Currently browsing posts about: Food-safety

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

The FDA and CDC are investigating.

[They have received] four consumer complaints of infant illness…All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.

Bill Marler’s Food Poison Journal has more about Cronobacter sakazakii (formerly known as Enterobacter sakazakii) in infant formula.

The FDA reports:

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.

Helena Bottemiller Evich, writing in Politico, is right on top of this situation.

The FDA first received a report of a foodborne illness suspected to be linked to infant formula in September — four months before issuing a recall of three major brands this week after four babies were hospitalized and one died, according to a state agency.

The [recall]…comes after reports of illnesses came to FDA and the Centers for Disease Control and Prevention between September and January. The Minnesota Department of Health investigated a case of an infant who was sickened by Cronobacter sakazakii in September 2021, the state agency told POLITICO.

She also Tweeted:

I’ve gotten a bunch of reports that the formula recall includes these (often unsolicited) packs that formula companies send new parents. So check those, too!

Warning to parents: if you are using any Abbott formula products, check the labels.  Do not feed recalled products to your infant.

Comment: Anything wrong with infant formula is a terrible problem because that’s all infants are fed and they are completely dependent on those products.  We will have to wait and see why the FDA:

• Did not push Abbott to recall these products four months ago.
• Did not mention the gift pack of formula given to new mothers.

And Bill Marler writes: “I have some questions about the Cronobacter and Salmonella infant formula outbreak: Why are illnesses not universally reportable and why was there a two year gap in FDA inspections at plant?”

Also worrying is that the FDA still does not have the authority to demand immediate recalls of potentially harmful products.

The Food Safety Modernization Act gave the FDA recall authority, but tied its hands.

FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA.

You will be amused to know that SAHCODHA stands for Serious Adverse Health Consequences or Death to Humans or Animals.

Leafy greens pose a seemingly intractable food safety problem.

• They are responsible for many harmful and deadly outbreaks of toxic E. coli (lawyer Bill Marler has a handy table listing outbreaks from 1995 to 2019).
• They are mostly eaten raw.
• They are often grown on land adjacent to dairy farms or cattle grazing or irrigated with water containing waste from animal agriculture.

The FDA is now taking on this last point.  It is is proposing standards for water use on produce for human consumption:  FDA.  Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: Notice of proposed rulemaking.  The key provisions:

This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require
expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations.

Translation: Farms would have to assess where contamination of irrigation water might occur and take steps to prevent it, but will not have to test the water.

In its press release, the FDA says:

Today, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule (PSR).

This updates the FDA’s previous attempts:

• Food Safety Modernization Act Proposed Rule on Agricultural Water
• Agricultural Water Assessment Fact Sheet  
• FSMA Final Rule on Produce Safety

Food safety lawyer Bill Marler asks: Is FDA creating a HACCP for Produce? Are assessment and mitigation going to create safer produce?

He notes that the FDA is focusing on “pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.”  This requires produce growers to evaluate local pathogen risks such as cattle operations and/or wild animal populations and then take measures to prevent them from contaminating water supplies.

But without having to test the water, it’s going to be hard to confirm that the assessment of risk actually reduces it.  Marler says:

So, in my view the jury is still out on 1) will eliminating water testing and increasing assessments make for a safer product? and, 2) should there not be a recognition that produce is essentially a “ready-to-eat” product grown outside with the risks inherent by what is directly around it or what may blow or flow to it, and therefore a broader environmental approach will be required to assure produce safety?

Is the FDA backing off of safety requirements?  The link explains how to file comments.  Now is the time to weigh in.

In a press release, the USDA says it is going to take action against Salmonella contamination of poultry in order to get closer to the national target of a 25% reduction in Salmonella illnesses.

Despite consistent reductions in the occurrence of Salmonella in poultry products, more than 1 million consumer illnesses due to Salmonella occur annually, and it is estimated (PDF, 1.4 MB) that over 23% of those illnesses are due to consumption of chicken and turkey…USDA intends to seek stakeholder feedback on specific Salmonella control and measurement strategies, including pilot projects, in poultry slaughter and processing establishments. A key component of this approach is encouraging preharvest controls to reduce Salmonella contamination coming into the slaughterhouse.

The North American Meat Institute says its members are happy to assist (Salmonella is a problem for poultry, not beef).

The National Chicken Council also pledged to assist with the pilot projects, but then put the onus of responsibility squarely on you.

Even with very low levels of pathogens, there is still the possibility of illness if a raw product is improperly handled or cooked. Increased consumer education about proper handling and cooking of raw meat must be part of any framework moving forward. Proper handling and cooking of poultry is the one thing that will eliminate any risk of foodborne illness. All bacteria potentially found on raw chicken, regardless of strain, are fully destroyed by handling the product properly and cooking it to an internal temperature of 165°.

The newly formed Coalition for Poultry Food Safety Reform, led by Center for Science in the Public Interest, welcomes the USDA’s announcement, but insists that USDA’s food safety oversight needs to extend from farm to fork.

Comment: The USDA’s jurisdiction starts at the slaughterhouse, but chickens coming into the plant are already contaminated with Salmonella.  This means prevention has to start on the farm, and poultry producers would have to institute procedures to keep their flocks free of Salmonella. They would much rather you cooked your chicken properly.

The latest big Salmonella outbreak is due to onions, an FDA-regulated food.

FDA’s traceback investigation is ongoing but has identified ProSource Produce, LLC (also known as ProSource Inc.) of Hailey, Idaho, and Keeler Family Farms of Deming, New Mexico, as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.

Keeler Family Farms issued a voluntary recall.   ProSource Produce LLC also issued a voluntary recall.

The CDC has the statistics:

Comment: I wrote about a previous onion recall last year.   Food safety lawyer Bill Marler asks: What did we learn – or not – from the 2020 Salmonella Outbreak linked to onions?  That investigation, as he emphasizes, identified probable causes:

• potentially contaminated sources of irrigation water;
• sheep grazing on adjacent land;
• signs of animal intrusion, including scat (fecal droppings), and large flocks of birds that may spread contamination; and
• food contact surfaces that had not been inspected, maintained, or cleaned as frequently as necessary to protect against the contamination of produce.

The FDA lists all the products that have been recalled so far.  It also displays their labels.  If you have onions from these companies, treat them like biosafety hazards.  If you can’t bear to throw them out, at least boil them and sterilize everything they could have contacted.

Xavier Naville.  The Lettuce Diaries: How a Frenchman Found Gold Growing Vegetables in China.  Earnshaw Books, 2021. 

The publicist for this quirky book sent it to me and I have to admit being charmed by it.  The French author started out in international corporate food, managing canteens in 70 countries for the Compass Group and based in Paris.

At age 27, almost on a whim, he went to Shanghai to sell salads to the Chinese (who didn’t eat salads) and oversee the production of vegetables for KFC and other fast food places.

He was, to say the least, ignorant of Chinese language and culture but learned a lot during the twenty years or so he spent there.

His book is about how his naivete and uncertainty got in the way of getting small farmers to grow lettuce and other vegetables consistently and safely, and how he slowly and painfully learned to speak and write Chinese, and learn the importance of guanxi (personal relationships essential for getting anything done in China).

He is so modest, so hard on himself, and so likable that I wanted him to succeed—which he did, and quite well.

Among other things, his company produced bagged salads for Chinese supermarkets.  Food safety maven that I am, I won’t even buy bagged salads in the U.S.  His descriptions of small-scale food production are terrifying.

He reports no outbreaks due to his products, although he talks about plenty of others, including the melamine-in-infant-formula scandal predicted by the earlier melamine-in-pet-food scandal I wrote about in Pet Food Politics.  

I liked his thoughtfulness about his experience.

All these years, I had viewed the microscopic farming plots as a barrier to the modernization of China’s agriculture.  But after a few hours with my Chinese friends, I was beginning to see things differently.  Where would all these seasonal foods come from if there were fewer farmers?  Would there still be regional differences?  If China follows the developmental path of the West, the number of farmers will shrink while operations increase in size.  Farms will focus on scale and productivity, specializing in fewer crops, breeding the most productive ones and neglecting some that have a higher nutritional content but lower returns per acre.  Is that really what Chinese consumers want?

…family farmers weren’t necessarily just an obstacle on China’s path toward modernization; they might actually be its cultural gatekeepers, protecting the local food industry and underpinning a renaissance of Chinese beliefs that will be key to the health of both the Chinese people and the safety of the foods they cherish.  (p. 246)

Quirky?  Definitely for a business book, but in a good way.  I enjoyed reading it.

[The author is now a food business consultant in Oakland, CA].

The CDC is investigating an outbreak of illnesses from toxic E. coli most likely caught from commercial cake mix, of all things.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the eight people interviewed, six (75%) reported tasting or eating raw batter made with a cake mix. People reported buying different varieties and brands of cake mix.

Even so, the cases are related.

DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS). WGS showed that bacteria from sick people’s samples are closely related genetically. This means that people in this outbreak likely got sick from the same food.

FDA is conducting a traceback investigation using purchase records from locations where sick people bought cake mix to try to determine a common cake mix brand or production facility.

I’m guessing that the source of the E. coli is contaminated flour.

This is not the first time that eating raw cake mix has caused illness.

As Food Safety News reports, another cake mix episode occurred in 2018, but that time it was from Salmonella (maybe from eggs?).

It also reports previous incidents with raw flour.

Raw flour and other ingredients can be individually contaminated and then cross-contaminate the entire mix.

Raw flour has caused two outbreaks in recent years, one in 2016 and another in 2019.

About 100 people are known to have been sickened with E. coli from eating raw flour.

I’ve posted previously about safety problems with General Mills flour.

And in 2009, there were E. coli problems with raw cookie dough; but then it was hard then to figure out whether the cause was eggs or flour.

Now, the FDA is testing cake mixes to try to identify a common source.

While all this is going on, the CDC advises:

Eating raw cake batter can make you sick. Raw cake batter can contain harmful germs like E. coli. Germs are killed only when raw batter is baked or cooked. Follow safe food handling practices when you are baking and cooking with cake mixes, flour, and other raw ingredients:

Good advice, and easier to follow with cake mixes than with cookie dough, alas.

I am indebted to Food Safety News for this item: FAO (Food and Agriculture Organization of the UN) has issued a statement:  COVID-19 is not a food safety issue (see my previous posts on this).

• Food does not spread the virus.
• Food packaging does not spread the virus.

Highlights of the FAO’s conclusions:

• Coronaviruses cannot multiply in food or on inanimate surfaces; they can only multiply in humans and certain animals. Once in the environment, viruses degrade and becomes less infectious.
• It is important to note that, although the detection of virus or viral ribonucleic acid (RNA) remnants on foods and food packaging provides evidence of previous contamination and is not disputed, there is no confirmation of SARS-CoV-2, or any other respiratory illness-causing virus, being transmitted by food or food packaging and causing illnesses in people who touch the contaminated food products or packaging.
• The virus responsible for COVID-19 is susceptible to most commonly used disinfectants and sanitizing agents used in the food processing environment. Standard cleaning and sanitizing procedures…should therefore be effective at disinfecting the food processing environment.

Well, at least that, and what a relief.

That still leaves us with these preventive measures: vaccinate, mask up, and avoid unmasked crowds.

The USDA has compiled a long list of documents related to the cost of the leading 15 foodborne microbial illnesses that affect Americans.   It also has produced a summary of this information.

Fifteen pathogens account for over 95 percent of the illnesses and deaths from foodborne illnesses in the U.S. (those for which the CDC can identify a cause).

The CDC estimates that these 15 pathogens cause about 8.9 million cases of illness, 54,000 hospitalizations, and 1,480 deaths each year.

In 2018, these cost about $17.6 billion in health care, hospitalization, lost wages, and other economic burdens, an increase of $2 billion over estimates in 2013.

Five pathogens are responsible for most of these costs.

Economists have an odd way of estimating these costs.  They factor in an economic value for preventing each death from foodborne illness.  In 2013, they estimated the value of each death prevented as $8.7 million; this estimate increased to $9.7 million each in 2018.

The bottom line: we need to do a much better job of preventing foodborne illness for reasons of cost as well as human suffering.

Leafy greens contaminated with toxic E. coli make eaters very sick (this is an understatement).

Toxic E. coli are excreted by cattle raised in the vicinity of lettuce and spinach fields.

But leafy green safety is overseen by FDA whereas everything having to do with food animals is overseen by USDA.

This is why the latest moves by FDA about leafy green safety are so noteworthy.

• The FDA is warning leafy green growers that they must take better precautions to prevent E. coli contamination.
• It also is warning cattle growers that they must prevent wastes from contaminating leafy green fields.

The Big Question: Will—can—the FDA force cattle ranchers and leafy green growers to adhere to food safety precautionary measures?

Let’s hope.

Here are the relevant documents:

FDA statement on release of a report on a 2020 outbreak

The findings of foodborne illness outbreak investigations since 2013 suggest that a likely contributing factor for contamination of leafy greens has been the proximity of cattle. Cattle have been repeatedly demonstrated to be a persistent source of pathogenic E. coli, including E. coli O157:H7.

Considering this, we recommend that all growers be aware of and consider adjacent land use practices, especially as it relates to the presence of livestock, and the interface between farmland, rangeland and other agricultural areas, and conduct appropriate risk assessments and implement risk mitigation strategies, where appropriate.

Report on the 2020 outbreak investigation

The analysis has confirmed a positive match to the outbreak strain in a sample of cattle feces, which was collected during follow-up investigations on a roadside, uphill from where leafy greens or other food identified in the traceback investigation were grown. While the finding does not provide definitive information on how E. coli may have contaminated product during the growing and harvesting season, it does confirm the presence of a strain of E. coli O157:H7 that causes recurring outbreaks in a more narrowly defined growing region and a potential, continued source of contamination.

Leafy Green STEC Action Plan

As outbreaks have continued to occur, despite significant efforts in recent years, greater emphasis will be needed around such complex issues as adjacent land use, agricultural water, and understanding likely routes by which human pathogens may contaminate leafy greens.

Former FDA food safety official Michael Taylor’s comment on these documents

FDA declared the recurring strain implicated in the 2020 outbreak to be a “reasonably foreseeable hazard,” which FDA attributed to the presence of cattle on land adjacent to growing fields.  This finding seems obvious and shouldn’t be surprising. The surprise, however, is that FDA used regulatory language to express its finding and spelled out the implications: farms covered by the FSMA produce safety rule “are required to implement science and risk-based preventive measures” to minimize the risk of serious illness or death from the E. coli hazard…I do not anticipate FDA taking judicial action to enforce its April 6 finding, absent egregious practices or clear negligence in a particular leafy green growing situation. I do see, however, a heightened sense of urgency at FDA and frustration that efforts to date have not solved the leafy greens safety problem. I share that frustration.    

Food safety lawyer Bill Marler’s comment

The FDA took specific aim at California growers as the cause of repeated and ongoing outbreaks, putting the responsibility of combating the outbreaks squarely on the growers.

FDA’s investigations into foodborne illness outbreaks are available from its outbreak page.  These are the ones from 2020.