Tag Archives: FDA

Food Safety Supply Chain panel 2017

Industry Experts Weigh in on Supply Chain Issues

By Maria Fontanazza
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Food Safety Supply Chain panel 2017

The Food Safety Supply Chain conference brought together industry stakeholders from FDA, CFSAN, GFSI’s certification programs, academia and food companies to discuss strategies and challenges of the supply chain in a more complex global environment. The two-day event was held earlier this month at U.S. Pharmacopeial Convention in Rockville, Maryland. Here’s what some of the speakers had to say.

(Click images to enlarge)

Sharon Mayl, FDA You can’t build safety at the border; you have to build in safety before you get to the border… The Foreign Supplier Verification rule requires importers for first time to share responsibility of products that are coming into country. We have written this rule with a lot of flexibility. – Sharon Mayl, senior advisor for policy to the deputy commissioner for foods and veterinary medicine, FDA, on the FSMA FSVP rule
Jennifer Thomas, CFSAN Transportation of food is a piece that doesn’t get a lot of attention, but it’s a very important part in ensuring the safety of food…[FDA is] in the process of developing a small entities compliance guide. We’re also revising the guidance we did in 2010 to ensure that it’s consistent with the rule. – Jennifer Thomas, director, division of enforcement, office of compliance, CFSAN, on the FSMA Sanitary Transportation of Human Food rule

Food fraud can lead to a public health threat—and should be managed under a food safety management system. – John Spink, Ph.D., director and assistant professor, Michigan State University, on supply chain transparency and food fraud

Russell Statman, Registrar Corp. When you’re looking at the Foreign Supplier Verification Program, you also have to approve your suppliers. There are several aspects to this—you have to check their record with FDA, whether they have any warning letters or on import alert. That doesn’t mean you can’t buy from them, it just means you have to investigate what the problem is. – Russell Statman, executive director, Registrar Corp., on the FSVP rule
FDA doesn’t have jurisdiction over aquaculture farms. So we’re working with countries that do. Any country that has a significant industry has good aquaculture practice programs (GAqP)— every country now has one—so we’re working with them now to make them better. ­– Brett Koonse, consumer safety officer, FDA, on aquaculture and food safety Brett Koonse, FDA

[The Sanitary Transportation of Human Food rule is important because of] the role that transportation has played in the past regarding foodborne outbreaks. We have to be proactive. We can’t learn from our mistakes anymore. – Debby Newslow, president, DL Newslow & Associates

Food Safety Supply Chain panel 2017
(left to right) John Wadie of 3M Food Safety, Melanie Neumann, Terry Levee and Jorge Hernandez

Food safety should not be about just meeting the regulations. Suppliers must still meet the standards of your business.  – Jorge Hernandez, chief food safety officer, Wholesome International

Collaboration and partnership are the only way your going to gain the transparency you need in the supply chain and build your brand for the protection it needs. – Melanie Neumann, president and global food safety attorney, Neumann Risk Services, LLC

One of reasons retailers take [visibility] seriously is that we’re the last line of defense. If you buy something at the grocery store and you get sick, you don’t remember the manufacturer of the product, you remember where you [bought] the product. – Terry Levee, senior director of food safety, Giant Eagle

Gluten free

FDA Project Finds Gluten-Free Labeled Products Meeting Standards

By Food Safety Tech Staff
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Gluten free

Accurate labeling of gluten-free products is a big deal for consumers who have celiac disease, as they can suffer potentially serious health issues when they eat gluten. FDA set standards for the labeling of gluten-free products in August 2013 (with a compliance date of August 5, 2014) and recently announced results of a sampling assignment that was conducted to assess compliance with the final rule.

Of the 702 samples taken from 250 products labeled as “gluten-free”, FDA found that more than 99.5% of the samples to be in compliance with the agency’s requirement.

“Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence.” ­ – FDA

The analytical results are available on FDA’s website.

Scott Gottlieb, M.D., FDA

Scott Gottlieb Confirmed to Lead FDA

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner. The vote was 57 to 42.

Gottlieb has extensive experience in healthcare and has been outspoke about the long approval process, along with the Medicare coverage process. However, he has not been vocal about food safety issues, so his impact on the food industry remains to be seen.

He previously served as deputy commissioner for medical and scientific affairs during the George W. Bush administration and was most recently a fellow at the American Enterprise Institute, a venture fund that invests in life sciences, medical technology and healthcare services.

Emulate, FDA, organ chip

Are Organs-on-Chips the Next Pioneers in Food Safety?

By Food Safety Tech Staff
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Emulate, FDA, organ chip

FDA is evaluating the use of micro-engineered chips as a potential model for studying hazards in food. Last week the agency announced a multi-year cooperative R&D agreement (CRADA) with Emulate, Inc., a manufacturer of organ-on-chip technology that “emulates human biology. The company’s Human Emulation System, a platform that includes organ-chips, instrumentation and software, recreates the natural physiology of human tissues and organs with the intention of providing a “predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing,” according to the company’s press release.

“The flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body. The chips are translucent, giving researchers a window into the inner workings of the organ being studied.” – Suzanne Fitzpatrick, Ph.D., senior advisor for toxicology, CFSAN

In the agency’s blog, FDA Voice, Fitzpatrick states that the chip technology could shed light on how the body processes an ingredient in a supplement or how a toxin(s) affects cells. It could also one day lead to much less animal testing, if at all. The goal of the research, which will begin with a liver-chip, is to be able to predict how organs will respond to exposure to chemical hazards in foods, cosmetics and dietary supplements more precisely than cell culture or animal-based tests. In the future, other organ-chips may be used, including kidney, lung and intestine models.

Bryan Armentrout, Food Leadership Group
FST Soapbox

Tips on Handling an FDA Audit

By Bryan Armentrout
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Bryan Armentrout, Food Leadership Group

Here’s a typical scenario.

You are the QA Manager for a dairy manufacturing facility in the Midwest. It’s been a long week and you decide to come in a little earlier than normal to catch up on paperwork. You find out when you arrive that product is on hold because the filling line is down. Maintenance is all over the machines, and orders are piling up; the paperwork will have to wait. You head out to the line to see what you can do to help.

This only happens when the plant manager is on vacation, you think to yourself.

As you walk out to the floor, your ears perk up as you hear your name paged over the intercom. The receptionist needs you in the front office—immediately.

What now?

You can’t think of anyone who is scheduled to visit today. You heart sinks a little. You don’t like surprises and this could be a bad one.

You come around the corner to the lobby to see exactly who you were hoping you wouldn’t see: An FDA investigator.

“My name is Investigator Brown,” he says as he flashes a badge. “We’ve had an allegation of an illness from your product. I am here to look into it.”

You smile politely and nod. He does not smile. You motion for him to follow you to a conference room.

Your day just got a whole lot longer.

How will this go?

The answer to that question is, in many ways, up to you.

FDA investigators are people and they take their job as seriously as you do. They are there because they need answers. Their boss expects answers. If people are getting sick, they need to find out quickly and take action. If this is truly the case, you need to know as well. So does your boss. No one wants people to get sick.

The absolute wrong thing to do in this situation is to not have a plan. You need to know how to handle a regulatory inspection. You need a plan to prevent a misunderstanding or create a situation where something minor gets blown out of proportion.

This is not the time to play it by ear. You need training and you need a plan.

An important point to remember is that your product may not have caused the illness. People often assume the last food they ate is the one that made them sick. In reality, incubation times may take significantly longer for symptoms to manifest. Samples of the product in question are rarely available to test. Dosage, health of the person, and other factors also come into play. You need to work with facts and not supposition—as does the FDA.

Tips for an FDA Inspection

  1. You are guilty until proven innocent
  2. You are not alone
  3. You are the company spokesperson
  4. Take lots of notes
  5. Seek first to understand, then to be understood
  6. Answer the question being asked
  7. Know what is in scope and what is out of scope
  8. Don’t sign or initial anything

1. You are guilty until proven innocent

In general, you can assume that FDA thinks you are at fault; that is why they are there. You will have a hole to dig yourself out of before you can convince them otherwise. Don’t let that rattle you, they are only doing their job, and your job is to show them all the great food safety programs you have in place to prevent what they are concerned about. Keep this in mind as you go through the visit. If you are doing a good job, you should see their demeanor soften as they gain confidence in what you do.

2. You are not alone

Don’t be a hero, you need a team to help you in this situation. You need the people in the plant and you need people at corporate ready to back you up. You most likely also need access to outside counsel that specializes in food regulations. Your role in the room is to facilitate and work with FDA to get them what they need. You and FDA are on the same side of the table in this respect. Both of you are working to find out if the illness is real.

If you are not sure of an answer, say so! Call corporate QA and your legal counsel and discuss it. Find out what the answer is from someone who does know. If you still don’t have an answer, it’s better to admit it than to make something up. Tell them when they can expect an answer, even if it may be after the audit concludes. Never make stuff up.

3. You are the company spokesperson

The company should have only one voice (most likely, you) responding during the inspection. This avoids confusion and keeps you in control over the message being delivered. Other agencies, such as OSHA, have the right under the law to interview employees during an investigation. It is not that clear cut with FDA. Make sure you explain to FDA that you are the designated spokesperson for this inspection and that all questions need to be routed through you. The personnel in the facility need to understand this as well and defer to you if FDA questions them. If the question is out of the ordinary, it may need to be in writing. When on the floor, never leave the investigator alone, accompany them at all times (don’t go crazy, they can use the bathroom by themselves).

4. Take lots of notes

Have someone who can tag along with you to take written notes of the visit. Train them on what you expect. Time stamp the notes and use a stream of consciousness approach. Write down everything, more notes are preferred. You may need them in the future. Never take the notes yourself, you are going to be too busy to do that. Mark the notes confidential and do not give a copy to FDA. Also, make sure that you have a clear and explicit ‘no photography’ policy in place. Train your people and enforce it. FDA may want to take pictures and they will tell you that they have the right to do so. That is open to debate and the issue has yet to be resolved in court. In the meantime, your policy is clear, so insist that they do not take pictures. This is your plant and your proprietary process; even with the best care, your competitors might find out more than they should about what you do.

5. Seek First to Understand, then to be Understood

This rule applies everywhere in life, and especially during an FDA inspection. Gather all the information you can. Are they going to take samples? If so, you need to prepare for that. Ask for the purpose of the visit and any supporting information you can get. Seek to first meet the needs to the investigator and to understand the exact context of the inquiry. The better you understand the purpose, the easier the day will be. Just like the investigator, you have a boss. You have limits to what you can and cannot do. Make sure the FDA understands that you are the representative, but the answer may need to come from other sources. Company policies are not written by you and cannot be altered. You are both on the same side of the table and rules need to be followed. They will understand and respect that.

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FSMA, Food Safety Tech, FDA

FDA Announces Waivers to FSMA Sanitary Transportation Rule

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

As of today, April 6, larger companies are expected to be compliant with the FSMA Sanitary Transportation rule. However, yesterday FDA announced its intention to waive the rule’s requirements in specific cases in which foods did not need to be protected from becoming unsafe. The FDA waivers apply to businesses that have transportation operations subject to State-Federal controls, including:

  • Businesses that have valid permits and inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.
  • Food establishments that are authorized to operate when engaged as receivers; shippers and carriers in operations in which food is delivered directly to customers; other locations the establishment or its affiliates operate that serve or sell food directly to consumers.
  • Businesses that transport molluscan shellfish that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority.
Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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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.

FDA’s CAPT Palmer Orlandi Promoted for Public Health Leadership

By Food Safety Tech Staff
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Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, has been promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi received the flag-grade promotion during a ceremony held Thursday afternoon in the FDA Wiley Building.

“As the senior ranking officers in the Commissioned Corps, flag officers exemplify the core values for which Commissioned Officers of the U.S. Public Health Service are held in high esteem. Flag officers provide executive-level leadership within the Department and within the Agencies in which they serve. Our flag officers also carry the title of Assistant Surgeon General and, as such, we rely on them to support special initiatives and exhibit the highest caliber of public health leadership.” – Commissioned Corps of the U.S. Public Health Service

Palmer Orlandi, FDA, Food Safety Consortium
WATCH THE VIDEO: Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium.

Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.

Orlandi received a Commission as an officer in the U.S. Army in 1981. He has been an officer in the Commission Corps of the Public Health Service since 1991.

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

GFSI in 2017: The Year of FSMA Compliance

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

This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.

At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.

GFSI Conformance

The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.

GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.

With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.

As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.

FSMA Compliance

During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.

By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.

The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.

This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.

Bringing GFSI and FSMA Together

The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.

As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).

In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.

Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.

As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.

Global Food Safety Conference

The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:

  • Food safety management commitment and corporate governance
  • Required training of food safety roles, including management, staff and operations
  • Specific requirements of the documented food safety program or written programs under FSMA
  • FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
  • Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
  • The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
  • How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
  • Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
  • Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
  • Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration

Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.