Hire me: Looks like youse could use some editors

US: FDA takes steps to build a stronger workforce

Scott Gottlieb

https://blogs.fda.gov/fdavoice/index.php/2017/11/fda-takes-steps-to-build-a-stronger-workforce/

I’m a Canadian, U.S. and Australian citizen (and maybe UK too), my scientific c.v. doesn’t suck, so I’ll work anywhere (and I’m cute with puppies, 15 years ago).

FDA faces challenges related to building and maintaining a diverse, talented, and dedicated professional workforce. The agency’s responsibilities increasingly demand a staff with specialized skills; and our own process sometimes doesn’t fully support our ability to recruit and retain the people we need. Congress has given FDA new resources and authorities to build and maintain our talented workforce. But the agency still needs to do more to expand on these opportunities and solidify our workforce.

A few months ago, I announced that FDA is taking action to build a stronger workforce by making key process improvements related to hiring and retention. Our people are the agency’s most important asset. We need to invest in our approach to how we hire and retain our staff.

To achieve this goal, we’ve established an FDA Hiring Initiative to reimagine the agency’s hiring practices and procedures with the goal of attracting, recruiting, hiring and retaining professionals who will support FDA’s mission. As part of that initiative, I requested a comprehensive evaluation of our hiring practices and procedures.

Today, FDA is releasing the Initial Assessment of FDA Hiring and Retentionreport. This comprehensive survey identifies the root causes of our current challenges and provides a roadmap for our future.

Building and retaining talented staff is critical to FDA’s ability to meet our public health mission. We’re launching a comprehensive effort to streamline our hiring practices with a focus on recruiting and retaining a world-class workforce. As a first step, FDA will hold a public meeting later this month to share the results of the report, our thinking for overhauling the hiring process, and to solicit public comment.

We’ll also be getting feedback from FDA staff since our people have the best perspective on the challenges they see recruiting the best and brightest people, and keeping them at FDA.

We also intend to conduct a hiring pilot early next year that will leverage the key findings from the initial assessment and that will modernize and streamline hiring practices by using new IT tools and eliminating unnecessary processes. The pilot will focus on the end to end hiring process beginning with the day the need for new staff is identified to the day a candidate is hired. It will directly align our administrative hiring procedures with the scientific objectives of our programsThe new, more efficient approach in the pilot will focus on hiring several critical occupations in the medical product areas to support commitments of the Prescription Drug User Fee Act (PDUFA) VI and the Biosimilar User Fee Act (BsUFA) II.

As part of the initiative, we’ve established a Scientific Staffing team that will focus on recruiting scientists and conducting proactive outreach to professional associations and academia. Our scientific recruitment team will develop digital and social media tools, which will provide FDA with modern recruitment and outreach techniques. These efforts, combined with the successes of the hiring pilot, will yield a future state of efficient, consistent, processes that helps us get the right people in the right roles to achieve results.

The soul of FDA and our public health mission is our people. Retaining the people who help us achieve our successes is as important as recruiting new colleagues to help us meet our future challenges. 

 

Eating too much black licorice is harmful, FDA warns

I’ve never liked licorice, especially the black stuff.

Reminds me of a grandparent’s decaying hard candy dish.

The U.S. Food and Drug Administration is, according to Ashley May of USA Today, warning consumers not eat large amounts of black licorice.

The candy, made from a shrub usually found in Greece, Turkey and Asia, contains a compound (glycyrrhizin) that can lower a person’s potassium levels, FDA experts say. So, eating too much could cause heart problems, high blood pressure, swelling and sluggishness, an FDA advisory reports.  

Last year, the FDA heard of at least one case of black licorice causing health problems, according to the advisory. 

Especially for those 40-years-old and older, eating two ounces of black licorice a day for at least two weeks could throw off heart rhythms. 

30 sick: Salmonella linked to tuna

Marissa Harshman of the Spokesman-Review writes Clark County Public Health officials in Washington state were among the first to identify a nationwide salmonella outbreak linked to tuna loins and tuna steaks.

Locally, the case began with five reports of illness to Clark County Public Health in late August. Since then, the outbreak has grown to 30 cases in seven states and led to a recall of a California-based company’s tuna products.

The outbreak includes six confirmed and two presumed cases in Clark County, said Dr. Alan Melnick, Clark County health officer.

The investigation is continuing at the national level by the Food and Drug Administration and the Centers for Disease Control and Prevention.

“The fact that little, old Clark County was able to be one of the first people to pick up on this ongoing outbreak really highlights the strengths of this system we’ve developed,” said Madison Riethman, an applied epidemiology fellow at Clark County Public Health, during a county health board meeting Wednesday.

And what did little old Clark County do to publicize the outbreak, go public to try and prevent others getting sick.

The first rule of public health is, as encapsulated by Riethman, make public health look good.

Local health officials first learned of a possible outbreak on Aug. 29, when local laboratories reported five cases of salmonella, a bacteria that causes illness with symptoms such as diarrhea, fever and abdominal cramps. Typically, the department gets three to eight reports each month, Riethman said.

“The fact that we got five in one day was a big red flag,” she said.

Fancy food ain’t safe food: New York edition

One of New York’s most expensive restaurants is in some trouble with the Food and Drug Administration over its fresh fish.

John Tozzi of Bloomberg writes that Masa, which earned three Michelin stars for its $595 tasting menu (before drinks and tax), received a warning letter from the FDA dated Oct. 16 alleging violations of federal rules that govern seafood imports. “Your fresh trevally and fresh Katsuwonus pelamis (Katsuo), also known as skipjack tuna or bonito,” the agency wrote in a letter published online this week, “have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

“We take FDA regulations very seriously and, of course, food safety is always a priority. We are working closely with our purveyors in Japan to get this resolved quickly,” said Tina Clabbers, a representative for Masa, in an email.

While the the FDA doesn’t typically regulate individual restaurants, the agency has jurisdiction over seafood importers. Inspectors visited Masa on June 22, according to the letter, which redacted the name of the restaurant’s fish supplier.

The letter doesn’t specify the precise nature of the violation, and a spokesperson in the FDA’s New York district office was not available for comment.

FDA: Juice safety

My wife has gotten me on a freshly squeezed juice regimen every morning because admittedly I don’t eat enough fruits and vegetables. We’ll juice anything from kale, spinach, lemons to apples. The juicer cost me a fortune but I feel great, I love my wife.

The FDA is promoting juice safety due to the potential microbial risks associated with juicing.

The Baltimore Times reports:

As fall arrives, so do drives in the country and drinking fresh-squeezed juices and cider.
Unfortunately, serious outbreaks of foodborne illness, often called “food poisoning,” have been traced to drinking fruit and vegetable juice and cider that have not been pasteurized or otherwise treated to kill harmful bacteria.
The U.S. Food and Drug Administration (FDA) reminds consumers this fall to read the label carefully on juice and cider products.
Juices provide many important nutrients, but consuming untreated juices can pose health risks to your family. When fruits and vegetables are fresh-squeezed or used raw, bacteria from the produce can end up in your juice or cider. Unless the produce or the juice has been treated to destroy any harmful bacteria, the juice could be contaminated. While most people’s immune systems can usually fight off the effects of foodborne illness, children, older adults, pregnant women, and people with weakened immune systems (such as transplant patients and individuals with HIV/AIDS, cancer, and diabetes) risk serious illnesses or even death from drinking untreated juices.
Most of the juice sold in the United States is pasteurized (heat-treated) to kill harmful bacteria. Juice products may also be treated by non-heat processes for the same purpose. However, some grocery stores, health food stores, cider mills, farmers’ markets, and juice bars sell packaged juice that was made on site that has not been pasteurized or otherwise processed to ensure its safety. These untreated products should be kept under refrigeration and are required to carry the following warning on the label:
WARNING: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.
However, the FDA does not require warning labels on juice or cider that is fresh-squeezed and sold by the glass, such as at apple orchards, farmers’ markets, roadside stands, and juice bars.
Follow these simple steps to prevent illness when purchasing juice:
•Look for the warning label to avoid the purchase of untreated juices. You can find pasteurized or otherwise treated products in your grocers’ refrigerated sections, frozen food cases, or in non-refrigerated containers, such as juice boxes, bottles, or cans. Untreated juice is most likely to be sold in the refrigerated section of a grocery store.
•Don’t hesitate to ask if you are unsure if a juice product is treated, if the labeling is unclear, or if the juice or cider is sold by the glass.
Consuming dangerous foodborne bacteria will usually cause illness within one to three days of eating the contaminated food. However, sickness can also occur within 20 minutes or up to six weeks later. Symptoms of foodborne illness include: vomiting, diarrhea, abdominal pain, and flu-like symptoms (such as fever, headache, and body ache). If you think that you or a family member has a foodborne illness, contact your healthcare provider immediately.

Sprouts still suck: FDA sampling shows sprouts a problem

There’s a reason Walmart and Costco and Kroger stopped selling raw sprouts: they suck, meaning that, like raw milk, they cause a disproportionate percentage of illness based on low consumption rates.

The U.S. Food and Drug Administration wrote in a recent report sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the U.S. linked to sprouts. The U.S. outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths (and, tragically, many more in Canada, Australia, Japan and Europe).

A table of sprout-related outbreaks is available at http://barfblog.com/wp-content/uploads/2016/02/Sprout-associated-outbreaks-2-23-16.xlsx.

From the executive summary:

The U.S. Food and Drug Administration (FDA) set out to collect and test sprouts in 2014 as part of a new proactive and preventive approach to deploying its sampling resources with the ultimate goal of keeping contaminated food from reaching consumers.

The new approach, detailed in the Background section of this report (page 4), centers on the testing of a statistically determined number of samples of targeted foods over a relatively short period of time, 12 to18 months, to ensure a statistically valid amount of data is available for decision making. This approach helps the agency determine if there are common factors – such as origin, season, or variety – associated with pathogen findings.

The FDA issued the sprouts assignment in January 2014 under its new sampling model. The assignment targeted sprouts at three points in the production process (seeds, finished product and spent irrigation water), with the aim of collecting and testing 1,600 samples to determine the prevalence of select pathogens in the commodity. As background, the FDA designed its sampling plan such that if contamination of one percent or greater was present in the commodity, the agency would detect it. The FDA monitored the assignment closely to gather lessons learned and make changes to its sampling procedures if needed to address trends or food safety issues. About one year into the assignment, the FDA decided to stop its collection and testing at 825 samples because it had already collected samples on more than one occasion from many of the sprouting operations known to the agency and its state partners. The sample set acquired was sufficient for the FDA to estimate the bacterial prevalences in the commodity with a 95 percent confidence interval of 0% to 2% for a one percent contamination rate.

The FDA tested only domestically grown sprouts for this assignment because virtually all sprouts eaten in the United States are grown domestically due to the commodity’s delicate nature and relatively short shelf-life. Of note, the industry features a preponderance of relatively small operations.

The FDA tested the sprout samples for three pathogens: Salmonella, Listeria monocytogenes and Escherichia coli (E. coli) O157:H7. Based on the test results, the FDA found the prevalence of Salmonella in the finished product sprouts to be 0.21 percent. The agency also found that the prevalence of Salmonella in seeds (2.35%) was significantly higher than in finished product (0.21%) and in spent irrigation water (0.54%). Based on the test results, the FDA found the prevalence of Listeria monocytogenes in the finished product to be 1.28 percent. There was no significant difference in the prevalence of Listeria monocytogenes based on point in the production process. None of the samples tested positive for E. coli O157:H7. The agency did not test seed for E. coli O157:H7 due to limitations associated with the test method.

Among the FDA’s other findings, the agency found most of the positive samples at a small number of sprouting operations. Specifically, the FDA found violative samples at eight (8.5%) of the 94 sprouting operations visited for purposes of this assignment. The fact that the agency found multiple positive samples at some of these operations underscores the need for sprouting operations to comply with the agency’s Produce Safety Regulation (published November 2015), which seeks to prevent outbreaks of foodborne illness and improve sprout safety.

To address the positive samples, the FDA worked with the firms that owned or released the affected product to conduct voluntary recalls or to have their consignees destroy it, and then followed up with inspections. Of particular note, this sampling assignment helped detect and stop an outbreak of listeriosis while it still entailed a small number of cases, as described in the Public Health Impact section of this report (page 14). This assignment also prompted six product recalls.

The FDA will continue to consider microbial contamination of sprouts and how best to reduce it. Such contamination remains a concern to the FDA given the aforementioned outbreak and the recalls initiated. Going forward, the FDA intends to inspect sprouting operations to ensure they are complying, as applicable, with the Produce Safety Rule, which includes new requirements for sprouts growers. The agency has no plans to conduct additional large-scale sampling of sprouts at this time but may sample the commodity in accordance with its longstanding approach to food sampling, which centers on (but is not limited to) the following criteria:

  • A firm has a previous history of unmitigated microbial contamination in the environment (e.g., human illness, recalled or seized product, previous inspectional history, or environmental pathogens without proper corrective actions by the facility), or
  • Inspectional observations that warrant collection of samples for microbiological analyses.

The complete report is available at https://www.fda.gov/downloads/Food/ComplianceEnforcement/Sampling/UCM566981.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Impossible Burger, regulatory gaps, and money. Always money

I want hamburgers temperature-verified to 160F.

Blood is a terrible indicator.

Stephanie Strom of the NY Times writes that one of the chief selling points of the Impossible Burger, a much ballyhooed plant-based burger patty, is its resemblance to meat, right down to the taste and beeflike “blood.”

Those qualities, from an ingredient produced by a genetically engineered yeast, have made the burger a darling among high-end restaurants like Momofuku Nishi in New York and Jardinière in San Francisco, and have attracted more than $250 million in investment for the company behind it, Impossible Foods.

Bill Gates is an investor.

That makes me want to run to my Mac.

The genetically engineered yeast thingy is just thrown in there to raise alarm.

My 1985 daily squash partner, Andy, was working on genetically engineered yeast for wine back in the day. Our bottling parties were legend.

Now, its secret sauce — soy leghemoglobin, a substance found in nature in the roots of soybean plants that the company makes in its laboratory — has raised regulatory questions.

Impossible Foods wants the Food and Drug Administration to confirm that the ingredient is safe to eat. But the agency has expressed concern that it has never been consumed by humans and may be an allergen, according to documents obtained under a Freedom of Information request by the ETC Group as well as other environmental and consumer organizations and shared with The New York Times.

“F.D.A. believes the arguments presented, individually and collectively, do not establish the safety of soy leghemoglobin for consumption,” agency officials wrote in a memo they prepared for a phone conversation with the company on Aug. 3, 2015, “nor do they point to a general recognition of safety.”

Impossible Foods can still sell its burger despite the F.D.A. findings, which did not conclude soy leghemoglobin was unsafe. The company plans to resubmit its petition to the agency.

Impossible Foods is finding out what happens when a fast-moving venture capital business runs headlong into the staid world of government regulation.

In the case of Impossible Foods, the debate centers on its use of soy leghemoglobin, which the company’s engineered yeast produces and forms an important ingredient behind the business.

The company was started in 2011 by Pat Brown, a chemist at Stanford University. His approach, involving genetics, microbiology and cutting-edge chemistry attracted venture capitalists also eager to find plant-and lab-based replacements for hamburgers and chicken wings.

Impossible Foods sought to woo top chefs with a splashy sales pitch about how the burger mimicked the aroma, attributes and taste of real beef. When soy leghemoglobin breaks down, it releases a protein known as heme, giving it that meatlike texture.

Within three years of its founding, Impossible Foods landed big-name investors like Khosla, Mr. Gates and the Hong Kong billionaire Li Ka-Shing. This month, Temasek Holdings, Singapore’s sovereign wealth fund, joined an investment round that added $75 million to the company’s coffers.

“I love V.C.s and particularly the ones that invested in us,” Mr. Brown said at a TechCrunch conference in May, referring to venture capital firms. “But it’s truly astonishing how little diligence they do in terms of the actual science that underlies some tech companies.”

The F.D.A.’s approval is not required for new ingredients. Companies can hire consultants to run tests, and they have no obligation to inform the agency of their findings, a process known as self-affirmation.

Impossible Foods adhered to that procedure, concluding in 2014 that soy leghemoglobin was safe. But it went further, seeking the regulator’s imprimatur.

“We respect the role the F.D.A. plays in ensuring the safety of our food supply, and we believe the public wants and deserves transparency and access to any information they need to decide for themselves whether any food they might eat is safe and wholesome,” Rachel Konrad, a spokeswoman for Impossible Foods, wrote in an email.

The F.D.A., however, wanted the company to show the ingredient was safe specifically for humans. It told Impossible Foods to establish the safety of the more than 40 other proteins that make up part of its soy leghemoglobin. F.D.A. officials said the company’s assessment of the potential for the ingredient to be an allergen was deficient.

“This product has been touted as the ‘secret sauce’ in the Impossible Burger,” said Jim Thomas, program director at the ETC Group, the Canadian environmental organization that started the Freedom of Information request. “Now we know that the F.D.A. had questions about it, but it was put on the market anyway.”

Ms. Konrad defended the burger, writing it “is entirely safe to eat” and “fully compliant with all F.D.A. regulations.” She said the company was “taking extra steps to provide additional data to the F.D.A. beyond what’s required.”

Impossible Foods, she said, has tested its ingredient on rats fed “well above” the amount of soy leghemoglobin in its burger. Ms. Konrad said the company’s expert panel had determined those tests also demonstrated the ingredient was safe, and that the company would thus resubmit its petition for F.D.A. confirmation this month.

This is a novel food, and makes Canada’s approach to regulation of food safety sane, for a while.

1 dead, 46 sick: Multistate outbreak of Salmonella Kiambu linked to Maradol papayas

Mangos, I love; papayas, not so much.

The U.S. Centers for Disease Control and Prevention (CDC), public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella Kiambu infections.

A total of 47 people infected with the outbreak strain of Salmonella Kiambu have been reported from 12 states.

Twelve ill people have been hospitalized. One death has been reported from New York City.

Illnesses started on dates ranging from May 17, 2017 to June 28, 2017. Ill people range in age from less than 1 year to 95, with a median age of 27. Among ill people, 67% are female. Among 31 people with available information, 18 (58%) are of Hispanic ethnicity. Among 33 people with available information, 12 (36%) report being hospitalized. One death was reported from New York City.

Epidemiologic and laboratory evidence collected to date indicates that Maradol papayas are a likely source of this multistate outbreak.

CDC recommends that consumers not eat, restaurants not serve, and retailers not sell Maradol papayas until we learn more.

If you aren’t sure if the papaya you bought is a Maradol papaya, you can ask the place of purchase. Restaurants and retailers can ask their supplier.

When in doubt, don’t eat, sell, or serve them and throw them out.

Wash and sanitize countertops as well as drawers or shelves in refrigerators where papayas were stored.

This investigation is ongoing. CDC will provide updates when more information is available.

Atypical BSE in Alabama cow

The U.S. Department of Agriculture (USDA) announced an atypical case of Bovine Spongiform Encephalopathy (BSE), a neurologic disease of cattle, in an eleven-year old cow in Alabama.  This animal never entered slaughter channels and at no time presented a risk to the food supply, or to human health in the United States.

USDA Animal and Plant Health Inspection Service’s (APHIS) National Veterinary Services Laboratories (NVSL) have determined that this cow was positive for atypical (L-type) BSE.  The animal was showing clinical signs and was found through routine surveillance at an Alabama livestock market. 

BSE is the form that occurred primarily in the United Kingdom, beginning in the late 1980’s, and it has been linked to variant Creutzfeldt-Jakob disease (vCJD) in people. The primary source of infection for classical BSE is feed contaminated with the infectious prion agent, such as meat-and-bone meal containing protein derived from rendered infected cattle. Regulations from the Food and Drug Administration (FDA) have prohibited the inclusion of mammalian protein in feed for cattle and other ruminants since 1997 and have also prohibited high-risk tissue materials in all animal feed since 2009.

Atypical BSE is different, and it generally occurs in older cattle, usually 8 years of age or greater. It seems to arise rarely and spontaneously in all cattle populations.

This is the nation’s 5th detection of BSE.  Of the four previous U.S. cases, the first was a case of classical BSE that was imported from Canada; the rest have been atypical (H- or L-type) BSE.