Tag Archives: FSMA

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.

FDA

FDA and NASDA Collaborate on $1.3 Million Produce Safety Program

By Food Safety Tech Staff
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FDA

Yesterday FDA announced a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to enable more support of developing, implementing and improving programs related to the Produce Safety rule. The agreement will provide funding to help NASDA work with state and territorial produce safety regulatory programs to facilitate the safe production of fresh fruits and vegetables, along with better understanding of the Produce Safety Rule and its requirements.

“This advances the agency’s efforts to develop a nationally integrated food safety system by helping to ensure consistency of state and territorial produce safety regulatory programs with the Produce Safety Rule,” FDA stated in a release.

The current program has $1.3 million in funding. During the first two years of the cooperative agreement, NASDA will work with FDA on implementing and updating the On-Farm Readiness Review system with the agency and its partners in state and territorial produce safety programs. During the third through fifth years of the program, NASDA will help FDA in establishing and promoting a “uniform foundation of produce safety” to help create a national produce safety regulatory program.

Melody Ge, Corvium
FST Soapbox

Compliance with the Intentional Adulteration Rule: Using FMEA for Your Vulnerability Assessment

By Melody Ge
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Melody Ge, Corvium

What is FMEA? What is a vulnerability assessment (VA)? How can these two be linked? Despite what you may think, there are similarities between these two methods. FMEA (Failure Modes and Effects Analysis) methods can be utilized to help objectively assess the vulnerable steps within your process.

After July 26, 2019, businesses other than small and very small businesses (defined by FDA) must comply with the FSMA Intentional Adulteration (IA) Rule. The rule is intended to enforce industry regulation to conduct vulnerability assessments and address proper mitigation plans to prevent any potential fraud risks within the food defense plan. For small businesses, the compliance date is July 27, 2020; for very small businesses, the compliance date is July 26, 2021.

Although the IA rule does not specify a particular method that you must use to conduct your VA and address proper mitigation plans, the following elements must be considered during your evaluation and mitigation strategy and must be implemented at each actionable step afterwards:

  • The potential public health impact (e.g., severity and scale) if a contaminant were added (21 CFR 121.130(a)(1))
  • The degree of physical access to the product (21 CFR 121.130(a)(2))
  • The ability of an attacker to successfully contaminate the product (21 CFR 121.130(a)(3))

During the 2019 Food Safety Consortium, Melody Ge will present: How to prepare ourselves in this data-driven transitioning time for the smart food safety era? | October 2 @ 10 am FMEA is a Six Sigma method widely used in operations when implementing a new process. It is a structured approach to discover potential failures that may exist within the design of a product or process. Within FMEA, the RPN (Risk Priority Number) score is used to prioritize risks and is calculated by Severity × Occurrence × Detection. RPN is a quantified number that helps you prioritize risks when determining actions. If we employ the same mentality, FMEA is a useful method in helping to identify vulnerable steps based on the risk within your process. Take a close look at how the RPN is generated; the following three components are also important during the vulnerability assessment.

Severity or the potential public health impact (e.g., severity and scale) if a contaminant were added.
Severity is identified when considering the consequence of when a processing step goes out of control; or thinking about the severity of the health impact. We can consider those impacts or consequences using four common categories:

  • Biological contaminants
  • Chemical contaminants
  • Physical contaminants
  • Intentional adulteration for economic gain contaminants

Occurrence or the degree of physical access to the product.

Occurrence is identified when considering how frequently a process step is expected to go out of defined controls. Is it once a week or once a month? Depending on how often the step goes out of defined controls, this will trigger different action steps as well as mitigation plans.

Detection or the ability of an attacker to successfully contaminate the product.

Detection is considered by how easy it can be detected when the failure occurs. For example, within the food production operation, mixing steps is relatively easier than a CIP step to be detected. More references could be found in FDA’s definition of KAT (Key Activity Types, as discussed in the draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration”), such as:

  • Bulk and liquid receiving and storage
  • Liquid storage and handling
  • Secondary ingredient handling
  • Mixing and similar activities

Once the RPN is identified, then the vulnerable steps can be sorted based on the RPN. To utilize this approach, Table 1 provides a template to be considered using FMEA for the vulnerability assessment.

Process Step Description Is it KAT? (Y/N) RPN Action Process Step Mitigation Strategy Explanation
Sev Occ Det RPN
Table 1: Determine the vulnerable steps (for reference)

As IA rules regulate, a mitigation plan must be generated once a vulnerable step is identified. The intention of the plan shall ensure those risks identified are mitigated and controlled so that the final finished products are not impacted or contaminated. One tip to begin this process is to start with reviewing your current control plan for potential food safety risks. As FSMA Preventive Controls are fully implemented, all food plants shall have a food safety plan in place with validated control plans that are intended to reduce risks for potential physical, chemical, biological and adulteration for economic gain. Sometimes, these risks are highly associated with potential vulnerable steps for intentional adulteration, especially those processing steps associated with potential economic gain hazards. If those controls are not working properly, then we can seek out other mitigation plans. Nevertheless, regardless of what steps are taken, they have to be validated to show that the IA risks are effectively mitigated. Monitoring and verification shall be conducted as well once the mitigation plan is implemented.

Of course, like all food safety management systems, every food plant should have its own designated plans based on the products being produced, operations implemented and the nature of the production. Ultimately, it will be your choice to find an effective method that fits your production culture. However, the intention should always be in compliance with the IA rules: Identify the vulnerable steps within the process, and conduct mitigation plans to control the risks of intentional adulteration.

Audit

Webinar Series: Improve Your Hazard Analysis

By Food Safety Tech Staff
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Audit
Patricia Wester, PA Wester Consulting
Patricia Wester, PA Wester Consulting and Founder, The Association for Food Safety Auditing Professionals

The most commonly cited observation during a Preventive Controls inspection is an incomplete or incorrect hazard analysis, according to FDA data. Food Safety Tech is hosting a special complimentary webinar series, instructed by Patricia Wester, founder of The Association for Food Safety Auditing Professionals, that will provide attendees with important tips on conducting and documenting a thorough hazard analysis. During the one-hour event, Wester will help participants understand how to recognize gaps in a hazard analysis as well as share best practices for closing those gaps. The content is geared toward food safety professionals and auditors who develop, manage or review food safety plans in a Preventive Controls landscape.

What: “Did You Know?” Tips on Improving Your Hazard Analysis
Date: Wednesday, September 18, 2019
Time: 12pm – 1pm ET
Register for the webinar

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Top Tips for PCQI Training Success

By Maria Fontanazza
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In a recent exclusive column on Food Safety Tech, Laura Lombard, CEO of ImEPIK, discusses why food companies should be investing in PCQI training beyond basic FSMA requirements. During the following Q&A, she expands on these insights further to shed light on some of the misunderstandings companies have when it comes to the PCQI requirements under FSMA as well as tips for how to approach PCQI training itself.

Food Safety Tech: What are some of the misconceptions with the FSMA PCQI requirements?

Laura Lombard, IMEPIK
Is Your Facility Properly Prepared to Ensure Preventive Controls Are Met? Read this exclusive column by Laura Lombard.

Laura Lombard: The FSMA rule allows for alternate PCQI training in addition to the original FSPCA training. PCQI trainings are accepted as long as they meet the standardized curriculum recognized by the FDA. The FDA never intended that one organization have a monopoly over PCQI training but equally wants to ensure that core competencies in preventive controls are met.

The FSMA regulation does not require you to have a different PCQI per facility. However, it does require a PCQI to be in charge of an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to oversee these different food safety plans to ensure that food safety plans are regularly updated and properly implemented.

FST: How should food companies be investing in PCQI training beyond the basic FSMA requirements?

Lombard: It’s very important to have at least one back up PCQI in place to ensure you are always covered if your head PCQI is out sick, on family leave, departs from the company, etc. This isn’t only to meet the FDA requirement of having a PCQI on your team, but also to ensure you are keeping your brand, product, and customers safe. The more you can protect yourself from having to do a recall of your product, the better. Recalls cost an average of $10 million, and this does not including damage to your brand and customer retention.

ImEpik and Food Safety Tech have partnered to offer PCQI online training, with special pricing options for attendees of the 2019 Food Safety Consortium Conference & Expo | Learn moreFST: What are your top tips for companies regarding PCQI training?

Lombard: Be proactive in ensuring your employees are trained. The regulation is the minimum required, but for a small investment, you can ensure more of your food safety staff is current on best practices to ensure your products’ quality and safety.

Look for training that fits your individual or company needs and learning styles. Look for training that is interactive and going to test knowledge rather than just death by PowerPoint. Again, the goal shouldn’t be to check a regulatory box but to ensure that your staff has the knowledge needed to maintain your brands quality, reputation and customer base.

FST: What are some of the differences between the various PCQI trainings on the market?

Lombard: There are three types of trainings that all require 20-hours of content: 1) An in-person version where an instructor leads a 2 or 2.5 day training, 2) a blended-online version that has some content that is self-paced but also requires a set time and date for a webinar portion, and 3) a 100% self-paced online course that does not require a webinar. Some of the blended versions claim to be 100% online. It is true in the sense that both the self-paced content and webinar are computer-based, but it is not as convenient as being able to do the entire training on your schedule. All versions have their pros and cons, but doing the course online can save your company significant time and money by not requiring travel or set timeframes. We have learned that online versions allow learners more opportunity for mastering the material through regular assessments and remediation as needed. It is also an opportunity to practice knowledge through scenarios in a low-risk environment. Lastly, done correctly, online training can be more interactive through the use of games, videos and audio tools to keep learners engaged.

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Failure to Have Foreign Supplier Verification Plan a Common Inspection Observation

By Maria Fontanazza
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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

 

Laura Lombard, IMEPIK
FST Soapbox

Is Your Facility Properly Prepared to Ensure Preventive Controls are Met?

By Laura Lombard
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Laura Lombard, IMEPIK

Under FSMA, you are required to have at least one Preventive Control Qualified Individual (PCQI) on your staff at all times to build and manage your food safety plan(s) for your manufacturing facilities. Per the regulation, PCQIs “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.” (Subpart C Section 117.180 (c) (1))

First and foremost, have you met the basic requirement of having at least one trained PCQI? There are now both online and in-person options to ensure your that food safety or quality assurance manager has had the proper training. Most online options require set times and dates like the in-person version to complete the training. Only one PCQI training currently on the market is completely self-paced and available 24-7. No matter which option you choose, it is a baseline that you ensure you have checked that regulatory box before the FDA comes to inspect your facility.

But what if your PCQI needs to take extended medical leave or moves on to another job? It is a proactive and smart move to have a back-up PCQI trained to both help support your PCQI under regular circumstances and be ready to step in if your quality assurance manager becomes unavailable. For a relatively small investment, you can ensure your company is meeting the regulatory requirement and has the training to provide a safe, quality product.

The FSMA regulation does not require you to have a PCQI for every facility but does require an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to ensure that food safety plans are regularly updated and properly implemented. Many companies are now training the entire quality assurance department or a facility cross-functional team to be PCQIs and participate on the food safety team. Again, the relatively small investment in properly training personnel can save your company hundreds of thousands or millions of dollars in costly recalls, lost revenue due to negative brand reputation, and FDA fines. The average recall costs $10 million, not including brand damage and lost customers.

It is simply prudent to invest in PCQI training beyond the basic requirement of the FSMA regulation. Companies should train their quality assurance or food safety staff at the PCQI level to protect a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more that can be saved in costly recalls, loss of current or potential customers, and brand reputation. Lastly, a company with a robust safety culture has a competitive advantage over competitors who are less inclined to invest sufficiently in their food safety training and may suffer financial repercussions and damage to reputation as a result of recalls and customer quality assurance complaints.

Question mark

FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Question mark

Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)

  1.  FSMA requires all records for the reevaluation of cGMPs every three years.
    • FALSE. Only 28% knew this.
  2. Implementation records are required for every FSMA requirement.
    • TRUE. 74% got this right.
  3. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
    • TRUE. 90% answered correctly.
  4. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
    • FALSE. Respondents were almost evenly split. 51% answered correctly.
  5. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
    • TRUE. 92% answered on target.
  6. Written supply chain plans are not included in FSMA food safety plans.
    • FALSE. 81% answered correctly.
  7. Mandatory recalls are provided under FSMA as a new requirement.
    • TRUE. 63% answered correctly.
  8. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
    • FALSE. 74% got this right.
  9. cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
    • TRUE. 77% answered correctly.
  10. You do not need to document records of all product testing under FSMA.
    • FALSE. 82% answered correctly.
  11. FSMA preventive controls does not require hazards be addressed under the HACCP plan.
    • FALSE. 69% got this right.
  12. The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
    • FALSE. 82% answered correctly.

Surprised by the results? Provide feedback in the comments section.

We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Create your own user feedback survey

Ned Sharpless, Frank Yiannas, FDA

FDA’s ‘New Era of Smarter Food Safety’ to Focus on Traceability, Digital Technology and E-Commerce

By Food Safety Tech Staff
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Ned Sharpless, Frank Yiannas, FDA

“It’s time to look to the future of food safety once again,” declared Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas in a press statement released yesterday. Although progress has been made in implementing FSMA and with the development of the GenomeTrakr Network, the agency wants to move forward in taking advantage of the innovative technologies that will help make the food supply more digital, traceable and safer. With that effort comes the creation of a “Blueprint for a New Era of Smarter Food Safety”, which will speak to “traceability, digital technologies and evolving food business models”. Sharpless and Yiannas outlined the significant role that these components will play.

Digital technology in food traceability. Digital technologies could play a crucial part in rapidly identifying and tracing contaminated food back to its origin—changing the timespan from days or weeks to minutes or seconds. FDA intends to look at new ways that it can evaluate new technologies and improve its ability to quickly track and trace food throughout the supply chain. “Access to information during an outbreak about the origin of contaminated food will help us conduct more timely root cause analysis and apply these learnings to prevent future incidents from happening in the first place,” stated Sharpless and Yiannas. This means a shift away from paper-based systems.

Ned Sharpless, Frank Yiannas, FDA
(left to right) Ned Sharpless, M.D., FDA acting commissioner and Frank Yiannas, deputy commissioner of food policy and response. Image courtesy of FDA

Emerging technologies. Artificial intelligence (AI), distributed ledgers (no, they didn’t directly say “blockchain”), the Internet of Things, sensors and other emerging technologies could enable more transparency within the supply chain as well as consumer side of things. The FDA leaders announced a pilot program that will use AI and machine learning to assess food imports at the U.S. point of entry.

E-Commerce. “Evolving food business models”, also known as e-commerce, is growing fast and changing how consumers get their food. With food delivery introduces food safety issues such as those related to packaging and temperature control. FDA is exploring how it can collaborate with federal, state and local stakeholders to figure out ways to address these potential problems.

Sharpless and Yiannas emphasized the end-goal in keeping the food of American consumers safe. “So, welcome to the new era of smarter food safety that is people-led, FSMA-based and technology-enabled!”

AFSAP, audits

AFSAP Second Annual Stakeholders Meeting to Be Held During Food Safety Supply Chain Conference

By Trish Wester
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AFSAP, audits

2018 Recap: As VQIP implementation began, confusion among the accreditation bodies (ABs) and certification bodies (CBs) was clearly evident, and options for explanations from FDA were limited. To facilitate information sharing, AFSAP hosted an open gathering of all interested parties to hear from FDA. The inaugural AFSAP Auditing Stakeholders meeting provided a unique opportunity for the auditing community at large to interact with FDA and expand their knowledge on the regulatory use of audits in FSMA. CB attendees gained valuable insight into their hybrid role as part Scheme Owner under the Third-Party Certification Program (TPP) and its operational challenges in the global community. After vigorous discussion, the development of a consensus program for FDA’s TPP audits emerged, although the definitive mechanism to achieve this objective was still to be determined. AFSAP established a membership category for CB’s, and has continued to pursue solutions to these and other audit related issues, but information sharing has been limited to members.

2019: Although progress has been made, there is still a need for information sharing among all interested parties. Once again, the 2nd Auditing Stakeholders Meeting will be co-located with the Food Safety Supply Chain Conference in Rockville, MD, May 29–30, 2019.

AFSAP extends a gracious thank you to them for supporting AFSAP’s mission and goals.

The 2019 Auditing Stakeholder meeting will build on the TPP knowledge base, incorporating other areas that overlap with auditing and auditor development in general. FDA has a new TPP management team participating this year, along with some familiar faces from 2018. Join AFSAP in welcoming them to our event!

We have an exciting agenda planned for this year that includes a members-only session, an at-large session, and updates from FDA’s new TPP team. Association announcements will be provided after the Association’s members meeting has concluded.

AFSAP Membership Meeting

  • Association updates; Accomplishments, Partnerships & Alliances, Plans and Activities
  • Committee Updates
    • The Auditor Development Committee/Chair introductions
  • AFSAP’s Voluntary Consensus Standard (VCS) for FDA’s 3rd Party Audit
  • VCS Board: Introductions and Nominations
    • The review and publication process for a VCS

Auditing Community Meeting Highlights

  • SGS’ Hank Karayan
    • The Accreditation Experience – Lessons Learned
  • Just the FAQ’s – Common questions and misconceptions
  • New! TPP Audit Templates and Auditor Trainings

Contact AFSAP for registration information: info@afsap.org

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.