Tag Archives: food safety plan

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
1 Comment
Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

FSMA, One Year Later: Top 5 Things We’ve Learned

By Erika Miller
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Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.

5. Don’t Scrap Your Current Plan

Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.

4. Education Is Key

A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).

3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”

Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.

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

FSMA Preventive Controls Corrective Action Requirements

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

FSMA Preventive Controls and Food Safety Plans must document specific use and management of corrective actions within Food Safety programs to satisfy the regulations and meet associated compliance dates. This requirement recently took effect under the Preventive Controls Rule on September 19, 2016 for companies with more than 500 corporate employees; food companies with fewer than 500 corporate employees have an additional year.

TEST YOUR FSMA SMARTS! Take the FSMA IQ TESTAs the FSMA Preventive Control rules move to enforcement status, food companies must prepare to best respond to the requirements and, correspondingly, to add the required written corrective action programs and records within Food Safety Plans. This may include providing an additional level of evidence that the company distributes safe food products to and from the United States.

With pending scheduled inspections on the horizon and the expanded authority of the FDA to conduct at-will inspections, it is critical for these programs to be written, verified and maintained at all times.  Important to note, even if this is a previously established program, you must be in compliance with the provisions of Section 117 of FSMA.

Learn more about FSMA Preventive Controls  at the 2016 Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERThe more formalized programs and supporting evidence of compliance must include internal audits by Qualified Auditors, with coordinated oversight by your Qualified Individuals. Inspectors now have the authority to enforce the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Qualified Auditors, in addition to Food Safety Plan Qualified Individuals, to oversee corrective action audits for evidence assurance.

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 corrective actions under FSMA Preventive Controls. To complete your own assessment, review and compare your programs to the questions below.

FSMA, Corrective Actions checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of corrective action programs for FSMA compliance.

Get Compliance-Ready

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

Rachel Montgomery

Keep Calm and Be Sure You Have a PCQI—Soon!

By Rachel Montgomery
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Rachel Montgomery

You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”

Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.

For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.

Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.

Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.

Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.

If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.

Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.

FST Soapbox

Inquiries, Responses and Audits: The Chipotle Effect

By Dan Bernkopf
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In an age where news is reported instantly, those outside the food industry have a heightened awareness and concern over their favorite brands’ commitment to food safety. Conversely, every food industry’s safety and quality operations teams are more than likely putting measures in place to tighten up their supply chain controls and re-evaluate their own food safety programs to ensure that their companies don’t become the next headline.

You better believe suppliers and their customers alike are also re-evaluating their ability to quickly, and effectively, respond to such an incident with the data and records needed to determine root causes—and with good merit, especially if you take a step back and really think about what is needed when a response or inquiry comes in surrounding a Chipotle-type food safety incident. Responses to such incidents typically fall along the lines of: 

  • Evidence of current food safety plan, including comprehensive risk analysis, HACCP/HARPC plan, validation studies or documents
  • Inspection data and documents on your suppliers, including onsite inspection, transportation and product receiving inspections, complete with non-compliance reports and CAPAs for the last six months
  • All data records relative to your internal processing CCP(s) or equivalent, including monitoring frequencies and all non-compliance reports, complete with their CAPAs for the last six months
  • All regulatory and non-regulatory audit reports or actions, including non-compliance reports and their CAPAs
  • Additional available internal or external laboratory evidence that demonstrates environmental monitoring of your facilities and resulting continuous improvement and sanitation validation for the last two years
  • Additional internal or external laboratory pathogen monitoring programs for field, transportation, raw material supply and finished products, etc. as evidence to support your food safety program

The sheer volume of records, data and information needed in such an on-demand short timeframe can be extremely overwhelming. Without quick access to the critical records needed to determine root cause or, more importantly, thwart an incident from expanding, food safety and quality operations should be taking a close look at how they are managing their food safety data records and reports.

Are binders full of documents, or a combination of paper/silo data records going to suffice when it comes to inquiries, responses (and audits)? Or, is there a better way to manage food safety and quality data to ensure not only data is accessible, but also that food safety programs are working?

One sure bet is that there will be a higher number of audits and inquiries. Is your team and/or supplier prepared for the increase of these types of activities?

  • Inquiry: A request for a single or series of data and or documents usually related to a specific FSQA event or question
  • Response: The collected data, data reports, document or document reports related to a specific audit or inquiry
  • Audit: An activity that reviews one or many elements of a food safety plan to assure that the plan is complete, performed as described and meets the food safety design as intended. Audits are known and expected activities to review such safety plan elements even though the actual audit date and time may be known or unknown

We all know that audits are often lengthy exercises, yet they are still predictable. On the other hand, inquiries can be more difficult in that information requests may involve a very deep dive into a very specific area of inquiry.

In all honesty, if inquiries or responses or audits have to be planned for in advance, then you are not prepared. In order to always be prepared, it’s imperative to have better systems in place to manage any type of internal or external examination of your food safety and quality information. Regardless of whether it is an audit, response or inquiry, it is important to have easy access to records, verify that your programs are working, have corrective actions in place, and show visibility (and transparency) in your operation.

Thus it all comes back to how you or your suppliers are managing food safety records day in, day out. If FSQA operations are still relying on manual-based food safety and quality management processes versus food safety and quality management technologies, then chances are that you’re reacting to latent results, and you’re not able to identify trends and opportunities for improvement. The burden to manage inquires, responses or audits—as they continue to grow in cadence—will become overwhelming.

Without a doubt, the Chipotle effect is being felt throughout the industry. There will be increased accountability to ensure an adequate food safety program is in place and verification that the program is working. It will become even more imperative—and expected—that data and records are readily available to efficiently respond to inquiries, responses and audits.

FSMA, Food Safety Tech, FDA

Certified to FSSC 22000? You’re Ready for FSMA

By Maria Fontanazza
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FSMA, Food Safety Tech, FDA

If my company is GFSI-certified, is it also FSMA compliant? The answer is: With shared goals of producing safe food, coordinating preventive measures and ensuring continuous improvement, if your company is FSSC 22000 certified, you’re well on the road to FSMA compliance, according to Jacqueline Southee, Ph.D., U.S. Liaison, FSSC 22000.  Southee discussed several areas in which FSSC 22000 aligns with FSMA as part of a recent Leadership Series, “GFSI in the Age of FSMA”.

Supply Chain Visibility

FSSC 22000 is applicable to all aspects of the supply chain and requires interactive communication (all of which must be documented), from the downstream level in ensuring raw materials and suppliers meet requirements of ISO 22000 framework to communication with customers and suppliers to verify and control hazards.

FSMA controls the hazard of food within the United States, says Southee, whereas GFSI certification is a global initiative, thereby extending supply chain visibility to foreign suppliers.

The Food Safety Plan

There has been much discussion surrounding building a FSMA-ready food safety plan and the migration from HACCP to HARPC. “HARPC can be referred to as HACCP with preventive controls,” says Southee. FSSC 22000 provides a flexible yet robust approach in a framework that is applicable to all situations (i.e., different manufacturers have different issues, such as producing ice cream versus baked goods). Rather than being prescriptive, the prerequisite program has the flexibility to apply to a particular situation. In addition, validation, verification, monitoring and documentation are an inherent part of the ISO 22000 approach and the FSSC 22000 certification.

FSSC 22000 serves as an effective tool in preparing companies for FSMA compliance. “We’re not a regulatory system; FDA has that domain,” says Southee. “They’re the ones that carry the responsibility of meeting those regulations. We work with everyone…to do the best job we can.”

Audit Readiness

Being audit ready all the time is a key part of preparing for FSMA. FSSC 22000 certifies a food safety management system (a three-year certification cycle) and requires internal audits of company performance, along with helping companies ensure that their records are organized at all times. The goal is to install a management system that enables constant monitoring, reevaluation and assessment as part of an ongoing process of keeping food safe, according to Southee. “If you’re certified and have an effective ongoing management system, unannounced audits won’t be an issue,” she says.

Food Safety Culture

FSSC 22000 and ISO 22000 provide a strong foundation for building food safety culture. ISO 22000 requires proof of management commitment to the food safety process, along with accountability, and for management to make resources available to see the food safety process through. “We agree that culture has to come from the top,” says Southee. “The personnel have to see that management is committed, and the culture will come from that commitment.” It also requires constant communication, up and down the supply chain as well as internally. This includes involving all employees and making sure that they know what they’re doing (i.e., training). “Everyone needs to know they’re valued and important, and how their function contributes to the function of safe food,” says Southee.

FSMA Alignment and Gap Analysis

There are sure to be some gaps when it comes to FSSC 22000 and FSMA. FSSC 22000 has commissioned a gap analysis to compare the preventive controls for human and animal food rules with the GFSI scheme and will add addendums as needed. Areas of review include a requirement to include food fraud into the hazard analysis and a review of unannounced audit protocol.  

How GFSI Schemes Align With FSMA Compliance

By Food Safety Tech Staff
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With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.

Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series,  “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:

  • How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
    • Supplier Controls
    • Building a food safety plan
    • Migrating from HACCP to HARPC
    • Being audit ready all the time
    • Environmental monitoring … human & animal food rules … and much more
  • What changes to the scheme have been made (or are planned) to better align with FSMA
  • Gaps the leaders see in FSMA that are filled by their scheme
  • What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance

The series, which launches September 25 is complimentary. Learn more and register at: http://www.safetychain.com/GFSI-Webinar-Series

SafetyChain webinar series
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.

Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.

The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.

Top 3 Things to Know about President Obama’s FY 2016 Food Safety Budget Proposal

By Miranda Peguese
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Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

Food safety funding has been a major focal point for the FY 2016 budget proposed by President Obama. Primarily due in support of the fact that all major Food Safety Modernization Act (FSMA) rules are scheduled to take effect by the end of FY 2016, the increased focus will impact each of the agencies governing food safety within the US and all entities which fall under their jurisdiction.

Here are three things to know about the proposed food safety funding allocation for FY 2016:

1. There will be a sizeable increase in the allocation of food safety funding.

President Obama’s $3.99 trillion FY 2016 budget proposal allocates $1.6 billion for food safety, a significant increase in food safety funding over previous years. This would include increases of $301 million for the U.S. Food and Drug Administration (FDA) to support new measures under the Food Safety Modernization Act (FSMA), resulting in a $109 million increase over the previous year as well as an additional $2.1 million increase to the Centers for Disease Control and Prevention (CDC) over FY 2015’s $48 million allocation going towards food safety.

USDA budget requests would decrease slightly for FY 2016, requesting $1.012 billion vs. $1.016 billion for the previous year’s budget as a result of program related cost savings and correlated efficiencies and expects that a portion of the $2.9 billion for agricultural research and extension activities would support additional food safety requirements set forth by FSMA.

2. The proposed increase in food safety funds would include a prioritized food safety spending plan.

The increases to the allocated funding for food safety do not come without guidance. The funding increase includes a detailed plan for spending to include the following allocation:

  • $32 million for Nation Integrated Food Safety System
  • $25.5 million for New Import Safety Systems
  • $25 million for Inspection Modernization Training
  • $11.5 million for Industry Education and Technical Assistance
  • $4.5 million for Risk Analytics and Evaluation
  • $4 million for Technical Staffing and Guidance Development

The top three funding allocations noted are for integration, import, and inspection. These allotments directly reflect the directives set forth in FSMA

3. The plan also includes a proposed single food safety regulatory entity.

In addition to the increase in funding, the new plan outlined by President Obama also asks for Congress to combine several programs overseeing US food safety into a single agency under the Department of Health and Human Services (HHS). Advocates of the plan state that the combination would provide “focused, centralized leadership, a primary voice on food safety standards and compliance with those standards, and clear lines of responsibility and accountability”, citing the current food safety system as being fragmented and outdated. Currently, a total of 12 agencies enforce 30 different laws. An alternate proposal has also been put forth by two members of congress which would suggest the formation of a new food safety agency independent of HHS.

How does this affect your facility? Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

To learn more about the food safety allocations within the proposed FY 2016 budget, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm432576.htm and http://www.usda.gov/wps/portal/usda/usdahome?navid=BUDGET.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Top 5 FSMA Challenges

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

The year 2015 is almost two months in, and the U.S. Food and Drug Administration has got its head down looking at the comments to the re-proposed rules under the Food Safety Modernization Act (FSMA), with the first of several deadlines – August 31, 2014 – looming ahead.

Against this backdrop, food safety experts Dr. David Acheson, and Melanie Neumann, at The Acheson Group, discussed the Top 5 Challenges for becoming FSMA Compliant with SafetyChain Software’s Barbara Levin.

The top 5 challenges were identified as:

  1. Determining exactly which rules apply to you and what compliance will involve;
  2. Building a food safety plan – migrating from HACCP to HARPC;
  3. If you are a registered firm – building a supply chain management program;
  4. Determining what testing you will need to do; and
  5. Determining recordkeeping requirements for FDA.

Why have the above been identified as the top 5?

FSMA has thrown out a number of different rules, and for food companies, figuring out where you should fit can be difficult. For instance, should you be looking at Preventive Controls, or Foreign Supplier Verification Program? The language in the Produce Rule is complicated, so if you are a mixed type facility, it can be challenging. While most companies are familiar with Hazard Analysis at Critical Control Points or HACCP, the concept of migrating into Hazard Analysis and Risk-based Preventive Controls or HARPC is not that easy.

Getting a handle around your supply chain and its various components is just difficult, and just understanding what this requirement will involve will be a huge challenge.

While testing of agricultural water was addressed in the initial Produce Rule, the re-proposed Preventive Controls rule included environmental monitoring and finished product testing as requirements for compliance. It will be a challenge for companies to determine what kind of testing they will need to do.

Keeping track of the variety and volume of records that FDA will need to for FSMA will be a huge challenge.

While we could have picked up many more than five, these were the top five that we think will be the most challenging.

To determine what rules will apply to you and what will compliance involve, what are the top things you should be doing now?

Firstly, if you are not starting already to see what applies to you, then you are already behind. Do a FSMA readiness assessment and look at all the rules to determine which ones apply to you. For instance, if you are a company that makes cereal and cookies, then you probably don’t need to worry about the produce rule.

Once you determine the rules that are applicable to you, then the heavy lifting begins. You need to do a gap analysis to see where you are now and where you need to get to. Drawing out this road map to compliance then becomes critical, and that’s what companies need to do be doing now.

Building a food safety plan and migrating from HACCP to HARPC, what are the top things that you should be doing?

The goal of the preventive controls rule is to encourage food companies to start thinking much more about prevention. While HACCP principles are a great start, in some areas, it could be limited in scope, and focused only on critical control points that we can measure. But HARPC expands our thinking to risks that we can control that are beyond classic HACCP thinking, and don’t fit nicely into the seven steps of HACCP. For instance, hand washing – we may not be able to measure this, but this would still be a critical step to control risk. So it will be a challenge for food companies to take their HACCP program and elevate it to HARPC thinking.

If you are a registered firm, building a supply chain management program has been identified as the third challenge. How do you know if you have to register? What can you do now to build a supply chain management program? And would you consider this the biggest challenge for FSMA compliance?

The requirement for food companies to register has nothing to do with FSMA; it was included as part of Bioterrorism Act. According to this, if you are packing, holding, processing or manufacturing food, you need to register with FDA. FSMA added the requirement that this registration would need to be updated every two years. This requirement is now important as several of the supply chain management program rules, which are part of the Preventive Controls rule, apply to companies that need to register.

The requirement to have a supply chain management program was in very early versions of FSMA and then got pulled out, and then now it’s back. And it’s not going away. What can you do to prepare for this rule? Look at all your suppliers, look at who they are, what they are shipping to you – do a hazard analysis of all their products, know their risks and understand what they are doing to control that risk.

For instance, your supplier Mr. Smith is supplying you ground black pepper, which you are using in a variety of products. We have determined that ground black pepper has a potential for Salmonella risk and has been historically linked to Salmonella. So you need to do a hazard analysis and determine if it is a risky food and who is controlling that risk. Is it you or Mr. Smith, and that depends on what you are using that ingredient for. If you use it as a garnish in based potato chips, then there is no cooking or kill-step involved, so the risk should be controlled by Mr. Smith. Thus, FDA will expect you to figure out that Mr. Smith is indeed controlling that risk, which you can do through site visits and data.

Another scenario is that you get that pepper from Mr. Smith, but you are using it in soup, and thus, have your own kill step to control that risk. So you don’t need to pay that visit, put have your own procedures to address risk with that ingredient.

While ground black pepper is a straightforward example, where it gets tricky is when you have to do this will ALL your ingredients. Companies typically have hundreds of suppliers and thousands of ingredients. So start NOW to understand how this little part of the preventive controls rule will affect you; you only have about 18 months to figure this out. And for that reason, I think this will be a huge challenge.

How can companies determine what testing they will need to do? What should companies starting doing now?

While the original produce rule included testing requirements for water, the other testing requirements mandated by FSMA are mostly new. The preventive controls rule now requires food companies to have an environmental monitoring program in place. FDA has also laid out a strategy in which finished product testing can be used as a risk control system. It’s not mandated per se, but it may be a way to exercise the preventive controls rule. Companies need to plan right now to determine what kind of testing they will need to do, how to document it etc. The environmental monitoring program and product testing requirements are new. So start looking at these programs, understand the rules to determine which of these rules apply to you, and do the gap analysis and FSMA readiness assessment now.

You have identified that record keeping requirements for FDA will a major challenge. How can companies prepare for this?

Record keeping will be an area where companies are most likely to struggle. There will be mounds and mounds of documents that will be generated because of the FSMA rules. The days of filing cabinets are over, and it will be really hard to do this in a manual environment. Companies need to look at technology and automation to manage all this data. If companies happen to be regulated by dual agencies, we are talking about even more information that they need to collect and keep track of. So automate NOW.

We often notice that companies are keeping track of the right data and documentation, but are unable to prove this, and retrieve the information when needed. With FSMA, the agency is going to say, ‘if you can’t prove it, it didn’t happen.’ So companies need to get smart about having effective document retrieval systems.

Are there any additional challenges that FDA isn’t talking about that companies need to look out for?

While the above challenges broadly capture the most significant challenges, we think the following may also be something that companies would need to prepare for:

  1. High-risk list: This year, we expect FDA to announce some rules regarding this.
  2. Traceability requirements: FDA may reveal more about this and how his will link to the high-risk list.
  3. Voluntary Qualified Importer Program or VQIP: The needs and requirements for this are still not clear. We expect some rules to be proposed this year.
  4. Additionally, while we don’t expect it to happen, if FDA makes any radical changes with the final rules, that could generate some new challenges.

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