Tag Archives: foreign supplier verification program

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.
Robert Garfield, Senior Vice President of the Safe Quality Food Institute

How Does SQF Certification Prepare You for Better FSMA Compliance?

By Food Safety Tech Staff
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Robert Garfield, Senior Vice President of the Safe Quality Food Institute

“Over a period of time, things have changed for the corner suite, and many CEOs and presidents of corporations understand that with the media today and the way that FDA has improved its ability to focus on contamination, something needed to happen,” said Robert Garfield, senior vice president at SQFI during the recent “SQF in the Age of FSMA” webinar. “It’s not everything that we wanted…but it’s a rule that brings the regulations up to where they need to be in this century.”

GFSI leaders will be available during the Food Safety Consortium conference. On Wednesday, November 18, don’t miss the session, “The Role of Technology in Ensuring Accessible, Actionable Data to Tackle FSMA Compliance”. LEARN MOREGarfield discussed the role of SQF certification in FSMA compliance during part one of the 2015 GFSI Leadership webcast series. Hot topics included:

  • Foreign supplier verification program alignment
  • Building a food safety plan, including HACCP to HARPC migration
  • Being audit ready and record keeping requirements
  • Environmental monitoring
  • “Farm-to-fork” and safety controls
  • SQF scheme changes to align with FSMA
  • How SQF fills in the gaps in FSMA requirements

The next webinar takes place Friday, October 30 and covers the alignment of BRC certification with FSMA. John Kukoly, director of BRC Americas, is the featured speaker. Register here for the complimentary webinar.

Holly Mockus, Product Manager, Alchemy Systems

Real Training Needs – Time and Resources

By Holly Mockus
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Holly Mockus, Product Manager, Alchemy Systems

With the announcement on September 19, 2014 of the released re-proposals to the main FSMA-related rules – Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program – it is time to take another look at the real need within the food industry related to training and education.

The word ‘train’ in some form or format appears over 100 times in the Produce Safety rule and the Preventive Controls for Human Food documents. One Hundred Times! This is clear indication that it’s time to take another look at the training programs in place today.

When asked, managers and supervisors responsible for training today typically respond that their biggest challenges or needs are having the time and resources available to conduct meaningful training for the workforce. Gone are the days where a ‘good’ training program consisted of shoehorning a training session into a segment of line downtime and hoping for enough time to cover all the learning objectives. As regulatory and customer emphasis on employee empowerment and engagement continues to escalate – food industry training programs must grow and evolve.

Here are some basic areas that need the proper time and resource dedication for maximum impact:

  • An analysis to determine gaps in the current training program should be very robust. Don’t skimp on the resources needed to do an effective job here. The use of this data is the first steps on the training journey and becomes the cornerstone as you build employee expertise.
  • The development of content should not be under resourced at any step in the process. Content is critical in providing the ‘How’ and the ‘Why’ (Who, Where, and When too). Worry less about fitting the material into a specific time slot and more about the quality and applicability for the specific workforce audience.
  • Partnering with a Subject Matter Expert or a content provider is an investment that will pay dividends as employees soak in the knowledge and ask for more.
  • Delivering the content in an environment that is conducive to group training where there are now distractions, all questions and answers can be heard by the participants in another resource that is critical to the success of a robust and effective program. Learning labs for more one-on-one self-directed learners are another means of providing knowledge to the workforce without having to incur line downtime. An investment that will pay for itself in a relatively short period of time.
  • Coaching employees for success in one of the best gifts that a supervisor or manager can provide. Constructively correcting incorrect behaviors and positively reinforcing good behaviors may take good people skills and a little extra time. Making it a habit costs very little and will provide a clear concise roadmap throughout the training process.

Training is a journey, not a destination. Teaching ‘how’ starts the journey – ‘why’ builds the culture. Spending time and resources for training should be a no-brainer for the food industry today. Stop looking at training as time spent losing operational effectiveness and start looking at training as the best investment you can make in your people, products and brands!

Hear the author speak more on Food Safety training at the Food Safety Consortium, November 17-18, 2014, Schaumburg, IL. Click here for more details and to register.