Tag Archives: FDA

Michael Taylor FDA

Food Safety Over Past 25 Years: ‘Everything Has Changed’

By Maria Fontanazza
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Michael Taylor FDA

The effect that the 1993 E. coli O157:H7 outbreak had on the food industry was tremendous. Responsible for more than 600 illnesses and the deaths of four children, the outbreak led to significant changes in the industry’s approach to food safety. “[It] drove a shift in food safety that many had been working toward for years,” said Rima Khabbaz, M.D., acting deputy director for infectious diseases at CDC during the “We Were There” CDC lecture series, adding that the focus moved to food suppliers and how they could make their products safer. “The outbreak drove a paradigm shift that opened the door to food safety,” said Patricia Griffin, M.D., chief of the CDC’s enteric diseases epidemiology branch during the lecture.

Deirdre Schlunegger and Michael Taylor
Deirdre Schlunegger, CEO of Stop Foodborne Illness, and Michael Taylor at Stop event celebrating Food Safety Heroes during the 2015 Food Safety Consortium.

Within a few years, several actions and initiatives paved the way for notable progress. In 1994, Mike Taylor, who was administrator of USDA’s FSIS at the time, made a speech that “shocked and outraged the industry,” said Griffin, where he stated, “we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.” From there, the USDA worked on legislation that was the first major advance in meat regulation. In 1996 the agency established the Pathogen Reduction Rule to improve meat inspection. The same year CDC’s PulseNet was born, the nationwide lab network that uses DNA fingerprinting to help identify outbreaks early, along with the Foodborne Diseases Active Surveillance Network (FoodNet), an epidemiological system that tracks incidents and trends related to food.

In a Q&A with Food Safety Tech, Mike Taylor, most recently the former FDA commissioner for foods and veterinary medicine, discusses the dramatic change that industry has undergone during the past 25 years, from FSMA to technology advancements to food safety culture.

Food Safety Past, Present and Future at the 2017 Food Safety Consortium: Recognizing the 1993 Jack In the Box E. coli outbreak as the event that propelled the current food safety movement. Mike Taylor, Bill Marler, Esq. and Ann Marie McNamara (Target Corp.), who took the reins from the late David Theno at Jack In the Box, will discuss Theno’s impact on the industry. The session continues through a timeline of the evolution of food safety from 1993 to present, and then the future, where we will cover the IoT, social media, food safety culture and technology. It will be followed by the STOP Foodborne Illness Award Ceremony. Wednesday, November 29, 2017, 4:00–5:30 pm | LEARN MORE

Food Safety Tech: Reflecting on how far the industry has come since the E.coli O157:H7 outbreak involving Jack in the Box in 1993, what key areas of progress have been made since?

Michael Taylor: I think there are very major ones obviously. You have to remember where things were when the Jack-in-the-Box [outbreak] happened. We were in a place where USDA programs said it was not responsible for pathogens in raw meat and that consumers are supposed to cook the product; [and] industry was operating under traditional methods. Microbial methods were typically conducted for quality not for safety; you had the loss of public confidence and a terrible situation in which consumers were pointing at industry, and industry was pointing at consumers, and no one was taking clear responsibility for safety of the product.

Now we are in a completely different environment where not only is there clarity about industry’s responsibility for monitoring pathogens, there’s also been enormous progress by industry to put in place microbial testing, something David Theno pioneered and is now a central part of food safety management systems for meat safety.

Everything has changed.

These [institutional] arrangements exist not only in the meat industry, but now across the whole food industry. There’s the emergence of GFSI taking responsibility for managing the supply chain for food safety, food safety culture taking hold broadly across leading companies in the industry, and FSMA codifying for 80% of the food supply that FDA regulates the principles of risk-based prevention and continuous improvement on food safety.

I think it’s rather dramatic how far the industry’s food safety regulatory system has come since [the] Jack in the Box [outbreak].

FST: How has FSMA helped to align industry priorities?

Michael Taylor FDA
Mike Taylor was on the front lines of change in the meat industry.

Taylor: Let’s focus on the events first leading up to FSMA—for example, the outbreaks or illnesses associated with leafy greens [and] peanut butter, and problems with imported products—those events in the world aligned industry priorities around the need to modernize the food safety laws and to enact FSMA. It was the coming together of industry and consumer interests, and the expert community around the principles of comprehensive risk-based prevention that vaporized into FSMA. Now FSMA is the framework within which companies are organizing their food safety systems in accordance with these modern principles of prevention.

And clearly what’s been codified in FSMA and some of the key elements are becoming organizing principles where industry is aligning our priorities for food safety. Environmental monitoring where that’s an appropriate verification control for a company’s hygiene and pathogen control—that’s clearly a priority that folks are aligning on. The issue of supplier verification for domestic and foreign supply is a priority that has been elevated by FSMA, and so has the whole issue of training and employee capacity, whether it’s in processing facilities or on farms, as well as food safety culture. If you’re going to be effectively preventive you need to deal with the human dimension of your food safety system.

These are examples of ways in which FSMA is aligning industry priorities.

Read the rest of the interview on page 2 (link below).

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FSMA

How the Sanitary Transportation Rule Waiver Applies to Retail Food Establishments

By Food Safety Tech Staff
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FSMA

This week the FDA issued another guidance document to explain a waiver to the Sanitary Transportation rule and that it applies to retail food establishments that sell food for humans as well as those that sell both human and animal food. It does not apply to establishments that exclusively sell animal food.

“The Sanitary Transportation rule established a process by which FDA may waive any of the rule’s requirements for certain classes of persons, vehicles, or types of food if doing so will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.” – FDA

In April, FDA announced three waivers that apply to businesses with transportation operations subject to State-Federal controls. Since this time, FDA stated that it has received questions regarding whether the term “retail food establishment” also applies to businesses that sell animal food. “The purpose of the guidance document is to clarify that the waiver is intended to apply to establishments that are covered by human food regulations based on the FDA Food Code and administered by state and local authorities,” FDA stated in a news release.

Earlier this month FDA released three guidances related to low-acid canned foods, juice HACCP and seafood HACCP.

FSMA

FSMA Exempt? FDA Guidances Explain

By Food Safety Tech Staff
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FSMA

This week FDA released three guidances to help food producers understand how the FSMA rules apply to their commodities. The regulations covered in the guidances pertain to low-acid canned foods (LACF), juice HACCP and seafood HACCP. Since FDA’s regulations for HACCP and LACF were in place before the FSMA final rules were established, the agency is clarifying the FSMA requirements as well as exemptions for these products.

The following guidances are available on FDA’s website:

FSMA, Food Safety Tech, FDA

FSMA Update: FDA Launches Accredited Third-Party Certification Site

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

On Wednesday FDA launched a website where organizations can apply to be recognized as a third-party accreditation body. The certifications are used either to establish eligibility to participate in the voluntary qualified importer program, which provides expedited review and entry of food for eligible participants, or in circumstances in which FDA requires an imported food to be certified to keep potentially harmful food from entering the United States.

“Accredited Third-Party Certification is a voluntary program in which FDA recognizes ‘accreditation bodies’ that will have the responsibility of accrediting third-party ‘certification bodies’. The certification bodies will conduct food safety audits and issue certifications of foreign food facilities.” – FDA

Organizations can fill out a program application on FDA’s website.

Ask the FDA: Recognizing Third Party Accreditation Bodies

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, FDA

Scott Gottlieb Confirmed to Lead FDA

By Food Safety Tech Staff
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Scott Gottlieb, 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.