(NEW YORK) — The death toll in the devastating flooding that hit eastern Kentucky is continuing to rise as more rain threatens the region, according to officials.
A total of 28 people have been confirmed dead, but that number is expected to increase again, Kentucky Gov. Andy Beshear announced Sunday afternoon. The death toll includes at least four children, Beshear said on Saturday.
“We do know of additional bodies that have been recovered but we cannot confirm those deaths at this time,” Beshear said in a recorded video posted online.
Beshear described “widespread damage” that displaced thousands of people, including power outages for thousands of people as well as washed out roads, destroyed homes and flooded schools. Beshear is expected to visit some of the regions impacted by the flooding on Sunday.
More rain is forecast in the area on Sunday and Monday as search and rescue teams continue to look for those who are unaccounted for. The additional precipitation could potentially cause water levels to rise again, with 2 inches to 4 inches of rain possible in the same area that experienced the catastrophic flooding that began with heavy rains on Wednesday.
More than 600 people have been rescued by aircraft and boat since the flooding began, Beshear said.
The destruction in Kentucky is the latest extreme flooding event to take place in the U.S. in less than a week.
Heavy downpours caused flash flooding in Las Vegas on Friday, with rising waters seen on roadways and parking garages in busy parts of Sin City.
The megadrought has caused the soil in the region to become so dry that it could not absorb the heavy rains, which helped to contribute to the flooding.
Earlier in the week, a flash flooding emergency occurred near St. Louis, which had a record-breaking 8.56 inches of rain in less than 24 hours. One person was found dead in a car on Tuesday after the water began to recede, officials said.
Kentucky is working to establish shelters, Beshear said, asking those who want to help to donate cleaning supplies or water. Last week, President Joe Biden approved a disaster declaration.
“Let us wrap our arms around eastern Kentucky and pray for those impacted,” Beshear said.
ABC News’ Matt Foster, Kenton Gewecke and Emily Shapiro contributed to this report.
(RONALD TOWNSHIP, Mich.) — Two cyclists were killed and three others injured when a car ran into them at Ronald Township, Michigan, Saturday morning, law enforcement officials announced.
The cyclists were participating in the Make-A-Wish Michigan 35th Annual Wish-A-Mile Bicycle Tour, a three-day endurance ride throughout most of Michigan, when they were struck, officials said.
Texas police search for suspect in death of world-class cyclist
According to the Ionia County Sheriff Office, the men were traveling southbound when they were hit by an SUV traveling northbound.
One bicyclist was declared dead on the scene, while the other was flown to Spectrum Health Butterworth Hospital in Grand Rapids but died from his injuries. The three cyclists who survived are hospitalized with severe injuries, police said.
The police aren’t releasing information on the driver pending an investigation, but he was arrested on two counts of Operating While Intoxicated Causing Death.
“It is with heavy hearts we remember our riders impacted by the tragedy yesterday,” Make-A-Wish Michigan tweeted on Sunday. “Our staff and the entire Make-A-Wish family are heartbroken and offer our deepest sympathy for the riders involved, their loved ones, and all members of the Wish-A-Mile (WAM) community at this time.”
The cyclists’ names will be released once all next-of-kin are notified.
(FRANKFORT, Kentucky) — The death toll in the devastating flooding that hit eastern Kentucky is continuing to rise as more rain threatens the region, according to officials.
A total of 26 people have been confirmed dead, but that number is expected to increase again, Kentucky Gov. Andy Beshear announced Sunday morning. The death toll includes at least four children, Beshear said on Saturday.
The death toll in the devastating flooding that hit eastern Kentucky is continuing to rise as more rain threatens the region, according to officials.
A total of 26 people have been confirmed dead, but that number is expected to increase again, Kentucky Gov. Andy Beshear announced Sunday morning. The death toll includes at least four children, Beshear said on Saturday.
More rain is forecast in the area on Sunday and Monday as search and rescue teams continue to look for those who are unaccounted for. The additional precipitation could potentially cause water levels to rise again, with 2 inches to 4 inches of rain possible in the same area that experienced the catastrophic flooding that began with heavy rains on Wednesday.
More than 600 people have been rescued by aircraft and boat since the flooding began, Beshear said.
The destruction in Kentucky is the latest extreme flooding event to take place in the U.S. in less than a week.
Heavy downpours caused flash flooding in Las Vegas on Friday, with rising waters seen on roadways and parking garages in busy parts of Sin City.
The megadrought has caused the soil in the region to become so dry that it could not absorb the heavy rains, which helped to contribute to the flooding.
Earlier in the week, a flash flooding emergency occurred near St. Louis, which had a record-breaking 8.56 inches of rain in less than 24 hours. One person was found dead in a car on Tuesday after the water began to recede, officials said.
Kentucky is working to establish shelters, Beshear said, asking those who want to help to donate cleaning supplies or water. Last week, President Joe Biden approved a disaster declaration.
“Let us wrap our arms around eastern Kentucky and pray for those impacted,” Beshear said.
ABC News’ Matt Foster, Kenton Gewecke and Emily Shapiro contributed to this report.
(NEW YORK) — The story of a 10-year-old rape victim traveling from Ohio to Indiana to receive abortion care captured headlines earlier this month, illustrating what impact the Supreme Court decision to overturn Roe V. Wade, a landmark decision which established a federal right to abortion, has had on access to abortion for people around the country.
While many attempted to discredit reporting surrounding the case, the identity of the suspected rapist was ultimately revealed when charges were filed against him. But still, it remained unclear how common abortions are among young people, especially minors.
According to the Guttmacher Institute, a reproductive health policy research organization, there were 4,460 pregnancies among people ages 14 and younger in 2017. The institute estimates that around half of those pregnancies, 1,960, ended in abortion.
The institute gathers its data by conducting a census of all known abortion providers in the U.S. every few years, but its most recent publicly released national data is from 2017.
While data released by the Centers for Disease Control and Prevention in 2019 is more recent, the data is incomplete as not all states mandate reporting from all their health facilities and not all states report their data to the agency, Isaac Maddow-Zimet, a researcher at Guttmacher, told ABC News.
Lauren Ralph, an epidemiologist at the University of California, San Francisco’s Department of Obstetrics, Gynecology and Reproductive Sciences, told ABC News in an interview that she believes the CDC’s abortion data is an underestimate by about 1/3.
Abortions in minors represent about 4% of all abortions in the U.S. every year, Ralph said, speaking of data gathered by the Guttmacher Institute.
The Guttmacher data shows that abortions among people between the ages of 15 and 17 account for 3.4% of abortions in the U.S and abortions among people under the age of 15 account for 0.2% of abortions in the U.S.
Ralph estimates that there are around 1,800 abortions in people under the age of 15 in the U.S. every year.
An abortion provider in Indiana told ABC News in an interview that it is relatively common to see patients who are minors.
“These patients exist, this was not a one off type of situation. Instead, this is something that every abortion provider has seen and has taken care of, and has experience with,” Katie McHugh, an abortion provider in Indiana said.
McHugh works at three abortion clinics, and said just one of those clinics saw 400 patients last month. She said the two other clinics each see between 300 and 350 patients, per month.
“It is certainly not the majority of the cases that I take care of but, when I queried my clinics where I work, we estimated that between 3 and 5% of our patients are minors,” McHugh said, calling it a rough estimate of the number of minors they see.
McHugh said about half or so of those patients report that the pregnancies were as a result of rape.
McHugh’s most recent case of a young girl was a pre-teen patient around the age of 12 or 13, who she was able to provide abortion care.
Before the Supreme Court ruling, McHugh said she had begun seeing some patients from Kentucky, where some abortion restrictions limiting access to abortion were being put in place. But, since the Supreme Court ruling, McHugh said more than half of the patients she has seen are from Kentucky and Ohio.
She also said she has been seeing a fewer number of patients coming from as far away as Alabama, Texas, Tennessee and Oklahoma.
“We’ve seen more people have younger ages, but we’ve just seen more people in general,” McHugh said, speaking of patients she has seen after Roe was overturned.
But even before the Supreme Court decision, experts said minors faced more barriers to abortions than adults.
Some states, including Indiana, have laws requiring minors, generally people under the age of 18, to get legal consent from their parents to get an abortion, or go through judicial bypass and get a judge to sign off on getting the procedure.
According to Guttmacher, 36 states require parental involvement, either parental consent or parental notification, in a minor’s decision to get an abortion and 21 states require parental consent.
“The system is so challenging to navigate and to try to do so as a minor who can’t drive themselves, who can’t pay for things themselves, because they’re too young to legally work and yet, they’re having to face these kinds of major health care decisions on their own, is so tragic to see,” McHugh said.
McHugh said the judicial bypass system in Indiana runs relatively smoothly in the state, but said it is designed to be “cumbersome” and to “place burden on patients.”
“It works very well to do those things where it puts up lots of barriers, especially for minors and for the very young minors,” McHugh said.
“Because of legal requirements to either have parental consent, or to go through the court system, to prove to a judge that the person is competent enough to make a decision like this on their own, there is a significant delay in care,” she added.
McHugh called the system “ridiculous,” saying that delaying care could possibly increase a patient’s risk for more complicated abortion care depending on what stage of the pregnancy they are in.
In young girls, carrying a pregnancy to term is riskier than getting an abortion, when compared with adults, McHugh said.
“When we look at studies, [young patients are] at a higher risk of developing medical problems like diabetes and high blood pressure. They’re at a much higher risk, especially in very young patients, of needing a C-section, simply because their bones and their joints are not developed enough to accommodate a vaginal birth,” McHugh said.
C-sections also come with their own risks, including the possibility that the patients would need the procedure again in the future, McHugh said.
(NEW YORK) — Universities across the country are studying their relationship to slavery and are being called on by students to address their histories by making symbolic and financial reparations.
During the colonial era the wealth of universities, in the form of endowments and benefactors, was inextricably tied to the slave trade, numerous university presidents owned enslaved people and famous alumni such as John C. Calhoun championed the cause of slavery. Enslaved people were owned by universities and worked on campuses until the abolition of slavery.
Now, students at those institutions are organizing. They are focusing on erecting monuments, taxing endowments, creating divestment campaigns and offering alternative campus tours that highlight the university’s history of slavery. Students are also pushing schools to identify and support descendants of people enslaved by the universities.
At Brown University in Providence, Rhode Island, senior Carina Sandoval was “really hopeful” when she cast her ballot last year in the student referendum, which asked students whether they thought the university should make efforts to identify descendants of people enslaved by the institution and make some form of reparations to them.
More than 80% of the student body said yes to both measures, yet Sandoval said the university did not respond.
“A number of my co-organizers and I have been increasingly disillusioned with the referendum process, as it feels like a stalling tactic by the university,” Sandoval told ABC News. “In any case, it’s made it clear that campaigning exclusively within the university alone is ineffective.”
According to a landmark 2006 report on Brown’s history, early trustees of the university owned enslaved people, and the first building on campus, University Hall, was built by enslaved people. The Brown family, for whom the university is named, were slave traders, the report states.
“We always welcome the opportunity to engage in a direct and positive dialogue with students, and the question of reparations remains an important one that will continue to prompt exploration on campus,” a university spokesperson said in a statement provided to ABC News.
Sandoval and more than a dozen other students are part of a group called “Coalition for University Accountability,” which formed two years ago with the goal of educating students about the history and legacy of slavery at the university and passing two bills in the city government, both of which would tax the university.
One bill would allow the city to tax the university’s property “notwithstanding any charter provision,” because the university is tax-exempt in the state constitution.
A Boston Globe analysis found that taxing Brown’s properties would give the city an estimated $48 million annually.
Another bill would enable the city to tax the university endowment, which is $6.9 billion, at a maximum rate of 2%. The bill also states that the revenue can “be used only for the host’s public school district.”
Gabe Mernoff, a senior at Brown who grew up in Providence and is a member of the “Coalition for University Accountability,” said the idea of taxing the university specifically is something “you hear about all the time from people” in the city.
“We want Brown to not only be a good neighbor, but a neighbor that actively uses its resources and its vast wealth to promote social justice in Providence and Rhode Island,” said Mernoff.
“[It’s] wealth originally has been built on injustices like slavery and other forms of exploitation in subsequent centuries and today it’s gentrifying a lot,” he added.
A spokesperson for the university said in a statement, “Brown continues to believe that taxes imposed through legislative efforts impede the efforts of higher education institutions,” adding that “legislative efforts such as these tend to overlook that Brown provides extensive contributions to the community we call home in significant areas that meet public need and offset the need for greater public resources.”
On other campuses, student organizing has focused on increasing the payments many universities make voluntarily to local municipalities to compensate for the university’s tax-exempt status. These payments, called PILOT, or payment in lieu of taxes, represent a small fraction of what they would presumably “owe.”
Last year, Yale University agreed to increase its annual PILOT payments, which were approximately $13 million, by $10 million over the next five years.
Local organizer Remedy Sharif cites a multi-year organizing campaign, undertaken by community members, teachers’ unions, graduate and undergraduate students, with the slogans “Pay Your Fair Share” and “Yale Respect New Haven,” as the reason for this decision.
“When you’re facing a 40-plus billion-dollar multinational corporation, it takes a lot of power,” said Sharif. “Our community was building that power and applying that pressure, but we also needed those allies on the inside.”
A spokesperson for the university issued a statement saying, “for decades, Yale has regularly increased its voluntary payments to New Haven. Our most recent increase is the largest yet,” adding that “these contributions reflect the continued evolution of our strong commitment to, and partnership with, our hometown.”
The most recent data published by the Lincoln Institute of Land Policy shows that 70 universities across the country make PILOT-type payments.
Another strategy that is being used by student organizers is calling for universities to divest endowments from certain industries.
At Harvard University, where the administration recently announced a $100 million reparations fund, student and community organizers have been focused on getting the university to divest from the prison industry.
The Harvard Prison Divestment Campaign filed a lawsuit against the university in 2020, alleging that the university had engaged in “untrue and misleading advertising” because “at the time that President Drew Faust publicy [sic] promised to understand and adress [sic] Harvard’s complicitly [sic] with slavery, Defendant Harvard Corporation was invested in and profiting off of the continued enslavement of mostly Black and brown peoples in prison,” the lawsuit reads.
The case was dismissed last year, with the court deciding that the six Harvard students who filed the lawsuit “lack[ed] standing to challenge the investment decisions at issue in this suit.”
In the most recent update from the Harvard & the Legacy of Slavery implementation committee, Harvard professor and committee chair Martha Minow said, “we are immersed in listening to many people, gathering ideas, and moving ahead on the task of advising the president and other senior administrators, and developing suggestions for further work.”
A spokesperson for Harvard University declined a request from ABC News to comment specifically on the subject of divestment.
“Universities typically dramatically overstate the limitations on what they can use their endowments for,” said Charlie Eaton, professor of sociology at the University of California, Merced, and author of “Bankers in the Ivory Tower.” “If the university has a will to use its endowment toward racial equity it will,” said Eaton.
In 2015, both Columbia University and the University of California system announced they were divesting their endowment from the private prison industry.
At the University of Chicago, student and community organizers have demanded $1 billion in “reparations” from the university to the South Side of Chicago, as part of a multi-pronged campaign asking the university to respond to its historical ties to slavery and allegations of gentrification.
Current and former doctoral students have sought to highlight the link between the current organization, wealth and status of the University of Chicago and what is called the “Old University of Chicago,” which was founded by Illinois senator and slave owner Stephen A. Douglas, making the case that Douglas’ original endowment, generated from enslaved laborers, made the university possible.
“The University of Chicago has developed deep partnerships with our community and the City of Chicago,” a spokesperson for the University of Chicago said in a statement. “We are continuing to make far-reaching contributions to address community priorities and enhance the quality of life on the South Side.”
“The University of Chicago that exists today was founded in 1890,” the spokesperson for the university said. “The earlier university was founded by Douglas in 1856 and financially collapsed in 1886, with no endowment and its land and buildings foreclosed by creditors.”
The student organizers, calling themselves “University of Chicago Against Displacement,” also have joined with community organizations to demand a community benefits agreement, a legal contract between a real-estate developer and organizations representing residents, from the city of Chicago.
The focus of the coalition is preventing gentrification and displacement they say will be caused by building of the Obama Presidential Library in the South Side, which is currently under construction.
The city of Chicago did not respond to repeated requests from ABC News for comment.
Universities have taken down monuments to slave owners closely affiliated with the university, and erected monuments that memorialize the histories of enslaved people within the university. More than 95 universities have joined the “Universities Studying Slavery” consortium, organized by the University of Virginia.
At the University of Mississippi, Columbia University, the University of Alabama and Harvard University, visitors can go on alternative campus tours that are meant to highlight the university’s history of slavery.
Universities have published reports on their own historical ties to slavery comprising hundreds of pages, and Georgetown University has begun offering special consideration in the admissions process to descendants of enslaved people owned by the Maryland Province of Jesuits after the university officially apologized in 2017 for the sale of 272 enslaved people in 1838 to fundraise for the school.
In 2019, Georgetown students voted to create a reparations fund that would serve the descendant community. The school responded by creating a reconciliation fund, which receives minimum funding of $400,000 a year and is dedicated to “support[ing] community-based projects to benefit the Descendant community,” a spokesperson for the university said. It has also funded a charitable foundation, run by a board that includes descendants.
“We are committed to continuing to understand and respond to our involvement in the institution of slavery and ensure that our community members engage with this history and work toward racial justice,” the spokesperson added.
“There is a tradition among students going back, at least to the 1960s, of promoting racial justice,” said Robert Cohen, professor of History and Social Studies Education at New York University. “This issue of reparations, and [reckoning with the] history of slavery on the university campus, is consistent with that.”
Olivia Henry, a third-year student at Georgetown University, said she has personally connected with descendants of enslaved people sold by Georgetown University and visited the plantation in Louisiana where their ancestors labored.
Henry is involved with organizing a school supply drive for Maringouin, Louisiana, where many of the descendants live, coordinating teach-ins for fellow students to learn about Georgetown’s history, and advocating for the construction of a memorial on campus.
“The reparations are not meant to be in any way, shape or form a cop-out for meaningful engagement with the descendant community. They are a part of Georgetown and if they want access to Georgetown’s resources that should be part of their disposal,” said Henry.
“It takes sending that first message [to descendants], and just kind of hoping that people respond. And if they don’t, there’s no requirement for people to talk to me,” said Henry. “But I’m trying to have that door open.”
(NEW YORK) — Some of the operational deficiencies that helped trigger the massive shutdown of Abbott Nutrition’s infant formula plant earlier this year have also been found at some other companies’ factories, according to an ABC News investigation of some of the other formula makers that have stepped in to help fill empty American grocery shelves in the midst of the critical nationwide shortage.
The pathogen that prompted those concerns, Cronobacter sakazakii, can be widely found in the environment — but in infants, it can be deadly.
Its discovery inside Abbott’s Sturgis, Michigan, plant prompted a massive voluntary formula recall in February, after four babies who had consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants subsequently died, although Abbott maintains there has not been conclusive evidence that its formula caused the infant illnesses, since none of the Cronobacter strains found at their plant matched the two samples genetically sequenced from the sickened infants.
Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a pattern of serious operational deficiencies and consumer complaints — which led to its closure.
Abbott’s shutdown ricocheted across the country, exacerbating the supply shortage and forcing families to scramble for alternatives in the hyper-concentrated formula market. In the wake of Abbott’s recall, other companies jumped in to ramp up manufacturing to help mitigate the strain.
Yet within the last five years, those companies — Reckitt’s Mead Johnson, Gerber, and Perrigo’s PBM — have also not been immune to operational and even contamination-related concerns.
Nearly a decade’s worth of FDA inspections obtained through the regulatory intelligence company Redica Systems and reviewed by ABC News have found the presence of Cronobacter in environmental sampling, in critical and high-hygiene areas, and even in finished product from some of these formula manufacturers’ American plants.
In some cases, investigators found crucial equipment in a state that could nurture the spread of potentially dangerous pathogens, according to inspection reports.
‘Rigorously managing the environment’
Cronobacter is exceptionally hardy, experts say. It is also “fairly common” in places like soil — but that’s exactly why “rigorously managing the environment” in formula factories and “taking proactive steps to prevent pathogens from creeping into our foods” are particularly important, food safety expert Scott Faber told ABC News.
Akin to a restaurant health inspector, the FDA performs no-notice inspections of U.S. manufacturing facilities to ensure companies are complying with manufacturing and cleanliness standards; they also perform inspections when alerted by a company that product contamination has been found — or when consumer complaints prompt a for-cause probe into whether the company is upholding an acceptable standard.
ABC News has reviewed FDA inspection documents for the three other domestic companies which, along with Abbott, have been responsible for roughly 90% of the country’s formula market.
The right set of circumstances can compound a perfect storm of risk factors for potentially dangerous pathogens to survive, experts say — and that’s especially worrisome when a contaminant like Cronobacter lurks where food is made for babies, who are among those most vulnerable to that germ.
“Especially for sensitive populations, that quality control is so important. You don’t want contamination to rise to a level where it becomes a problem,” Dr. Amy Edwards, a pediatrician and associate medical director for infection control at UH Rainbow Babies & Children’s Hospital in Ohio, told ABC News. “That’s why inspections are meant to be incredibly invasive — we have to get close enough to zero contamination levels to be safe.”
Mead Johnson
In August 2021, FDA investigators made a routine visit to Mead Johnson’s plant in Evansville, Indiana, where it has operated for more than a century. An inspection report notifying the company’s management of objectionable conditions, called a Form 483, was issued, after investigators found the plant’s data wasn’t recorded frequently enough to ensure proper sterility of their product.
FDA investigators said that company records indicated Cronobacter was found in one of the plant’s rooms, and that the area was subsequently sanitized. A plant operator was observed not washing his hands between glove changes, and not changing his gloves between touching non-food and food contact surfaces.
The employee was subsequently retrained, Mead Johnson told the FDA, according to inspection documents. But it was not the first time investigators had flagged concerns at one of Mead Johnson’s plants.
In late 2017, seven investigators visited Mead Johnson’s plant in Zeeland, Michigan, after the company had alerted the FDA that two finished batches of Enfamil formula — batches that had already been exported from the country — tested positive for Cronobacter. An FDA inspection revealed that Cronobacter had been found “in critical and high hygiene areas of the processing environment on 26 occasions” between mid-January and late August of 2017, documents obtained by ABC News show.
FDA investigators also said they found Cronobacter specifically in areas that risked leading to “potential contamination” of “food contact surfaces.”
The potential problems the FDA discovered at the plant were addressed in time for later inspections — but food safety experts told ABC News these issues can become a serious problem if not immediately dealt with.
“Cronobacter is an environmental pathogen — it’s everywhere,” food safety attorney Bill Marler said. “But it’s really, really bad to have it in infant formula.”
Mead Johnson’s plant had “multiple wall leaks,” nonconformity reports reviewed by the FDA said, as well as “equipment condensation” in areas where positive Cronobacter samples were later found.
“Leaks are the bane of infection control,” Edwards said. “Water is life; if you’re not controlling your water, then you are not controlling your bacteria.”
The Zeeland facility submitted a corrective action plan, promising “increased frequency of cleaning the areas where positive results were identified, evaluation and inspection of equipment” and “repairs to equipment and the facility as needed.”
FDA investigators followed up with the Zeeland plant in spring 2018. The facility had retooled its sanitization procedures, implemented dryer inspections, and made repairs to flooring, water infiltration, and caulking.
Returning in March 2019, investigators noted the plant’s environmental monitoring program had identified and mitigated several instances of Cronobacter in various areas of the plant.
In a statement to ABC News, Reckitt, of which Mead Johnson is a division, maintained that the company manufactures their formula “using the highest standards for quality and safety,” adding that whenever the FDA finds an issue they “immediately develop and implement an action plan to address the issue.”
Reckitt said they “regularly review and enhance” their facilities’ manufacturing processes “and invest in new technologies and equipment,” adding that their “robust operating protocols meet or exceed the highest regulatory standards,” which they employed while “safely” increasing infant formula amid the shortage.
An FDA spokesperson, when asked for comment regarding their investigators’ findings of Cronobacter at multiple formula companies’ facilities, said the agency “takes its responsibility seriously” to ensure the rigorous safety of American foods, and that the agency is reexamining whether more can be done.
Based on a “close look at recent and historical findings” from inspections, the FDA spokesperson said, “We will be looking at what additional strategies could be employed to better prevent microbial contamination during the production of powdered infant formula,” adding the agency is “conducting an evaluation” of their response to the formula crisis “to determine what additional steps should be taken to ensure the maximum effectiveness of agency programs and policies related to infant formula and medical food.”
Nevertheless, said the spokesperson, “It is important to note that it’s a firm’s responsibility to ensure the consistent quality and safety of the products they produce.”
“We are most interested in how aggressively a firm addresses and responds to potential contamination,” the FDA spokesperson said.
Steven Lynn, the former director of the FDA’s pharmaceutical Office of Manufacturing and Product Quality, told ABC News that manufacturers’ oversight “must be robust to assure no adulterated product reaches the vulnerable infant population they serve.”
“It sounds easy, but it’s not,” said Lynn, an expert on good manufacturing practices. “Problems can and do occur. That’s a fact of life.”
Lynn, who reviewed the inspection documents obtained by ABC News, noted that there appear to be “problematic similarities” among some of the formula manufacturers’ lapses in quality control, including “issues with inadequate process controls, including cleaning, sampling and ultimately controlling the production environment to assure there is no microbial contamination,” he said.
Lynn said that FDA investigators did what they were supposed to do: identify deficiencies for the companies to fix.
“The key is making sure the issues are thoroughly investigated, and then implementing robust solutions to correct and prevent them from reoccurring in the future,” in order to ensure that “safe formula is on the market,” Lynn said.
Gerber
In August 2021, FDA investigators made a routine visit to Nestlé Nutrition’s Gateway facility in Eau Claire, Wisconsin, which makes Gerber products. They found “dirty scoops used during the previous production day” lying on a stainless steel table in one of the raw material rooms, and “debris” on the floor.
It was determined that some cleaning activities were resulting in water getting “trapped in cracks in the floor” and “onto equipment located on lower decks.”
In addition, Cronobacter was detected in an in-process powder sample of infant formula.
The finished lot of that product was immediately destroyed.
FDA investigators discussed their findings and suggested remedies with management, but did not issue a Form 483 at that time, according to inspection documents reviewed by ABC News.
A Gerber spokesperson told ABC News that their infant formulas go through up to 500 quality and safety checks, “many of which are above and beyond regulatory requirements.”
“If we find Cronobactor or any other contaminant in the product, that is when we take the most extreme reaction,” Scott Fitz, Vice President of Technical & Production for Gerber told ABC News.
“All the product in that batch is blocked, and all the batches around that product are blocked,” he said, adding that the company thoroughly investigates the contaminant’s origins and destroys any impacted product.
“Given the sensitive consumer we’re dealing with, we can’t take the chance of it getting to shelf,” Fitz said. “This isn’t about regulation, it’s about doing what’s right.”
PBM Nutritionals
After a routine visit in August 2019, the FDA issued a Form 483 identifying a cold storage temperature regulation deficiency at the Milton, Vermont, plant of PBM Nutritionals, a subsidiary of Perrigo, which makes store-brand formulas for retailers like Walmart and Amazon.
Investigators found that some of the facility’s data was not specific enough “to ensure there is no significant growth of microorganisms of public health significance” in their storage tanks. Documents provided by the company to the FDA noted a recent roof leak had overwhelmed the drainage system, and that, upon inspection, environmental sample swabs tested positive for Cronobacter before additional cleaning.
In a statement to ABC News, Perrigo said they are “proud” of their compliance track record, adding that the Cronobacter within the plant had been found by their own self-monitoring, rather than by FDA investigators.
“Our facilities in Vermont and Ohio are in good regulatory standing and remain compliant with all FDA processes and procedures,” they said.
Perrigo said they had hired independent experts “a few years ago” to “enhance” their manufacturing processes and protective measures. The company said the experts found their “aging equipment could lead to concerns in the future,” so they invested approximately $110 million in improving formula plant quality, and hired an additional 100 quality and sanitation personnel.
Perrigo said that they had addressed the FDA’s observation regarding cold storage.
“Our quality control process is a continuous improvement process, and any concerns found are promptly addressed,” the company said.
“Everybody knows what the persistent problems are that cause bacterial contamination in product,” said Marler, the food safety attorney. “It’s cracks, water, old equipment. It’s when companies stop realizing they’re producing food that is going into the bodies of babies and they start thinking about it as a widget, as a commodity.”
Patrick Stone, a former FDA investigator, says factories that make infant formula should be held to a higher quality-control standard than other mass market food products. But too often, he said, “it actually takes an outbreak or something to happen before people wake up and say …. ‘Why is this happening?'”
Abbott Nutrition
After inspecting Abbott’s Sturgis facility earlier this year, FDA chief Dr. Robert Califf described the “shocking” and “egregiously unsanitary conditions” investigators had found.
“Standing water; cracks in the key equipment that present the potential for bacterial contamination to persist, particularly in the presence of moisture; leaks on the roof; a previous citation for inadequate hand washing,” Califf testified before Congress in May. “Many signs of a disappointing lack of attention to the culture of safety, in this product that is so essential to the lives of our most precious people.”
Investigators discovered five strains of Cronobacter from environmental sampling of Abbott’s plant, and Abbott ultimately agreed to shutter the facility and recall the formula.
Food safety experts ABC spoke with emphasized the importance of establishing — and adhering to — a proactive protocol for rooting out risk factors, before they snowball.
“You don’t wait for the accident to happen before you build a stoplight,” said Faber, the food safety expert. “You probe your factory for where pathogens could be lurking, and then adopt critical controls to eradicate them.
“If we’re seeing any of the conditions found at Sturgis in other plants, we need to ask whether that philosophy has been sufficiently embraced,” he said.
“Abbott has a zero-tolerance policy for Cronobacter in our plants, which is why we took the steps we did at Sturgis,” an Abbott spokesperson said. “Our highest priority is getting babies safe, quality formula they need.”
Further complicating the matter is that Cronobacter infection is listed as a reportable illness by only one U.S. state: Minnesota, where the first of the four infants was reported infected after consuming Abbott’s formula last September.
Because there are no national requirements that Cronobacter be reported, doctors and labs are not required to report cases to their local health department — which leaves the FDA to rely on consumer complaints and health care providers for on-the-ground data regarding infections.
“Until you increase that oversight, you’re going to limp from mini-outbreak to mini-outbreak,” Marler said.
A ‘stringent enough’ system?
In August 2017, a few months before the FDA found Cronobacter inside Mead Johnson’s Zeeland plant, a two-week old infant from Illinois was declared brain dead after being diagnosed with a Cronobacter infection. The infant had consumed “multiple lots of Enfamil Newborn Premium ready-to-feed liquid milk product at the hospital, and some product was sent home with the parents,” FDA inspection reports say.
But FDA sampling of the available formula was negative for Cronobacter.
Reckitt told ABC News they “cooperate fully with the FDA to investigate consumer complaints,” underscoring that their formula had never conclusively been proven as the cause of an illness.
In the case of Abbott, too, no conclusive causation has been proven between the Cronobacter found at the Sturgis plant and infants’ illness or death. Nevertheless, FDA chief Califf noted in congressional testimony that “we cannot rule it out either, as the confluence of events is highly unusual. There is no dispute that the facility was unacceptably unsanitary.”
“There is some room for human error, but not for persistent human error,” said Edwards. the pediatrician. “You have to have your process in place. And you have to have a process for monitoring your process to make sure it’s always being followed.”
When several controls fail at once, it risks prompting an unfortunate domino effect and “raises important questions about whether our current regulatory system is stringent enough,” Faber said.
The FDA spokesperson told ABC News that the agency is assessing whether their annual surveillance inspections of formula facilities should include more environmental sampling going forward, albeit in a way that “minimizes any disruptions to the supply chain.”
In June, ABC News was first to report that the Health and Human Services’ Office of Inspector General had launched an audit into how the FDA responded leading up to the recall and closure of Abbott’s Sturgis plant.
The CDC says Cronobacter infections are rare, but serious in infants — noting that powdered formula can be contaminated at a processing facility, or at home. Because Cronobacter can survive so well — on kitchen counters, on sinks, or in a manufacturing plant — the CDC recommends that families using formula wash hands frequently around infants, thoroughly clean bottles, and safely store any powdered formula, or, if possible, use liquid formula.
“There are babies out there whose lives depend on formula. So what happens when the thing that you’re giving your baby is actually the thing that makes them sick?” Edwards said. “That is incredibly scary. For parents, for all of us.”
ABC News’ Eric M. Strauss contributed to this report.
(DECATUR, Ga.) — The family of a Georgia woman who died after she was taken into custody and fell out of a moving police patrol car earlier this month is demanding answers in her death.
Brianna Grier, 28, was taken into custody on July 15 after two Hancock County Sheriff’s Office responded to her home in Sparta, Georgia, authorities said.
Her mother had called 911 because her daughter was having a mental health crisis, according to civil rights attorney Ben Crump, who is representing the family.
While being transported to the sheriff’s office, Grier fell out of a patrol car and sustained “significant injuries,” the Georgia Bureau of Investigation (GBI), which is investigating the death, said in a statement.
Grier suffered brain trauma and was in a coma before she died on July 21, according to Crump.
“Yet again, we have another African American citizen killed in just an unbelievable way while in the custody of the police,” Crump said during a press briefing Friday.
The briefing comes two days after GBI released new details in the incident.
According to GBI, Grier was placed in the backseat of the patrol car while handcuffed with no seatbelt on. The rear passenger side door was never closed before they drove away, GBI said.
Before the deputies placed her in the car, Gier was on the ground “refusing to get in the patrol car” and “made a statement that she was going to harm herself,” GBI said.
Both the rear driver’s side door and rear passenger side door were open while the deputies put Grier in the backseat, but they only closed the rear driver’s side door before leaving the scene and driving a short distance, GBI said.
“The investigation shows that the deputy thought he closed the rear passenger side door,” GBI said. “Body camera footage reveals the deputies had no other contact with Grier from the time she was placed in the car until she fell out of the moving car.”
The family is calling for more transparency as they try to make sense of what happened, including the release of the body-camera footage.
“We’re trying to get answers of what really happened, that’s all we want to know,” Grier’s father, Marvin Grier, said during Friday’s press event. “We want to know what happened.”
“That was my child,” he continued. “That was my child.”
The incident is still under investigation by GBI.
Hancock County Sheriff Terrell Primus told protesters gathered outside the sheriff’s office on Wednesday that he plans to release body-camera footage of the incident once GBI’s investigation is completed, the Union-Recorder reported.
“A lot of people have already drawn their own conclusions,” he said, according to the publication. “Some people already feel as though we have things to hide. But we do not have anything to hide. The video footage will show evidence based on what has been stated already.”
Crump said his team plans to perform an independent autopsy once her body is released from GBI, and that they will investigate what led to Grier, a mother of 3-year-old twin daughters, falling out of the car while it was moving.
“That’s what we are primarily for — is to get answers and demand justice,” Crump said. “What this is really about is those 3-year-old little babies [who are] going to have to grow up without their mother.”
Gerald Griggs, president of the Georgia State Conference of the NAACP, joined the family on Friday and called for accountability.
“To the Hancock County sheriff, it’s time to be transparent. It’s time to be accountable,” he said. “To the GBI, it’s time for y’all to meet with this family. To the governor, it’s time for you to recognize, again, that Georgia has a police accountability problem.”
“Georgians of all color deserve to feel protected in the custody and control of law enforcement,” he said.
(GATLINBURG, Tenn.) — There is an ongoing investigation after a woman was found dead in an apparent suicide at a theme park in the Smoky Mountains, police said.
The woman, Jessica Rhea Ford, 40, was found on Thursday night beneath the Scenic Chondola at Anakeesta, according to a statement from the Gatlinburg police.
The City of Gatlinburg said that they are continuing the investigation as an apparent suicide, in part due to witness statements holding that the victim jumped from the chairlift.
The Gatlinburg Fire & Rescue Department responded to the scene at 7:41 p.m. for an incident on the park’s chairlift. The woman’s body was found shortly thereafter.
Sevier County Medical Examiners’ Office responded to the scene and pronounced the victim dead.
The office told ABC News that the body of the deceased was taken in for an autopsy Thursday night, and is still being examined.
The office said that they cannot offer any further information on the cause of death until the investigation of the incident is complete.
The incident remains under investigation, the city of Gatlinburg said.
The Gatlinburg Police Department has not yet responded to ABC News’ request for further details.
“A tragic incident occurred this evening. 911 was called immediately. Our hearts are with the family of the deceased,” Anakeesta said in a statement.
The area the victim was found was underneath the chairlift that brings guests to and from attractions on the mountain, according to police.
WVLT News spoke to two witnesses on scene.
Jeffrey McConnell told WVLT News he was visiting the Gatlinburg attraction with his fiancée and three children.
According to McConnell, the woman, who he described as being in her late-20′s, fell from the chairlift once it was about three-quarters of the way up the mountain.
McConnell told WVLT News that other visitors tried to alert the woman that her safety railing was up before the fall happened, but she did not respond.
Jay Deuro, another witness who spoke with WVLT News, said the Anakeesta staff kept the rides going despite the fall.
On his way back down, McConnell told WVLT News that staff told visitors to “not look down” as they got onto the chairlift.
A spokesperson from Anakeesta told ABC News that staff only operated the chairlift long enough for riders to exit before shutting it down. The spokesperson added that staff used its transportation fleet to allow the guests to exit the mountain top.
“We mourn this tragic loss of life. Our deepest sympathies are with the family,” the spokesperson said.
(NEW YORK) — Nothing gets New Yorkers steamed like traffic woes and close encounters with the native wildlife — a.k.a. rats. Now the city is considering changes to trash pickup rules that could affect both.
The department says it’s “strongly considering” requiring individual black trash bags to be placed outside after 8 p.m. The city will pick the bags up during overnight hours to minimize time on the street.
“New Yorkers put millions of pounds of trash and recycling on the street starting at 4pm – right as the evening rush is getting underway – and then it stays out, serving as a nightclub for rats and other pests, until it’s collected. Well soon, we’re going to try to shut the club down,” the department said in a statement.
Carve-outs under consideration would apply to most commercial and residential buildings.
Residential building owners would be permitted to put their trash out at 6 p.m., to conform to daytime maintenance staffing, as long as they place the trash in a bin with a secure lid.
Businesses would be permitted to put their trash out in the hour before closing for the day, to minimize staffing disruption, as long as the trash is also in bins with secure lids. For many businesses, that would be in the 4 p.m. or 5 p.m. hour
For their part, the sanitation department will shift to picking up more trash in the midnight to 8 a.m. shift, prioritizing the single bags. That will also help get the sanitation vehicles off the roads earlier, easing street traffic during the morning commute.
The aim is for residents, particularly those using individual black bags, to try to put their trash out later at night and for sanitation to try to pick it up earlier in the morning, which will help ease the rats and the traffic concurrently.
The Rent Stabilization Association, which represents 25,000 owners of more than 1 million apartments in the five boroughs, told ABC News the policy will likely not eliminate the rat issue entirely.
“This is not going to alleviate the city’s rat problem,” a spokesperson for the association said. “Rats aren’t on a feeding schedule.”
(NEW YORK) — “A lot of people” remain unaccounted for amid devastating flooding in Kentucky, Gov. Andy Beshear said Friday.
“We’re going to do our best to find them all,” Beshear said, without providing a number of the missing.
Beshear toured the devastation by helicopter on Friday and called it the worst flooding he’s seen since being in office.
The official death toll stands at 16, including two children.
Beshear said Friday afternoon that he’s learned of the recovery of four children’s bodies, adding, “We do not have an official update at this time as they have to be verified” by the Department for Public Health.
The governor anticipated that authorities may be updating the number of deceased for “several weeks.”
On Thursday, Beshear called it “one of the worst, most devastating” floods in the state’s history and said he anticipates this will be one of the deadliest floods in Kentucky in “a very long time.”
The flooding hit Kentucky late Wednesday, pounding the state with 2 to 5 inches of rain.
Kentucky is combating washed out roads, destroyed homes and flooded schools, according to the governor.
Thousands of residents are expected to lose their homes, he said.
More than 294 people have been rescued from floodwaters in eastern Kentucky so far and that number will likely rise, Beshear said.
The rain may return to Kentucky late Sunday through early next week, but significant rainfall isn’t expected.
“While rain totals are not expected to be as high, flooding still remains a concern due to saturated grounds,” the governor tweeted.
President Joe Biden approved a disaster declaration and is receiving updates “very regularly,” White House press secretary Karine Jean-Pierre said Friday.
“Our hearts break for the families of those who have lost their lives or are missing, and to all those who have been impacted,” she said.
ABC News’ Alexandra Faul, Kenton Gewecke, Josh Hoyos, Justin Ryan Gomez and Morgan Winsor contributed to this report.
