Dear Editor,

As an advocate for comprehensive organizational change in FDA’s Food Program, I give Commissioner Califf and his team the credit they are due for the changes he announced this week. I still think that food inspectors should report to the Food Program leader, but the Commissioner’s plan moves strongly in the direction of a unified structure that can operate with much greater efficiency and unity of purpose than the current structure.   

As I read the proposal, it effectively dismantles the old version of the Office of Regulatory Affairs by taking out the state partnership office, the field food labs, and most of ORA’s headquarters staff working on food and moving them into a reshuffled version of the Center for Food Safety and Applied Nutrition under a single accountable leader. These are big changes, for which the commissioner deserves credit. Overall, it looks to me like a new organization with a chance for a fresh start, albeit with huge implementation challenges.  

My largest outstanding question is whether the new Deputy Commissioner will ultimately have the formal and practical authority within FDA to fully implement the reorganization plan, in both headquarters and the field, and to lead the necessary shift to a food safety culture of transparent engagement and collaboration, laser focused on risk-based prevention of foodborne illness.  The new structure makes this culture change possible but not inevitable.  FDA deserves the food community’s continued input and support to make it happen. 

Mike Taylor
Former FDA deputy commissioner for foods and current Board Member Emeritus at Stop Foodborne Illness

Dear colleagues,

As her service comes to an end on May 31, it is appropriate to thank Dr. Susan Mayne for more than eight years of professional dedication as Director of FDA’s Center for Food Safety and Applied Nutrition. Upon her arrival in 2015, Dr. Mayne made it a priority to learn quickly the ongoing issues within CFSAN offices while also providing leadership in an expanded applied nutrition component at the center. She brought a bright and upbeat personality and interacted frequently with CFSAN leaders and other employees on issues impacting food safety, applied nutrition, foodborne outbreaks, recalls, new regulations and a multitude of other items.

During her tenure as CFSAN Director, it was necessary for Dr. Mayne to move quickly through a constantly changing environment of complex issues. She did so with the expert professionalism demanded of a center director. Her skillful leadership and work ethic were key attributes in the successful completion of many CFSAN achievements, such as issuing multiple FSMA rules and guidance documents, along with addressing PFAS chemicals, toxic elements in foods targeting infants and children, asbestos in talc-containing cosmetics, sesame as a major food allergen, and providing consumers with new information on the Nutrition Facts label to support healthy food choices, among many, many others.

CFSAN provided staff with a professional work environment where we worked as a team to address common goals such as promulgation of impactful regulations, clarification of agency expectations through guidance documents, development of strong stakeholder relationships, and informing stakeholders of agency positions through public presentations. Prior to our independent retirements of recent years, both of us had a large variety of interactions with Dr. Mayne and her immediate staff. Those interactions clearly displayed Dr. Mayne’s vision and leadership skills needed to ensure that CFSAN would survive and thrive despite budget and administrative challenges. From a variety of food-related issues to dealing with Covid, or dealing with a 35-day government shutdown, Dr. Mayne provided a steady hand in overcoming obstacles and meeting the next challenge around the corner. For her dedicated leadership over the years, we are grateful to her and wish her well in her future endeavors.

In summary, Dr. Mayne provided strong, deliberate leadership for CFSAN during both smooth and turbulent times. She maintained an even-handed approach to ensure that center priorities and employees received appropriate attention by FDA. The accomplishments of CFSAN under Dr Mayne’s leadership will have a major impact on food safety and nutrition for years to come, and she deserves recognition and thanks for all she helped CFSAN accomplish.

Kind regards,

Jenny Scott
Senior Advisor (retired) CFSAN Office of Food Safety

Mickey Parish, Ph.D.
CFSAN Senior Science Advisor (retired)

2

The pubic is the primary loser of last month’s decision by the Conference of Food Protection (CFP) to cancel the proposed re-establishment of the Hand Hygiene Committee, an issue advocated by The Center for Foodborne Illness Research and Prevention (CFI). The biennial meeting, in Houston, TX, took this action, ignoring the impact of a Model Food Code without a standard for a Clean Hand for at least 2 more years:

1. Operators are forced to make hand hygiene decisions without the science.
2. Inspectors are forced to fill in boxes on their reports that give little direction to improve compliance. What is “compliance” without a standard?
3. Deprived of this standard, Operators’ efforts to create a Food Safety Culture are compromised.
4. Would-be technology developers are discouraged without the science. Official opinions change quite frequently i.e., handwash temperature, time, use of a nail brush, wipes, and COVID driven acceptance of alcohol-based hand sanitizers (ABHS).
5. It is incompatible with the FDA’s “New Era of Smarter Food Safety” initiative.

 The recreation of the Hand Hygiene Committee was recommended to gather and interpret the latest hand hygiene research and provide direction for new studies. Their findings could then have been operationalized by those foodservice and food processors to better serve the away-from-home public, their customers.

Council I’s 22 members reviewed the issue, including this definition of a Clean Hand: 

A Clean Hand in the foodservice and food processing industries is one that is unlikely to transfer pathogens from the hand to food, surfaces or directly to other people.

This verbal description was developed as a common ground starting point as researchers look to add the science, the evidence, needed by operators to make better informed hand hygiene decisions. Secondarily, this action demonstrated how a diverse group of food safety professionals could work together in the interest of public health.

The unlikely to transfer phrase lights the path to the essential research protocol. An established independent laboratory responded to the call and submitted a proposal. If Operators truly want the science behind a Clean Hand, might they directly fund it. If 12 sponsors could be recruited at $4,500 each, the research could be completed this Summer. The research protocol would be shared with all “investors”. Invoices would be sent from the lab with no added third-party fees.

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I am frustrated that Consumer Reports and other companies will not distinguish us and other small producers who offer a premium troll caught canned tuna. Yes it costs more money and no it is not in every store in the US. Since our tuna is canned in the USA, it is going to cost more money to be produced and is produced under more strict processing standards. 

Not all albacore in the can is the same either. We offer you young and fatty, low mercury, high omega 3, sustainably caught albacore tuna.

Our very professional crew is paid well. This of course adds to our cost of production. 

Albacore tuna migrate out of our fishing zone into tropical water at age 3-5 approximately. This fact largely explains how it is that we are catching ONLY the young albacore (under 5 years old.) 

This is one of the most sustainable fishing methods in the world, virtually no other species are caught using this method. If you purchase less expensive tuna from big producers, generally you are purchasing longline caught tuna. Longline fishing catches the older larger albacore (and significant other species) in tropical water. These albacore have been collecting mercury throughout their 15-20 year life and have built up mercury in their system.

We do test our tuna for mercury, our results are posted on our website tunatuna.com. 

Not all albacore are the same. I fished albacore on the St. Jude for 15 years, throughout that time I observed that the albacore we catch are small (a good trip average is 15 lbs per fish.) Further testing has indicated that these fish have high omega 3 and selenium. 

We understand and regret that not everyone can afford to buy canned tuna processed in the United States that is caught by fishermen who are paid fairly. But we want to create awareness that cheap tuna is a bad thing on many levels.

You can tell the difference between these pictures, ours is the canned tuna on the right. The fat from the tuna is glistening and 

The meat is solid since the fish is cooked from raw in the can. You will notice that the muscle in the “other” can is seperated, this is because the fish is conventionally processed – pre cooked (whole) before filling the can. In this method the fish is steam cooked while round (to avoid the expense and loss of recovery implied by filleting.) The effect of this processing method on the flavor and content of the meat is unavoidable. 

Our tuna is properly handled and canned in the United States. Thank you all for your support.

Joseph and Joyce Malley St. Jude tuna

Consumer Reports is supporting a proposal announced April 25 by the USDA to declare salmonella an adulterant in breaded stuffed raw chicken products at low levels so that the agency can more effectively respond to foodborne illness outbreaks. CR praised the proposed rule as an important first step to address widespread salmonella contamination and is encouraging the agency to adopt additional measures to protect the public from the dangerous bacteria in other chicken products. 

“Far too many people get sick every year from poultry contaminated with salmonella bacteria that could be avoided with stricter industry prevention practices,” said Brian Ronholm, director of food policy for Consumer Reports.  “The USDA’s proposal on salmonella in breaded and raw chicken products is a very encouraging formal step in the process, and it demonstrates they are serious about pursuing measures aimed at reducing Salmonella illness rates. We look forward to working with USDA to quickly move this forward.” 

Breaded raw stuffed chicken products include some chicken cordon bleu and chicken Kiev products found in the freezer section of the grocery store.  These products may appear cooked to consumers but they contain raw chicken and are only heat-treated by manufacturers to set the batter or breading.

Under the proposal announced today, breaded and stuffed raw chicken products would be considered adulterated if they tested positive for Salmonella at 1 colony forming unit (CFU) per gram prior to stuffing and breading.  The adulterated designation would require companies to recall any product that tests positive above this low level of contamination, instead of waiting for outbreaks when people get sick.  

Salmonella is widespread in chicken in part because of the often crowded and filthy conditions in which they are raised. A recent CR investigation, for example, found almost one-third of ground chicken samples tested contained salmonella.  Nearly 1.35 million Americans get sick from salmonella every year, about one-fifth of those cases come from chicken or turkey.

While the USDA requires producers to test poultry for salmonella, a processing facility is allowed to have the bacteria in up to 9.8 percent of all whole birds it tests, 15.4 percent of all parts, and 25 percent of ground chicken. Producers that exceed these amounts are given what amounts to a warning, but not prevented from selling the meat.

Consumer Reports has called on the USDA to set more aggressive goals to sharply reduce the percentage of chicken samples allowed to test positive for salmonella and to focus on reducing the salmonella strains that pose the biggest threat to human health. CR also believes the USDA needs more authority to inspect poultry plants and should close facilities immediately when high salmonella rates are found.

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I saw your story regarding the “Dirty Dozen” list and would appreciate your consideration of updating your content to include some additional facts and information for your readers so there is a balanced perspective and inclusive of peer reviewed studies, not just claims from Environmental Working Group.

Peer reviewed research published in the Journal of Toxicology found that the recommendation in the “Dirty Dozen” list to substitute organic forms of produce for conventional does not result in any decrease in risk for consumers because residues on conventionally grown are so low, if present at all. 

The research also found that the list authors follow no scientifically established methodology in the development of their list.

Further, the U.S. Department of Agriculture’s (USDA) Pesticide Data Program (PDP) consistently finds that over 99 percent of foods sampled had residue levels well below Environmental Protection Agency (EPA) safety standards with 25% having no detectable residues at all. According to the USDA: “Based on the PDP data, consumers can feel confident about eating a diet that is rich in fresh fruits and vegetables.”

And the EPA states: “EPA is confident that the fruits and vegetables our children are eating are safer than ever. EPA evaluates new and existing pesticides to ensure that they can be used with a reasonable certainty of no harm to infants and children as well as adults. EPA works continually to review and improve safety standards that apply to pesticide residues on food.”

The “Dirty Dozen” list authors admit that their list does not assess risk nor do they apply basic tenets of toxicology in the development of their list. From Environmental Working Group’s (EWG) “Dirty Dozen” report: “The Shoppers Guide does not incorporate risk assessment into the calculations.  All pesticides are weighted equally, and we do not factor in the levels deemed acceptable by the EPA.”

Research published in the journal Nutrition Today has also shown that fear-based messaging used by groups like the EWG may result in consumers purchasing less produce – organic or conventionally grown.  And, in a survey conducted by the Alliance for Food and Farming (AFF), 94 percent of registered dietitians agreed that the “Dirty Dozen” messaging negatively impacts their ability to increase consumption of fruits and vegetables among their clients and consumers.

“The consumption of fruits and vegetables can help decrease chronic diseases, such as heart disease, diabetes and cancer. These fear tactics used in the ‘Dirty Dozen’ report are actually hurting consumers, especially the vulnerable populations, and may lead consumers to eat even less produce,” says Dr. Sylvia Klinger, DBA, MS, RD, founder of Hispanic Food Communications who serves on the AFF’s Management Board. 

In a report released by the Centers for Disease Control (CDC) last year, only one in 10 Americans consume enough fruits and vegetables each day, which is unchanged from previous survey levels announced in 2015.  Those living below or close to the poverty level were the least likely to meet vegetable recommendations.

From the CDC: “Continued efforts to increase fruit and vegetable consumption by improving access and affordability in diverse community and institutional settings will help mitigate health disparities among U.S. residents. Additional policies and programs that will increase access to fruits and vegetables in places where U.S. residents live, learn, work, and play, might increase consumption and improve health.”

From: Teresa Thorne, Executive Director
Alliance for Food and Farming

The Alliance for Food and Farming is a non-profit organization formed in 1989 which represents organic and conventional farmers. Alliance contributors are limited to farmers of fruits and vegetables, companies that sell, market or ship fruits and vegetables or organizations that represent produce farmers. Our mission is to provide credible, science based information about the safety of fruits and vegetables

I am writing in response to the opinion piece published on March 13, 2023, titled “Be Best or Be Better,” by Bill Marler. The article references a letter sent by FDA on March 8 to the infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population. In the opinion piece, Mr. Marler charges the agency to do three things, which I would like to respond to.

First, Mr. Marler says FDA should “put an inspector in every plant 24/7”
Manufacturers are responsible for ensuring the safety of the formula they sell to consumers, and it’s FDA’s responsibility to verify through the use of inspections that they are taking the appropriate steps and meeting the legal requirements to keep the food they produce safe. We believe that gaining access to additional information regarding positive product samples discovered during production, as requested in the letter, would allow the agency to verify that appropriate corrective actions are taken by firms when positive samples are found. This kind of robust food safety data can allow us to make risk-informed compliance decisions while also continuing to support the much-needed growth and diversity of this market.

Importantly, the FDA has set targets to inspect facilities that produce infant formula annually, even prior to a requirement to do so established in the Food and Drug Omnibus Reform Act of 2022. This is above and beyond what is required in the FDA Food Safety Modernization Act (FSMA), which mandates high-risk facilities to be inspected at least once every 3 years and non-high-risk facilities to be inspected at least once every 5 years. We’ve taken this approach because annual routine inspections provide us with valuable insight into the operations within these facilities, but we can, and do, conduct additional follow-up or for-cause inspections as appropriate. In addition, through our prevention strategy, we are working to establish a specialized, dedicated cadre of investigators to conduct infant formula inspections. While we have been continuing to ensure that our staff who conduct or support infant formula inspections are receiving the latest and most relevant training, the dedicated cadre will allow us to have our most knowledgeable and experienced staff with the necessary expertise to focus on infant formula products.    

Second, Mr. Marler says FDA should “mandate testing of products and the facility”
FDA does not have the authority to require firms to notify us of product positives if the product has not left their facility, and we don’t have authority to mandate firms conduct Whole Genome Sequencing (WGS) or share the isolates to upload into the NCBI database. We agree, however, that requiring manufacturers to report positive product samples to us would serve the public health; that’s why the agency has explicitly sought that authority as part of the President’s FY24 budget request. As the FDA conducted our investigation at the Abbott Nutrition facility in Sturgis, Michigan, and inspected other infant formula facilities, it became increasingly apparent that having additional information about positive product samples, even if those products did not leave the facility, would help to ensure appropriate corrective actions are taken by the firms, and would help us to better understand the overall picture of infant formula safety. Therefore, the FDA included a notification requirement in the consent decree with Abbott that was entered on May 16, 2022 regarding the Sturgis facility. A month later, in a follow up to the May 25 and May 26 congressional hearings, we also made Congress aware of the gap in authority to require all manufacturers to report to us when positive product samples are found. Our current regulation in 21 CFR 106.150 requiring notification only when adulterated or misbranded product has left the facility is rooted in the authority Congress provided in section 412(e)(1)(B) of the Federal Food, Drug & Cosmetic (FD&C) Act. Therefore, only Congress can mandate that infant formula manufacturers provide the FDA with notification outside of that limited set of circumstances. 

However, food safety cannot wait for new laws to be enacted. And ultimately, under current law, it is the responsibility of infant formula manufacturers to ensure the safety of the formula they allow to enter into the market. That is why our letter – sharing the latest information we have on safety — is so important.

Third, Mr. Marler says FDA should “work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.”
The FDA supports elevating Cronobacter sakazakii infection among infants as a nationally notifiable disease and we have included this action as part of our prevention strategy. However, adding a disease to the Nationally Notifiable Disease list is something that is led by the Council of State and Territorial Epidemiologists (CSTE) with support from CDC. 

Because Cronobacter is not a reportable disease and because severe infections are rare, WGS is rarely performed on cases, so we have less genomic data to work with to help us link cases to each other, to a product, or to a food production environment. For example, the National Center for Biotechnology Information (NCBI) database has only 1,249 isolates of Cronobacter compared to more than 500,000 isolates of Salmonella enterica, a nationally notifiable disease. When we have illnesses of salmonellosis, we have compiled a lot of genomic data to work with right from the start.  This challenge surfaced earlier on during our investigation at the Abbott Sturgis facility, and we immediately began working with CSTE and CDC to explore a path forward toward making Cronobacter a nationally notifiable disease.  Therefore, we agree that increased genomic data, particularly through the uploading of sequences to the NCBI database, would be extremely helpful and we are encouraging industry to do this as we work with them on the prevention strategy. 

The FDA remains committed to strengthening the resiliency and safety of infant formula in the U.S., however there are significant gaps in data and authority that we have identified and are seeking support to address. We are tackling much of this work through the continued development of our Cronobacter prevention strategy, and an upcoming National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, as directed by Food and Drug Omnibus Reform Act of 2022. We would like to work with all our stakeholders to elevate these issues, implement new approaches, and pursue additional resources, so that together we can protect the health of our youngest, and most vulnerable populations.

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Dear Editor:

This letter is in reference to a recent Letter from the Editor in Food Safety News (“An independent food safety board is far better than anything FDA Commissioner does on his own”), dated January 29, 2023. As some may remember, I had the great privilege of serving as Undersecretary for Food Safety at the U.S. Department of Agriculture from 2001 to 2004. During that time, we faced several foodborne illness events and meat recalls due to contamination with E. coli O157:H7 (ground beef patties) and Listeria monocytogenes (ready-to-eat cold cuts), among others. To address these and other issues, we focused on ensuring that our inspectors were well trained in the science of the Hazard Analysis Critical Control Points system (HACCP), forming teams of auditors to ensure that plans were not only in effect at meat processing plants, but that they had been developed in a science-based manner. In fact, we made sure that all regulations we would issue would be based strictly on science and evidence, not speculation. As a result of our activities, the rate of contamination of ready-to-eat meat and poultry with L. monocytogenes dropped from 0.64% in 2005 to 0.33% in 2017 (Mamber, S.W., et al, 2020 J. Food Prot. 83(9):1598-1606), and illnesses due to E. coli O157:H7 decreased by 42%, reaching the CDC’s Healthy People 2010 Goals for foodborne illnesses due to this organism ahead of schedule (cdc.gov/mmwr, April 15, 2010).

During that time, there had been calls from various groups urging the formation of a single food safety agency, to include both the Food Safety Inspection Service (FSIS) which was under my authority, and the Food and Drug Administration (FDA), which was under the authority of the Commissioner of FDA. As Undersecretary, I was most proud of the fact that FSIS worked well with other agencies within USDA, such as the Animal and Plant Health Inspection Service (APHIS) and the Food and Nutrition Service (FNS), both of which had relevance to food safety. In addition, FSIS worked well with FDA, with then Deputy Commissioner Dr. Lester Crawford and I interacting frequently, as we were not only facing unintentional food contamination, but also the potential for bioterrorism acts in the wake of September 11th. It became evident that each agency served its purpose, as per the mandates that specific laws had provided, such as the Federal Meat Inspection Act for FSIS, and the Food, Drug & Cosmetic Act for FDA. It was also very evident that given the very unique authorities of each agency through very different laws, that we all needed to work well together. This was in fact what followed, with Dr. Crawford and I ensuring that the agencies we oversaw were well staffed with knowledgeable professionals, but also empowered to carry out their duties, obviating the need for a single food safety agency.

I think we can all agree that ensuring the safety of our food supply is an incredibly important activity that cannot be underestimated. It requires that the regulations that federal agencies like FSIS and FDA promulgate be based on science, and that these agencies be led through a structure that ensures proper supervision of the right number of well-trained staff so that said regulations can be rigorously enforced. Evidence shows that there have been some issues related to enforcement in the “food” portion of FDA, most recently demonstrated by the Abbott Labs infant formula incident. However, what we don’t need is the unnecessary upheaval of federal agencies, but rather to concentrate where the problems are, and then fix them.

This brings me to the point of this letter: that FDA does not need to be removed from the Department of Health & Human Services. Rather, that we should look to follow the FSIS model, an agency that is within USDA, with great connectivity to other agencies within that department, fully independent, fully empowered, yet well connected. Similarly, FDA needs to be split into two agencies, one for foods, and one for drugs and cosmetics, both remaining within the Department of Health & Human Services. Each agency would then be led by a presidentially appointed Commissioner. By remaining within HHS, both agencies would then be able to continue to work closely with each other, as they are both provided with authority from the same law, the FD&C Act, as well as with other entities within HHS such as the Centers for Disease Control. Importantly, the new “Foods Agency” would then be empowered to have its own structure, focused entirely on foods under its jurisdiction, just like FSIS has within USDA. This should translate into a better managed agency, able to respond to whistleblowers and to surveillance data much more quickly. Of course, adequate funding for such an agency is of primary importance, as long as it is efficiently designed as to avoid bureaucratic delays in developing, monitoring, and enforcement of its regulations.

Dr. Elsa A. Murano, Former Undersecretary for Food Safety at USDA
Director of the Norman Borlaug Institute for International Agriculture
President Emerita and Professor of Food Science & Technology
Texas A&M University

The Department of Environmental Conservation, a government agency in Alaska responsible for making sure citizens have access to safe food at the grocery store, has put out a proposed regulation change that would allow the sale of unpasteurized, virtually unregulated milk, in Alaskan grocery stores. 

Currently, raw milk in Alaska is only allowed to be sold through herd shares. This law allows the small percentage of people who are interested in raw milk the opportunity to consume it by buying a portion of a cow and therefore technically they are consuming their own raw milk.  It has never been illegal in Alaska for people who own cows to consume the milk raw from those cows if they chose to do so, knowing there are pathogen risks (bad germs) when drinking raw milk. http://www.akleg.gov/basis/get_documents.asp?session=31&docid=23171 

Alaska now wants to open up the raw milk market to all its consumers by allowing on-farm and retail sales. This is a dangerous idea! People would have access to raw milk without knowing the dangers, especially if they bought it for their children. There have been raw milk outbreaks of food poisoning in Alaska. They were contained because a smaller number of people consumed the milk. These outbreaks would have been much larger, affecting many more people, if the raw milk had been sold in the grocery stores:

• https://www.foodsafetynews.com/2011/08/outbreak-tied-to-raw-milk-continues-in-alaska/ 
• https://dhss.alaska.gov/News/Documents/press/2013/SecondCampyOutbreak_PR_05232013.pdf 

The elephant in the room when discussing the issue of raw milk is an organization that passionately believes that raw milk is more nutritious than pasteurized milk. This grassroots organization is behind advancing raw milk legislation at the state level. The pro raw milk camp believes raw milk has healing benefits that consumers have been prevented from knowing about. Though there have been some studies showing a benefit to drinking raw milk, every single one of the scientists included a statement in the literature that more research should to be done to explore possible benefits because the harm of drinking raw milk is much greater than any perceived benefit, especially in children. The literature also shows that heat-treating — also known as pasteurization — milk does not diminish the nutritional benefits of milk. 

Consider this, a person who smokes tobacco is up to 30 times more likely to develop cancer than a person who does not smoke. A person who drinks raw milk is almost 100 times more likely to get sick than someone who drinks pasteurized milk. Information on raw milk outbreaks can be found on the CDC’s website. https://www.cdc.gov/foodsafety/rawmilk/rawmilk-outbreaks.html 

In two years, the U.S. Pasteurized Milk Ordinance (PMO) will celebrate 100 years of implementation. It is easy to forget that prior to pasteurization of milk (heat treatment to kill the bad germs) illnesses and deaths attributable to milk have decreased from about 25 percent of all illnesses just before World War II to now less than 1 percent when milk meets the standards outlined in the PMO. One hundred years ago, the majority of these illnesses were in children.  

It is one of the government’s primary duties through public health work to promote consumers’ good health and protect its consumers from harm. Those most at risk when drinking raw milk are children, the elderly, and immune compromised. 

We are so fortunate to live in times where it is not unreasonable to expect to live into our 80s. That is a far cry from the early 1900s, where many did not expect to see their 50th birthdays. There are many reasons for the significant jump, but advances in food safety are among the top. It is easy to take store bought, pasteurized milk for granted. None of us experienced life when children routinely died from bovine tuberculosis, undulant fever, scarlet fever, typhoid, or diphtheria when consuming raw milk.  

Today illness and deaths from raw milk and raw milk products are from “new” germs like pathogenic E. coli, Salmonella, and Campylobacter. Keep in mind that cows lay in their manure and defecate while being milked. It is very easy for any of these germs to get in the milk. These germs, called pathogens, cause more than diarrhea and vomiting.  https://www.fda.gov/food/buy-store-serve-safe-food/dangers-raw-milk-unpasteurized-milk-can-pose-serious-health-risk   https://www.cdc.gov/foodsafety/rawmilk/raw-milk-videos.html 

It’s not a time to lessen standards or throw away proven technologies or practices that have worked to keep our milk supply safe — pasteurization.  Heat treatment kills germs. This is a scientific fact. 

The bottom line is that American consumers expect that the food offered for sale at the grocery store is not going to sicken or kill them or those they love. If this change for raw milk goes through, the only way a consumer will know the dangers will be to read the warning label. I don’t know anyone who looks for warning labels on food at the grocery store to let them know that eating the food product might send their child to the hospital fighting for their lives. Who would even think to look for such labels on milk? What are the chances a person who accidently buys raw milk sold in the store even knows a risk exists? 

In 2015, a study was released showing that children were at the highest risk for raw milk illnesses.  59 percent of the outbreaks involved a least one child younger than 5 and children age 1 to 4 years old accounted for 38 percent of illnesses caused by Salmonella and 28 percent by Shiga toxin-producing E.coli.  https://wwwnc.cdc.gov/eid/article/21/1/14-0447_article 

Here are some real-life video stories of children and adults who have been harmed by raw milk.  A couple are heartbreaking to watch; lifelong damage was done.  https://realrawmilkfacts.com/real-life-stories 

Alaska is not the first state to legalize commercial distribution of raw milk, but it should not make the same mistake that states like Washington have made, where recalls for “dirty” milk are routine and the number of illnesses has skyrocketed. Knowing the facts, why would Alaska make a decision that would harm children who don’t get a choice about pasteurized or non-pasteurized milk? If you would like to read up on the proposal in Alaska and offer your thoughts, the state is accepting comments until February 22, 2022. https://dec.alaska.gov/eh/vet/regulations/raw-milk-and-products/ 

About the author: This letter is posted anonymously at the author’s request and with Food Safety News having knowledge of the author.

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Dear Editor,

Recently, a contributed opinion column on March 5, 2021, in Food Safety News made a case concerning food safety issues in the plant due to the FDA inspections or FSMA out of compliance issues. It listed a Top Ten list of typical challenges based on the experience of the writer as an FDA and legal expert of 42 years. The writer, Joseph Levitt, said he learned from food companies facing food safety and compliance challenges; one repeated phrase came through, “I wish I’d acted sooner.” He framed “acted sooner” as calling lawyers to advise how the manufacturer should defend themselves. The law is transparent concerning compliance. FDA findings from the Top Ten list relevant to reaching a lawyer after the incident has occurred. A lawyer, at that point, is after the damage is already done. “Sooner rather than later’”means following the legal requirements under the Food Safety Modernization Act (FSMA) to implement “preventive controls.”

In this discourse, we will show how (FSMA), if strategically implemented, will be aptly designated sooner rather than later. Operationalizing the law should be done electronically as a system, with error-proofing and management by exception for executing the controls — leaving the lawyering as a last resort. The need is to have an implemented system. 

Here is the Top Ten list and how each of the issues can be addressed in a thought out preventive electronic system with controls — to prevent the problems from occurring in the first place rather than after the fact — which then really requires a lawyer. 

1. Notification of Outbreak: You have been contacted by the FDA and/or CDC that your company’s product has been associated with an outbreak of foodborne illness. You need help right away, to help you determine if the product needs to be recalled and if your plant needs to be shut down, and if so, what will be needed to restart.

117.139- Recall plan

You should have a written recall plan, which includes what will be needed to restart. However, according to the law, there is overlapping preventive control verification — the attendant, Internal PCQI, External PCQI. Three instances of review have to be bypassed to reach the customer to necessitate a recall. Strategic means — auto alerts to management when binary or monitoring values are not met or entered by the attendant at the point of application. Management immediately knows that there are occurring issues to address to nip the said issues in the bud. 

Restart will be triggered by an auto corrective action, which sends alerts when the corrective action is closed.

2. Bad results from FDA swab-a-thon: You have been contacted by FDA and told that they took environmental swabs in your facility and found one or more positive findings of a food pathogen, such as Salmonella or Listeria. If not handled properly, this could be the beginning of bad things to come. That is because FDA will do DNA fingerprinting, called Whole Genome Sequencing (WGS), of your sample, keep it on file, and if they come back a year later and find the same thing, FDA could make you recall all product made in the intervening time under the “resident strain” theory.

117.135/117.150 Preventive Control / Corrective Action

The problem is not a positive environmental swab reading, but what is done about it. Therefore, you want a method to be immediately informed to be alerted, in the first place if the prescribed test is performed, triggers a non-conformance and a corrective action, and alerts that the corrective action was completed in the statutory time of seven days.  

3. FDA sends you a warning letter: This means FDA has already determined that your product is legally adulterated or misbranded — you are officially on the naughty list — and if not remedied promptly, it could lead to any of the regulatory actions mentioned above. Note that FDA generally only sends one warning letter per facility, so just receiving it means you are in legal jeopardy.

117.135 Preventive Control 

It also means — your preventive controls are ineffective. It would help if you had preventive control with binary and/or monitoring features that trigger a non-conformance when either the requirements observed are not met or the monitoring value is out of range. The system cannot proceed until the triggered non-conformances are treated and verified by the internal PCQI (Preventive Controls Qualified Individual) and External PCQI electronically. 

4. FDA invites you to a Regulatory Meeting:  This is an in-person version of the Warning Letter and carries all of the same cautions and risks.

117.301 Records

Records from the preventive control activity should be made available at the regulatory meeting, preferably electronically, which is time stamped with the people conducting the activities. Provide evidence of trained to employees to perform the activities at a specific points in the process. If the employee chooses not to treat with an auto corrective action, management is also electronically alerted. 

5. You receive a second 483 Inspectional Observations report in the same facility: This is a red flag for the FDA. It means they feel they cannot trust you to fix your problems on your own. An escalation is almost certain to follow if you do not immediately change course and nip this in the bud. How you respond to that second 483 will be very important, and an experienced food regulatory lawyer can help you put your best foot forward.

117.150 Corrective Action.

An escalation can be avoided because immediately when an out of spec or binary requirement is not met all the elements of the corrective become available, and depending on what it is, validation 117.160 and reanalysis 117.170, if required, is included in the corrective action electronic format to enable improvements to change course. 

6.  You receive your first 483 for a facility, but it is long, scary or the inspection itself was verbally contentious. FDA can escalate its activities even after a single bad inspection if the agency feels it went badly enough. At a minimum, you need a second opinion from an experienced food regulatory lawyer.

117.135 Preventive Controls

Before the 483, a rule of thumb is to identify a master list of all assets and surfaces and determine if a preventive control, including monitoring, covers it. A system is needed to determine if all assets/ surfaces compare to the master list and whether the preventive control per the prescribed frequency is completed for asset/surface and receive an alert when not completed.  A bad inspection triggers the corrective action. However, the preventive controls should minimize the occurrence of issues to cause a bad inspection. 

7. Your finished product testing program shows a product positive for a food pathogen – usually Salmonella or Listeria. It is highly unusual to get even a single product positive, so this is an incredibly important warning signal. If an outbreak is a 5-alarm fire, a finished product positive is still a 3-alarm fire. You need to act quickly or the house could burn down. In addition to a food regulatory lawyer, you will also probably need an external scientific consultant to help you find the root cause and take necessary remedial action.

117.135/150 – Preventive Control /Corrective Action 

Once input into the system, your test results should trigger a corrective action for all product testing if product is positive.There should be an alert on the seventh day to complete and close the corrective action. If you are within the seven days, it cannot be registered as an FDA finding. Nevertheless, you need to have irrefutable records to demonstrate the timeframe because an FDA audit in the future, outside the statutory time frame — can result in a finding. Electronic real-time records will support the seven days. 

8. You have a series of positive environmental findings in your facility for Salmonella or Listeria. This is an example of: Where there’s smoke, fire may follow. Remember that FDA will have access to those testing records, so these findings will become immediately visible to an FDA inspector. You need an objective viewpoint to assess whether or not your corrective actions will be seen by the FDA as sufficient. Always best to act before the FDA inspector is in your plant.

117.135/117.150 Preventive Control / Corrective Action 

The out-of-range test results should be immediately available to the attendant, triggered, and cannot be bypassed for that action, as corrective action is triggered, which must be acted upon within seven days. The fields in the corrective action should direct completing the corrective action. 

A subsequent alert is sent if it is late more than seven days and when the corrective action is closed.  

9. You have findings that make you question if you need to file with FDA a Reportable Food Registry (RFR) report. This is sometimes a tricky decision. If you decide not to file you should have clear written documentation as to your rationale and an objective second opinion that it is legally defensible.

117.301 Recordkeeping

FSMA never states that there cannot be a defect or non-conformance — it is the capability to manage and have the documentation to prove it. If your system captures your documentation as stated, your submittal of a file to the Reportable Food Registry will show the methodology to be correct. So with the correct method, the worst that could happen is the FDA can return it, with the confidence your methodology is intact. You are using the RTF to show off competence — less intrusion in the future. 

10. You have findings that make you question if you need to recall a product, or if you should continue to ship a product. Often this will be related to the RFR decision-making above. You may have had an adverse incident at your plant, an unexpected spike in environmental test findings, or even a foreign material or quality issue. The same principle applies — make the right decision and document it well and get experienced advice in doing so.

117.139 Recall

Properly implemented – FSMA presents layered inspections or audits. 1) binary or monitoring parameters at the point of application that triggers non-conformance; 2) Internal PCQI verifies; 3) External receiving facility verifies. These three layers of verification should avoid recalls. If a recall is still needed, it can be done electronically.  

It is hoped that we could demonstrate the use of technology to operationalize FSMA with layered preventive controls, alerts to top management, and auto corrective actions to minimize the after-the-fact lawyering. The list of Top Ten issues can practically be eliminated ‘ sooner than later. 

— Jeffrey Lewis, Fellow Chartered Quality Institute, PCQI
Director of Safety In Your Hand Inc.
fsmafoodsafety.com

Editor’s note: This letter is in response to a contributed column by Joseph A. Levitt is a former director of FDA’s Center for Food Safety and Applied Nutrition. He is currently senior counsel in the Washington D.C. office of Hogan Lovells US LLP The law firm handles FDA and USDA food safety and compliance matters.

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Dear Editor,

This is in regard to the FSN publication Nov. 18, 2020: “Food and drug officials weigh in on federal Salmonella rules for poultry” by Steven Mandernach, AFDO. Here is my response that I submitted Nov. 20, 2020: 

It appears from the Editor’s note (on the Nov. 18 piece), that Mr. Steven Mandernach, the AFDO executive director, presented these comments on the AFDO’s salmonella position earlier this fall. (The author of this letter stated that Mandernach is an attorney.)

We are reminded that a “fact” is a statement that can be proven true or false. However, an “opinion” is an expression of a person’s feelings that cannot be proven. Thus, I want to take this opportunity to make a few fact-based observations that may result in a better understanding of so-called “Salmonella rules” and their effectiveness, if any. 

AFDO Statement: “Let me start by thanking Under Secretary Dr. Mindy Brashears and FSIS (USDA’s Food Safety and Inspection Service) for the opportunity to provide comment on this important topic.”

Fact #1: Under Secretary for the USDA Office of Food Safety Dr. Mindy Brashears is a political appointee under the current Trump Administration. Dr. Brashears has proven expertise and degrees in food technology and food microbiology. While she holds numerous animal feed-related patents in pathogen reduction in feeds, however, to my knowledge, she has little or no first-hand experience in FSIS field-related activities, laws, and regulations. Therefore, her comments on this topic may be limited in scope for the FSIS jurisdiction under the current laws (FMIA and PPIA). More about this later.

AFDO Statement: “AFDO and its members were among the early advocates working with Dr. Wiley for the adoption of the nation’s first food safety laws including the Meat Inspection Act and Pure Food Acts in 1906.”

Fact #2: The history: In 1862, President Lincoln appointed a chemist, Charles M. Wetherill, to lead the USDA’s Division of Chemistry, which in 1901 became the Bureau of Chemistry. In 1883, Harvey Wiley, M.D., was appointed chief chemist at USDA. Dr. Wiley had devoted his career to raising public awareness of problems with adulterated food; developing standards for food processing and campaigning for the Pure Food and Drugs Act (PFDA). 

Both the Pure Food and Drug Act (PFDA) and the Federal Meat Inspection Act (FMIA) became law on the same day in 1906 under USDA’s Bureau of Chemistry. Then in 1927, USDA’s Bureau of Chemistry, was reorganized and renamed the Food, Drug, and Insecticide Administration and then, in 1931, it was renamed the Food and Drug Administration (FDA).

In 1938, FDA updated PFDA and created the Federal Food, Drug and Cosmetic Act (FFDCA) and again in 1958, in response to the public’s concern about invisible hazards from chemicals added directly or indirectly to foods, the FFDCA was amended with the Food Additive Amendment to ensure the safety of ingredients used in processed foods, including animal drug residues in meat and poultry products. 

It was not until 1940 that the FDA was moved from USDA to the Federal Security Agency, which in 1953 became the Department of Health, Education, and Welfare—now the Department of Health and Human Services (HHS).

After spending almost a decade in the drafting stage, the FDA created the Food Safety Modernization Act (FSMA) that was signed into law by President Barack Obama on Jan. 4, 2011. The FSMA gave the FDA new authorities to regulate the way foods are grown, harvested and processed.

Unfortunately, since 1906 the FMIA has never been updated, although in 1957 Congress did pass the Poultry Products Inspection Act. 

Conclusion: While Dr. Wiley was instrumental in the PFDA, history does not give him any credence to being involved with FMIA. It therefore appears that AFDO had historical involvement with PFDA, FFDCA and probably FSMA and not FMIA or PPIA. Also, in examining the board membership of AFDO, the only FSIS employee listed, Carlynne Cockrum, is a lawyer who recently joined FSIS from USDA-OGC and has no background listed activities with the FSIS field activities.

AFDO Statement: As we continue this work, focusing on improving the results for Healthy People 2030, we have identified a handful of key concepts for Salmonella; . . .”

Fact #3: As most of know, Healthy People 2030 sets data-driven national objectives to improve health and well-being over the next decade. The entire program is housed under and managed by HHS/ODPHP and includes 355 core (or measurable) objectives as well as developmental and research objectives. Healthy People 2030 includes a wide range of objectives developed by workgroups made up of subject matter experts (SMEs) in specific topics. FSIS has membership in the Food Safety Workgroup, which has 5 other major federal offices outside USDA. Unfortunately, the current FSIS website does not list a single specific Healthy People 2030 -target objective or goal that this agency is working on.  

AFDO Statement: AFDO and its members look forward to partnering with all those engaged in the food safety system so that by 2030 the Salmonella reduction targets have been met and exceeded, resulting in fewer people being impacted by foodborne illness.

Fact #4: While I commend AFDO’s efforts in support of the 2030 Salmonella reduction targets, before anything can proceed in this matter for meat and poultry, the current laws, FMIA and PPIA, must be modified or other laws enacted to provide federal oversight of pre-harvest on-farm food safety issues by USDA and FDA. 

Please note that neither USDA/APHIS, nor USDA/FSIS, nor FDA/CVM, nor FDA/CFSAN have any on-farm jurisdiction for food-safety related issues. Whereas APHIS has jurisdiction for animal diseases and CVM for drug-use violation oversight, none of these authorities cover any other human public health or food safety issues connected to poultry or livestock and the possible resistant microbial presence in feed or the food animals — as carriers. 

Although FSIS, APHIS, and CDC have made attempts to follow-up on animals that may be harboring and spreading Salmonella-related infections, the industry has blocked any such attempt. This is exemplified in the New York Times articles from last year. 

Whether we label Salmonella an “adulterant” or not, the microbe will not obey human commands. To control these pathogens the regulations must be modified, otherwise the poultry or meat markets by the industry should be consumed with the understanding that, even if there is a “USDA Inspected & Passed” stamp on the product, it was not checked for any pathogens prior to the application of this stamp and therefore – let the buyer — consumer — beware of the danger of these pathogens and handle the product accordingly. 

NB: My comments are based on my over 45 years experience in public health and food safety, with nine years as a state veterinarian and over 35 years in USDA/FSIS – starting as a field-level veterinarian and finishing my career at the top as the agency’s Chief PHV. and the Senior Leader for Chemistry, Toxicology & Related Sciences. Also, although I am not a lawyer, I have taken comprehensive graduate-level courses in all the U.S. food and drug laws from U.S. top universities. I am also PCQI certified, under the FDA/FSMA requirement. 

Thanks for this opportunity to comment.

 — Dr. Pat Basu
Founder and owner of Food, Drug, and HACCP Consulting LLC

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Dear Editor,

This letter addresses a recent publication by L.A. Cox, about which Food Safety News wrote in the article “Faster line speeds may not be the food safety issue some thought.” Mr. Cox is an industry supporter whose research is harmful to public health. His support of high-speed slaughter falls in line with his historical industry alliances. Furthermore, he based his publication “Higher Line Speed in Young Chicken Slaughter Establishments Does Not Predict Increased Salmonella Contamination Risks” on fundamentally flawed data. 

Mr. Cox’s study relied on Food Safety and Inspection Service (“FSIS”) data that slaughterhouses generated by operating under a waiver program. This waiver program decreases the number of FSIS inspectors at each slaughterhouse and largely allows slaughterhouses to self-regulate. These slaughterhouses were able to submit falsified or inaccurate information that indicated compliance with FSIS standards. A neutral third-party did not check to ensure the slaughterhouses’ data was accurate. Dependence on such unreliable data renders Mr. Cox’s conclusions dubious at best. 

Indeed, the Government Accountability Project’s Food Integrity Campaign gathered testimony from FSIS inspectors – who worked in the very waivered slaughterhouses whose data Cox relied on – which makes clear that these slaughterhouses manipulated their systems to evade detection of violations. For instance, many waivered slaughterhouses changed the order of their line speed inspection procedures so that FSIS inspectors could not submit Noncompliance Reports for the myriad adulterated carcasses that entered the food supply. 

And, an affidavit (Issue Area: “Food Safety,” Campaign: “High-Speed Poultry,” Affidavit #7) from a slaughterhouse supervisor avers that leadership heavily influenced workers not to report violations they witnessed. They explained that supervisors “would mix a ‘good’ flock with the bad flock and turn up the speed of the evisceration line so that it would be more difficult for the [FSIS] inspector to catch the bad birds.” The supervisor further explained they would change expiration date labels on products to make the slaughterhouse look like it was meeting its fresh poultry quota when it was actually sending older products to consumers. The supervisor also witnessed the slaughterhouse’s Hazard Analysis and Critical Control Points Coordinator – who is responsible for identifying food safety and public health concerns – falsely record temperatures of meat refrigeration equipment to make the slaughterhouse appear to be in compliance. 

In addition, many inspectors stated in their affidavits that they would not eat produce from the waivered slaughterhouses in which they worked, and that they were concerned for the public’s health should high-speed chicken slaughter become the national standard. 

Reliance on such flawed data is unsurprising given Mr. Cox’s history of making statistical conclusions that support industries, which imperil the environment and public health. For instance, he concluded that humans would be worse off if the agriculture industry stopped feeding their food-destined animals certain antibiotics—a practice intended to increase animals’ weight quickly and cheaply. Scientists have linked using antibiotics for this purpose to the development of antibiotic-resistant illnesses in humans, which cause approximately 35,000 deaths every year.  Several peer–reviewed publications have confirmed that this antibiotic use does cause antibiotic-resistant diseases and harms human consumers. Furthermore, Mr. Cox’s publication contradicts data that the Centers for Disease Control and Prevention has published for years. 

The FSIS needs neutral studies that scientists base on reliable data in order to inform the public whether high-speed slaughter lines are safe, or are simply another way for the poultry industry to compromise human health for one more dollar.

— Jessica Chapman of the Animal Law Litigation Clinic, Lewis & Clark Law School

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Dear Editor,

Food Safety News is a daily “must read” for me in representing the National Association of Egg Farms in producing eggs in conventional caged systems nationwide. I appreciate the insights into numerous food safety issues. A recent Letter to the Editor has a cage-free egg farmer claiming cage-free egg production improves on the safety of shell eggs sold to the consuming public.

The frustration of this cage-free egg farmer is readily apparent, but it does not allow his generalizations about commercial farmers as the source of Salmonella. The farmer was criticizing the Food Safety News article on Salmonella coming from backyard poultry flocks. He failed to recognize the source of that information is the Centers for Disease Control & Prevention. Yet, the farmer criticizing Food Safety News in his claims that “Large commercial poultry operations that have always used antibiotics inappropriately are the source of salmonella contamination so widespread that the eggs are now laid with the bacteria inside from infected hens. These and other commercial livestock operations that fed low levels of antibiotics because it increased growth rates are also the source of the antibiotic resistant bacteria like MRSA that plague us today. This is the reason the government now requires a warning on egg packages that eggs should be “thoroughly cooked before eating.”

Permit me to set the record straight. Commercial egg farmers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, have their farm inspected by the U.S. Food and Drug Administration officials to ensure they have implemented an egg safety program to prevent Salmonella enteritidis. This regulation (21 CFR Parts 16 and 118) Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation was issued on July 9, 2009, and remains in force today. https://www.govinfo.gov/content/pkg/FR-2009-07-09/pdf/E9-16119.pdf. The regulation requires preventive measures during the production of eggs in poultry houses and requires subsequent refrigeration during storage and transportation.

As to the farmer’s claim that large commercial farms use antibiotics inappropriately, he should know that antibiotics provided egg-laying chickens are not given routinely, but only when the chickens become sick. Antibiotics are not used for growth promotion. The eggs cannot be sold when a flock is being administered with antibiotics until after a prescribed withdrawal period.

Other issues with cage-free egg production include the report from The U.S. Animal Health Association October 17, 2017, which stated: “Ascarids (round worms) are increasingly being found in cage-free operations with the concern being the possibility of a consumer finding an egg with a roundworm contained inside. Most all cage-free egg producers have had such an occurrence.” Chickens pick up roundworms when they come into contact with infected feces on the ground. The Journal Food Control published a study June 17, 2014, entitled “Microbiological Contamination of Shell Eggs Produced in Conventional and Free-Range Housing Systems.” The conclusions show why cages became the preferred method of producing safer eggs: “Battery caged hens (conventional cages) are standing on wire slats that allow feces to fall to a manure collection system beneath the hens. Conversely, free-range hens (cage-free) laid their eggs in nest boxes on shavings and the eggs remained in contact with hens, shavings and fecal material until they are collected. The longer contact time with free-range hens, shavings and feces would explain the higher enterobacteriaceae counts on free-range eggs as compared to battery caged eggs.”

Penn State researchers in September 2016 published their research findings that eggs from small flocks of chickens are more likely to be contaminated with Salmonella enteritidis as eggs sold in grocery stores, which typically come from larger flocks of caged layers. 

Now consider the benefits of producing eggs from caged layers. Researchers at the Egg Industry Center in Ames, IA, found that today’s hens are living longer due to better health, better nutrition and better living environments. These researchers studied U.S. egg production over a 50-year period, from 1960 to 2010. Today’s egg farmers are producing more eggs in 2010 than 50 years earlier. Using 1960 technology to produce the 2010 egg supply would have required 78 million more hens, 1.3 million more acres of corn and 1.8 million more acres of soybeans.

In comparison to 1960 technology, today’s commercial egg farmers are using conventional cages to be able to feed 72 percent more people.

Thank you.

— Ken Klippen, President
National Association of Egg Farmers

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Dear Editor,

I am writing in response to the STEC E. coli article related to the Purdue Study.

I am a board adviser for the Aquaponic Association and a commercial aquaponic grower. We believe that the Purdue study was very flawed and that they had poor handling procedures and created a cross-contamination issue between their other cattle, swing and livestock production and the aquaponic and hydroponic systems in the study. Furthermore they did not perform traceback as they mentioned it was outside the scope of work. In addition, they allowed a level 2 STEC E. coli contaminate to remain in their study systems and lab environments possibly endangering students, staff and potentially even cross contaminating their larger systems. This seems horribly negligent.

No other study has found fish feces to be the source of a pathogen. The only relationship is for fish that are reared in water that is already been contaminated with mammal or human feces.

Here is the Aquaponic Association response written by several university professors from U.S. and Canada as well as commercial members.

— Tawnya Sawyer

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Dear Editor:

Will your supermarket warn you about hazardous food? Absolutely.

Fortunately for the nation’s grocery shoppers, the food industry has honed its expertise over the years – their reputation and economic viability demand they get this right. What U.S. PIRG describes in its recent survey as a communication challenge regarding food recalls, is only the final step of a food safety management program to effectively and efficiently remove potentially harmful products from commerce.

And believe me, a lot of people have opinions about how this information should be delivered to consumers since supermarkets touch the lives of 100 million households, and 91% of adults are regular food shoppers.

In our recent comments to the U.S. Food and Drug Administration (FDA), we addressed how food retailers respond to recalls with their supply chain partners. Ultimately, the food supply chain works within the regulatory framework and acts quickly to remove recalled product from shelves and notify shoppers. This is the most fundamental service grocers provide to maintain the trust of their customers. How they communicate this information is largely based on feedback from shoppers. According to FMI U.S. Grocery Shopper Trends 2019, while television remains a top source during a crisis, digital communications methods in the form of email and text messages lead the way in how consumers prefer to hear about food recalls.

Still, we recognize that communication preferences vary generationally and regionally. Therefore, retailers utilize multiple methods of communication depending on the circumstances to communicate recalls to their customers.

While every recall is a response to risk mitigation, they are not always associated with a health danger. Undeclared allergens are actually the leading cause of U.S. food recalls. The FDA has stated that Reportable Food Registry reports of undeclared food allergens increased from 30 percent to 47 percent  during the five year period from 2009-2013. For example, a wheat-based food may erroneously be marked as gluten free. As a proactive measure to better understand root-cause labeling errors, FMI and its Foundation awarded the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska – Lincoln’s Food Science and Technology Department a $20,000 grant in September 2017 to identify issues and to recommend best-practice procedures for manufacturers, suppliers and retailers in order to reduce undeclared allergen recalls. FMI Foundation is proud to support research which aims to improve public health efforts nationwide.

We will continue to participate in the comments process with government agencies, and our industry remains committed to communicating relevant recall information to customers wherever – and however – they shop.

— Hilary Thesmar, Ph D, RD, CFS, chief food and product safety officer and senior vice president for food safety at FMI.

About FMI: According to the organization’s website, the Food Marketing Institute was formed in 1977 through the merger of the National Association of Food Chains and Super Market Institute, two organizations that had served the industry since the 1930s. Robert Aders, former U.S. undersecretary of labor, became its first president and CEO and served from 1977 – 1993. Other presidents and CEOs of the organization have been Timothy M. Hammonds from 1993 – 2008, and Leslie G. Sarasin from 2008 – present.

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In relation to your recent story, ‘Microenterprise home kitchens’ look for food safety exemptions in Washington, I live in Missouri. In the St Louis area we have rentable fully equipped commercial kitchens so the entrepreneurs can work in an environment where they learn the right way to do things, are available to health inspections, and conform to all the food safety requirements. This is a far better option to keep public safety than allowing home kitchens.

Rates are affordable. Generally a minimum of four hours at $20 to $25 an hour.

An example is The Creative Cookery. They were the last one I used before retiring and selling my business to one of the chef’s who was also a user of the shared kitchen.

One thing a small emerging business needs is contact with others who are trying to do similar things. You can help each other and learn from each. Before I retired I was a presenter who often did presentations to other small business owners for the local SBA.

Anyway, I thought this option was missing from your article on home kitchens.

— Laura Bozzay

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Opinion

Interesting read on the decision of permanently banning horse slaughter in the US – and exports? Why are Canada and Mexico still receiving horses for slaughter?

The bill should also address the inhumane transport of horses in cattle liners – they are transferred near the border to larger trailers to give the appearance of humane transport before clearing the borders. These are “reject” horses from the race tracks and from people doing uncontrolled breeding of horses to get a cute foal; then they become a burden to care and train so they are starved or dumped and considered feral.

Have a proper strategy for the unwanted horses. Create a fee for racetracks that requires proper adoption of the losers from the track. Create a license for breeders – a fee high enough they have to have a plan for the foals.

Humane societies don’t go far enough in this issue.

Just plain banning for ethical reasons does not prevent unwanted horses. There are legal means of raising horses for meat and very successful – just like the other meat industries there are withdrawal periods for medications – so apply them the same to horses.

— Toni Allardyce-Harris

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Dear Editor,

As a former CFIA ( Canadian Food Inspection Agency) inspector, I have been following this story regarding the change in inspections on the hog plants with great interest. Change is hard but it doesn’t mean the job is eliminated. For the hog program to have the plant do the inspections is a good business move and it can free up the inspectors to focus more on other areas in the plant.

Canada has approved MPIP ( Modernized Poultry Inspection Program) and a recent hog modernized program. The plants had to go through a graduated process in order to enable full inspection by plant line workers. It still entails full inspection but hands off. An inspector shadows the workers and ensures all defects are detected.

The plant must maintain regular statiscally accurate sampling inspections for carcass defects using a coordinated statistical sample plan and the CFIA inspectors perform mirror inspections to verify the line is still operating with minimal defects.

I do not know if the USDA is tasked with approval and training for the independent plant inspections, but this method may be the best for both sides. Presence in the plants is still maintained and the inspectors can focus on other compliance verifications through the operations. The CFIA has CVS and SIP which is a structured program to inspect various prerequisites and critical areas based on the plants’ HACCP plans.

I do not know how the U.S. structures their inspections, but line efficiencies are needed in all types of slaughter facilities to minimize animal stress at slaughter and keep pathogen growth in check after product is processed

— Toni Allardyce-Harris

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Dear Editor,

I am submitting this letter in response to Dan Flynn’s earlier piece regarding pork inspection line speeds.

The federal government’s decision to put pork producers in charge of their own food safety inspections — while letting them set the line speeds that inspection workers must follow — is a recipe for disaster, despite what Flynn would have you believe.

Under a rule change that became final in December 2019, the U.S. Department of Agriculture will put pork producers largely in charge of their own food safety inspections. Instead of requiring federal employees to conduct comprehensive examinations of each animal carcass, those inspections now will be handled by workers hired by the pork companies themselves.

The pork companies will be able to adjust the inspection line speeds whenever they like — potentially putting workers at higher risk of injury as they have less and less time to inspect each animal.

Make no mistake, this rule change isn’t about meeting higher food safety standards. It’s about moving product faster and cutting cost for the meat companies. About 40 percent of federal inspector jobs in hog slaughter plants will be lost as the work is outsourced to lower paid, less skilled company workers.

The new pork rule follows similar changes made to the poultry inspection process a few years ago. It’s all part of a larger assault on the hardworking federal employees who help guarantee that the food you eat is safe.

As the head of the union that represents more than 6,500 food inspectors nationwide, I happen to believe that the USDA’s only concerns should be the safety of our food and the safety of its employees. On both those counts, the agency gets a Grade F performance.

— Paula Schelling
President, American Federation of Government Employees Council 45

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Dear Editor,

Editor Dan Flynn’s Jan. 12 letter supporting the USDA’s new swine slaughter rule perpetuates so many falsehoods, it merits a lengthy response. Among other things, the new rule removes all line speed limits in pig slaughter plants. Despite Flynn’s claims, which were based on his visit to a veal plant in the Netherlands that operates under an entirely different regulatory regime, the evidence in the United States shows that the New Swine Inspection System (NSIS) will significantly increase the risk of injury to the people who work the lines.

Meatpacking is already one of the most dangerous industries for workers in America. Every day, tens of thousands of hog slaughter workers make the same repetitive motions, thousands upon thousands of times a day, using saws, hooks, and knives to slaughter and break down hogs into the pork steaks that we all buy and eat.

The plants are loud, wet, and slippery from fat and grease. They are hot on the slaughter side and very cold on the fabrication side. The production pressure on all workers is unrelenting — keep the lines running at all costs. The result: overall injury and illness rates twice the national average; and illness rates, which include repetitive motion injuries, among the highest of all industries in the United States.

The scientific evidence in the record for the NSIS is clear: the faster hog slaughter workers must do their tasks, the higher the risk of injury. The record contains more than three decades of studies directly tying line speeds to the industry’s staggeringly high rate of work-related injuries and illnesses. In fact, 30 years ago, the Occupational Safety and Health Administration (OSHA) published guidelines to help meatpackers reduce the high rates of repetitive motion disorders in their plants, stating that one way to decrease these disorders is by “reducing the total number of repetitions per employee by such means as decreasing production rates.” OSHA, however, does not directly regulate line speeds. And despite its 30-year-old recommendation, line speeds have not decreased and injury rates remain shockingly high.

Worker safety is not a red herring. There are real negative consequences for workers, consumers, and animal welfare. Even USDA stated in its NSIS proposed rule that “evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety.” High rates of worker injury lead to high turnover rates, which studies have shown leads to decreases in food safety. In fact, the USDA did not allow chicken plants to increase their line speeds in the 2014 New Poultry Inspection System because of concerns about the impact on worker and consumer safety. But the current USDA completely failed to address this concern in finalizing the NSIS.

The USDA received thousands of comments requesting that it consider the impact of the proposed rule on worker safety — just like USDA would consider any other unintended consequences of its regulatory action, as agencies are required to do as a basic principle of governance. These commenters submitted detailed, credible evidence, but were given the brush-off.

When the USDA first proposed its rule removing line speed limits, it relied on a flawed data analysis—which it tried to hide from the public—that downplayed the dangers posed to workers. After being lambasted by statistical experts for its head-scratching findings, the USDA has since tried to wash its hands of any worker safety analysis, claiming it lacks the necessary expertise to even examine the evidence on the impact on worker safety. Readers should be aware that the USDA’s own Office of Inspector General has opened an investigation into the agency’s reliance on a disingenuous analysis in the proposed rule, the lack of transparency, and other irregularities.

Editor Flynn’s statement that the challenge to the NSIS was brought by “the U.S. union representing our friends the meat inspectors” is simply wrong. None of the three court cases challenging the NSIS were brought by any union representing meat inspectors. Rather, the pending Minnesota case was brought by unions representing the hog slaughter plant employees — the tens of thousands of workers who slaughter and break and box up the pork in processing plants nationwide, and whose physical health and safety are at stake.

It’s clear from the final rule that the USDA is fully aware that workers in pork slaughter houses will now work harder and faster because of this rule. When the agency conducted its cost-benefit analysis, the main benefits came from hog slaughter plants being allowed to crank up the chain speed and make all workers do their jobs faster. Assuming a line speed increase of 12.49 percent, USDA found that each plant that adopts the NSIS will see a profit increase of $2.04 million. That’s what this rule change is really about.

 — Debbie Berkowitz
program director of worker safety and health at the National Employment Law Project and previously chief of staff and senior adviser at the Occupational Safety and Health Administration

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Editor’s note: We want to hear from our readers, and that’s you. Letters to the Editor can be submitted via the Contact Us link on our website.

Editor’s note: We want to hear from our readers, and that’s you. Letters to the Editor can be submitted via the Contact Us link on our website.

Dear Editor,

2018 has been marked by high profile food recalls ranging from romaine lettuce and thousands of pounds of ground beef to Ritz Crackers and goldfish. Grocery shopping shouldn’t be a game of Russian Roulette where what you pick up for dinner might make you and your family sick.

Over the past 40 years, we’ve gotten a lot better at identifying foods that are contaminated, but that’s not enough. From tracing the cause of contamination, identifying the variety of products affected by the contamination, removing them from shelves, and notifying consumers who may have already purchased them; locating the food is just the first step.

One potential solution to these problems is blockchain, which many know as the technological backbone of cryptocurrencies like Bitcoin. Tech innovators are working on using blockchain technology to monitor supply chains in everything from retail and pharmaceuticals to health insurance and industrial emissions.

Essentially, blockchain is a decentralized cloud-based ledger that, as Frank Yiannas, vice president of food safety for Walmart, says, could become the “equivalent of FedEx tracking for food.” Each time there is a transaction in the food’s journey, information about it is added as a “block” to the online network ledger. Information from harvest crew, date, and time, to temperature, storage, and sanitization along each step of the path from farm to store can be easily and quickly uploaded.

This transaction information can be vital to containing the public health impacts of contamination. For example, in 2015 an E. Coli related flour recall was made a whopping 6 months after the initial outbreak of the disease was discovered. These delays risk serious health consequences and point to the need to streamline the process of agriculture supply chain transparency.

The obvious challenge in implementing blockchain technology in food safety is in accurately collecting and inputting the data into the ledger. Additionally, producers, who already backlash to food safety auditors may not buy into the process. However, increasing consumer demand for traceability may push the use of transformational technology like blockchain into the public eye. Updating our food safety policies to give producers and consumers the information they need to protect themselves will will demand new methods and technologies.

 — Viveth Karthikeyan

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Dear Editor,

Fecal contamination is very common in the butchering process of animals. During the process of disemboweling the chickens, the intestines may break or cut accidentally.  Fecal material is spilled on and into the chickens. Fecal material is loaded with E. coli and Salmonella in chickens. The chickens are run into ice bath to cool and are allowed to gain 13 percent water weight gain from cooling process. The ice bath contains fecal material from normal slaughter process and exposes all the birds to contamination. Line speeds are exceeding fast and USDA inspectors do not touch birds to examine birds, but use mirrors to see the back side of birds.

Work has been done to reduce the Salmonella in live birds, but you still have to handle the chicken properly at home, and wash hands often, not cross contaminate and sanitize work areas.

Support for irradiation of meat is very poor, but is the only way you can get it 100 percent clean. I have not heard of lab grown chicken yet, but that may come soon.

Cattle are exposed to fecal contamination in some different ways. The crowded beef in waiting pens are exposed to fecal matter on the hides. The dried fecal material on hide will become airborne when the hide is pulled off the animal exposing all the carcasses to fecal dust.

Now before we panic, there is some good news. All of us are full of good E. coli which helps us to digest food. Beef is said to be tastier after being in cooler and the good bacteria growing on it than just after slaughter. Lucky for us that the 0157 strain of E. coli is uncommon. The problem is that in big plants the meat is processed and shipped in many different directions making recall difficult.

Bottom line is to take responsibility for sanitation at home and be open to the idea of irradiation.

Scott Vandell, registered sanitarian
Division of Health Protection, Public Health Services for RiverStone Health of Billings, MT

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I try to read about food safety threats and notify family and friends every time see one that is pertinent. Each time, it occurs to me that there is an “us vs. them” attitude between producers and inspection authorities. The “us vs. them” should be between us as humans and the threat, usually bacteria, aka bugs. Instead, it becomes a point-the-finger, blame-game competition.

In the case of the Kerry company, for instance, why not collectively”do the necessary operations to prevent continuation of the danger? That means the government agency would assist in the correction process, not just point out there is — or might be — a problem.

My life experience was in commercial construction. We had numerous safety inspections, audits and weekly meetings pointing out — what we already knew — that construction is a potentially dangerous profession. The only people who actually helped were those who presented viable solutions to a given problem. Sometimes it was training, usually the responsibility of respective unions, employers and knowledgeable, experienced, employees — not necessarily the inspector.

At one point, the threat of an OSHA inspection was considered a reason for our company to close the project rather than allow an inspector to impose unreasonable fines and even the threat of imprisonment for their perception of willful violations of the rules. The adversarial relationship was counter-productive.

On food safety there must be a concerted effort between FDA — or whoever is in charge of regulating a specific food — and businesses to end the threat, not to point fingers.

Just a thought from someone who is not really close to the problem, except I do eat food. In the Kerry plant, couldn’t it be closed for clean-up. like starting with live steam as in the old days?
And to promote an actual solution, why not a “super fund” to assist each unfortunate company that is cursed with these problems to clean and sanitize? That could help offset the expense of doing the right thing. Of course, I can see how this could be used by the unscrupulous to turn a profit just as so many well-intentioned ideas have in the past.

Bottom line: It is us humans vs. them bugs, not each other.

— Jim Dixon

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Let’s be clear and stick to the facts when discussing line speeds in poultry plants. Parsing words and bending facts will have real victims: consumer and worker safety. There is no such thing as just increasing line speeds in the inspection area of a plant and not impacting the line speeds in the entire plant. FSIS was clear in acknowledging this when it proposed changing the way poultry would be inspected.

A line speed increase not only increases how many birds per minute are slaughtered and inspected, it results in more birds being processed per minute throughout the plant. And when it comes to worker safety, there is no doubt that the faster the line speeds the greater the risk of harm to workers. Let’s look back at the original rulemaking process.

In August of 2014, the USDA’s Food Safety and Inspection Service (FSIS) promulgated the final rule for the Modernization of the Poultry Slaughter Inspection System. The final rule, which created the New Poultry Inspections System (NPIS), went through almost two-and-a-half years of public notice and comment, during with the USDA received more than 250,000 public comments. According to FSIS, the issue they received the most comments on was the potential negative effect that increased line speeds might have on the health and safety of workers in poultry slaughter establishments.

The final poultry inspection rule promulgated by the FSIS did not contain a line speed increase. In fact, as part of the rulemaking, the agency flatly rejected any line speed increase in poultry plants. Instead, the FSIS decided to maintain the existing maximum line speed of 140 birds per minute. In making this decision, it should be clear that the USDA considered extensive comments on all sides: the poultry industry, worker advocates, consumer safety experts, and other affected stakeholders. In reaching this conclusion, the government specifically explained that maintaining the maximum line speed of 140 birds per minute would allow the agency to assess the impact of the various changes and new technologies adopted by establishments under the NPIS.

Most important to this debate, FSIS also specifically concluded  that they would  not reconsider this decision on  maximum line speed rates until the NPIS  had  been fully implemented on a wide scale and the agency had gained a least a year of experience under the new system. According to FSIS, poultry plants are slowly opting into the new system, and as of yet there has not been wide scale implementation.

In its initial proposal, USDA clearly stated that any increase in the maximum line speed would not only affect the inspection process, but would result in more birds being processed per minute. That’s right, more birds being processed per minute. The USDA was clear that if current inspection line speeds were increased, workers in poultry plants would be processing more birds per minute.

It was clear that the speed governing inspection of newly slaughtered birds in poultry plants also affects the speed at which workers in both the slaughter and processing sides of the plants would be working.

The petition by the National Chicken Council requests that chicken plants be able to run their lines as fast as they would like. They are advocating for no line speed limits at all. This request is made despite the fact that even in the 20 chicken plants that are in an old pilot program (HIMP) that allows chicken plant line speeds up to 175 birds per minute, the average line speed is 131 birds per minute, well below the currently allowed 140 birds per minute.

There are many additional arguments beyond endangering workers and consumers on why the USDA must reject the NCC’s petition—including that it would undermine the rulemaking process, violate the Administrative Procedures Act, and would be inconsistent with the Department’s wavier regulations. But it’s important not to obfuscate the issue.

The author is a Senior Fellow at the non-partisan, not-for-profit National Employment Law Project. She previously served as the Chief of Staff and then Senior Policy Advisor at the Occupational Safety and Health Administration.

Deborah Berkowitz
Senior Fellow, National Employment Law Project
Previously Chief of Staff and Senior Policy Advisor, at the Occupational Safety and Health Administration

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The proposed rule is strongly backed by the meatpacking industry, but the fact is that raising line speeds in pork processing plants will only make a bad situation worse. Workers who bring food to our tables deserve safety and dignity on the job, and consumers deserve and demand safe food.

If the USDA proposal goes into effect as written, the result will be a higher risk of food contamination and more amputations and other disabling injuries for animal slaughtering workers.

The USDA is proposing to allow pork producers to use their own staff, in place of federal inspectors, to look for fecal matter and other contaminants on the pork processing lines. This approach has already been tried, with alarming results. A report from the USDA’s Office of Inspector General found significant problems with food safety issues at pork processing plants that have piloted “self-inspection.”

Meatpacking workers currently experience a higher rate of occupational illnesses than workers in any other industry, 17 times higher than workers nationwide. The USDA proposal is part of an industry-backed plan to privatize safety inspections at U.S. pork processing plants, which currently slaughter an average of 1,100 hogs per hour.

The USDA should put this unwise proposal back on the shelf, and come back with a plan that provides rigorous, science-based protections for everyone who produces our food – and everyone who eats it.

Jessica Martinez
Co-Executive Director, National Council for Occupational Safety and Health

Celeste Monforton
Public health lecturer, Texas State University

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Editor’s note:

Dear Colleagues from Johns Hopkins Center for a Livable Future:

I appreciate that you wrote expressing your concerns about the implementation of California Senate Bill 27 (SB 27) via letter dated October 13, 2017. The only way to ensure that a collaborative process continues as we move toward the goal of mitigating the rate of development of antimicrobial resistance in order to protect public, animal, and environmental health, is to communicate concerns.

Your first concern that we are not collecting Veterinary Feed Directive (VFD) data is easy to address because we are going to collect that data. We have the authority to collect this data, there are strong data retention laws in place that preserve the data, and our strategic plan calls for the collection of VFD data. We have visited ALL facilities in California that submitted a letter of intent to FDA to manufacture or distribute medicated feeds using VFD’s and have ensured that they are retaining the needed data.

Due to the time sensitivity, we are currently focusing activities on enhancing compliance with antimicrobial use laws that will be effective in 2018, including ensuring the VFD’s are filled out properly so the baseline data collected is meaningful, but as we bring newly funded staff on board, we will be well prepared to collect and analyze VFD data, including historical data, for use in our initial 2019 report to the legislature. However, we do not feel this information alone is sufficient for evaluating the effects of stewardship best practices which are also being developed as we gain staff, so we are initiating much more in depth data gathering studies as well.

To your second point about “regular pattern” use of antimicrobials for preventative purposes, we have a different understanding of the situation. We agree that SB 27 clearly limits regular pattern use for prevention, but the issue is not that someone wants a “loophole.” Remember that animal owners and veterinarians also want to preserve the potency of antibiotics, perhaps more than most people since not only do they and their families need effective antibiotics, but they want to be able to keep their animals healthy well into the future.

The issue is that trained and licensed veterinarians want the autonomy to use their skills when practicing medicine within the framework of California law, so finding the best wording was challenging. That being said, we agree that the wording on our website did not exactly reflect SB 27. It was not intentional and we have been working on how to improve it ever since these concerns were pointed out.

To reduce confusion, we have now removed the items of concern from our website. Because the law itself is fairly explicit, to avoid confusion as we approach 2018, we will likely just use the exact wording from SB 27 in the future.

Again, while we may come at this issue from different backgrounds, I truly believe we share common goals as we implement SB 27, so we encourage you to stay engaged and continue this productive dialogue. Your letters are helpful and welcomed because they formalize your concerns, but also feel free to contact me directly at (916) 900-5000 or via email at [email protected].

Thank you for your continued support of effective implementation of SB 27. Sincerely,

Annette Jones, D.V.M.
California State Veterinarian and Director

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