Tag Archives: FSMA

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.

Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

FDA Investigators Take New Approach with FSMA

By Food Safety Tech Staff
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Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

One of the industry concerns related to FSMA implementation surrounds the change in approach required of FDA investigators—from a resolutions approach to a systematic method of assessing systems and facilities. During an FDA Town Hall at the Food Safety Consortium, Michael Taylor, deputy commissioner for foods and veterinary medicine at the agency explained that he was initially concerned about this shift, but is now pleased with the enthusiasm he sees among FDA investigators. “They’re part of a public health force that is out there empowered and supported in the verifying the systems… as opposed to the historic role of collecting evidence [and] going back to the office…” he said.

FDA Work Begins on FSMA Implementation

By Food Safety Tech Staff
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Part II of Michael Taylor’s speech at the Food Safety Consortium gets into what’s at stake as the implementation stage of FSMA begins. “We’re regulating areas we haven’t regulated before,” said Watch Part I of Michael Taylor’s speech HERETaylor, as he acknowledged the work FDA has been doing with produce growers and the enforceable standards that will now be present on farms. He also indicated the challenges ahead in regulating imports and managing the supply chain—more than 150 countries send food products to the United States, and this continues to grow rapidly.

“We see the import aspect of implementation perhaps being the most daunting in the sense that it’s really requiring us to work in completely new ways with foreign partners, with the import community, and a whole new robust toolkit…that needs to be used in a strategic new way,” said Taylor.

Michael Taylor reflects on FSMA journey

Metrics for FSMA Compliance a Work in Progress

By Food Safety Tech Staff
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Michael Taylor reflects on FSMA journey

Ideally, FDA wants to have the ability to use metrics for monitoring and measuring reductions in foodborne illnesses. However, this is extremely difficult right now, according to Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. At the 2015 Food Safety Consortium, Taylor responds to an audience question of whether metrics for FSMA compliance have been established.

FDA Reflects on Monumental Effort of FSMA

By Food Safety Tech Staff
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Four years in the making and the FSMA implementation journey has begun. Michael Taylor, deputy commissioner for Watch Part II of Taylor’s speechfoods and veterinary medicine at FDA, describes, from a high-level perspective, what lies ahead in his first public speech since five of the seven rules were finalized. The following video is Part I of Taylor’s speech at the 2015 Food Safety Consortium conference.

Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

By Food Safety Tech Staff
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Palmer Orlandi, FDA, Food Safety Consortium

Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.

According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:

  • Mutual reliance on partners (federal, state and FDA)
  • Data-sharing capabilities (how data is generated and transmitted)
  • Acceptance of lab data

Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.

FSMA: Biggest Challenge is Preparation, Outbreaks Still to Come, Says FDA

By Maria Fontanazza
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FDA's Michael Taylor called the journey to FSMA an "amazingly robust process". (Click to enlarge)
FDA’s Michael Taylor called the journey to FSMA an “amazingly robust process”. VIEW VIDEO

FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”

In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.

Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators.
Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators. (Click to enlarge)

Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.

One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.

Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”

Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium take a selfie to capture the "Kodak" moment.
Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium, take a selfie to capture the “Kodak” moment.

All images by amyBcreative photography.

Randy Fields, Repositrak
FST Soapbox

Dealing with FSMA’s Documentation Demands

By Randy Fields
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Randy Fields, Repositrak

With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for the safety of their supply chains. In addition, FSMA’s focus on prevention and its seven new rules requires retailers and wholesalers to collect, manage and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and extend two years back. And here’s the kicker: Senior executives are now responsible for the compliance of their supply chain with FSMA.

At the Food Safety Consortium, Affiliated Foods Midwest (AFM) will talk about their preparation for FSMA compliance and decision to move away from their “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused heavily on documenting preventive measures, AFM executive leadership assessed the company’s gaps and determined they needed to be more proactive.  John Grimes, director of safety for AFM, estimated that at the start of the company’s journey, about 30% of vendors were non-compliant with the three records they required: Certificates of Liability with specified limits, Hold Harmless forms and W-9s. 

“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected. We also needed to increase compliance, be more proactive, and so we were looking to automate our systems,” explains Grimes.

AFM decided to adopt the cloud-based Compliance Management System to proactively manage both business-related documents and FSMA-related records. Once implemented, the wholesaler’s non-compliance among vendors was reduced by 60% in the first 90 days through proactive alerts, automated exception reporting and focused, personal follow up. 

On Thursday, November 19, Randy Fields and John Grimes will discuss “FSMA Compliance Really Starts With Knowing Your Supply Chain” at the Food Safety Consortium. LEARN MORE“With our prior system I could find a requested document within 24 hours, but with the cloud-based compliance management system, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” says Grimes.

Document management at AFM is now much more proactive vs. reactive.  The Compliance Management System automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. The system enables AFM to proactively manage more documents by vendor than ever before.   

The active approach that our staff enables its customers to take in managing compliance is really its differentiator. Each customer is provided with a dedicated team to reach out to their vendors to speed enrollment and quickly address their compliance issues.

According to Grimes, as more retailers and wholesalers adopt this type of system, the vendor community will move more quickly to embrace solutions that will help them comply with FSMA.

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.
Jacob Bowland, Heateflex
In the Food Lab

FSMA to Increase Role for Food Microbiology Testing Laboratories

By Jacob Bowland
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Jacob Bowland, Heateflex

As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.

Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities.  Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.

In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records.  Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility.  This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon.  LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.

In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs.  The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.