Tag Archives: FSVP

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

 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSVP: What Has Changed in the Re-proposed Rule?

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent FSMA Fridays webinar, Dr. David Acheson, and Melanie Neumann of The Acheson Group covered some of these changes and its impact on the food industry. Food Safety Tech presents some excerpts:

What is FSVP all about?

Dr. Acheson: The foreign supplier verification program is supply chain risk control for imported foods. Following the melamine in pet foods scandal that originated in China, the legislation was aimed at tightening preventive controls for imported foods. The rule concerns companies that import food from foreign manufacturers, and requires them to ensure that those suppliers are complaint with FDA requirements in the U.S. and thus, you are addressing risks along the supply chain.

How did the re-proposals change FVSP rules?

While there are several changes proposed, the entire substance of the FSVP rules haven’t changed as whole. Overall the changes seem to align the FSVP rule closer to the preventive controls rule in terms of wording and intent. Some of the changes include:

  • Approved Suppliers: As long as an importer can demonstrate that they have a process to approve suppliers, and that they follow it, there is no need for them to maintain a list of approved suppliers. However, this raises a question: If you don’t have a list of suppliers, do you know if your supplier is approved or not?
  • Supplier Risk: FDA now requires an evaluation of supplier risk along with product risk. Factors that should be considered include regulatory compliance, the history with the supplier (including test results and their willingness to correct problems), and any other relevant factors.
  • Audit requirements: In the original rules, FDA asked whether or not an initial audit and subsequent annual audits should be required when an importer identifies hazards that could cause serious adverse health consequences or death to humans or animals. In the supplement, FDA has basically said that yes, audits should be required under these circumstances, but has also given the flexibility in stating that if an importer can demonstrate that the risk can be managed in some other way, and that suppliers can be just as effectively verified through other means, then the importer is free to use other tools, or to decrease frequency of the audits.
  • Duplication of efforts: FDA will not require food manufacturing facilities who are subject to preventive controls (and who rely on suppliers to control significant hazards) to keep a whole additional plan in place to comply with FSVP.
  • Definition of very small importer: In the re-proposed rule, FDA has set $ 1 million in annual sales as the definition for very small importer, which aligns with the definition in the Preventive Controls rule.

Will food and beverage importers be expected to do onsite audits of foreign suppliers?

As described above, importers are supposed to do onsite audits, but only for significant hazards. Earlier FDA had provided two options. In the re-proposal, FDA seems to going with Option 1, which requires an annual audit for those supplier with significant hazards, but had added flexibility, by which the importer can determine another way of determining risk, or a less frequent audit schedule in lieu of that annual audit. But here’ the concern: While I embrace flexibility and decision making power at the industry or importer level, but there’s no objective bar set. The new requirement seems to say, ‘You have to do this, but you don’t have to do this, if you think you don’t have to do it!’ As a lawyer, looking at this in writing, it raises some flags about enforcement.

Click here for more on this exciting and evolving topic, including answers on where GFSI audits fit in, and what should U.S. importers be doing now to be ready to comply with FSVP requirements.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.