Tag Archives: foreign supplier verification program

Accreditation

Why Accredited Services Increase Business Opportunities And Contribute To The Harmonization Of Regulations

By Natalia Larrimer, Jacqueline Southee, Ph.D.
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Accreditation

Accreditation is an internationally accepted independent oversight process for maintaining operational standards and ensuring confidence. It is accepted by many governments and private industries, including at various levels of the global food supply.

Recognized within the food industry and endorsed by the Global Food Safety Initiative (GFSI), the process of accredited certification has become essential for business.

In the United States, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), in its rule on accredited third-party certification, incorporates the accreditation process for oversight over third-party certification bodies certifying foreign food facilities manufacturing for import into the United States.

With accredited services increasingly becoming an integral part of business operations, many wonder how the processes of accreditation and certification work.

Accreditation is the process of ensuring that an organization has the necessary technical competence to perform a specific task, and has met and continues to meet a specific set of operational requirements. An accreditation body (AB) uses internationally established techniques and procedures to assess conformity assessment bodies (CABs) against recognized standards to ensure their impartiality, competence, and ability to produce consistently reliable, technically sound and impartial results.

Accreditation provides formal recognition that an organization is competent to carry out specific tasks, and provides an independent assessment of conformity assessment bodies (CABs)1 against recognized standards to ensure their impartiality and competence. Accreditation provides assurance to a CAB’s customers and industry that the CAB continuously operates according to internationally accepted criteria applicable to CAB’s scope of accreditation.

Although there is flexibility for an AB to design its accreditation process within the constraints of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the standard to which all internationally recognized ABs must conform, some aspects are mandatory.

As part of the application process, the applicant for accreditation submits information about the desired scope of accreditation and its documented quality management system. The AB conducts a document review to verify that the applicant has documented all management system requirements specified in the relevant criteria and any other applicable requirements. Additional requirements could include, for example, those mandated by a specific regulatory authority or industry. During the assessment, through witnessing of the CAB conducting a conformity assessment activity, interviews of personnel, and review of records and other objective evidence, the AB’s assessment team verifies the CAB’s technical competence and implementation of the quality management system.

The applicant is required to provide corrective action for all identified deficiencies. Only after all identified issues have been addressed can the accreditation decision process begin. To ensure that the accreditation decision is impartial, members of the assessment team do not take part in the decision. The designated decision maker, which may be a group or an individual, is responsible for reviewing the assessment team’s recommendation and ensuring that all accreditation requirements have been met by the applicant and are properly documented before granting accreditation.

A certificate and scope of accreditation are issued only after a favorable accreditation decision.

Once accredited, the CAB is regularly re-assessed to ensure continued conformance to the accreditation requirements, and to confirm that the required standard of operation is being maintained.

To ensure transparency, the AB is required to make publicly available information on the status and scope of accreditation for each accredited CAB. Any changes occurring after initial accreditation, such as suspension for all or part of the scope of accreditation, are published on the AB’s website.

It is important to note while ABs provide oversight over CABs, internationally recognized ABs are themselves subject to regular oversight from organizations orchestrating the harmonization and recognition of the accreditation process internationally.

The International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) provide this international oversight. ABs that are signatories of the ILAC and/or IAF mutual recognition agreements (MLAs or MRAs) must conform with the requirements of ISO/IEC 17011 as applicable program-specific requirements, and are admitted to the agreements for a specific capability, for example, as an accreditor for testing labs or for management systems certification bodies. Technical competence of the AB and conformance to the requirements is verified through rigorous on site evaluation by other member of the IAF or ILAC community.

Without international oversight, there would be no evidence or confirmation that an AB operates in accordance with international requirements when providing oversight of accredited CABs. This oversight provides assurance that the AB understands the CAB’s process and can attest to the CAB’s competence.

The IAF, MLA and ILAC agreements are internationally recognized forms of approval; signatories have demonstrated their compliance with specified standards and requirements. Accreditation by a signatory of the ILAC MRA and/or IAF MLA provides assurance that decisions are based on reliable results, thus minimizing risk.

This is of particular importance in the constantly evolving global food-supply network. Many specifiers, such as regulatory authorities, have acknowledged the importance of credible accreditation programs.

A number of government agencies in the United States and around the world, including the U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA) and the Canadian Food Inspection Agency (CFIA), have mandated accreditation by an internationally recognized accrediting body for their programs.

Accreditation within the MLA/MRA process helps regulators meet their legislative responsibilities by providing assurance that testing, inspection and evaluation results are issued by organizations whose technical competence and compliance with specified criteria has been verified by an independent third party. It provides assurance to stakeholders, such as the regulatory authorities, that the accredited CAB operates in accordance with recognized and accepted criteria.

Continue to page 2 below.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Checklist: Foreign Supplier Verification Program Requirements

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

As all the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and, correspondingly, to develop required programs such as the Foreign Supplier Verification Program (FSVP) rule. The FSVP requires impacted companies to document specific verification steps to satisfy regulations and meet foreign-supplied shipment information requirements. These requirements took effect on May 30, 2017 for companies importing certain food products to the United States.

How much do you know about FSVP? Test your smarts by taking the FSMA FSVP IQ Test here Ultimately, the purpose of the FSVP is to document the shipping paperwork necessary to provide evidence and verification that a foreign supplier’s food-grade product shipped to a U.S. customer meets the requirements of FSMA. A company’s FSVP may include providing an additional level of evidence that the foreign company distributes safe foreign-supplied food products to the United States, the qualification of these suppliers, verification of supplier and shipment information, and records to verify the shipment of all imported food under FSMA and food safety plans. This information provides the U.S. customer receiving the product necessary proof of compliance and a record that the foreign-supplied material meets imported food product requirements.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA FSVP requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA, Foreign Supplier Verification Program
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Foreign Supplier Verification Program (FSVP) for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA FSVP requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions above will help companies identify areas to consider regarding their FSVP programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Results: FSMA IQ Test on Foreign Supplier Verification Program

By Food Safety Tech Staff
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The results are in! A couple of weeks ago, we asked readers to take a survey to test their knowledge of the Foreign Supplier Verification Program, and most passed with flying colors. If you didn’t take the test yet, you can view it here. The following are the results:

  1. You are only required for your foreign suppliers to meet your company requirements. FALSE
    • 89% answered correctly
  2. All required records for each applicable foreign-supplied product must be maintained for each shipment. TRUE
    • 93% answered correctly
  3. Your FSVP does not require that information for each lot of each product under the program be provided. FALSE
    • 84% answered correctly
  4. Just the location of the manufacturer of the product is required for the entity. FALSE
    • 90% answered correctly
  5. Foreign supplied shipments should include records to comprise the listing of all required information. TRUE
    • 91% answered correctly
  6. A qualified foreign supplier must have a Qualified Individual over the manufacturing of food product that is shipped to the United States. TRUE
    • 83% answered correctly
  7. A foreign supplier does not need to be registered under FDA requirements if the shipment of product is going to a registered facility in the United States. FALSE
    • 78% answered correctly
  8. A foreign supplier of food to the United States must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States. TRUE
    • 94% answered correctly
  9. The product information, including COA compliance, is not required for each lot of a product on a foreign-supplied shipment. FALSE
    • 83% answered correctly
  10. A food broker of foreign-supplied product to the United States does not have any responsibility of meeting the FSMA requirements. FALSE
    • 92% answered correctly
Question mark

FSMA IQ Test Part I: Foreign Supplier Verification Program

By Food Safety Tech Staff
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Question mark

The FSMA Foreign Supplier Verification Program (FSVP) has many elements that must be met. Do you know the correct response to these questions?

Kestrel ManagementWorking with Bill Bremer, principal of food safety compliance at Kestrel Management, LLC, Food Safety Tech is continuing its FSMA IQ test series. Results will be posted monthly in our Food Safety Consortium newsletter leading up to the 2017 event.

Confirm your company’s responsibility in meeting FSMA FSVP compliance by answering True or False.

Imports

Industry Needs More Help Understanding Import Safety Under FSMA

By Food Safety Tech Staff
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Imports

Need help understanding FSMA? Attend the 2016 Food Safety Consortium, December 7–8 in Schaumburg, IL | LEARN MORE In a 22-page report released last week, FDA outlined its findings from three public meetings held in June about the implementation of the FSMA import safety programs. The report, “Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs”, reviews the questions asked to participants about challenges and understanding in complying with the Foreign Supplier Verification Programs (FSVP), Accredited Third-Party Certification, and the Voluntary Qualified Importer Programs (VQIP) under FSMA. The agency analyzed data from 350 participants, and made the following conclusions:

Industry wants help in understanding what is required under the FSMA provisions, including clearer, concise information from the FDA

  • Industry may achieve faster compliance with FSVP if members are shown how it differs from existing food safety practices and compliance schemes
  • Organizing FSVP compliance information by commodity and sector may help in faster comprehension of rule
  • Small importers and food producers are at higher risk of failing to comply with FSVP
  • Generating case studies and other foreign supplier education mediums may aid in faster compliance with FSVP requirements
  • Importers will likely consider cost, return on investment and effort necessary to participant when deciding whether to sign up for VQIP, which will provide expedited clearance to qualified participants
  • Industry would benefit from FDA sharing information in a faster, clearer and more concise manner
  • FDA can use its existing facility registration database and existing relationships with industry to continue outreach efforts and elevate FSMA and FSVP compliance awareness

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.

Gary Smith, Eurofins’ Food Safety Systems

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza
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Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, director of food safety, Eurofins Scientific

Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

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.