Shit of the sea: Imported seafood shipments rejected by US FDA for ‘unsafe levels of filth and bacteria”

A new USDA analysis of the Food and Drug Administration’s import refusals report reveals that the FDA rejected tens of thousands of imported seafood shipments because they were unfit for human consumption.

shrimp.vietnamFrom 2005 to 2013, nearly 18,000 shipments were refused entry into the United States for containing unsafe levels of “filth,” veterinary drug residues and Salmonella, which is responsible for thousand hospitalizations per year and hundreds of deaths. “Filth” is a catchall term used to describe anything that shouldn’t be in food—like rat feces, parasites, illegal antibiotics and glass shards. 

The USDA summarized their findings by saying, “The safety of imported seafood clearly continues to be of significant concern, based on the number of shipments refused by FDA.”

Currently, the majority of all food refusals are seafood products; while the FDA is responsible for ensuring the safety of any food imported from foreign countries, they only have the manpower to inspect less than 1 percent of the 1.2 billion pounds of shrimp entering into the country each year.

The American Shrimp Processors Association (ASPA), a group representing the US Gulf and Southeast Atlantic Coast shrimp fishing industry, has expressed great concern over the findings. Dr. David Veal, the President of ASPA, was quoted as saying, “This issue goes beyond the FDA; I don’t think it’s unreasonable to expect food suppliers to take some responsibility for the health and safety of their products.” While there are a few more FDA inspectors now than a couple years ago, the ratio of shipments to inspectors is still impossibly high. Veal continued, “We hope shrimp exporters will take a more proactive role in assuring that suppliers adhere to laws designed to protect the people who buy their products.”

Truckin: FDA releases final rule to ensure food safety during transport

The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation.

truckinThe rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The action is part of a larger effort to focus on prevention of food safety problems throughout the food chain, and the rule implements the Sanitary Food Transportation Act of 2005 (SFTA) as well as the requirement in section 111 of FSMA that instructed FDA to issue SFTA regulations. The regulation will apply to food transported within the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Shippers, loaders, carriers and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States are also subject to the final rule.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The rule was proposed in February 2014 and takes into consideration more than 200 comments submitted by the transportation industry, food industry, government regulatory partners, international trading partners, consumer advocates, tribal organizations and others. It also builds on the transportation industry’s best practices for cleaning, inspecting, maintaining, loading and unloading and operating vehicles and transportation equipment.

Implementation of the sanitary transportation rule and all FSMA final rules will require partnership, education and training.

Going public (not so much): Dole inspections show recalls, but no contamination in Ohio facility

If Dole can’t answer basic questions about the safety of its packaged leafy greens, why should consumers buy the stuff, let alone feel confident?

160122-dole-salad-mn-1530_8b681a6748a4253c3ec1c087b4cd8b0d.nbcnews-fp-1200-800Dole salad products had been recalled in recent years due to concerns about salmonella and listeria before the recent outbreak that shuttered the Springfield facility in January, federal inspection documents show.

The Springfield News-Sun reviewed U.S. Food and Drug Administration records dating back to 2011 obtained through a Freedom of Information Act request.

Those documents show the Springfield plant recalled products a handful of times after traces of listeria and salmonella were found in pre-packaged salad mixes produced there. However samples collected during subsequent inspections didn’t find evidence of contamination at the plant.

A recent lawsuit filed by a Warren County woman also cited at least eight prior outbreaks or recalls company-wide stretching back to 2006.

Dole voluntarily closed the Springfield site in January. It’s not clear whether the site has reopened, in part because company leaders have declined to comment multiple times, but the parking lots is often full of cars.

Products packaged at the facility in the current outbreak were linked to at least 19 hospitalizations in the U.S. in nine states, including one death in Michigan.

In Canada, the outbreak was linked to 14 illnesses in five provinces. Three people in Canada died, however it hasn’t been determined if listeria contributed to those deaths.

listeria4A food safety expert said it’s not uncommon for a food processing facility to remain shuttered for weeks or even months after a significant outbreak.

“This is pretty normal and falls within the expected range of remediation efforts on the part of the organization,” said Naila Khalil, an associate professor in the Center of Global Health at Wright State University.

The Springfield News-Sun reviewed dozens of pages of FDA inspection reports obtained through a public records request.

Those documents show FDA inspectors visited a handful of times since 2011 after samples collected by various agencies contained pathogens like listeria, E. coli and salmonella.

The records also show subsequent samples collected at the Springfield facility didn’t test positive for those pathogens.

The FDA inspected the Springfield site in March 2014 after Canadian public health authorities detected a sample of listeria in a pre-packaged salad blend processed here. Dole voluntarily recalled the product.

In that case, the FDA issued a report to the company for failure to maintain floors and walls in good repair and failure to provide adequate screening or other protection against pests. Additional observations included food residue found on multiple surfaces, water leaks and ice melt dripping onto the floor of the finished product warehouse from a container of iced broccoli.

Specific concerns listed in the report include a cutting board found with deep grooves that couldn’t easily be cleaned, ruts in the floor containing standing water and peeling paint and rust.

Company officials were cooperative and pledged to address those concerns, the report says.

The documents also provide a glimpse into Dole’s sampling and prevention procedures.

The firm collects environmental, water, raw material and finished product sampling, the FDA documents show. The 2014 inspection showed the company’s goal is 50 samples per week, chosen from a list of pre-designated locations on a rotating basis.

In cases in which a pathogen is detected, the area is cleaned and sanitized, followed by additional swabs in a pattern around where the original sample was taken and repeated until no additional traces are found.

Why wouldn’t Dole just make such data public and quell whispers of conspiracy?

 

Raw is risky: Pressed Juicery edition

Besides the high sugar levels, I don’t frequent those funky juice bars and I don’t buy unpasteurized juice because of the risk of bacterial contamination.

pressed-juicery-reviewI haven’t seen frozen juice in Australia, but as Sloan sings, “three cans of water provokes me.”

Hayden Slater, chief executive thingy of Fresno, CA-based Pressed Juicery, received a catchy letter from the U.S. Food and Drug Administration (FDA) which said that after numerous inspections in 2015, that the juice manufacturing facility had serious violations from the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120).

This inspection resulted in FDA’s issuance of a Form FDA-483 Inspectional Observations (FDA-483), at the conclusion of the inspection. 

Mr. Slater, your juice sucks.

  1. Your HACCP plan does not include control measures that will consistently produce, at a minimum a 5-log reduction of the most pertinent microorganism(s) of public health significance that is likely to occur in the juice, for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a). Your HACCP plan for “Ready to Drink Beverages, Soups (Food Drink), Freeze and Toppings,” which includes low acid 100% juices (pH > 4.6), does not have control measures for the pertinent microorganism, Clostridium botulinum. Furthermore, the validation study conducted by Food Microbiological Laboratories to validate the microbial load reduction of Salmonella spp. and E. coli O157:H7 in your juice products using the High Hydrostatic Pressure (HHP) process did not take into consideration the pertinent microorganism C. botulinum for the low acid products. Additionally, FDA recommends you provide a validation study for each of the products you manufacture, to demonstrate, at a minimum, a 5-log reduction of the most pertinent microorganism(s) of concern.

FDA believes that it is necessary to address the control of hazards that could occur in low acid refrigerated juices subjected to severe temperature abuse. Further guidance on this public health issue can be found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072481.htm].

  1. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A “food hazard” is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your HACCP plan for “Ready to Drink Beverages, Soups (Food Drink), Freeze and Toppings,” which includes juice blends with apple juice, does not list the food hazard patulin. Because patulin, a mycotoxin, can occur in apple juice from rotting or molding apples and is not destroyed with thermal processing, it is reasonably likely to occur in your juice products that contain apple juice.

29 sick, 3 dead: Canadians wrap up Dole listeria investigation

Doug Carder of The Packer reports the Public Health Agency of Canada has wrapped up its investigation into a listeria outbreak linked to Dole Fresh Vegetables Inc.’s processing plant in Springfield, Ohio, that infected more than a dozen Canadians.

listeria4“Given that the source of the outbreak was identified and contaminated products have been recalled from the market, the outbreak investigation coordinating committee has been deactivated and the investigation is coming to a close,” according to a report posted on the Canadian health agency’s website regarding the investigation which began in late January.

The agency investigated 14 cases of Listeria monocytogenes in five Canadian provinces: Ontario (9), Quebec (2), New Brunswick (1), Prince Edward Island (1), and Newfoundland and Labrador (1), according to the report. Individuals became ill between May 2015 and February, the agency reported.

“All cases have been hospitalized, and three people have died, however it has not been determined if listeria contributed to the cause of these deaths,” according to Public Health Agency of Canada’s final report.

Dole reported Jan. 21 to U.S. health officials with the Food and Drug Administration and the Centers for Disease Control and Prevention that it had suspended operations at the Ohio plant once it learned of the possible connection to the listeria outbreak. On Jan. 27, the company voluntarily recalled all Dole and private-label packaged salads produced there.

FDA confirmed Jan. 28 the presence of Listeria monocytogenes in a packaged salad produced at the Springfield plant.

As of Feb. 25, the CDC had reported the outbreak had infected 18 people in nine states. All cases required hospitalization, according to CDC.

Laboratory results from the Canadian Food Inspection Agency confirmed a link between recalled packaged salad products and the listeria outbreak in Canada, according to the report. Lab results “confirmed that the Canadian and U.S. listeria outbreaks are highly genetically related,” according to the Canadian health agency’s report.

While Canadian health officials have concluded their investigation, the U.S. investigation into the outbreak remains active, according to FDA.

Way forward for safer eggs: Forget faith-based food safety, inspections and audits are never enough

The editorial board of The Des Moines Register writes that if there’s one lesson to be learned from the 2010 salmonella outbreak that originated in Iowa and sickened thousands of consumers nationwide, it’s the high cost of failing to properly regulate egg audit.checklistproduction.

Maybe.

But what constitutes proper regulation?

What constitutes proper audits and inspections?

How can consumers choose?

Jack and Peter DeCoster, who were criminally charged for the way they ran the Quality Egg operation in Iowa, were bad actors, as the Iowa egg industry now admits. But what sort of regulatory system do we have that allows scofflaws to not only flourish but also become some of the industry’s biggest players?

That’s a question our governor and state legislators have steadfastly, and very deliberately, refused to address. Still, it has to be asked, particularly in light of the recent revelations that the Iowa Department of Agriculture and Land Stewardship indefinitely suspended its inspection of egg production facilities last year to eliminate any risk of inspectors spreading the bird flu virus.

After the 2010 salmonella outbreak and shortly before leaving office, Iowa Gov. Chet Culver proposed a series of reforms aimed at addressing five vulnerabilities in Iowa’s egg production regulations. None have been acted upon by the Branstad administration.

Among the proposed reforms:

More stringent state oversight of the smaller egg farms — those with fewer than 3,000 laying hens — that are exempt from federal regulations.

AIB.audit.eggsState-mandated reporting, by both testing laboratories and egg producers, of positive tests for salmonella enteritidis.

Accreditation and certification standards for laboratories that perform testing for salmonella.

Creation of a state-mandated salmonella detection and prevention program, with minimum training and competency standards for the staff.

Creation of a new funding stream to support the implementation of a comprehensive, statewide egg-safety program.

But that’s not enough.

Consumers and their pocketbooks will drive food safety innovation and accountability at retail.

Market food safety at retail so consumers can choose.

Audits and inspections are never enough: A critique to enhance food safety

30.aug.12

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

http://www.sciencedirect.com/science/article/pii/S0956713512004409?v=s5

Abstract

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

Nebraska health board recommends no bare hands for restaurants

The No. 1 cause of what people often call food poisoning is not spoiled food. It is a flu-like illness called norovirus that comes with diarrhea and vomiting.

handwash_south_park(2)And the No. 1 cause of norovirus is people who have the virus on their hands touching food without gloves.

To help prevent outbreaks of the virus, a health-related advisory group to the Lincoln-Lancaster County Health Department has recommended the city tighten restaurant rules, seriously limiting when staff can touch ready-to-serve food with their bare hands.

The City Council likely will hold a public hearing on the no-bare-hands policy April 11. The Health Department advisory board approved it in early March. 

The idea behind the policy is that once food is cooked, no staffer should touch it before a customer eats it, said Scott Holmes, manager of the Environmental Health Division with the local health department. 

The proposed rule does allow some exceptions.

Staff can touch ready-to-eat food before it’s cooked, garnish beverages and wash fruits and vegetables with bare hands.

Some eating establishments already follow a no-bare-hands policy, including those that serve vulnerable or high-risk populations — people in custodial care, assisted-living facilities, hospitals, nursing homes and senior centers, for example.

And many chain restaurants already have such policies, Holmes said.

The local proposal follows a national model, with some exceptions. The committee that developed the Lincoln policy eliminated a few of the rules, ones that created the most controversy in other communities.

Iowa egg oversight ended last year

Jason Clayworth of The Des Moines Register reports that Iowa, the epicenter of a nationwide salmonella outbreak that sickened thousands of people nearly six years ago, has suspended its egg facility inspections to guard against a recurrence of bird flu. While the risk may be slight, state agriculture officials say they fear that inspectors might spread the virus from one flock to another as they visit egg facilities.

egg.farmGovernment officials and egg industry supporters contend that suspending inspections, which stopped almost a year ago, has not compromised food safety. Farmers are still expected to follow safety regulations, some put in place after the 2010 egg recall.

But critics say the lack of inspections in the nation’s top-producing egg state jeopardizes food safety for biosecurity and leaves the precautions up to corporate farm operators. And they point to the most recently available reports from federal or state inspections, done before the checks ended, to emphasize why such oversight is necessary.

Those records show:

STRAY ANIMALS: Multiple incidents of stray animals getting inside poultry houses, including one site where “approximately eight” frogs were found. Contact between poultry and other animals that can carry disease is forbidden in the facilities. That includes amphibians, which can carry salmonella and cause serious illness to humans.

REFRIGERATION: Not washing or storing eggs at appropriate temperatures at multiple facilities.

BOTCHED TESTS: Improper or no testing for salmonella as required by federal rules in at least 14 sites.

RODENTS: Evidence of rodent infestations, including

“This is jaw-dropping. I just don’t know what else to say,” said Marion Nestle, a professor of nutrition at New York University and an author of books on food safety. “The inspectors are turning up potential hazards. Why anybody would tell you with a straight face that suspending these inspections is no big deal is beyond my comprehension.”

cafe-free.eggOscar Garrison, a food safety executive for United Egg Producers, said stopping bird flu also impacts human health. The virus led to the destruction of more than 31 million chickens, turkeys and other birds in Iowa last year.

Garrison said he believes that suspending the inspections was an appropriate step, given the context of the bird flu catastrophe.

Other top-producing egg states have either continued to inspect egg producers during the outbreak or stopped temporarily and later resumed them, the Register found. Ohio, the second-largest egg-producing state, and Texas, the nation’s fifth-top egg producer, resumed their inspections late last year. Indiana, the third-largest, continued its inspection throughout, as did fourth-largest Pennsylvania, state officials said.

Pennsylvania officials changed their protocol after the outbreak, instructing inspectors to wait at least seven days between inspection visits to different farms. Such an alternative — or requiring inspectors to wear biosafety gear — is more sensible than suspending inspections entirely, said William Marler, a Seattle attorney whose firm represented more than 100 victims of the 2010 nationwide salmonella outbreak whose origins were traced to Iowa.

“Given the black eye Iowa’s egg production got in 2010, it just seems shortsighted to suspend the inspections,” Marler said. “It sends a completely wrong message to consumers.”

In 2010 eggs contaminated with salmonella from Wright County Egg showed up in 23 states and resulted in a recall of 550 million eggs.

salmonella.eggsThe government reported that at least 1,939 cases of illness were likely associated with the outbreak. But some believe the number to be more than 50,000 people, citing  Centers for Disease and Prevention reports that estimate that for every reported illness, more than 38 go unreported.

Austin “Jack” DeCoster and his son, Peter, were sentenced in April to 90 days in jail and fined $100,000 each for their role in the outbreak.

Their trials brought to light what federal officials said was a deliberate and routine effort to avoid proper health regulations. That included falsifying paperwork to a firm that inspected the plant. On the eve of each audit, workers were given blank, signed audit forms and told to fabricate data for the report, prosecutors said.

After reports of human illness, regulators made findings that included rodent infestations and as much as 8 feet of manure beneath some of the facilities.

FDA investigates video of Kellogg’s worker pissing on Rice Krispies

The US Food and Drug Administration (FDA) has opened a criminal investigation after a video of a man urinating on a Kellogg factory assembly line surfaced online, the company announced.

kellogg's.pee.mar.16The video, which was uploaded to worldstarhiphop.com on Friday, shows a man urinating on cereal as it comes off the assembly line. It then pans to a sign featuring the Kellogg’s logo.

An internal investigation by the food giant found that the video was recorded in 2014 at a factory in Memphis, Tennessee.

A statement from the company said products “potentially affected” by the urine would be past their expiration dates by now.

Battle Creek-based Kellogg on Monday apologized to customers over a video in which a man urinated into a Rice Krispies Treats production line.

Thank you Mel Gibson and Dr. Ozß: Dietary supplements and nonprescription drug products may harm you, natural doesn’t mean safe

The U.S. Food and Drug Administration reports that if you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams mel.gibson.supplementsabound.

And in the U.S. too.

According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.

“These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets,” Nunez says. For example, Native Americans, Latinos, Asians and Africans may have a long tradition of turning to more herbal or so-called “natural” remedies. Many advertisers put the word “natural” somewhere on the package of a product, knowing it inspires trust in certain groups.

But just because a product claims to be natural doesn’t necessarily mean it’s safe, says Gary Coody, R. Ph., FDA’s national health fraud coordinator. Likewise, just because a product claims to be natural does not mean that it’s free of hidden drug ingredients.

Furthermore, these products may also be contaminated or contain potentially harmful chemicals or drug ingredients not listed on the label.

For example, many products that claim to help people lose weight contain hidden and dangerous prescription drug ingredients such as sibutramine. Sibutramine was in Meridia, a formerly FDA-approved drug that was removed from the market in October 2010 because clinical data indicated it posed an increased risk of heart problems and strokes.