The Role of the "FSVP Importer" in FSMA

The Foreign Supplier Verification Program (FSVP) under FDA, was enacted in 2015 to require that foreign suppliers of food provide the same level of food protection for their food as provided by our public health system. This is needed, as outbreaks of foodborne illness continue to occur both in foreign and domestically sourced foods. Under this law, importers (also known as “FSVP importers” for the purpose of the FSVP law, as explained below) must perform a verification that a foreign supplier of food has complied with at least two new major FDA-FSMA federal rules; Produce Safety, and the CGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food Rules.

FDA will hold the importer legally liable to ensure compliance with their requirements. The importer must approve the foreign supplier before bringing food into the US. The level of scrutiny applied to the importer’s approval process is based on a risk assessment of the supplier’s performance and historical risk of the commodity, akin to a Hazard Analysis in a Hazard Analysis Critical Control Point (HACCP) plan. While the traditional HACPP risk assessment model is complex, the FSVP makes the risk assessment a straightforward process. What is required in the FSVP version of the Hazard Analysis is to determine the “reasonably foreseeable hazards” in the commodity, based on the history of safety of the commodity, the history of the supplier meeting their own nation’s regulations, and conformance with US buyer’s requirements.

To make such approval decisions, the importer must be a “Qualified Individual” as well as an “FSVP Importer”, and must be able to read and understand food safety documents such as audits, monitoring, training records, and microbial test results. Qualifications for the person designated as the FSVP Importer are not explicitly spelled out in the rules, however, education, training and experience are mentioned.

Importers of food act as the intermediary between the foreign supplier and customers in the US. They arrange for cross-border shipments by preparing the US Customs filings for each food item brought into the US. The Customs forms have been changed by FDA to include an entry for the “FSVP importer” for each line item of food. It is estimated that 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood, making the importer’s new food safety role very significant for both foreign and domestic trade. For example, an importer may have to disapprove a supplier and discontinue using them, thereby preventing the supplier’s food from entry.

Placing the burden of verification of legal compliance by the supplier on the food importer may have some unique benefits and improve public health protection, but raises conflict of interest questions. Shifting the compliance role to the importer will change how importers, suppliers, food brokers, customs brokers, manufacturers and retailers operate. The entire supply chain must communicate, and make buying decisions considering the new FSVP regulations. How everyone in the supply chain will comply with these new laws, while protecting their business interests, and maintaining transparency remains to be seen.

Importers must be competent to make sometimes challenging decisions about the supplier’s performance in granting entry approval. To accomplish the verification that a food item is safe to import, importers look at the hazard analysis and Food Safety Plan prepared by the supplier, and evaluate it considering the importer’s own hazard analysis. They must also evaluate compliance with the supplier’s own food safety laws and rules in the country of origin and research the history of reports of contamination through The Reportable Food Registry. They should know about past and current compliance issues with the Preventive Controls or Produce Safety Rule. Perhaps most importantly an importer must stay informed about reported foodborne illness outbreaks associated with the commodity and/or supplier, product recalls, and withdrawals, and import refusals at the port of entry.

The FSVP is both a law, and a program that importers must have in place, with policies and procedures for foreign supplier approval, evaluation, verification, and corrective actions, all of which require extensive records.

Records are the key to compliance, and FDA will inspect records by coming to the office of the registered FSVP importer. Or otherwise, FDA can request the records be sent to them in electronic form or as paper copies.

The FSVP rule requires that the FSVP importer be in the US. and register with Dunn and Bradstreet to obtain a unique facility identifier or “DUNS number”. The DUNS number is a key part of the customs filing. It cannot be overemphasized that The FSVP importer placed on the Customs record must be a Qualified Individual under the FSVP law, through education training and experience, and possess the depth of knowledge needed to perform somewhat complex risks assessments at several levels of the supply chain. Not all food importers will be comfortable in their new role as FSVP importer. Not all will have the technical and scientific knowledge and experience needed to successfully develop their own risk assessment, and assess a risk assessment done by others. Additionally, the FSVP importer must document this entire process for a variety of foods and facilities, including farms, packing houses, processors, manufacturers and distributors.


Therefore, there is a growing need for many “FSVP-Qualified Individuals”. All in the food supply chain should become more familiar with the FSVP rule so they can improve compliance throughout the food industry, minimize the potential for unsafe food and protect our nation’s interests in foreign food trade.

Screening Food Workers to Prevent Trasmission of Foodborne Disease

In years past the practice in the US was to require a health certificate to work in the food industry. While on the surface this sounds like something to consider, the use of medical evaluation of food workers was often done without specific tests, medical personnel relying on medical history and a physical exam. Without specific tests carriers of infection are difficult to detect, and such exams alone cannot predict future health status. In many parts of the world, this practice is still evoked while it  is no longer considered to be necessary in the US.

Since a medical screen is relied upon by some as a preventive measure, our scientific methods of developing food safety systems makes us have to evaluate the validity of this process. We must determine the reliability of results for preventing foodborne illness alone. In a food safety system, other communicable disease such as sexually transmitted disease, or strictly respiratory diseases like TB or influenza do not enter into the hazard analysis..

A medical screening process proven effective through a validated method would be in conformance with ISO22000:2005 or HACCP methods; requirements based on them would then be food safety preventive measures.

To be in conformance, tests must be specific for etiological agents of disease, be predictive of communicable disease status at time of employment and be relative to future health status. Reliable tests provide the validity for a medical exam at time of employment. Tests for Salmonella typhi, Giardia, other protozoan and higher parasites, skin and upper respiratory infections (staph and strep) and other chronic or semi chronic disease (hepatitis A-D, mononucleosis)  transmissible through food might be considered. In addition, triage of employees might be beneficial in a “hazard analysis” context as one might try to discriminate and sort between:

  • 1) Those who are not infected and not likely to be infected in the future
  • 2) Those who are likely to be infected in the future
  • 3) Those who are likely to be infectious now
  • 4) Those for whom immediate care might make a positive difference in outcome

The food safety and public health benefits of any medical-screening model needs to be tested before including it in a food safety management system.

In the past, the medical screening of food workers has proven not to be predictive of future infectious status and both the public health and medical communities question its value in public health protection.

While each country and region has its own relatively unique disease transmission issues, prevention of disease in the first place is always better than testing for it afterwards.

Food-borne Illness and its Effect on Tourism in Egypt



Food-borne Illness and its Effect on Tourism in Egypt

Egypt is a land of mystery and excitement that has drawn world travelers for centuries. Unlike many developing nations, the rich history and close ties to our own culture makes this travel destination especially attractive.

Whether one travels to Mexico City, Madrid, Hong Kong or Cairo, however, the dilemma is the same. According to the CDC “Traveler’s Diarrhea” is a common aliment affecting up to 50% of persons visiting foreign destinations”. However, sometimes it is more than a brief, self-limiting illness.

Many nations, including our own, struggle with food safety issues and fixing them takes a coordinated approach amongst many constituents such as government, industry and the public. Food safety problems often intersect with wider public health needs and progress is hindered if problems such as poverty, social unrest and political instability are not also addressed.

Egypt suffers like the US from fragmentation in its public health mission. Currently, there are multiple agencies with similar responsibilities to protect the public from food safety hazards and little formal coordination between them. To make food safety a reality for tourists essentially means that food safety must be assured for the average Egyptian; therefore, Egypt needs a strong, coordinated public health infrastructure.

Tourists might not stop coming to Egypt due to a few reports of diarrhea, however, widespread reporting of severe cases, and lawsuits, will make tour operators much more selective, and bring pressure on the Egyptian hospitality industry to clean up its act.

The greater challenge is for Egypt to ensure that it has the capacity to sustain a safe food supply for its own people. In doing so, it ensures safe food for the rest of us who want to see Egypt for ourselves.


UK: Couple seek legal help in holiday illness fight


A couple who say they were left with long-term debilitating illnesses after contracting a bug on holiday are taking legal action. Nina Shenton, aged 20, is still undergoing tests for continuing sickness. Her partner Richard Gerrard, aged 24, has been diagnosed with painful reactive arthritis triggered by a virus (bacteria? – dp) following their week-long trip to the Zouara Hotel, Sharm El Sheikh, Egypt, in April.

The pair came down with stomach bugs within hours of arriving and were stuck in their rooms for the rest of the week, ruining their first holiday together. Miss Shenton, of Barn Gate Street, Leek, said: "To me, the food was disgusting. We felt the meat was undercooked and the buffet was left out for long periods of time, with new food being piled on top of the old food – we even noticed flies landing on the food.

"Also, lots of other guests were complaining about illness.

"We fell ill after our first meal there. I had terrible stomach cramps and was being sick.

"Six months later, my stomach is still swollen, I have chronic pain and bouts of sickness.

"I can't believe people are still being sent there on holiday after what we have been through."

Mr Gerrard, of Church Lane, Cauldon, had to be signed off work as a builder for five weeks and is still recovering.

He said: "The holiday was a complete nightmare”.

"We were still sick for a month afterwards and when that went, I had terrible pain in my joints and was in so much agony I couldn't stand."

Now the couple want to recover the costs of the holiday, at £400 per person, medical bills, including more than £500 spent on prescriptions, and loss of earnings.

Joanne Beddow, of Irwin Mitchell Solicitors, who is representing the couple, said: "Mr Gerrard and Miss Shenton are not the only people to have suffered illness at the Zouara Hotel.

"We see no end to the complaints from holidaymakers who return having suffered illness abroad.

"Incidents such as this should be a trigger for tour operators and hoteliers to do more to ensure the health and safety of their guests."

A spokesman for tour operator said: "We have launched a full enquiry and are liaising with Jetline Travel, the travel agent who booked the holiday, to ensure a response as soon as possible."


Chinese Addicted to Melamine

In another shocking episode of adulteration, Chinese public health officials have announced the recall of infant formula contaminated with melamine. The Chinese obviously have a problem; last year Chinese manufacturers contaminated pet foods with melamine in a fraudulent effort to boost the protein level to make more money. The draw of this additive is apparently irresistible to Chinese food manufacturers. Even after the public execution of officials and others involved in food safety scandals, the Chinese are unable to restrain themselves and have poisoned thousands of their own babies, and may have tried to hide it. Of course, this brings to our attention that unbridled greed is at work in China, with the complicity's of their international trading partners. The Chinese manufacturers of the contaminated baby formula that has killed a number of children and sickened thousands has ties to international food suppliers, one of whom knew of the contamination for weeks. Accountability and liability should extend to all who have had business dealings with this firm; the final revelation of the deadly threat was delayed according to the story below by official Chinese inaction. If this is true, and history would support that conclusion, Chinese food safety, regulation and public health protection must be questioned for every product produced in China and firms doing business in China need to keep their Chinese partners under close surveillance.

Here is a link to recent infamous Chinese product safety scandals

Original Article: Chinese hospitals are fighting to save the lives of some of the 1,253 babies who have fallen sick after they were fed milk powder contaminated with an industrial chemical used to make plastic cups and saucers.

Two babies have already died from drinking the formula laced with melamine in a ploy by farmers to boost the apparent protein content of the milk that they sold to one of the best-known milk powder manufacturers in the country. Police have arrested nineteen people, including two brothers who ran a milk collection station.

The brothers are alleged to have added melamine to milk that they sold on from farmers. State media said that their milk had been rejected several times previously by the manufacturer Sanlu Group.

The scandal came to light only because of the intervention of Helen Clark, the New Zealand Prime Minister, who was informed by the New Zealand joint venture partner of the Chinese company of its failure to persuade it to recall the product. Ms Clark said that the food giant Fonterra had been trying for weeks to make Sanlu Group recall the product but “the local authorities in China would not do it”. Fonterra has a 43 per cent stake in Sanlu, but had to follow Chinese rules in handling the incident.

Sanlu halted production last week after investigators found that the melamine in its milk powder caused kidney stones and other complications in infants. It recalled all its products made before August 6.

The children are victims of two of China’s greatest evils: greed and secrecy. Greed has contributed to poor safety: only a few years ago 13 babies died after they were fed a sub-stand-ard fake formula marketed under the Sanlu brand. The determination to stage a perfect Olympic Games may also have delayed revelation of the adulterated milk powder. Twenty-one topics were banned from Chinese media during the Olympics – eighth on the list was food safety scandals.

Li Changjiang, the Minister of the General Administration of Quality Supervision, Inspection and Quarantine, said: “It’s shocking. It’s a crime against the people.”

The eleven-month-old son of a lawyer, who identified himself only as Mr Sun, is in hospital after being fed the milk powder since he was two days old. The child’s nanny had told Mr Sun that he had difficulty urinating. Mr Sun told The Times: “We told her to give him more water. Who would ever think of the milk powder?

“We both regret not paying more attention to our son or we might have identified the problem earlier.”

By yesterday morning illnesses linked to the powder had been diagnosed in 1,253 children, with 340 still in hospital and 53 in serious condition.

Toxic history

— Half of all dangerous goods seized in Europe in 2007 came from China

— Last year China found two companies guilty of intentionally exporting contaminated pet food

— US authorities last year gave warning that monkfish imported from China may be puffer fish, containing a potentially deadly toxin

— In 2005 Sudan 1, a carcinogenic food colouring, was found in Chinese branches of KFC

— In January a survey found almost two thirds of Chinese people were worried about food safety

Sources: European Commission, Times archives

Egypt Tackles Food Safety-an American Perspective

Egypt is becoming aware of the importance of food safety to its people, and for its well-being as a nation. However, it is important to note that Egypt is not alone in these concerns. Here in the US we just experienced our worst outbreak of Salmonella through contaminated vegetables, and the end of our food supply contamination problem is not in sight. The global problem of food safety requires a global approach, so it is heartening as an American to see Egypt move forward as a nation to help solve this worldwide problem. Egypt is joining the growing number of nations who are creating, rational, science-based food safety strategies to protect public health. This is the right thing to do for public health. Ensuring food safety is critical for all of us and a healthy populace will enhance all other public health and safety initiatives. The worldwide food safety problem will be solved as each country advances its own reforms. Thank you Dr. Mansour, for beginning this effort in your wonderful and fascinating country. Please read below.


Food Safety Project Chief: 500,000 Food Violations

 By  Metwalli Salem, Hisham Yassin and Mohamed Haroun    17/9/2008

The head of the Food Safety Agency Project Hussein Mansour said a workingteam has been formed to prepare a strategic plan of action for the agency once alaw was enacted to establish it.

During a banquet organized by USAID, Mansour said the agency aims at unifyingcontrol over regulations and conditions relating to safe food.


He noted that official reports have monitored increasing rates of fraud onmarkets, adding that the number of food violations reached 500,000 casesannually. The number of officially registered factories amounted to 3000', producing 20% of food production while the remaining 80% is produced byunregistered factories.


Mansour noted that the large number of bodies checking food and thedifference in human and technical capabilities of labs might be the reasonbehind low quality of food.

World organizations concerned with human health advised people who travel toEgypt to be vaccinated against Hepatitis A and Typhoid before traveling for theprobability of taking polluted food or water.


Egypt is considered, according to Mansour, one of the countries where ratesof contracting such viruses are high, especially in case of visiting ruralareas.


Studies conducted by the National Research Institute proved that 100% ofsamples taken from honey are polluted with chloramphenicol, which causes anemiaand spinal atrophy.

Food pollution negatively affects the national economy, he said, noting thatthe US rejected a food shipment from Egypt because it was polluted withpesticides, as well as low quality of packaging

Moreover, the EU rejected a shipment of soybeans and sunflower seeds becausethey were contaminated with aflatoxin.


Mansour warned against the effect of food pollution on general health, whichmight lead to the spread of summer diseases and contracting Hepatitis A andkidney failure.


He noted dairy products sold in rural areas and some cities are considered amain reason for contracting several diseases, such as tuberculosis, brucellosis, typhoid, scarlet fever, diphtheria, yellow fever, paratyphoid and dysentery.


Mansour revealed that a sound animal produces microbe-free meat, but it ispolluted at slaughtering. Studies proved that the average microbes in the meatafter slaughtering hit 216 microbes in each square centimeter and increase to 10-20 millions and 66 millions after reaching the butcher.

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