Tag Archives: FSVP

Imports
Food Safety Attorney

The Ins and Outs of FSMA’s Foreign Supplier Verification Program

By Jennifer Allen
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Imports

In recent years, through regulations created under the Food Safety Modernization Act, the FDA has adopted a preventive approach to food safety, in contrast to the Whack-A-Mole strategy of dealing with foodborne illness that proceeded the FSMA. Thus, an alphabet soup of new processes, such as HACCP and HARPC, have taken center stage. But with so much food being imported from other countries, these regulations could very easily be undermined. Enter the Foreign Supplier Verification Program, or FSVP (found at 21 CFR 1.500 et seq.).

The FSVP’s purpose is to ensure that importers of foods from outside of the United States have adequate assurance that these foods were harvested, grown, manufactured, processed and/or packaged using protections equivalent to those imposed by the FDA on U.S. foods. The regulations define a foreign supplier as the establishment that manufactures, processes or grows the food, or raises the animal, for export to the United States, without further manufacturing or processing by others (besides labeling or other similar de minimis activities). Absent an exemption, importers of foreign foods and the foreign suppliers themselves must comply with the FSVP.

Under the FSVP, importers must conduct a hazard analysis for each type of food they import. They must then approve each foreign supplier they use, taking into consideration the results of that analysis; the identity of the entity that will be minimizing or preventing any hazards; the foreign supplier’s performance; and any other relevant factors. And importers must document this process and their approval of each foreign supplier. This process should take place every three years or whenever circumstances change. And since having an approved foreign supplier has limited effect if importers don’t limit their food imports to those approved suppliers, importers must also have written processes in place to ensure that they import foods only from approved suppliers.

The FSVP is not a one-and-done process. After approving a particular foreign supplier, and before actually importing food for the first time, importers must determine which verification activities they will conduct to provide assurance that any identified hazards have either been significantly minimized or prevented, as well as the frequency of those activities. Depending on the particular food and the type of hazard, the importer must decide whether to conduct onsite audits, sampling and testing of food, a review of the foreign supplier’s relevant food safety records, any other appropriate activity, or a combination of these activities. And if the foreign supplier at any time fails to significantly minimize or prevent any identified hazards, then the importer must have steps in place to take corrective measures.

There are some foods that are exempt from the FSVP’s requirements. The requirements do not apply to juice and fish, food imported for research or personal consumption, alcoholic beverages, foods regulated by the USDA (meat, poultry, egg products), food that is merely shipped through the United States, and food that is manufactured, grown or raised in the United States, exported, and returned. In addition, imported canned foods are exempt, but only if the importer verifies and documents the foreign supplier’s compliance with the requirements of 21 CFR 113. There is also a partial exemption if the imported food will be incorporated into a canned product that complies with part 113. And importers are deemed to be in compliance with the FSVP if they are considered a “receiving facility” under 21 CFR 117 or 507 (hazard planning for human and animal food respectively) and if they either implement preventive controls for the imported food, are not required to do so, or have established and implemented a risk-based supply-chain program.

Last but not least, under 21 CFR 1.512, very small importers and those who import food from certain types of small foreign suppliers are required to adhere to a less burdensome set of regulations. A very small importer is one whose sales of human or animal food, in the previous three years, adjusted for inflation, totaled less than $1 million or $2.5 million per year respectively, when combined with the U.S. market value of any human or animal food imported, manufactured, processed, packed, or held without sale. Foreign suppliers are considered small if they are a qualified facility under parts 117 or 507, are a farm that is not considered to be a covered farm under 21 CFR 112, or if they export shell eggs and have fewer than 3,000 laying hens. Importers must keep records showing that part 1.512 applies.

Very small importers must obtain written assurance from their foreign suppliers before importing any food and every two years thereafter that the supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as U.S. regulations provide. Those importing food from certain small foreign suppliers must obtain written assurances from those suppliers that generally provide assurance that the food is safe.

As always, the devil is in the details. Before importing any food, importers should carefully review the regulations, preferably with legal assistance, to ensure that they do not run afoul of the law and inadvertently undermine the safety measures in place here in the U.S.

FDA Logo

FDA Issues Final Guidance for Foreign Supplier Verification Programs

By Food Safety Tech Staff
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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.

Koshal Ram and Ranjeet Klair

Acheson Group Expands into India

By Food Safety Tech Staff
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Koshal Ram and Ranjeet Klair

The Acheson Group (TAG), a global food safety and public health consulting team led by David Acheson, MD, former FDA Associate Commissioner for Foods, has expanded its operations to India.

As part of the expansion, TAG brought on two new team members. Food Safety Specialist Koshal Ram has nearly three decades of experience working in low-acid agri-food manufacturing and has held technical and global leadership roles managing supply chain food safety and product quality with multiple companies. Ram has a diploma in Quality Assurance and ISO from the University of Chennai, India. He speaks four languages (English, Hindi, Tamil and Kannada) and is a Preventive Controls Qualified Individual (PCQI) and an FSVP Qualified Individual. He is trained in Food Safety and Standards Act 2006, ISO 2000 requirements, QAS validation and verification of HACCP Plans and QAS development and implementation of HACCP Plans, Acidified Food Manufacturing School (21CFR section 108.25(f) and 114.10) and FDA Acidified Foods.

Ranjeet Klair will work in conjunction with Ram at TAG India as Director of Food Safety. She brings more than two decades of industry experience working with Canadian, U.S. and global food retailers, production plants and certification bodies in food safety, quality assurance and regulatory compliance. Klair holds a Master of Science degree in Food Sciences, Master of Global Food Law (Jurisprudence) degree and a Bachelor of Applied Science and certification in International Food Laws and Regulations. Along with completing a certification program for International Food Laws and Regulations, she is a BRC, FSSC22000, HACCP, PCQI, FSVP trainer and BRC, SQF, FSSC, ISO 22000, Gluten-free, GMP and Canada GAP lead auditor.

As a key component of service to India, TAG will provide expertise and resources to assist exporters in food safety efforts and domestic and foreign standards and regulatory compliance.

“With TAG’s 10-year anniversary quickly approaching, we are excited to bring on valuable new TAG Team members who can help further expand our business to different areas of the world,” said Dr. Acheson, TAG CEO and President. “Ranjeet’s and Koshal’s expertise and ability to work onsite with clientele throughout India enables us to bring TAG support to India.”

FDA

FDA Ready to Start Domestic Surveillance Inspections

By Food Safety Tech Staff
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FDA

Last week the FDA announced that it would resume conducting domestic surveillance inspections on February 7—affecting all commodities. The agency will continue with mission-critical domestic and foreign inspections, and leverage remote assessments when necessary. FDA will also conduct previously planned foreign surveillance inspections that have received country clearance and fall within the CDC’s Level 1 or Level 2 COVID travel recommendation.

“Throughout all these activities, the agency remains committed to the health and safety of its investigators and will provide the protection needed to safely inspect facilities and conduct investigations at the ports and in agency laboratories.” – FDA

FDA’s plans to start foreign prioritized inspections in April. It will also continue remote FSVP activities for human and animal foods. However, state inspections under the FDA contract have the authority to determine whether to make inspection decisions as per local information.

FDA

FDA Offers Help to Companies with Supply Chain Disruptions

By Food Safety Tech Staff
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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.

Kathryn Birmingham, ImEpik

Ask the Expert: ImEPIK Discusses Supply Chain Controls and PCQI Responsibilities Under FSMA

Kathryn Birmingham, ImEpik

Dr. Kathryn Birmingham, one of ImEPIK’s PCQI training experts, provides guidance to Juan, a future PCQI in a plant that receives ingredients for ready-to-eat energy bars.

Juan: I’m new on the food safety team at a small company and the next person to be trained as a PCQI. Our team wants to make sure we are meeting the requirements in our food safety plan under the Preventive Controls for Human Food Rule in FSMA. There are a lot of players along our ingredients supply chain. Who is ultimately responsible for product safety?

Kathryn Birmingham: As you know Juan, if you manufacture, process, hold or pack an ingredient or food product, food safety is your responsibility. For all of the players along the supply chain FSMA focuses on risk assessment and identifying hazards and preventive controls when required. Your team must have a plan and implement verification activities for the supply chain preventive controls for the food ingredients with hazards you have identified needing a control.

Juan: So, we are sourcing chocolate from a number of suppliers or our bars. They all provide COAs with the shipment that tell us the chocolate is manufactured to be free of pathogens like Salmonella. Usually we get a laboratory report on the sample testing for vegetative pathogens from the supplier for each shipment. We put that in our food safety plan to verify that the hazard was controlled by the supplier. But one of the suppliers has not provided sample testing results we requested. We have finished product to get out the door, but we have to ensure our product doesn’t harm consumers. On top of that, we can’t risk a costly product recall.

Kathryn: Right, Juan. That Certificate of Analysis may not be enough to verify that your chocolate supplier is effectively controlling for the hazard of Salmonella. For your product process flow the chocolate will never have a kill step to mitigate the hazard. If you cannot be sure that the hazard has been significantly minimized or prevented before receipt of the chocolate – per section 117.410 in the PCHF Rule – you have some choices to make. If you are using a foreign supplier there are considerations if the supplier is or is not in compliance with the FDA’s Foreign Supplier Verification Program.

Juan: So it looks like we may have to take on the cost and additional time of sample testing?

Kathryn: Remember, supplier approval is based on performance. If your supplier does not give you the evidence for verification you may need to conduct an onsite audit, perform sampling and testing and review other supplier records. You decide if the supplier meets your Supply Chain Control Program or Foreign Supply Chain Control Program.

Juan: My team members need to learn more about what we need to do to comply with FSMA and the PCHF Rule. Tell me about what we can learn through PCQI training.

Kathryn: Preventive Controls Qualified Individuals are trained in a methodical process for decision-making on hazards and preventive controls. The best training fosters a positive food safety culture and includes practice on team scenarios.

A PCQI must be able to identify hazards associated with a product and process, determine the appropriate preventive controls and develop associated monitoring and corrective actions for hazards that are identified. PCQIs must also establish and implement appropriate verification activities for the application of preventive controls. All of that is included in the food safety plan they oversee.

Juan: What choices do we have for online PCQI training?

Kathryn: First choose your food safety team members. If your company is registering with the FDA you are required to have at least one PCQI at each facility. Most companies train multiple or back up employees for the PCQI role to ensure they are covered during vacations, sick time, various shifts or employee turnover.

Look for courses that include the FDA’s standard curriculum, like ImEPIK’s PCQI Online. The PCHF Rule does not require that PCQIs hold a specific training certificate, but FDA inspectors want to see that the PCQI has been successful in a training with the requisite learning objectives and content. There are many PCQI training options on the market. Some providers claim that their training is the only accepted training – that’s simply not true.

Look for courses that have a multiple of scenarios with different food products and challenge situations for practice and wider breadth of learning.

ImEPIK’s PCQI Course is interactive and 100% online. The ten-module training is entirely self-paced thus does not require travel or scheduling on-line webinars or sessions. You simply log in, work through the course as you have time, and earn your completion certificate to document in your food safety plan. If you take a break, the work you have done will be saved, and you pick up where you left off when you return to the course. This allows for reflection and practice in the workplace as you move through the modules.

It’s an ever changing environment for the food safety professional and quality training makes a big difference in keeping up with changes and staying regulatory compliant. Take PCQI Online and position yourself and your facility for food safety success.

About Kathryn Birmingham, Ph.D

Kathryn Birmingham, ImEpikKathryn Birmingham, Ph.D., is Chief Operating Officer of ImEPIK. Birmingham leads the company’s course development teams and ensures that the online training solutions are of high quality. She is certified as a Lead Instructor to teach the FSPCA’s Preventive Controls Qualified Individual course.

Dr. Birmingham taught graduate and doctoral students at the University of Florida and served as Dean of Arts and Sciences at Florida State College. At the latter she lead the Biotechnology Degree program and Institute for Food Safety analytical lab. She was Principal Investigator (PI) for its National Science Foundation studies.

Content Sponsored by ImEPIK.

FDA

FDA to Conduct Remote Importer FSVP Inspections, Extends Comment Period for Lab Accreditation Proposed Rule

By Food Safety Tech Staff
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FDA

Today the FDA announced that it will begin requesting electronic records related to import records required under FSVP for Importers of Food for Humans and Animals. The agency is moving to remote inspections as a result of the COVID-19 pandemic. FDA stated that in “rare” instances it will onsite FSVP inspections—these situations include outbreaks.

“The FDA will immediately begin conducting a limited number of remote inspections, prioritizing the inspections of FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The Agency is also planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records.” – CFSAN Constituent Update

FDA has also extended the comment period for the Laboratory Accreditation Program Proposed Rule from April 6, 2020 to July 6, 2020.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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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.

magnifying glass

Failure to Have Foreign Supplier Verification Plan a Common Inspection Observation

By Maria Fontanazza
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magnifying glass

Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.

Thus far, common citations include:

  • No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
  • No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food

Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:

  • Approval of a foreign supplier
  • Evaluating foreign supplier performance, along with related risks
  • Establishing written procedures to ensure foreign supplier verification activities are performed
  • Review and assessment of another party’s evaluation of foreign supplier performance
  • Ensuring food was produced in compliance with low acid canned foods regulations
  • Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food FY 2017 285
Risk-based (hazards, importers and suppliers) FY 2018 792
Align with PC supply chain provisions FY 2019 (as of 5/28/19) 458 (FDA is planning for 880)
FDA oversees compliance via importer inspection
Foreign suppliers can help importers comply

 

Food Safety Tech

Call for Abstracts: Be a Part of the 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Tech

The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.

If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:

  • Food Safety Supply Chain Vulnerabilities & Solutions
  • Audits & Inspections
  • How to Write Supplier Specifications
  • Blockchain Technology
  • FSMA’s Sanitary Transportation Compliance Tools & Techniques
  • Supply Chain Traceability
  • FSMA’s FSVP Compliance Tools & Best Practices
  • Data, Predictive Analysis
  • Recalls: barcode labeling, case histories and lessons learned
  • Testing Strategies of the Supply Chain
  • Supplier Verification Best Practices
  • Supply Chain Risk Management
  • Food Safety Transportation, Distribution and Logistics
  • Food Authenticity
  • Food Safety/Quality Culture measurement in supplier management
  • Supplier Management Case Histories

Each abstract will be judged based on educational merit. The submission deadline is February 8, 2019.