureau Federation, known for its lobbying powers on the state and federal level. Both claim the distinction of representing the American farmer.
These contrasting views came to light this year in policies adopted by the two organizations during their annual meetings.
Smooth sailing at the NFU convention
During the NFU’s 111th annual convention, held earlier this month in Massachusetts, the delegates endorsed a strong pro-raw milk stance. They also supported the interstate shipment of raw milk, which is one of the items listed under the topic of “Food Safety.”
With an eye on the faltering dairy industry — due in large part to high feed costs and slumping demand — the NFU policy came out in support of raw milk because “it provides a viable market niche for dairies.”
However, because of the risk of cross-contamination with other milk that might contain pathogens, the NFU policy recommends that raw milk be bottled as the product of a single dairy and, wherever possible, at the physical location of that dairy.
The organization also supports policies, practices and standards of responsible raw milk production for dairy farmers who choose to produce raw milk or raw milk products for human consumption. And it calls for equal access to these products for all consumers who choose to consume raw milk.
Mark McAfee, co-owner of Fresno-based Organic Pastures, the largest raw milk producer in the United States, told Food Safety News that there was no reference to raw milk in NFU’s 2012 policy manual. This year, when he was selected to be a delegate from California, he went before the policy committee. The committee agreed to bring the issue before the whole body, where it won strong support.
In proposing the new policies, McAfee was supported by delegates from California, Pennsylvania and the Northeastern States.
“They recognized that raw milk is good for people,” he said. “It’s good for cows and it’s good for farmers.”
But as upbeat as McAfee is about the organization’s new policies on raw milk, he’s disappointed in the states that are suppressing sales of raw milk for human consumption.
“It leaves dairymen in those states up to their own devices to get raw milk to consumers,” he said, pointing out that a lack of strict state standards can pose food safety risks.
According to the FDA, 20 states explicitly prohibit sales of raw milk and 30 states allow it. Among the states that allow it, California, Arizona, Maine, New Hampshire, Pennsylvania, Utah and Washington have strict standards for the milk’s cleanliness. These standards are equivalent to the national and some international standards for pasteurized milk.
Although the FDA has no power over state laws pertaining to raw milk, it does have the authority to ban interstate sales of raw milk, an action it took in 1987 with an eye on preventing disease outbreaks linked to raw milk.
‘Vigorous’ discussion at the Farm Bureau meeting
In January, during the American Farm Bureau Federation’s annual meeting in Nashville, Tennessee, delegates approved a new policy stating that only pasteurized milk and milk products should be sold for human consumption. According to information from the organization, delegates approved the measure in light of the potential risks to public health posed by the consumption of raw milk.
AFBF president Bob Stallman told Jerry Hagstrom, publisher of Agweek, that delegates had a “vigorous discussion” about this topic.
Dale Moore, director of public policy for the organization, told Food Safety News that raw milk was the “sleeper issue” during the annual meeting.
What triggered concern about this, he said, was a proposed amendment allowing interstate sales of raw milk for human consumption.
“When this came up, there was a lot of surprise,” he said. “The dairy members jumped and said, ‘No, we’re opposed to this.’”
That led the organization to re-emphasize its opposition to raw milk for human consumption.
“We decided we’re going to stay opposed, not neutral, on this,” Moore said, pointing out that this decision was based on the fact that there have been no changes in FDA’s stance on raw milk.
According to FDA’s website on raw milk, a recent study conducted by the Centers for Disease Control and Prevention shows that the majority of dairy-related disease outbreaks have been linked to raw milk.
Even so, Moore emphasized that the organization’s stance against interstate sales of raw milk applies only to the FDA’s ban.
“We aren’t going to try to change state laws,” Moore said. “We want people at the state level to understand that this is not a policy on what’s happening in their states.”
Hard times in the dairy world
Organic Pastures’ McAfee told Food Safety News that sales of pasteurized milk are in steep decline, which has many dairy farmers across the nation scrambling for ways to stay in business. For some, raw milk offers a better business model.
“If sales of pasteurized milk were really strong, raw milk wouldn’t be as big an issue as it is,” McAfee said. “But a lot of dairy farmers are facing tough times. Some are throwing down the surrender flag and saying they’ll plant almonds or walnuts instead.”
This theory aligns with comments that Michael Marsh, CEO of the Western United Dairymen, shared with a reporter last fall for an article in the San Francisco Chronicle.
“Many dairy farmers are simply giving up and getting out,” he said. “The barns are coming down, the corrals pulled apart, and the ground planted with almonds, walnuts and pistachios.”
The same article also said that farmers are not only losing their farms but also their homes, which in many cases were their grandparents’ and parents’ homes.
In an e-mail to Food Safety News, Marsh said that according to the California Department of Food and Agriculture, California lost 105 dairy farms between 2011 and 2012. He also said that since last October, milk prices have fallen and feed costs still exceed the revenue producers receive.
Flip the coin, and farmers selling raw milk are generally having a better time of it. In McAfee’s case, for example, he’s seen sales increase by 25 percent at Organic Pastures.
“We’re a $10 million company now,” he said. “And that would be higher except our trucks just aren’t large enough to carry all the milk and milk products we produce. The raw milk industry is explosive and exciting.”
Things are going so well for him, in fact, that he’ll be building a brand new $3.5 million creamery next year. He describes the creamery as “very tourable with an educational area and quality assurance labs.”
He also envisions smaller raw milk dairies setting up “tourable” facilities and selling their milk and milk products to visitors very much like artisan-based wineries do now.
“They’ll be able to get good prices,” he said. “People will want to go to there.”
Hannah Smith-Brubaker, executive director of the Pennsylvania Farmers Union and co-owner of Village Acres Farm, agrees with McAffee that customer demand is the driving force behind dairy farmers’ interest in raw milk.
Her family, which includes two children ages 10 and 14, drinks raw milk and always has.
“It’s a superior nutritional product. I can’t imagine why a government agency should stand in the way of this,” she said, referring to the FDA’s ban on interstate sales of raw milk for human consumption.
She also said that raw milk provides a good discourse about food safety and puts the issue of direct sales from the farm to consumers on the table.
“It allows a farmer to have a good livelihood,” she said. “He’s selling the same unprocessed product to customers that he’s serving to his family.”
When she can’t get raw milk directly from the farmer, Smith-Brubaker said she’ll go to the store to buy it, typically paying $5 to $7 for a gallon, which she said goes almost entirely to the farmer. She contrasts that with far lower prices for pasteurized milk, with much of that going to the processor.
McAfee, meanwhile, believes that the day that safe and responsibly produced raw milk will be legal across the nation is coming. “This isn’t a black or white issue,” he said. “It’s an evolutionary process. I envision it as a 5 to 7-year roll-out.”
How safe is raw milk?
Last December, McAfee sued the FDA for allegedly turning its back on the dairy’s 2008 request for the agency to withdraw its current ban on sales of raw milk across state lines. Instead, he wants raw milk that is produced legally in one state, such as California, to be able to be shipped to another state that also allows sales of raw milk, such as neighboring Arizona.
Pointing to food safety concerns, McAfee said that he’s not asking for raw milk to be allowed across every state line in all cases because “sloppily produced raw milk can be dangerous.”
But in a Feb. 26, 2013 response to McAfee, Michael Landa, director of FDA’s Center for Food Safety and Applied Nutrition, made it clear that the agency isn’t going to budge on its ban on interstate commerce of raw milk.
Here are some of the points made in the agency’s response:
- Even if milk is produced under strict standards that require low coliform and somatic cell counts — both of which indicate that the milk meets certain sanitation standards — those low counts don’t indicate the presence or absence of harmful, potentially deadly pathogens.
- As of yet, there is no reliable method available to guarantee that raw milk from a state-regulated dairy or raw milk manufacturer is or will be free of pathogens.
- There have been nine recalls (quarantines) involving raw milk or raw milk products in California since 2006, seven of which have involved Organic Pastures.
“FDA has concluded that your petition fails to establish that current testing, state inspection and state regulation programs can adequately mitigate the dangers posed by raw milk,” wrote Landa in his conclusion.
McAfee told Food Safety News that he has no intention of throwing in the towel on this issue and that he’s drafting a new petition with scientific information that will be put before the judge.
“It will refute all the false statements in FDA’s response,” he said. “We’re going to keep the heat on their feet on this.”
In his e-mail to Food Safety News, Western United Dairymen CEO Marsh said that the Centers for Disease Control and Prevention last spring issued guidance finding that the consumption of raw milk was the country’s top food safety concern.
“Whenever we experience one of the iterative raw milk recalls and quarantines of raw milk sales in California, sales of all milk and dairy products suffers, not just sales to consumers of raw milk,” he said. “Unfortunately, consumers read or hear of yet another raw milk recall and what they retain is that ‘the milk is bad’ and consumption declines.”
What about this business model?
While many raw milk supporters say that producing and selling raw milk is a way for dairy farmers to stay in business, Jon Bansen, an Oregon organic dairy farmer and a member of the Organic Valley cooperative, would offer another option.
“Organic dairying is a good business model even though there’s been some downward pressure on prices,” he said, referring to grocery stores with private-label organic milk.
Bansen also pointed out that because most organic milk is pasteurized, there’s less for a dairy farmer to worry about when it comes to being sued. That’s not the case, he said, for raw milk producers who have to worry that their milk might get someone sick if foodborne pathogens get into the milk.
On the business side of the equation, he said he gets about $3 a gallon for the milk from his Jersey cows, which is considerably more than the price conventional dairy farmers receive for their milk.
But it’s not a slam dunk.
“My costs could be more than $3 per gallon if I don’t do a good job of it,” he said. “And if I were buying organic alfalfa and organic grain, I’d go broke.” Instead, he pastures his cows and raises the grains and hay he feeds his cows, which puts his costs “well under $3 a gallon.”
Now that his son has returned to the dairy, Bansen has increased his milking herd to 180 cows.
He said it’s easier to manage a small dairy such as his than a larger operation, where it’s a challenge to keep a close eye on things.
“The organic model really is the best of all worlds,” he said. “But you have to really think about all of the biological processes involved with the cows and the health of your soil. But when you do, organic dairying is really an enjoyable system. You get a lot of satisfaction out of it.”
Not that it’s as easy as simply deciding to switch over to organic dairying. It generally takes 3 years to transition to organic, and a dairy has to be close enough to a processor that will take its organic milk.
Consumer demand is the driver. Some consumers are willing to pay the higher prices for organic milk products based on the belief that they’re healthier. Others choose organic because they believe organic dairying is good for the environment and helps small family-scale dairy farms stay in business.
According to Organics Trade Association, 6 percent of all dairy products sold to U.S. consumers are organic. In 2011, nearly 2.1 billion pounds of organic milk products were sold — a 14.5 percent increase from the previous year and the second year in a row that sales increased by double digits, according to information from the USDA.
Triple J. Family Farms, based in Buffalo Lake, MN, recalled approximately 15,270 pounds of bone-in rib eye products Monday because the bovine’s vertebral column may not have been completely removed. USDA’s Food Safety and Inspection Service said not removing the vertebral column in cattle 30 months of age or older is a violation of regulations to control Bovine Spongiform Encephalopathy (BSE).
The recall is for approximately 40-lb boxes of “BEEF B/I RIB,” bearing any of the following case codes: “91-R109H-C,” “91-R109H-S,” “91-R109H-C-SB,” or “91-R109H-S-SB.” (See box label) Inside the USDA mark of inspection, the establishment number is “EST. 17466.”
The rib eye involved in the recall were packaged on various dates between Feb. 8, 2013, and March 21, 2013, and were distributed to an FSIS-inspected establishment in New York for further processing and distribution.
FSIS discovered the problem during a routine specified risk material (SRM) verification and it may have occurred as a result of a recent change in the company’s carcass separation practices.
Vertebral column is considered a SRM and must be removed from cattle of 30 months of age or older in accordance with FSIS regulations. SRMs are tissues that may contain the infective agent in cattle infected with BSE, also known as Mad Cow Disease, as well as materials that are closely associated with these potentially infective tissues.
Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent. There is no indication that any of the cattle slaughtered displayed any signs of BSE.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
The White House Office of Management and Budget significantly weakened the U.S. Food and Drug Administration’s draft food safety rules, documents posted on the Federal Register last week show. The hundreds of pages of documents, first discovered and reported by Food and Chemical News (subscription only) on Friday, confirm what food safety insiders had suspected – that OMB’s lengthy review stripped product and environmental testing requirements, among other provisions that FDA sought, from the preventive controls rule.
“Based on FDA’s original language, as revealed in the documents placed online by HHS, the agency did favor environmental monitoring for pathogens reasonably likely to occur as well as scientifically valid finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards,” Joan Murphy reported in Food Chemical News. “If environmental monitoring were to identify the presence of a pathogen, the facility would follow certain corrective action steps, according to the original proposal.”
Looking at the documents, which were apparently posted online by Health and Human Services to satisfy a 1993 executive order on transparency, it is clear that OMB eliminated such requirements in their edits to the proposal. Instead, testing is mentioned in an appendix, and the agency asks for comments.
While Food Safety Modernization Act watchers had speculated about such changes, seeing such edits in a track-change format offers a rare, detailed look at OMB’s review process. (The standard practice for economically significant regulations is to go through review at OMB’s Office of Information and Regulatory Affairs, but exactly what changes are made by the agency are often not disclosed.)
David Plunkett, a senior food safety attorney at the Center for Science in the Public Interest, said he wasn’t surprised that testing was one of the issues holding up the rules while they were under White House review.
“It’s OMB once again protecting corporate bottom lines at the expense of protection for public health,” said Plunkett. “Testing is critical to verification. I don’t think a preventive food safety system can be effective without it. Unfortunately, OMB bean counting of the wrong costs results in a less effective prevention program and ultimately continuing food safety problems.”
“We totally predicted that was what happened based on reading the rule and have been saying that since the rule came out – all about getting it out the door with acceptable political economics and now look for the private sector to weigh in,” said David Acheson, former associate commissioner of foods at FDA, now a consultant at Leavitt Partners.
As Food Chemical News reported, the changes OMB made to the proposed rules were “too numerous to cite,” but included eliminating requirements for maintaining a supplier approval and verification program or requirements to review complaints from consumers or customers that might be related to a company’s food safety plan, and striking a mention of an FDA investigator’s ability to copy records to demonstrate compliance. “Similar changes can be found between the draft of the proposed produce safety regulation and a large majority of the preamble is rewritten from the FDA draft,” the report noted.
OMB also added a year to the date by which farms would have to comply with the new rule. According to the documents, FDA had proposed allowing very small businesses three years to comply with the rule, small businesses two years and all other companies one year. During its review, OMB changed the time allowed for compliance to four years for very small businesses, three years for small businesses and two years for all other farms.
Why were all these changes made? “Undoubtedly election-year politics,” according to Marion Nestle, food politics expert, author, and professor at New York University.
“The election is over,” Nestle wrote on her blog Food Politics on Monday. “The FDA needs to do its job. Let’s get these items reinserted. The safety of Americans is at stake here.”
Food Safety News invites readers to review and weigh in on the documents, which can be viewed here.
The FDA did not respond to requests for comment.
This article has been updated to add comments.
Until recently, rotavirus was the leading cause of gastrointestinal illness in young children in the United States. Before a vaccine was developed for the virus in 2006, “almost all children in the United States were infected with rotavirus before their 5th birthday,” according to the Centers for Disease Control and Prevention (CDC).
Now, a new study funded by CDC shows that norovirus, another virus that infects the intestine, has surpassed rotavirus as the leading cause of gastroenteritis among children under five treated at healthcare facilities.
Researchers analyzed the cases of 1,295 young children who received medical attention for gastrointestinal symptoms in 2009 and 2010 and found that 21 percent of them were confirmed to have a norovirus infection, while 12 percent were sickened by rotavirus.
The study, published in the New England Journal of Medicine last week, estimates that norovirus accounts for 14,000 hospitalizations, 281,000 emergency department visits and 627,000 outpatient visits per year among children under five years old, for a total of almost 1 million health care visits annually.
The approximate cost of a norovirus infection resulting in hospitalization is $3,918, according to the study, while the cost of an emergency room visit is around $435 and an outpatient visit is an estimated $151. Treating norovirus patients in this age group costs over $273 million per year, conclude the authors.
Is this trend likely to continue in the future, or will a vaccine for norovirus reduce the incidence of this pathogen, as it did for rotavirus?
“There are several norovirus vaccines that are in various stages of development. However, one norovirus vaccine is in phase III clinical trials,” said Dr. Daniel C. Payne, lead author of the study, in an email to Food Safety News, referring to a nasally administered vaccine that was proven effective in a study published in NEJM in December of 2011.
“That vaccine is now being tested in a form for intramuscular injection among older adults,” said Payne.
In the meantime, there are still precautions people can take to prevent the spread of norovirus, he noted.
“Until specific interventions are available, the best ways to reduce the risk of norovirus infection are proper hand washing and good hygiene.”
Norovirus is transmitted via the fecal-oral route, and is spread easily in confined spaces such as cruise ships, daycares and elderly homes.
A norovirus infection is generally characterized by abdominal cramps, diarrhea and vomiting. More severe illness can occur in the elderly, small children and those with weakened immune systems.
Payne says CDC is also analyzing the burden of norovirus illness among the elderly, “another population vulnerable to norovirus infection.”
The parents of an 11-year-old girl sickened in the Salmonella outbreak that affected schoolchildren in Chicago’s northern suburbs have filed suit against organic foods company considered responsible for the outbreak.
Stacey Wescott and Brian Peterson of Elgin, Illinois filed a case against OrganicLife Thursday in Cook County District Court seeking damages following the illness of their daughter Sophia, who was hospitalized for four days as a result of her Salmonella infection.
OrganicLife was named as the likely source of the Salmonella Enteritidis outbreak that affected six private schools in Cook and Lake Counties last fall. A total of 18 illnesses were linked to the outbreak, with 8 cases confirmed by DNA testing of bacteria isolated from victims, and 9 more cases considered probable, according to an investigation report from the Illinois Department of Public Health. One family member contracted a secondary infection.
The outbreak began in mid-September and lasted through mid-October of 2012.
Sophia fell ill on September 20, 2012 after buying school meals manufactured by OrganicLife on September 17 and 19, according to the complaint.
She suffered from abdominal cramps, lethargy, nausea, vomiting and diarrhea. Over the next two days, her symptoms worsened and she developed a fever of 104 degrees. On Sunday, September 23, Stacey brought her daughter to the emergency room, where she was treated with IV fluids to hydrate her. She was then sent home, but here symptoms continued to worsen there. She could not keep any food or fluids down, and suffered from severe abdominal cramps and high fevers.
On Tuesday September 25, Stacey took Sophia back to the hospital, where she was admitted and found to have bodily fluid levels comparable to someone “starving to death,” according to the complaint. She was kept in the hospital for four days, before being released on September 29.
Doctors concluded that Sophia’s Salmonella infection was worsened by the fact that she has Thalassemia, a blood disorder that results in excessive destruction of red blood cells, according to the court documents.
A sample collected from Sophia’s stool confirmed that she had a Salmonella infection.
Her parents are seeking damages for medical expenses, lost wages and other costs related to her illness.
While the specific food carrying the bacteria was never identified, an inspection conducted at OrganicLife’s facilities on October 10 by investigators from IDPH revealed a number of unsanitary conditions, including food not kept at proper temperatures, employees handling ready-to-eat food with bare hands, inadequate hand washing by employees, employees handling trash and then food without changing gloves, water dripping from the ceiling above food and unclean food contact surfaces.
Health officials concluded that an infected food handler may have contaminated different batches of food that were then served at schools where students were sickened.
“Based on the extended range of onset dates and lack of cases in other areas, the most likely source of the contamination was an infected food handler who through inadequate hygiene may have intermittently contaminated food served at the schools,” said IDPH in its outbreak report.
Food temperature abuse may have contributed to the growth of bacteria, according to the health department.
Cetntral-Epicure Ltd. of Toronto, Ontario in Canada issued a voluntary recall of its Atlantic Smoked Salmon Friday citing potential Listeria monocytogenes contamination.
Product subject to this recall is sold in 100 g packages marked with UPC 0 61279 21200 6. The expiration date is BEST BEFORE 12MR26.
The Canadian Food Inspection Agency says there have been no illnesses connected to consumption of the recalled product to date.
Now the problem has cropped up in Canada, where this is the first recall of smoked salmon for Listeria risk this year, according to CFIA’s recall page. A cold smoked salmon product was recalled due to a risk of Listeria in February 2012 in British Columbia.
As Food Safety News reported in “Looking Back: The Story Behind Banning E. Coli O157:H7,” Taylor took the podium that day in San Francisco at the American Meat Institute’s annual convention to make his first, and arguably most significant, speech as the top food safety official at the U.S. Department of Agriculture.
“I am here to talk about change,” began Taylor, who had just become administrator for the USDA’s Food Safety Inspection Service (FSIS), as he looked out over his all-industry audience. “Change in what the public expects when it comes to food safety, change in how we at the FSIS are approaching our job, and change in the demands being placed on all those who produce, process and market meat and poultry for American consumers.”
Taylor explained his belief that the meat industry had an opportunity to move beyond the politics of food safety and find real solutions on the heels of the massive Jack in the Box E. coli O157:H7 outbreak in the Pacific Northwest that had happened a year before.
And then, Taylor uttered a few lines the industry may not have wanted to hear:
In one critical respect, our inspection program at FSIS does not currently meet the public expectation. There is a gap in our system. The fact is we do not deal directly enough and scientifically enough with the microbial pathogens that can make people sick.
To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.
We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated products from commerce.
And with that the world changed. This seemingly simple change – calling E. coli O157:H7 an adulterant – has over the last 20 years saved countless children from kidney failure and death. In the long run it has also saved the beef industry millions of dollars – dollars that would have gone into my pocket and the pockets of clients sickened by that deadly bacterium. And that has been a very good thing.
Over the last decades I have bumped into Mike at food safety conferences around the world, as he ushered in HACCP in the meat industry, as he worked on food safety in academia and as he performs his current food safety role at FDA – forcing the industry to think hard about how to prevent another Jack in the Box. During the run-up to the passage of the Food Safety Modernization Act (FSMA) in 2010, I watched as he deftly helped consumers and industry form partnerships to press for the most comprehensive changes in FDA rules in too many decades.
And during the last few years I have watched quietly as a few groups raised questions about his integrity, including a petition to President Obama to fire him.
Last Friday I flew from Seattle to spend two hours of Saturday in Boston participating in a panel before some 75 journalists at a session of the annual meeting of the Association of Health Care Journalists. Along with Mike Taylor and Will Daniels (food safety leader at Earthbound Farms), we discussed why foodborne illness persists as a challenging problem and what consumers, government and industry are doing to prevent it. Each of us had about 20 minutes each to speak. The plan then was to open it up for questions.
One of the first questions posed to Mike was not about E. coli O157:H7 or how with a limited budget was the FDA trying to implement FSMA. The first question was about Mike’s “Monsanto baggage,” specifically whether his past role working on biotechnology-related matters for Monsanto, created a conflict of interest for his current role at FDA as Deputy Commissioner for Foods and Veterinary Medicine.
As the question was being asked, I looked over at Mike and thought to myself, “he simply does not get paid enough to take this.” But, then again I thought, “heck he is a public servant. I suppose it simply comes with the territory.” But, I admit that I was surprised when he responded – politely – and with some details that I do not think he had ever talked about publicly.
Mike explained that his career included time as a staff lawyer at the FDA in the mid 1970s and then practicing law during the 1980s at a law firm that represented Monsanto. He then returned to FDA in 1991 as Deputy Commissioner for Policy under Commissioner David Kessler. He then led FSIS from 1994 – 1996, where I first heard of him. In the late 1990s he was employed at Monsanto itself for 16 months, and beginning in 2000 he spent almost a decade in academia doing policy research related to food safety and African agricultural development. In 2009 he returned to lead the food side of FDA.
Mike was candid with the fact that a history of moving in and out of government through the “revolving door” concerns people and can raise the question of whether his current role at FDA is conflicted by previous private sector roles. He explained to the questioner, that to guard against such conflicts, the government has clear rules about what a person can and cannot work on under those circumstances, and he follows those rules very carefully. For example, as Deputy Commissioner for Policy in the mid-’90s, Ethics Counsel said that he could work on general policy matters, such as policies for food labeling, but he was precluded from any involvement in specific product approvals of interest to Monsanto. So, he explained, among the mythologies surrounding his career was that he was involved in FDA’s decision to approve rBGH, the growth hormone used in dairy cows – he was not.
Surprisingly, Mike was not done setting the record straight. I say surprisingly, because in all the years I have known him, I had never heard him speak to the issue. He went directly to concerns about his time at Monsanto, and the suggestion one can find readily on the Internet that he is now and always is “Monsanto’s man.” The questioner was by now a bit out of sorts when Mike said, “nothing is further from the truth.”
Mike explained that while at Monsanto, he worked not as a “lobbyist,” but as the head of an internal think tank and as a policy advisor to senior management. In this role, he strongly advised Monsanto to drop its opposition to the labeling of biotech foods and to engage its external stakeholders in a more respectful and transparent way. Monsanto did not take his advice. He explained that he left Monsanto when it became clear that he would be unable to have any real impact. He realized that perhaps he was better suited to addressing issues that interested and concerned him from a more “objective platform,” which is why he spent the next decade in universities working primarily on policies affecting agriculture in Africa and food safety as a global public health and food system issue.
Mike explained that he did not feel conflicted by his past experience with biotechnology policy, but he understood concerns about it and thus that the “baggage” he carries is real to some. That is why he has removed himself from participation in deliberations and decision making on all biotech-related issues that arise in the foods and veterinary medicine programs at FDA even though he has thoughts on it.
Mike began to finish his answer with a bit of introspection – with the tone of someone at both the height of a career and also looking back. He said that he did his work at FDA every day with only one interest in mind, which is doing everything he can to fulfill the mission given by Congress to protect consumers and public health. He does this by working as closely as he can with stakeholders and partners, recognizing the need to find practical solutions that consider the wide range of perspectives on FDA issues held by the many people who care deeply about what FDA does. He said his only goal is to fully implement FSMA and address the range of other food safety, nutrition, and animal health issues central to the mission at FDA.
This week, I had time to do just a little research. Frankly, it does not take long to find where Mike addressed biotech issues in writing on several occasions. This included a 2003 commentary in the Journal Nature Biotechnology (Vol. 21, No. 8, Aug. 2003) in which he criticized the aggressive approach the U.S. government and biotechnology industry were taking to promote biotech crops overseas, including in Africa, and argued that “the United States should be on the side of empowering choice” in the adoption of biotechnology, “in whatever way works in any given country,” including through labeling. He also called in that commentary for policy change aimed at strengthening pre-market oversight of biotech foods. In another article (Taylor and Cayford, American Patent Policy, Biotechnology, and African Agriculture: The Case for Policy Change, Harvard Journal of Law & Technology (Vol. 17, No. 2, Spring 2004), he argued, in the interest of African food security, for changes in U.S. patent policy and international patent agreements that would reduce the control Monsanto and other biotech companies could exercise over biotech crop improvements that could genuinely benefit food security. To me these are not exactly the perspectives of someone looking out for Monsanto’s interests.
As the questions and answers wound down last week, I leaned over and asked Mike if he was up for a cup of coffee. Over a bad cup, I asked him why after all the years of being called “Monsanto’s Man” did he feel the need to say anything? He looked a bit perplexed at my question and said:
We’d all like to be judged for what we actually do rather than half-truths and myths on the Internet. I know I won’t satisfy those who object in principle to people working on FDA-related matters in both the public and private sector, or who think the rules governing these situations are not adequate, or who don’t like the policies FDA has made whether I worked on them or not. I fully understand and respect that point of view. About all I can say is that people in positions like mine work in the open, under the guidance and scrutiny of their bosses and many others, and I have always done my best to fulfill my responsibilities to FDA and its public health mission.
I am not sure we can ask more of Mike or anyone in government.