Tag Archives: foreign supplier verification

FDA Logo

FDA Issues Final Guidance for Foreign Supplier Verification Programs

By Food Safety Tech Staff
No Comments
FDA Logo

The FDA has issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. FSVP, which is part of the FDA Food Safety Modernization Act, makes importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.

This guidance includes recommendations on the requirements to analyze the hazards in food; evaluate a potential foreign supplier’s performance and the risk posed by the food; and determine and conduct appropriate foreign supplier verification activities.

The guidance also addresses how importers can meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

In response to comments received to the 2018 draft guidance, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information must be included in the FSVP; and who must develop and perform FSVP activities.

“Food” covered under FSVP includes:

  • Articles used for food or drink for humans or other animals,
  • Chewing gum, and
  • Articles used for components of any such article.

Training materials, developed in collaboration with the Food Safety Preventive Controls Alliance (FSPCA), are available to help facilitate FSVP compliance by importers.

Download the final guidance here.

FDA

FDA Offers Help to Companies with Supply Chain Disruptions

By Food Safety Tech Staff
No Comments
FDA

FDA has given an update on its resources to provide the industry with continued assistance as it struggles through the challenges presented by the ongoing pandemic.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
No Comments
AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

Steven Burton, Icicle Technologies
FST Soapbox

Could Blockchain Technology Drive FSVP Compliance?

By Steven Burton
5 Comments
Steven Burton, Icicle Technologies

From farm to fork, food produced today goes through more hands than ever before. A greater number of players in the production of even a single product could increase that the risk for foodborne illness. Not only do companies need to check incoming and outgoing products from their own facilities, but they also need to consider whether products that they are importing from other countries are compliant with local regulations, and whether the products that they are exporting are compliant with the regulations of the destination country.

The current traceability standard of “one step forward, one step back’”is less and less suited for the current global marketplace, and governments are demanding more. Handling all this information is a challenge for food producers of all sizes, around the world.

Taking Traceability Global with FSVP

Needless to say, with 600 million people contracting foodborne illnesses every year, there is a dire need for food traceability and transparency in the food supply chain. If and when something goes wrong, traceability gives oversight agencies greater visibility investigating the root causes of an outbreak to prevent further risk to the public. It also allows companies to minimize the financial impact of a recall if they are able to pinpoint exactly which lot numbers of their products are affected.

In response to the changes in the food industry, in 2011 the USFDA introduced FSMA to implement a more proactive food safety regulatory system. With FSMA came the Foreign Supplier Verification Program (FSVP), which basically extends FSMA regulations to companies supplying food to the United States. All U.S. importers are now required to monitor and manage their foreign suppliers through six steps of hazard analysis, record keeping and more. Given the complexity of the global food supply chain, this is by no means an easy undertaking and it is clear that technology is crucial to achieving this granular level of data management alone. Blockchain technology, however, might be the answer to this problem—and many other related ones.

What is Blockchain Technology?

Evolving from the digital financial world, blockchains are distributed databases that build a growing chain of ordered records, called blocks. This means that any type of information can be stored in a chronological, consistent and secure way; even if multiple users are involved, it is extremely difficult to alter a blockchain.

Since any information on the blockchain is shared with all of its users, they can view any transactions made historically and in real-time. Theoretically, this could allow authorities to pinpoint food problems within minutes, when previously it would take days, potentially saving many lives in the process.

Blockchain in Action in the Food Industry

In 2016, retail giant Walmart started using a pilot version of the technology in its stores, tracking two products using blockchain: A packaged produce item in the United States and pork in China. Walmart announced that the results were “very encouraging,” noting that using blockchain technology could dramatically increase the speed of traceability from days to minutes. In fact, Walmart is now taking it to the next level with a collaboration with one of China’s largest retailers, JD.com, and their suppliers, to bring a higher level of food safety to China.

Other major food suppliers and retailers—Dole, Driscoll’s, Golden State Foods, Kroger, McCormick and Company, McLane Company, Nestlé, Tyson Foods and Unilever—have also signalled their intention to work with IBM to create blockchain-based solutions. Blockchain technology is even being used to track the movement of tuna through the ocean and all the way to the consumer.

At the same time, implementing blockchain technology throughout the industry is a mammoth task. As of now, blockchain technology has a problem with scaling up and can only process a limited number of transactions per second, which would not be sufficient given the needs of the global supply chain. According to Coindesk, each transaction costs about $0.20, and can only store 80 bytes of data, so the bill might become quite hefty as well.

There’s also the fact that the food industry is traditionally slow to adopt new technologies. It’s not just about big players like Walmart—small, medium, and large businesses alike need to come onboard in order for this to become an industry-wide standard.

Can FSVP Unlock the Potential for Blockchain Technology?

There are several reasons why blockchain technology could be the key to tackling the complex challenge that is tracking and verifying foreign suppliers. Blockchains can help increase transparency and communication across the food supply chain, ensuring that there are no gaps and that records are widely available and up to date. When all the information about suppliers and products is easily accessible, the potential to increase the speed of recall response is very high.

Blockchain technology is also suited to FSVP’s goals, specifically. One of the main goals of FSVP and FSMA generally is to tackle the issues of food fraud, intentional adulteration and bioterrorism that are unique problems of our time, in terms of scale if nothing else. Such a modern problem requires modern solutions. Because the blockchain, forming the basis of cryptocurrencies like Bitcoin, focuses on security, it could mean that blockchains can help close the gaps that would be exploited by food companies employees, or other actors who harbor ill intent.

The reality, however, is that the level of industry-wide coordination—and voluntary transparency—that would be necessary to deliver real benefits is extremely high. The theoretical possibilities are exciting and hugely impactful; the practical reality is more complex. For blockchain to reach its full potential, it has to be universally mandated, which is highly unlikely given the current circumstances. It seems more likely that adoption in this area could be driven by industry organizations and/or government, but unfortunately, the recently proposed budget cuts for the FDA might block progress in the latter area.

Still, with major food suppliers and retailers leading the charge and taking blockchain technology for a test run, the rest of the industry is waiting with bated breath to see what happens next.

FDA

FDA Releases Five FSMA Guidance Documents

By Food Safety Tech Staff
No Comments
FDA

Today the FDA issued five guidance documents related to FSMA with the goal of assisting food importers and producers meet provisions in the regulation.

The first two documents are related to the Foreign Supplier Verification Program (FSVP) regulation. The FDA issued the draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, along with a small entity compliance guide. The third draft guidance is related to whether a measure provides the same level of public health protection as the corresponding requirement in 21 CFR part 112 or the PC requirements in part 117 or 507 . “This draft guidance aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food,” according to FDA.

The FDA also released a final chapter in the draft guidance related to FSMA requirements for hazard analysis and risk-based PCs for human food. The chapter is intended to assist food facilities in complying with the supply chain program requirements.

The fifth guidance is an announcement of the FDA’s policy to exercise enforcement discretion related to the FSVP rule regarding certain grain importers that bring the product into the United States as raw agricultural commodities. “This enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the PC rules,” stated FDA.

Imports

Import Safe Food, Stay Out of Trouble with FDA

By Maria Fontanazza
1 Comment
Imports

Food importers have clear objectives: To successfully bring safe food into the country by clearing U.S. Customs and Border Protection, to avoid FDA detention and to conduct business competitively in the United States. Under the FSMA final rule on Foreign Supplier Verification Programs (FSVP), importers must ensure their food is as safe as if it were produced in the United States and that it is not adulterated or misbranded.

Compliance, of course, is of utmost importance when it comes to avoiding issues with the FDA. However, in a more realistic sense, the best way to stay out of trouble with FDA is to avoid two circumstances, advised Russell Statman, executive director at Registrar Corp. (the firm is a U.S. agent for about 15,000 foreign facilities)—being dishonest and not taking the requirements seriously.

“Once you fall into one of those boxes, you’ll never get out,” Statman said. “It’s important when dealing with FDA to remember that. It’s not a building; it’s people. They don’t want to stop your shipments; they want to facilitate trade.” If your company is honestly working toward and making an effort to follow the rules, “FDA will keep working with you until the cows come home,” he said.

Statman discussed practical information surrounding FSVP that importers should consider during the Food Safety Supply Chain Conference earlier this week. Although there is flexibility built into the FSVP rule (as there is with all seven FSMA rules), importers must follow the law. To start, every importer must have DUNS number (provided by Dun & Bradstreet), which is free of charge. However, this can be a challenge for foreign companies, particularly those in China, according to Statman, who also said there may be instances in which Dun & Bradstreet tries to charge a fee. “It’s supposed to be free and quick. If you have problems with Dun & Bradstreet, you want to let FDA know.” He offered key pieces of advice for the FSVP requirements:

  • Hazard analysis. “You can’t rely on other people. If you’re producing food, do your own hazard analysis. Create a pamphlet that you can give to your customers. Then you don’t have to deal with all these requests—keep updating [the pamphlet], so it’s a living document. If you’re a foreign supplier and have a booklet, you’re steps ahead of your competition.”
  • Approval and compliance status review of suppliers: Check their record with FDA to find out whether they have any warning letters or on import alert. “That doesn’t mean you can’t buy from them, it just means you have to investigate what the problem is,” said Statman, but added that a lot of U.S. companies will not buy from importers that are flagged with an alert. And in many cases, companies do not know that they’re on import alert, so visit FDA’s website frequently to make sure you’re not on the list. “FDA doesn’t tell you when you’re on import alert. You want to check [because] asking them might not be good enough.”
  • Supplier verification activities: Verify that importers follow the entire rule.
  • Corrective actions
  • Periodic reassessment of FSVP
  • Importer identification at entry (DUNS number)
  • Recordkeeping: “In a very real, practical sense, your record stays with you,” said Statman. “If you’re an importer, you don’t want your shipment detained by FDA.” FDA uses a computer system called PREDICT that determines which entries they stop. The system comes up with a score for shipments that are at the highest risk. “Your PREDICT score if very important—some of these factors are secret, [and] some are public. The most important are in your control—your record and the importers record,” he added. “Before you send your first shipment for a new product, make sure everything is correct (i.e., registration, labeling). It’s worth the time.”

 

FSMA, Food Safety Tech, FDA

FDA Releases New Guidance on Foreign Supplier Verification Program

By Food Safety Tech Staff
No Comments
FSMA, Food Safety Tech, FDA

With the first FSVP compliance rule just two weeks away, FDA has published a new guidance to help importers that are subject to the rule. “Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation” specifically provides information on the following:

  • How an organization identifies itself as an importer of food at entry into the United States
  • Requirement to provide a unique facility identifier that is acceptable by FDA
  • Information on what to do if the importer cannot obtain a Dun & Bradstreet Data Universal Numbering System number in time for the compliance date

FDA also identified the importers that fall under the May 30, 2017 compliance date. The foreign supplier would fall into one of the following categories:

  • The supplier will not be covered by the FSMA PC or Produce Safety rules
  • The supplier is subject to the Preventive Controls for Human Food rule and is not a small business, qualified facility or subject to the Pasteurized Milk Ordinance
  • The supplier is subject to CGMP requirements in the FSMA Preventive Controls for Animal Food rule and is not a small business or qualified facility

For importers that are unsure as to whether they are required to comply with the FSVP rule, the agency released a one-page chart, “Am I Subject to FSVP?”, along with a fact sheet about the final rule and the requirements under it, compliance dates and additional information.

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
No Comments
Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

Contamination, Adulteration Remain Highest Priority

By Maria Fontanazza
No Comments

Increased media attention and consumer awareness of verifying ingredients, detecting allergens and effectively tracing the source of outbreaks has placed much higher scrutiny on food processors and manufacturers. With the anticipated FSMA final rule on intention adulteration (Focused Mitigation Strategies to Product Food Against Intentional Adulteration) expected in late spring, having the ability to effectively detect and address product contamination and adulteration will be of significant importance to manufacturers. In preparation for the upcoming Food Labs Conference March 7–8, Food Safety Tech sat down with Craig Schwandt, Ph.D., director of industrial services at McCrone Associates, to learn how contamination is currently affecting food companies and what they should be doing to protect their products and ensure consumer safety.

Craig Schwandt will be presenting “Contaminant Particle Identification: Establishing Provenance and Complying with FSMA” at this year’s Food Labs Conference | March 7–8 | LEARN MOREFood Safety Tech: What are the big issues facing the food industry related to product contamination?

Craig Schwandt: I think the biggest issue facing the food safety industry is realizing that FSMA, in its final ruling, comes with requirements to ensure food safety from farm to table. In the past, many [ingredients] were GRAs, or generally recognized as safe, so when there was a contaminant, [food companies] had a lot of liberty in disposing of the batch and weren’t too concerned about where it came from.

FSMA is going to require that [food companies] keep records of what contaminants are found, how they address it and whether it’s a recurring problem, and [that they] have a procedure in place to track back and [conduct] forensic analysis. In the analytical services industry we call it investigational analysis, which is a description of what actually takes place for ascertaining what the contaminant is and how it got there. That information is provided to clients so they can track back in their production process—all the way to the raw materials and then ascertain where the contaminants came from in that production chain.

The big challenge will be in recognizing that they have to start keeping records and then actually doing the investigation to determine what contaminants are there and determine where they’re coming in.

Craig Schwandt_McCrone Associates
Craig Schwandt, Ph.D., McCrone Associates

FST: Are companies taking the right steps to detect and identify contaminants in food?

Schwandt: Some of them do and some don’t.  At last year’s Institute of Food Technologist’s conference in Chicago, there was a session on FSMA in which there were representatives from FDA, the Grocery Manufacturers Association and a major food company.  I was a little bit shocked by the food company’s position.  They felt they didn’t need to take all of the steps required by FSMA because they dealt directly with producers from all over the world.  They felt removing intermediaries from their supply chain sufficiently protected their products from adulteration. This seems to be oversimplifying the production and supply chain process. Even though they may directly deal with farmers, there’s still opportunity from the time food stuff is harvested to being dried, placed in containers, and shipped from overseas to the U.S.—there are several steps where unintentional contaminants can arise. So to say they didn’t need to look at the potential for contamination because they dealt directly [with farmers] is a bit oversimplified.  I think this perspective typifies some of the industry’s viewpoint at the moment.

The Foreign Supplier Verification Program specifically addresses this concern.  Even companies that deal directly with producers and supplies in the country of the product’s origin will be required to demonstrate that they tested it and verified it as uncontaminated.

The understanding and recognition by suppliers of these new regulations is the biggest issue facing the food industry right now—especially now that the final rulings have been issued and we’re in the grace period before compliance with the regulation is required.

FST: What technologies are helping in the effort to fight product adulteration, especially as it relates to FSMA compliance?

Schwandt: Handheld instrumentation is making headway at identifying, at a gross scale, screening capabilities—handheld x-ray fluorescence instrumentation and handheld infrared spectroscopy, to identify things at the bulk level. Mass spectrometry methods and chromatography are exceptional at their ability to do really fast general screening for chemical adulterants. I think many of the food laboratories and food companies have in-house laboratories and screen in that general way.

In terms of some of the solid phase contaminants, I think there’s a lack of in-house capability at the moment where one can use simpler [methods] like optical microscopy and another microscopy-based methods to identify the physical solid phase contaminants.

A good example is the use of magnetometers.  Many companies use large-scale process line magnetometers to highlight the presence of metal pieces in their product. A magnetometer tells you that there are metal contaminants in your product, it does not provide a specific alloy identification.  Whether one needs to go further to use additional methods and actually ascertain the composition of the alloy, is the question.  That’s a new requirement—to identify what it is and then to try and assess where in the process it may have occurred. Using a microscopy-based method is advantageous because metal pieces are easily isolated and identified. Once food industry clients have an idea of what the alloy is, they can compare it to the metal alloys that make up their machinery along the way, whether it’s packaging or sorting machinery, [and] essentially establish where the particles enter into the food process.

Audit

The Multi-Step Process of Third-Party Accreditation

By Charles Breen
No Comments
Audit

The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.

An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.

The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:

  • FDA is responsible for officially recognizing accreditation bodies.
  • An officially recognized accreditation body will accredit third-party certification bodies.
  • The accredited third-party certification body will certify third-party auditors.
  • The certified auditors will conduct consultative and regulatory audits of food facilities.

If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.

In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.

FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.

Recognized accreditation bodies under TPA will be required to:

  • Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
  • Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
  • Self-evaluate and correct any problems in their own performance
  • Submit monitoring and self-assessment reports and other notifications to the FDA
  • Maintain and provide the FDA access to records required to be kept under the program

Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.

Pages: 1 2