FDA alleges food safety violations at New Bedford scallop plant

The US Food and Drug Administration (FDA) found “serious” food safety violations at a seafood processing facility operated by Massachusetts-based M&B Sea Products, the FDA said in a warning letter to the company.

raw.scallops.dillions.aug.09Refrigerated, reduced-oxygen packaged raw scallops at the facility have been “prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health,” the FDA said in the Aug. 26 letter.

John Murray, president of the New Bedford-based company, did not respond to requests for comment from Undercurrent News on Tuesday. Mutahar Shamsi, director of the FDA’s New England district, declined to comment on an open case.

Recent research on third-party audits

Ronald Doering, the first president of the Canadian Food Inspection Agency and the only one I can remember, writes in his Food Law column:

ron.doeringUntil recently there has been little serious research on the most significant food safety advance in the last decade, a develop­ment that has been entirely outside the realm of public law — the extraordinary growth of third-party supplier audits. There are now over 500 food safety audit firms, many of which have global operations.

The Food Safety Service Providers, an industry association representing nine leading private food safety audit firms, asserts that its members alone conduct more than 200,000 audits and inspections in more than 100 countries each year. It has been estimated that in the U.S. the scale of private food law auditing activity is now 10 times larger than that of the federal government, more than all federal and state efforts combined. Two recently published academic studies provide inter­esting insights into several aspects of this important new area of food law.

Audits and Inspections Are Never Enough: A Critique to Enhance Food Safety (Food Control, vol. 30, issue 2) by Douglas Powell et al. identifies the many limitations of third-party audits and doc­uments several cases of major foodborne illness outbreaks linked to food proces­sors that have passed third-party audits. Audits need to be supplemented by other measures such as microbial testing, and companies must have in-house capacity to meaningfully assess the audit results. Third-party audits are part of “a shift in food safety governance away from government regulation and inspection towards the development of private food safety standards.” This study represents a cogent caution to the audit industry that they must improve their systems, and a warning to the food industry that audits are never enough.

doug.ron.2.jan.13In the latest Wisconsin Law Review American law professors Timothy D. Lytton and Lesley K. McAllister (Oversight in Private Food Safety Auditing: Addressing Auditor Conflict of Interest, 2014) provide the first comprehensive analysis of one of the most serious problems with private food safety auditing — auditor conflict of interest. Auditors are paid by the company being audited. Suppliers have an interest in finding the cheapest and least intrusive audit that will provide a certificate, and auditors have a financial incentive to reduce the cost and rigour of audits to get business in a very competitive environment. This study analyzes several oversight mechanisms that have been developed to mitigate the conflict problem, but concludes that at this time there are still too few financial incentives to assure more rigorous auditing.

Considering how few inspections are actually carried out by the Food and Drug Administration (FDA) relative to the number of businesses it is responsible for, it is ironic that the U.S. has been so reluctant to embrace more fully the advantages that third-party audits represent. Perhaps this is because President Obama is so beholden to consumer activist groups that do not trust the in­dustry, believe that only FDA inspectors can stop big bad food companies from poisoning consumers, and who refuse to recognize that it is private audits that are increasingly the drivers of enhanced food safety. Obama has declared that it is the state that has the primary responsibility for food safety, and the former FDA com­missioner dismissed audit schemes as being merely “a business strategy, not a public health strategy.”

In Canada we have always recognized that while it is a shared effort, practically and legally it is food producers that have the primary responsibility for food safety. Industry recognized some years ago that they couldn’t meet this responsibility adequately just by complying with gov­ernment regulations — that they could protect their brand from recalls, minimize foodborne illness law suits, source ingredi­ents widely and trade internationally only if, among other things, they insisted on warranty agreements from suppliers and that these were backed up by independent third-party audits. There are many legal and other problems with these relatively new instruments at this still early stage in their development, but they’ve come a long way in the last 10 years.

Finding ways to better integrate public law-based food safety regulations with private law-based certification systems may prove to be one of our more inter­esting challenges in the decade ahead.

Blessed are the cheese makers (except those that have an import alert)

Following the don’t-age-on-wood-boards-uh-just-kidding incident earlier this year, the U.S. FDA are again raising the hackles of cheese purveyors. This time over an import alert.

According to Janet Fletcher of the L.A. Times Daily Dish, an FDA-issued alert on certain manufacturers of raw milk cheeses due to presumed insanitary conditions is keeping some top-selling cheeses off of baguettes.

In early August, these cheeses and many more landed on an FDA Import Alert because the agency found bacterial counts that exceeded its tolerance level. Cheeses on Import Alert can’t be sold in the U.S. until the producer documents corrective action and five samples test clean, a process that can take months.hqdefault

Of course, French creameries haven’t changed their recipes for any of these classic cheeses. But their wheels are flunking now because the FDA has drastically cut allowances for a typically harmless bacterium by a factor of 10.

The limits for nontoxigenic E. coli were cut from 100 MPN (most probable number) per gram to 10 MPN. These are bacteria that live in every human gut; they are typically harmless and we coexist happily. But the FDA considers them a marker for sanitation: If a cheese shows even modest levels of nontoxigenic E. coli, the facility that produced it must be insufficiently clean.

Dennis D’Amico, an assistant professor at the University of Connecticut whose specialty is dairy microbiology, says this premise is flawed.

“There was no health risk in all the years we operated at 100 MPN,” says David Gremmels of Oregon’s Rogue Creamery, which produces several raw-milk blues. “We look at this as an arbitrary change.”

Gremmels and others say they felt blindsided by the revised FDA guidelines, learning about them only when European cheeses began being held. The agency hasn’t offered any scientific support for the altered E. coli allowance, prompting unease about its decision making.

The stepped-up testing creates headaches for companies like Gourmet Imports, a Los Angeles cheese importer and distributor.

“In the past year, we’ve had delays on things you never would have imagined would be held before,” reports general manager Alex Brown. Even Parmigiano-Reggiano, a well-aged, low-moisture cheese unlikely to have microbial issues, was recently held for testing.

“It’s the safest cheese on the planet,” Brown says.

An import alert allows FDA to ask for more data (micro or inspection from an exporting country) and according to the Alert page, This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.

After a bit of digging I found a 2009 FDA Staff Compliance Policy Guide Sec. 527.300 Dairy Products – Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) that states:

The presence of Escherichia coli in a cheese and cheese product made from raw milk at a level greater than 100 MPN/g (Most Probable Number per gram) indicates insanitary conditions relating to contact with fecal matter, including poor employee hygiene practices, improperly sanitized utensils and equipment, or contaminated raw materials. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product, other than a cheese or cheese product made from raw milk, also indicates insanitary conditions. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product made from pasteurized milk indicates that contamination occurred after pasteurization.

Any government agency needs to clearly and effectively communicate risk-based decisions, (especially changes) and provide the evidence to back a particular decision.

Food additives on the rise as FDA scrutiny wanes

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

fda.gras.approvedAnd in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.

The FDA has received thousands of consumer complaints about additives in recent years, saying certain substances seem to trigger asthmatic attacks, serious bouts of vomiting, intestinal-tract disorders and other health problems.

At a pace far faster than in previous years, companies are adding secret ingredients to everything from energy drinks to granola bars. But the more widespread concern among food-safety advocates and some federal regulators is the quickening trend of companies opting for an expedited certification process to a degree never intended when it was established 17 years ago to, in part, help businesses.

A voluntary certification system has nearly replaced one that relied on a more formal, time-consuming review — where the FDA, rather than companies, made the final determination on what is safe. The result is that consumers have little way of being certain that the food products they buy won’t harm them.

“We aren’t saying we have a public health crisis,” Taylor said. “But we do have questions about whether we can do what people expect of us.”

‘Natural’ helps sell $40 billion worth of food in the U.S. every year—and the label means nothing

Nothing makes Americans buy a food product quite like the fabulously ambiguous word “natural.”

chobani.yogurtThe top 35 health claims and food labels include words most anyone who has been to a supermarket in the past five years should recognize—ones like “natural,” yes, but also “organic,” and “fat free,” and “carb conscious,” and “100 calories.”  These phrases helped the food industry sell more than $377 billion worth of masterfully marketed food items in the United States during the past year, according to data from market research firm Nielsen.

The list of lucrative food labels is long, and, at times, upsetting.

Many of these labels are pasted onto food packages for good reason. It’s imperative, after all, that consumers with celiac disease be able to tell which food items are gluten free, or that those with milk allergies be able to tell which are made without lactose.

But some are utterly meaningless. Take food labeled with the word “natural,” for instance. Actually, remember it, because it’s probably the most egregious example on supermarket shelves today. The food industry now sells almost $41 billion worth of food each year labeled with the word “natural,” according to data from Nielsen. And the “natural” means, well, nothing. The US Food and Drug Administration (FDA) doesn’t even have an official definition or delineation of what “natural” actually means. The only thing the FDA has regarding the word is this statement, on its website:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

market.naturalIt’s hardly the only misleading adjective the food industry is swinging around these days. The word organic, while a bit less nebulous, still means a good deal less than one might think. Several others, including ones that reference antioxidants, proteins, calcium and other vitamins and minerals, are confusing consumers by tricking them into believing certain food products are healthier than they actually are, a recent study found. And the trend is only likely to get worse. Many of the top grossing food labels are still growing—and fast.

(This is satire): FDA recalls food, out of an abundance of caution

Saying it was vitally important that citizens avoid consuming any of the affected items, the U.S. Food and Drug Administration issued a nationwide recall of all food Wednesday. “We are asking all Americans to return any edible products they own to the store where these items were purchased or to discard such items immediately,” margaret_hamburgsaid FDA commissioner Margaret Hamburg at a morning press conference, specifying that under no circumstances should Americans eat grains, meats, produce, nuts, dairy products, processed foodstuffs, sweets, spices, or any other source of sustenance, nor should they feed any of these foods to animals or leave them within the reach of children.

“If you are eating something right now, please discontinue doing so. We will let you know when it is okay to consume food again.” Hamburg noted that salt, baking soda, and all foods manufactured before 2002 were unaffected by the recall.

FDA rule could end consumer access to antibacterial soaps

Food safety nerd Don Schaffner says antimicrobials have a role, and I usually agree with Don (right, not exactly as shown).

 77fdonuts1In an effort to maintain consumer access to the benefits of antibacterial soaps, the American Cleaning Institute (ACI) and the Personal Care Products Council, along with input from leading independent scientists, filed extensive comments with FDA on its proposed rule. The comments demonstrate to the Agency that consumer antibacterial soaps are safe, effective, and promote public health.

The FDA’s proposal could eliminate the public’s access to safe and effective antibacterial soaps, including kitchens in the home and at daycare facilities.

Antibacterial soaps “are critical to public health because of the importance hand hygiene plays in the prevention of infection,” wrote the groups in their joint June 16 comments to FDA. “Washing the hands with an antiseptic handwash can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”

FDA appears to have not considered that the consumer category includes use of antibacterial soaps in public areas such as schools, airports, daycares, and other facilities. Consumer antiseptic products reduce the level of bacteria on skin, which reduces the risk of infection and disease.

sopranos.don't.fuck.with.usElimination of these products would put the general population at risk. For example, individuals using public restrooms would no longer have access to antiseptic hand soaps. 

The Topical Antimicrobial Coalition, which comprises ACI and the Council, estimated the costs of the proposed rule – associated with preventable gastrointestinal illnesses – that would occur if antiseptic hand wash products were not available.

The number of new cases of foodborne illness caused by bacteria such as E. coli, Salmonella, Shigella, and Campylobacter could range between 250,000 and 7.5 million, based on projections by Dr. Donald Schaffner, Professor at Rutgers University’s Food Science Department.

The groups’ comments also take issue with assertions in the proposed rule that challenge the safety of antibacterial ingredients.

“No scientific studies currently exist to demonstrate a correlation between the active ingredients considered in the proposed rule and adverse health effects on consumers. As a result, there are no measureable benefits of the proposed rule.”

Should have been done initially: FDA issues clarification on using wood shelving in artisanal cheesemaking

Recently, you may have heard some concerns suggesting the FDA has taken steps to end the long-standing practice in the cheesemaking industry of using wooden boards to age cheese. To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisanal cheese. Nor does the FDA Food Safety Modernization Act (FSMA) require any such action. Reports to the contrary are not accurate. 

cheese.wood.boardThe agency’s regulations do not specifically address the use of shelving made of wood in cheesemaking, nor is there any FSMA requirement in effect that addresses this issue. Moreover, the FDA has not taken any enforcement action based solely on the use of wooden shelves. 

At issue is a January 2014 communication from the agency’s Center for Food Safety and Applied Nutrition to the New York State Department of Agriculture and Markets’ Division of Milk Control and Dairy Services, which was sent in response to questions from New York State.  

The FDA recognizes that this communication has prompted concerns in the artisanal cheesemaking community. The communication was not intended as an official policy statement, but was provided as background information on the use of wooden shelving for aging cheeses and as an analysis of related scientific publications. Further, we recognize that the language used in this communication may have appeared more definitive than it should have, in light of the agency’s actual practices on this issue.  

The FDA has taken enforcement action in some situations where we have found the presence of Listeria monocytogenes at facilities that used such shelving. Since 2010, FDA inspections have found Listeria monocytogenes in more than 20 percent of inspections of artisanal cheesemakers. However, the FDA does not have data that directly associates these instances of contamination with the use of wood shelving. 

In the interest of public health, the FDA’s current regulations state that utensils and other surfaces that contact food must be “adequately cleanable” and “properly maintained.” Historically, the FDA has expressed concern about whether wood meets this requirement and these concerns have been noted in its inspectional findings. However, the FDA will engage with the artisanal cheesemaking community, state officials and others to learn more about current practices and discuss the safety of aging certain types of cheeses on wooden shelving, as well as to invite stakeholders to share any data or evidence they have gathered related to safety and the use of wood surfaces. We welcome this open dialogue.

Uh-huh: FDA promises help, not crackdown, on FSMA rules

When someone says they’re going to educate someone else, things have really gone off the rails.

The goal is to inform, with rapid, reliable, relevant and repeated information.

Fonzie_jumps_the_sharkAccording to The Packer, the U.S. Food and Drug Administration is looking to educate before it enforces new food safety laws.

Roberta Wagner, deputy director for regulatory affairs for the FDA’s Center for Food safety and Applied Nutrition told a June 11 workshop at United Fresh 2014 that all rules for the Food Safety Modernization Act are due from the agency in 2015.

Part of FDA’s challenge is creating a new way of treating inspections. For example, Wagner said that looking independent third-party audits showed new ways to determine whether a company has a culture of food safety.

“What we’re learning is that there is a line of questioning that help establish whether there is a food safety culture in a facility or on a given farm and we don’t have that line of questioning,” she said. ”We need to ask different questions to assess if there is a food safety culture in a given facility or in a growing operation.”

Wagner said the FDA also may want to give industry credit for making voluntary corrections. To do that, she said the agency plans capture more data on voluntary compliance.

“To elicit the culture change, we literally have to start with the way we hire, what we look at in our investigators, how we train our investigators and how we establish compliance strategies,” she said.

Food safety culture really has jumped the shark.

What about Listeria? Pregnant women advised to eat more fish

I was talking with daughter Braunwynn today about her future academic and travel plans. She also wanted to know my preferred way to cook pork chops.

But this is about fish, and as Braunwynn said when she was in Brisbane, “How can I go back after this?”

amy.pregnant.listeriaWe are fortunate in Brisbane to have a fabulous supply of seafood.

The U.S. Food and Drug Administration said women and children should eat more fish, but sidestepped the issue of raw or undercooked seafood for pregnant women.

It’d be nice for all the mothers out there, who are already inundated with contradictory messages, if FDA consolidated toxin and microbiological risk information into a cohesive message. For example, pregnant women shouldn’t be eating any refrigerated ready-to-eat seafood like salad or smoked salmon.

Liz Szabo of USA Today writes that federal officials for the first time are recommending that young children and pregnant or breastfeeding women eat a minimum of two to three servings a week of fish that is low in mercury, in order to give them important health benefits.

Current guidelines, released a decade ago, focused on limiting the amount of fish consumed by women who are pregnant or breastfeeding, due to concerns about contamination from methylmercury, which can cause brain damage, especially to developing brains, said Elizabeth Southerland of the Environmental Protection Agency, which released the new guidelines along with the Food and Drug Administration.

That advice apparently scared a lot of women into avoiding fish altogether. Research has shown that 21% of pregnant women ate no fish at all in the past month, said Stephen Ostroff, acting chief scientist at the FDA. Even among women who consumed fish, half ate fewer than 2 ounces a week.

braun.sorenne.2.aug.14But fish contain heart-healthy oils, such as omega-3 fatty acids, says Edward R.B. McCabe, medical director of the March of Dimes Foundation. There’s also limited evidence that fish oils may promote a baby’s brain development. McCabe praised the agencies’ decision to encourage more fish consumption, along with a balanced diet.

So now, instead of telling these women to eat no more than two servings of fish a week, officials advise them to eat at least two servings and up to three servings a week of fish that’s low in mercury. Officials continue to advise women to avoid four fish with higher mercury levels: shark; swordfish; king mackerel and tilefish from the Gulf of Mexico. Those four fish make up less than 2% of fish sold in the USA, Ostroff says.

Nine of the 10 most frequently sold fish in the USA are lower in mercury, Ostroff says. The fish used in fish sticks and other commercial products is also usually low in mercury, he said. Fish that are lower in mercury include shrimp, pollock, salmon, canned light tuna, tilapia, catfish and cod, he said.

“The health benefits far outweigh any risk,” Ostroff says.

The draft’s updated advice did recommend that pregnant or breastfeeding women limit their consumption of white (also called albacore) tuna to 6 ounces a week.