The foreign supplier verification rule is foreign to many importers

My friend, Roy Costa from Florida, sent along this piece and I deemed it worthy.

The foreign supplier verification rule is foreign to many importers, October 20, 2018

The Foreign Supplier Verification Rule (FSVP), 21 CFR Part 1, Subpart L, is the part of the Food Safety Modernization Act that regulates the importation of food covered by FDA. While the Act when into effect in 2015, some importers have not yet fully implemented an FSVP program.

An FSVP program is a risk-based system that ensures that foreign suppliers meet the same US rules for food safety as domestic suppliers. This means that importers must verify that FDA’s rules, the Current GMP Hazard Analysis and Risk Based Preventive Controls for Human and Animal Foods, and the Produce Safety rules, have been implemented by suppliers.

Importers bare the responsibility for verification of the safety of foods imported into the US. The Customs filings now include a line item for the “FSVP Importer”. This entry utilizes the Dunn and Bradstreet’s unique facility identifier-the DUNS Number; no food maybe imported without this filing. Whoever is identified as the FSVP Importer must be qualified through education and experience to understand any document submitted for verification, and is subject to unannounced FDA inspection.

The FSVP rule allows third-party audits, microbial, physical and chemical testing and operational records to be used for verification purposes. The key documents an importer must verify are the Food Safety Plan of foreign manufacturers, and the records that show compliance with the Produce Safety rule.

In order to understand these complex verification documents, one must understand the Hazard Analysis and Critical Control Point (HACCP) concept. Education in the Preventive Controls and Produce Safety rules will be necessary for most importers. Without a scientific background, understanding how to successfully apply the five preliminary HACCP steps and the seven HACCP principles is impossible, and the Produce rule requires a deep understanding of Good Agricultural Practices.

Some importers will not be qualified to make decisions about supplier approval, or even understand what is required of them, without training.

An importer must prepare his own FSVP program for each commodity he obtains, based on a risk assessment similar to HACCP. He can only do this if he is a FSVP Qualified Individual, although he can hire or use another Qualified Individual, if he is not so qualified.

The barriers of entry are high. If a supplier does not meet the rules, or if the importer cannot verify the safety of foods, no such foods can be obtained. This could put some importers out of business, and restrict trade in foreign foods.

The impact is huge for the global economy. Currently, imported foods make up an estimated 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.

The FSVP rule prohibits anyone with a financial interest in the outcome of verification to have a financial interest in an approval decision. The problems with conflicts of interest in this scheme are readily apparent, since many importers also own the operations of the foreign supplier, and virtually all importers have some kind of monetary incentive for bringing products into the US.

FDA has the authority to inspect the records of the FSVP Importer, and they typically do not notify in advance of a routine inspection. Once in the office, FDA has access to virtually all the records of the importing firm, and will expect that the firm has a Qualified Individual, policies and procedures, records, and a risk-based system to make decisions about supplier approval, with an approved supplier list. Without these vital documents, there will be no way an importer can demonstrate compliance.

At this time, FDA is making inspections to primarily educate the industry, but they will act if they find an importer violating US rules or obtaining unsafe foods.

With such dire consequences possible, one would expect that an importer would seek education in areas of legal compliance, but the industry has not shown overwhelming interest in taking the training needed to understand their responsibilities.

Eventually, the agency will take a focused approach to weeding out the non-compliant importing operations, but the job will be difficult. Policing these complex importer arrangements will not be an easy assignment; it is well known the importers sometimes flaunt the rules that have been in place, and engage in port shopping, ignoring Import Alerts, and outright deception. These new regulations should allow FDA to be more effective in detecting criminal activity, and I expect that penalties will be severe for importers who bring in contaminated foods that cause illness and death to US consumers.

I also expect that product liability will eventually stretch back to the importer in such cases, and that lawsuits will take into consideration the compliance history of the importer when perusing justice for victims of foodborne illness.

I strongly recommend that both foreign suppliers and importers take the Food Safety Preventive Controls Alliance FSVP course, and the other FSPCA relevant courses as needed, Preventive Controls for Human and Animal Foods, and Produce Safety Rules, and learn how to develop a compliant FSVP program.

Contact Environ Health Associates, Course Administration Manager; Katherine Jones 386-316-7266 for course registration.

Food fraud: Crab meat from Venezuela linked to 9 cases of vibrio in Maryland

While Maryland Blue Crabs are a staple in the DMV, many places do sell crabs, packaged crab meat, and crab cakes with crab from elsewhere.

Anne Cutler of Fox 26 says the National Aquarium in Baltimore reports that due to environmental degradation and years of overfishing, there’s not enough blue crab in the region to support demand, and grocery stores and restaurants often resort to selling imported crab.

According to ocean conservancy organization Oceana, 33 percent of the seafood purchased in the United States is actually mislabeled.

The National Aquarium reports that under current law, crab meat can be imported from around the world, pasteurized in-state and relabeled as “Maryland crabmeat.”

Nine people have contracted dangerous Vibrio infections in Maryland alone. The state’s Department of Health is warning residents to not eat crab meat from Venezuela.

“We’re selling a lot of crab meat, shrimp, lobster, whatever you want. We’re steaming it for you. And as far as this crab meat, we gotta get it from the eastern shore now, because we heard from the media what’s going on,” said Clarence Goodman, with Jessie Taylor Seafood.

Goodman says the company is not taking any chances — sticking with products almost exclusively from the eastern seaboard. 

The crab in question comes in the little plastic tubs. Consumers should look for a label on the side of the container that says where the meat is from. If it comes from Venezuela, you don’t want to get it.

Diners should also pay attention when buying crab cakes as well.A 2015 study from Oceana found that 38 percent of crab cakes being advertised as having locally sourced Chesapeake blue crab were actually made of imported meat.

In the state of Maryland, only a few dozen restaurants in the state reliably make their crab cakes from local crabmeat and the state does not require restaurants to identify the specific source of the meat.

The state has a listing of “True Blue” local restaurants that serve Maryland blue crab.

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.”

6 months jail; Brisbane grocer pleads guilty to illegal importation of frozen chicken and pork products

A Brisbane grocery chain owner who employed 35 people was jailed for six-months for illegally importing pork and chicken products into Australia from Korea, while the country was in the grip of a deadly foot-and-mouth disease outbreak.

Archerfield-based Limeke Corporation Pty Ltd and its sole director Mark Kim, 49, pleaded guilty in the Brisbane District Court to the illegal importation of more than 14 tonnes of frozen chicken and pork products worth more than $70,000 on six occasions throughout 2010.

Judge David Reid said the illegal importation of pork patties, cutlets, ham strips and sausages put Australia’s livestock industry at risk of an outbreak of foot-and-mouth disease that would have had “a devastating impact.”

He said the illegal importation of chicken products brought with them a risk of Avian Influenza and Newcastle disease, both of which had the capacity to “devastate” the poultry industry and could be characterised by “very high mortality rates”.

Judge Reid said there had been repeated outbreaks of foot-and-mouth disease and highly pathogenic Avian Influenza between 2006 and 2011 in Korea.

The court heard Kim’s company had been a quarantine-approved premises since March, 2000, but did not have a permit for the products he later smuggled in.

A shipment labelled as “frozen fishcakes, salted jellyfish and crab meat” was selected for a random quarantine inspection in late 2010 when a “number of suspect items were observed.”

Kim was sentenced to total of two-years and 11-months imprisonment, to be released on a good-behavior bond after six-months served.

Limeke Corporation was fined a total of $60,000.


Maggots in the pasta: Europe screens tainted Chinese food

Cypriot inspectors found arsenic in the frozen calamari. The Italians discovered maggots in the pasta. There were glass chips in the pumpkin seeds bound for Denmark, and Spanish regulators blocked a shipment of frozen duck meat because of forged papers. It has been a rough year for Chinese food exports to Europe.

At least German kids can eat their Chinese strawberries again.

Health authorities have given the all-clear after a recent poisoning of 11,000 children at hundreds of schools in Berlin and four other German states. A norovirus outbreak from a shipment of frozen Chinese berries led to severe diarrhea and vomiting, and 30 people were hospitalized.

German consumer agencies traced the outbreak to a single batch of berries. School cafeterias in eastern Germany were primarily affected, and improper food handling at industrial kitchens was seen as a possible cause.

The agencies’ strawberry statement did not identify the source country, although a spokesperson for the Federal Office of Consumer Protection and Food Safety told Food Production Daily that the berries “all came from the same batch imported from China.”

And a news report said the strawberries were grown, harvested and frozen in Qufu, the birthplace of Confucius, in Shandong Province.

It was the latest episode in China’s ongoing food-safety nightmare, which Rendezvous has chronicled, and the German newspaper Der Spiegel has now followed up with an investigation of Chinese food exports to Europe.

Those exports are growing widely and rapidly. The newspaper said Chinese food exports to Europe nearly doubled between 2005 and 2010. In Germany, food imports from China are up 26 percent since 2009.

Zhou Li, a food-safety expert and lecturer at Renmin University in Beijing, told Der Spiegel that Chinese farmers used to eat the same food that they grew and sold.

“But now that they are aware of the harmful effects of pesticides, fertilizers, hormones and antibiotics,” the article said, paraphrasing Mr. Zhou, “they still produce a portion of their farm products for the market and a portion for their own families. The only difference is that the food for their families is produced using traditional methods.

“In fact, many wealthy Chinese have bought their own farms so as not to be dependent on what’s available in supermarkets,” the story said, citing Mr. Zhou. “There are also reports of special plots of land used to produce food exclusively for senior government officials.”

Mozzarella mafia: cheese smuggling ring is brought down in Canada

Canadians have gone hardcore as notorious cheese smugglers.

NPR reports a “large scale Canada-U.S. cheese smuggling operation” has been brought down, after an international investigation tracked criminals who were skirting import duties and Canada’s higher cheese prices.

“The investigation revealed over $200,000 worth of cheese and other products were purchased and distributed for an estimated profit of over $165,000,” Niagara police said.

The smugglers — one current and one former police officer, and one civilian — reportedly sought out pizza restaurants to move their merchandise. News emerged this week that charges would soon be announced against what Mark called a “mozzarella mafia.”

As Windsor, Ontario, pizzeria owner Bob Abumeeiz told the CBC, he has been asked several times if he’s interested in buying cheese smuggled from America, where prices are anywhere from a third to half what they are in Canada.

“Cheese is the white gold in the restaurant business. Cheese is 50 percent of the taste on a pizza,” he said. “The price is rising every year two or three percent.”

The network operated in Ontario, where two of the accused have worked for the Niagara Regional Police Service.

U.S. halts imports of Canadian cured meat products

In the midst of the ongoing mess from the E. coli O157-linked XL plant in Edmonton, American meat inspectors this week began turning away loads of Canadian dry cured meat products from the borders, Global News has learned.

The Canadian Food Inspection Agency says it has been working with the U.S. for a number of months to resolve what is being called a “technical issue.”

“Their standards on those particular products and ours don’t fully align,” said CFIA spokesperson Dr. Richard Arsenault. “I can’t comment on as to why they took this specific decision, but we’re going to work through that.”

Jim Laws, ex-director of the Canadian Meat Council, told Global News that its members were aware of negotiations taking place but never received notice of an impending halt of exports.

“They want more proof that in fact the whole drying process, which is a pretty standard process does in fact, would kill off any harmful bacteria, if any were present,” said Laws. “These products like salami and prosciutto are traditionally very safe because they’re manufactured over 45 days, 90 days, prosciutto up to 6 months.”

Canada exports nearly $20 million worth of dry cured meat to the U.S. and producers say any delay in getting Canadian processors back on the market could be devastating.

Many dry meat producers fear this won’t help bolster the opinion of Canadian meat products, given the timing of the Alberta based XL Foods beef recall due to e-coli concerns. 

Meat gets around; Australian beef implicated in South Carolina E. coli positive sample

Australians don’t take kindly to suggestions their beef may have E. coli.

A Japanese chain serving raw beef tried the tactic in an E. coli O157:H7 outbreak last year that sickened 20 people, and now a positive sample in South Carolina – no people sick – has triggered diverse responses.

On May18, 2012, two South Carolina companies, Lancaster Frozen Foods and G&W Inc. announced they were recalling nearly 7,000 pounds of ground beef after a state testing program found an E. coli O157 positive sample (there was no mention of a possible connection with the E. coli O157:H7 outbreak in early May at a restaurant in South Carolina that sickened 11 people, but outbreaks do focus the attention of public health folks).

The Charlotte Observer reported the SC meat originated from an Australian packing plant, and that the companies no longer buy beef from the Australian company.

A few days later the story popped up throughout Australia, with meat types insisting the meat was safe and noting that more than 70 Australian plants are certified by the U.S. Department of Agriculture to export meat and poultry.

Australian TV got into the scrum, declaring that up to 13 Australian shipments of contaminated meat have been rejected by USDA in the past year, including nine loads of mutton contaminated with feces and one load because of veterinary drug residues.

Meat and Livestock Australia Ltd. said in January that one of the "major hurdles for Australian exports to the U.S. in 2012" would be increased non-O157 E. coli testing requirements. MLA estimated Australia’s beef exports to the U.S. in 2011 were valued at A$744 million.

The U.S. is Australia’s second largest export market for beef and its largest export market for lamb.

Seek and ye shall find: increased testing means increased positives, and it’s going to take diplomatic skills and data to better understand what a positive means.

In the short-term, blame the foreigners will remain politically appealing: Australia does it, U.S. does it, Canada does it, every country in Europe does it. 

Sushi eaters rejoice; slime from India; 141 sick

The sushi slime, or tuna backmeat that has now been linked to 141 confirmed Salmonella illnesses, up from 116, originated at a tuna processing facility in India.

Sushi eaters, you thought you were eating what? The U.S. Food and Drug Administration (FDA) has conducted a traceback of tuna from four of the outbreak clusters, in Connecticut, Rhode Island, Texas, and Wisconsin, and found that all four received the same imported frozen raw Nakaochi Scrape tuna product from a single tuna processing facility in India.

Chapman and I chatted today – with his kids, extended family, burgeoning home canning career – he had to escape the Food Safety Summit in D.C. to catch up. He told me one of the industry types said everyone uses this stuff, which has helped propel the popularity of sushi eating.

The U.S. Centers for Disease Control reported today the number of confirmed Salmonella Bareilly linked to this outbreak has increased to 141 from 20 states and the District of Columbia.

The number of ill persons identified in each state is as follows: Alabama (2), Arkansas (1), Connecticut (6), District of Columbia (2), Florida (1), Georgia (6), Illinois (13), Louisiana (3), Maryland (14), Massachusetts (9), Mississippi (2), Missouri (4), New Jersey (8), New York (28), North Carolina (2), Pennsylvania (6), Rhode Island (5), South Carolina (3), Texas (4), Virginia (8), and Wisconsin (14). 21 ill persons have been hospitalized, and no deaths have been reported.

Ensuring safe foods and medical products through stronger regulatory systems abroad

A new report calls on the U.S. Food and Drug Administration to export its regulatory knowhow to improve the safety of imports arriving in the U.S.

Almost 40 percent of the fruits and nuts and 85 percent of the seafood that Americans purchase come from aboard. More than 80 percent of active pharmaceutical ingredients are imported, and 40 percent of medicines are imported as finished products.

The report from a committee of the Institute of Medicine of the National Academies says many regulatory agencies abroad lack the legal framework, funding, training, and oversight that have helped to transform the FDA into one of the world’s top-notch regulatory agencies.

Jim Riviere, a professor of pharmacology at North Carolina State University, Raleigh, and chair of the committee said, "Globalization is not going to reverse. … No matter how much inspection we do, we are always going to find flawed products. We’re not saying we need to cut back on inspections, but all resources can’t be spent on inspection."

Instead, the IOM says the onus is on the FDA to help the exporting countries improve their own regulatory systems and supply chains, so that everyone can be more confident that what they’re producing is safe.