Tag Archives: FSVP

Erika Miller
FST Soapbox

When Worlds Collide

By Erika Miller
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Erika Miller

The Foreign Supplier Verification requirements of FSMA have perhaps been less well advertised than those of the Preventive Controls rules, but the compliance dates are fast approaching nevertheless. On May 30, 2017, a new field will appear in Ace, the software system wherein importers declare their imports and, in so doing, fulfill the requirements of many different U.S. regulations. This seemingly innocuous event will have serious and wide-reaching implications for all entities involved in the importation of food intended for consumption in the United States, but perhaps no one will be more affected than brokers and distributors, for they have long relied on the protection of their sources to ensure a share of the profits on their imports.

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Brokers and distributors often provide an important service by taking care of the legal requirements to bring a product into the country, and by purchasing large quantities of product that can then be broken down into more manageable quantities for their customers. Nowadays, information that was used to be transmitted to Customs and Border Protection (CBP) on paper forms is entered in Ace, which is a one-stop-shop software system that aggregates data on all imports. This data can then be accessed by several government agencies, including the FDA. Anyone wishing to bring food into the United States for consumption on our shores will be required to declare a Foreign Supplier Verification Program (FSVP) Importer for the food, and the names entered as FSVP Importers will then form a database from which the FDA will work to ensure enforcement of this program.

This FSVP Importer may or may not be the same as the Importer of Record (IOR). Large companies are already re-writing their import contracts to include this requirement, for it’s quite clear already that communication of expectations will be vital to the success of this program. The FDA recognizes that it is possible that unscrupulous parties may enter the name of a party as the FSVP Importer who does not realize their name has been entered; however, the main recourse for the injured party is to better communicate with their supply chain to ensure the issue does not arise again.

Although these technicalities are important to understand, it is perhaps even more interesting to consider the implications of all the FSMA requirements surrounding this rule. For example, FDA’s requirements for records are very clear, and each record must include the name and address of the facility at which it was created, in addition to other information. The rules of FSMA are also quite clear in stating that brokers or distributors cannot provide the necessary food safety paperwork on their own; rather, this documentation must come from the grower, manufacturer, processor—for a true farm-to-fork implementation, in keeping with the spirit of the rule.

What does this mean for the broker who sells to a large company that is perfectly capable of purchasing the large quantities required to “go direct”? Will they be cut out of their livelihoods by being forced to give this information to their customers? This is a question that has been raised in all the FSVP Importer classes held to date, and in reading the rule, it appears clear that the broker is expected to disclose their source. How else is it possible for them to follow the law, and assure their customer that the food was produced with the same level of food safety as if it were made here in the United States?

Foreign Supplier Verification, TraceGains A Comprehensive Guide to the Who, What & How to FSMA’s FSVP Rule

Have confusion regarding some of the specifics to FSMA’s Foreign Supplier Verification Program rule? You’re not alone… Are you the importer? What if you’re a broker? What are the actual contents of a verification program? This comprehensive guide can help answer some of these lingering questions, and will provide you with a couple real examples of FSVP in action.

This is a particularly interesting conundrum because at its heart, this is an issue of information exchange between private companies. Although the FDA does expect that some entity will keep the records to satisfy the requirements of the FSVP, they will not expect this paperwork to be transmitted to any government agency prior to approval of a load for import. Rather, the FDA will send electronic records requests to the entities declared as FSVP Importers later, wherein they will ask for the records related to previous shipments. Should the FSVP Importer declared at import not produce the required documentation at the time of this request, enforcement activities are expected to result (eventually, once the rule has gone into effect and regulation has begun).

It stands to reason that some entities may continue to operate in a fool’s paradise for some length of time, thinking nothing has really changed. This is incredibly dangerous for the business, its reputation and indeed, for the consumer. Times are obviously changing across the globe, and the FDA is doing its best to keep up with the demands of an increasingly complex global society. The broker who enters his own name without understanding the implications of what that means may find himself on the receiving end of a number of records requests from the FDA, with no records on hand with which to fulfill them. This is not an enviable position, and will likely result in an in-person visit from an investigator if the food imported is considered high-risk.

There are, of course, many brokers and distributors who are proactive and concerned about food safety. These are the companies that are sending multiple individuals to FSVP training to stay informed about the changing face of import regulations. Many of these brokers and distributors already gather paperwork such as third-party audit reports and letters of guarantee from their suppliers, but they do not transmit this information to their customers. Should these proactive companies be essentially punished for following the letter of the law? Even if a purchasing department has a warm personal relationship with their broker or distributor, if the C-suite sees an opportunity to save a substantial sum on their commodity of choice while increasing transparency in the supply chain, certainly those decisions will be made without regard for hurt feelings.

What about redaction? Can the brokers or distributors redact the sensitive information from the documents, and transmit them in that way? Perhaps, but after consultation with a brilliant and experienced legal mind, redaction may not be the panacea it first appears. For example, redaction of documents is a boring and redundant task, frequently relegated to the intern or other low-paid office worker due to its repetitive nature. These workers may perform the redaction lackadaisically, or use CTRL-F to find all appearances of the information to be redacted. In doing this, they often miss important information that appears in an image or is misspelled. Additionally, anyone who has spent much time in the food industry understands that this is a small world, and it is often easy to recognize a document simply from the style in which a particular company presents all its documentation. Clues such as colors, partial logos and incomplete redaction can lead to a shrewd individual deducing the original author of the documents quite easily.

Although there are no answers to be had at this juncture, especially considering that the compliance date for these requirements has not yet passed, it is important to think about all these implications, along with many others that are being brought to the forefront through the Importer workshops approved by the Food Safety Preventive Controls Alliance. The FDA readily admits they are learning right alongside industry, and they have every intention of continuing to educate while they regulate. If these issues cannot be hammered out between industry representatives and the FDA directly, it stands to reason the issue will eventually be brought before the courts, where the demands of capitalism will be weighed against those of regulation for food safety. Is there a legal precedent for this situation? If you know of one (or several), please leave the information in the comments below to continue the discussion.

Katy Jones, Foodlogiq
FST Soapbox

Supplier Management: Grow Strategic Partnerships and Drive Value Across the Supply Chain

By Katy Jones
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Katy Jones, Foodlogiq

According to a report by Kroll and The Economist Intelligence Unit, 17% of companies experienced some type of vendor, supplier or procurement fraud in 2015. While fraud is one of the more extreme examples of supplier management complications, the manufacturer-supplier relationship is notoriously fickle and can result in serious issues if attention and care is not reciprocal from the beginning.

With great communication and even better processes in place, your suppliers have the potential to become strategic partners for your brand, helping drive your values across the supply chain while also helping you achieve overarching business goals.

Do Your Homework

In order to foster positive supplier relations, it is important to consider all available options and carefully assess them before engaging. In the research phase, it is critical to get as many references as possible to ensure you align with a potential supplier when it comes to safety practices and brand values. Looking at a supplier’s history is an effective way to gauge how your partnership will pan out and catch any red flags before they become a bigger problem for the brand, whether that be poor communication habits, dishonesty about products or inconsistent record keeping.

FSMA deadlines for compliance with the Foreign Supplier Verification Program (FSVP) are right around the corner. With the changing regulatory landscape, thoroughly investigating potential suppliers is crucial, especially if they are outside of the United States, as the stakes are much higher. Under the FSVP, importers are essentially “guilty” until proven “innocent”—a sharp contrast from how foreign suppliers were previously handled by the FDA. The standards for imported food are stricter than ever, as are the consequences for companies that are found working with foreign suppliers without verification. With the FSVP, the FDA can halt all importations completely as long as they have reason to believe the supplier is not compliant with the program.

Communication Is Key

At the cornerstone of any good relationship is communication; the same goes for relationships within the food industry.

Once a supplier has been thoroughly vetted and is officially on the team, the key to maintaining a successful relationship is transparency. Without full transparency with suppliers, you can’t offer consumers reliable information about their food. At the same time, manufacturers need to be straightforward with their needs to ensure suppliers are able to uphold their expectations. By thoroughly communicating plans and expectations, you and your suppliers can effectively work together to achieve future goals.

At the start of a working relationship with a supplier, it is important to comprehensively onboard and train them in your plans and processes to avoid a lack of understanding down the line. By setting up an all-encompassing onboarding system, inclusive of checklists and background documents on procedures and standards, you can help ease growing pains and empower your new food supplier to become a trusted partner. For instance, if you use a specific supply chain technology, your suppliers should know ahead of time so they can receive adequate training on the solution. This will help streamline communication and minimize any bumps in the road.

Regular Check-Ups

While safety and contamination issues are undesirable, they are inevitable. When faced with an outbreak or contaminant in your supply chain, suppliers become your most crucial resource. A poorly handled recall can wreak havoc on a food manufacturer, with the potential to ruin a trusted brand. Having the correct protocols in place with suppliers to ensure proper procedures are followed quickly and efficiently is critical. In order to make sure suppliers are complying with standards, keeping complete records and maintaining proper safety practices, it is essential to perform regular supplier audits.

With the addition of new technologies in the last few years, monitoring supplier performance and implementing corrective actions has never been easier. There are companies that offer supplier management and food safety management software to enable manufacturers 24/7 end-to-end visibility into their food supply chain and suppliers’ practices, while simplifying communication. Supplier management software offers a single platform that allows a brand to safeguard important supplier documentation, submit proper records to regulators when audited, streamline supplier audits and compliance records, and communicate corrective actions.

Overall, supplier management software with end-to-end supply chain visibility is a great way to keep up with suppliers and rest assured that your company’s food safety guidelines are being followed at all times.

Keeping Consumers Safe and Happy

With the current state of food safety, keeping suppliers in check is absolutely crucial for brands. As the FDA is increasing regulations with the adoption of FSMA, manufacturers must be able to trust their suppliers to uphold these new standards. If there are any slip-ups, your brand is held accountable. At the same time, with the increasing number of high-profile recalls and foodborne illness reports, consumers are on high alert, and winning their trust is harder than ever; today’s conscious consumer expects total transparency from their food brands, something only achieved through a strong supplier management program.

Fortunately, given advancements in technology, manufacturers can now foster more proactive relationships, assess supplier performance and achieve mutual goals across the chain smoothly.

While good supplier management requires time and resources, it is worth the investment. Putting in the effort to foster strategic partnerships with suppliers is key to mitigating safety and contamination issues, meeting the FDA’s regulations, as well as keeping consumers safe and happy.

FSMA

FDA Addresses Hazards Requiring Control in New Draft Guidance

By Food Safety Tech Staff
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FSMA

Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.

“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.

The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).

Maria Fontanazza, Food Safety Tech and Christina Romas, Repositrak

Does the C-Suite Understand FSMA? Not Completely

By Food Safety Tech Staff
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Maria Fontanazza, Food Safety Tech and Christina Romas, Repositrak

One year ago, the industry was speculating about the details of the final FSMA rules, but was very much taking a “wait-and-see” approach. With all seven rules finalized, companies are now preparing for compliance. Beyond taking the steps to ensure that companies understand their responsibilities pertaining to each rule, there has been continual concern over a lack of C-suite awareness—both related to FSMA and knowing what is really happening at the ground level. “I think there’s been a culture shift with food safety professionals having more visibility to the leadership team and to the C-suite,” said Christina Romas, senior vice president at Repositrak, during a recent interview with Food Safety Tech.

When asked whether she thought the C-suite adequately understands FSMA, Romas succinctly replied, “no”. Watch the rest of the video to hear what Romas had to say about FSMA compliance challenges and which rule is getting the most attention from industry thus far.

 

Audit

The Multi-Step Process of Third-Party Accreditation

By Charles Breen
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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.

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TraQtion dashboard

New Software Warns of Out-of-Compliance Suppliers and Products

By Food Safety Tech Staff
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TraQtion dashboard
TraQtion dashboard
Screenshot of TraQtion dashboard. Click to enlarge (Courtesy of NSF International)

TraQtion has announced new software that is designed to help companies better manage supply chain risks. By scanning, evaluating and interpreting data, the upgraded cloud-based software is able to anticipate potential issues and whether corrective measure must be taken immediately, and alerts clients to suppliers, products and sites that pose a higher risk. Its intelligent compliance engine runs an algorithm in the background to provide visibility to problem areas and prioritizes responses across a company’s locations accordingly. A product inspection module automatically identifies in-spec and out-of-spec products through testing and inspection. A dashboard gives users an overview of the company’s quality and compliance program, and uses a color-coding system to rate suppliers, products and sites.

TraQtion is a wholly owned subsidiary of NSF International.

Food Safety Tech

Most Popular Stories of 2015

By Food Safety Tech Staff
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Food Safety Tech
Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry.

5: FSMA’s FSVP: Clearing the Confusion of Importing Rules

Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

4: When Someone Dies, It’s Not Business as Usual

“His actions resulted in technically more deaths than that of Charles Manson,” said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness.

3: Marijuana Edibles: Update on a Rapidly Developing Market

Marijuana has catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry

Steward Parnell, PCA, salmonella outbreak
Stewart Parnell sentenced to 28 years in prison.

2: Food Safety Culture: Measure What You Treasure

A renewed recognition of the importance of individual employee behavior within food processing and manufacturing organizations is shining a spotlight on awareness and accountability, but a standardized measure of food safety culture must be defined.

1: PCA Executives Sentenced: Stewart Parnell Gets Virtually Life in Prison

The landmark case sets a precedent for the food safety industry.

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
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Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.

FSMA Final Rules on Produce Safety, FSVP and Accredited Third-Party Certification Out

By Food Safety Tech Staff
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Unpublished documents available on Federal Register; FDA to weigh in at next week’s Food Safety Consortium.

FDA has released its final FSMA rules on produce safety, foreign supplier verification programs (FSVP) and accredited third-party certification. The documents were filed today and are scheduled to be published on the Federal Register the day after Thanksgiving, Friday, November 27.

An agency alert called the finalization of the rules “groundbreaking”, as FDA takes “major steps to prevent foodborne illness”.

The final FSMA rules (unpublished documents) are available for download:

Next week’s Food Safety Consortium will feature several sessions dedicated to the discussion of these rules, including:

  • “Ask the FDA” Town Hall with Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine
  • Foreign Supplier Verification with Eric Putnam of Wixon, Inc. and Shawn Stevens of Food Industry Counsel, LLC
  • Compliance for Accredited Third Party Auditing with Trish Wester of PA Waster Consulting and Janet Raddatz of Sargento Foods, Inc.

FSMA Update: FDA Submits Final Produce, FSVP, and Third-Party Accreditation Rules

By Food Safety Tech Staff
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Industry awaits Federal Register publication.

Today FDA announced that it submitted the final FSMA rules for produce safety, foreign supplier verification and third-party accreditation rules. As we await final publication by the Federal Register, here’s a look back at some of Food Safety Tech’s recent coverage related to FSMA issues:

Is your supplier program aligned with new FSMA rules?

The Real Cost of Not Having an Effective Food Safety Management System

How Does SQF Certification Prepare You for Better FSMA Compliance?

FDA Awards $600,000 for FSMA Training Center

Not to miss event this month: FDA to Weigh In on FSMA Enforcement at Food Safety Consortium