Remarks at the Food and Drug Law Institute’s Food Enforcement and Compliance Conference April 12, 2018

Speech | In Person

Stephen Ostroff, M.D.
FDA’s Deputy Commissioner for Foods and Veterinary Medicine
Food and Drug Law Institute’s Food Enforcement and Compliance Conference, Washington, D.C.

(Remarks as prepared for delivery)

Good morning. I’m glad to have been invited back to speak at another Food and Drug Law Institute event this year.

For those of you who regularly attend Institute conferences, you may recall that I’ve spoken several times at the annual conference in the role of Acting Commissioner, including last year. 

As my favorite philosopher Yogi Berra once said, “It’s déjà vu all over again.” 

The Commissioner’s speech is a daunting task, having to cover the entire waterfront of FDA activities.  It’s like the State of the Union for FDA. 
Last year I elected to flip the script and, for a change, talk first about the foods side of the house before discussing medical products and tobacco.  That was an homage to my usual job as Deputy Commissioner for Foods and Veterinary Medicine. 

But it was also an acknowledgement that there are many important things going on in the FDA foods program.  Things like food safety, nutrition, antimicrobial resistance, labeling, and genetic engineering, among others.   Sometimes they get overlooked by all the exciting and often more visible happenings in the drug and device industry. 

These issues reflect the changing nature of the food supply.  And they illustrate how FDA is working to ensure consumer confidence in the safety of that supply.  They also show how we are taking measures to provide consumers with information they’ve asked for to help them make informed choices about the foods they purchase and consume. 

It’s an incredibly busy time at FDA.  And, I must say, an incredibly productive and exciting time.   Things are getting done.  Things are moving.  That was true last year when I gave the Commissioner’s speech.  And it remains my message today.

The title of this conference caught my attention.  It’s the Food Enforcement and Compliance Conference.  Maybe it was called that because it’s an easier acronym – FECC.   But looking at it through my FDA lens, I’d probably have called it the Food Compliance and Enforcement Conference, or FCEC. 

That’s because it’s my perspective, and I think it’s one that is shared by my colleagues in CFSAN, CVM and ORA, that we’d devote our resources to help industry comply with our statutory and regulatory framework – to “help them get it right” – and to “educate before and while we regulate” before we’d engage in enforcement actions.  These are phrases many of you have heard before, and I don’t consider them to be just catch phrases.

We’d rather employ the carrot of assisting industry with compliance before coming along with the stick of enforcement. 

Let me share a couple of quotes regarding this issue. 

First, one from an economics professor in Spain – “Most bosses know instinctively that their power comes from their employee’s compliance rather than on threats or sanctions. “

While he’s discussing labor relations between a boss and employee, the sentiment is right.  Most responsible segments of the food industry comply because they recognize it’s in their best interest.  And it’s good for the bottom line.  Just ask anyone who’s been involved in a large recall what that costs a company.

Calvin Coolidge, not usually someone I quote, said “I sometimes wish that people would put a little more emphasis on the observance of the law than they do upon its enforcement.”
I tend to agree with him. 

But the truth is that for routine inspectional activities, FDA will almost always point out areas of non-compliance and give industry a chance to remedy the problems within a reasonable time frame rather than resorting immediately to enforcement actions.  Of course, when there are situations where the problems pose an immediate threat to public health or reflect blatant disregard for the regulations, we would act differently. 

That approach is not something new for FDA.  It’s the way we generally operate in the food arena. 

But these days we’re doing new things in the food safety and nutrition arena.  Things like FSMA and menu labeling.  The updated Nutrition Facts label.  But I want to assure you that even in these new areas, we’re not approaching things any differently. 

After all, I’m a food guy.  No one has to tell me that a carrot is more nutritious and tastes much better than a stick.    

So let’s get that out of the way. 

There’s a lot of ground I’d like to cover in the next few minutes. 

But first let me set the stage.

As I discussed recently at the GMA Science Forum, I’m a medical epidemiologist by training, and I follow closely the data on foodborne disease put out by my former colleagues at the Centers for Disease Control and Prevention (CDC).   

CDC issued its most recent FoodNet report a few weeks ago.  FoodNet monitors the incidence and trends in infections from eight foodborne bacteria and parasites across 10 active surveillance sites that together encompass about 15 percent of the U.S. population.  This year’s report covering 2017 shows there were 25,000 infections in these sites and 122 deaths. 

Those are big numbers reflecting a large problem.   

The latest data are complicated by the increasing use in clinical settings of a new category of diagnostic test called CIDTs (or Culture-Independent Diagnostic Tests) that don’t require the sample to be cultured in the lab.  These tests get the answer for a clinician much faster than traditional diagnostics. 

The more they are used, the more evident it becomes that these tests are likely uncovering illnesses that were previously invisible to us because of limitations in cultures.   They increase the number of illnesses detected. 

The use of these tests is making it challenging to evaluate trends, something I follow closely.  But the bottom line from the latest FoodNet data is:

1. the incidence of disease caused by these eight pathogens isn’t going down and in some instances is probably going up. 
2. And we’re not making progress towards attaining any of the federal Healthy People 2020 goals for reducing the incidence of foodborne disease from agents like Salmonella and Campylobacter. 

At best, we’re holding the line.  At worst, we’re losing ground.  Either way, we have our work cut out for us.  

That work is made more challenging by the fact that our foods come from all over the world and imported foods represent a higher and higher proportion of what we eat. 

Other countries now supply more than 50 percent of fresh fruit, almost 30 percent of vegetables, over 90 percent of spices, and an estimated 95 percent of seafood eaten by U.S. consumers.

Our work is more challenging because consumers increasingly prefer healthier and more nutritious foods.  That’s a good thing, especially in an era of obesity and diet-related chronic disease.  But many of these nutritious options fall into higher risk categories when it comes to food safety. 

Our work is also more challenging because of the fast-changing nature of today’s technology. 

Foods are not only being produced differently – think genetic engineering and synthesized meat and fish-like products.  They’re also being brought to consumers in ways that reflect the demands and opportunities of our times.  Things like direct-to-consumer on-line sales.  There’s even talk of home delivery by drone or robot.  

We’re fully behind innovations in the food supply and food technology of all kinds.  But we must assure these are produced and delivered safely so that we don’t inadvertently introduce food safety risks.  

That means making sure we have the tools and expertise within FDA to effectively evaluate these advances.  And making sure we focus our food safety efforts on addressing them while not stifling innovation.   

I think we’re up to the challenge and I know that FDA can count on the support of the Institute and those in attendance to do so with us.

Let me now turn to FSMA

We continue to make great progress in the transition from developing to implementing FSMA’s “foundational” rules. 

The preventive controls (PC) rule for human foods and modernized GMPs (Good Manufacturing Practices) are probably the furthest along to being the “new normal.” 

The preventive controls rule for animal food and GMPs are not far behind, even though routine PC inspections for this rule are not scheduled to begin until next year.  This allows more time for industry to implement the rule and assess the draft guidance issued in January.  It also allows time for our inspectors to get trained. 

Probably the most challenging areas in FSMA have been the produce rule, imports, and intentional adulteration.  These are challenging in part because FDA has not previously provided the level of oversight required by FSMA in these areas.

Produce Safety

January 2018 marked the first major compliance date for the Produce Safety rule when larger farms other than sprouts producers were required to comply.  However, as with animal PC, we won’t be starting routine inspections for this rule until next spring.

We made the decision to delay inspections until next year because we felt that everyone needed more time to do this right. We want farmers to have the tools they need to comply and federal, state and tribal regulators to have the tools they need to inspect.  

Over the coming months we will be focused on issuing draft guidance documents, delivering training, conducting voluntary on-farm readiness reviews, and increasing our communications and outreach to stakeholders.  

We have established a Produce Safety Network, whose regionally based experts will support both farmers and state/tribal regulators. 

Congress recently provided another $10.5 million for the Cooperative Agreement Program with the states to support development of their own produce safety programs.  These funds add to the $53 million awarded to 43 of the states in the first two years of this program. 

We expect additional states to come onboard with the new money. 

However, we know that by next year when inspections begin, not all states will be participating in the program.  Some not at all and some not in the inspectional and compliance component (Part B). 

In those states, FDA will need to step in and fill that role.  You need to be aware of the status of each of the states regarding who will be doing most routine inspections.   
The agricultural water requirements of the produce rule have been particularly challenging. 

They were widely seen by stakeholders and some within FDA, including me, as being too complex and costly to implement. 

We continue to explore how to simplify the microbial quality and testing requirements in ways that are still protective of public health.  In September, we proposed to extend the compliance dates for the agricultural water requirements to, at the earliest, January 2022, which would be the compliance date for large farms.

We don’t intend to take compliance actions regarding the ag water requirements while this rulemaking is underway and, if finalized, until the new compliance date. 

In the meantime, we are engaging with growers, regulators, extension agents and other stakeholders to learn more about what works for them and what doesn’t. 

A few weeks ago, we participated in the Agricultural Water Summit hosted by the Produce Safety Alliance. We heard from many stakeholders about their concerns and potential solutions.  This type of dialogue is crucial as we determine what to do and next steps.

You’ve also heard we’re working on the farm definition, which impacts the PC rules, foreign supplier verification, and the produce rule, among other requirements. 

We announced in January that we would exercise enforcement discretion while the definition was being reassessed and that changes would likely require rulemaking.  This will obviously take time. 

Our reassessment will consider other approaches instead of using criteria like ownership structures to determine whether an operation is a farm.  We will consider functional criteria that treat “like” activities similarly since the level of risk for “like” activities ought to be the same.  Therefore, they ought to be required, or not required, to do the same things.   

Imports

We have taken several different paths to reach our goal of strengthening our oversight of imports.

Through the Foreign Supplier Verification Programs (FSVP) rule, importers are responsible for ensuring that their foreign suppliers produce food in a way that meets applicable U.S. safety standards. 

This is a building block of our efforts to ensure parity in our oversight of domestic and imported foods. 

Last May was the first major compliance date for FSVP. 

In January we released four draft guidance documents, all intended to help importers meet the requirements of FSVP, including a draft guidance explaining what we mean when we require "the same level of public health protection" and providing a framework for complying with this requirement.

The Accredited Third-Party Certification rule establishes a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

We launched the website for organizations to apply to be recognized as accreditation bodies in June 2017, and recently recognized two accreditation bodies.

There are other ways in which we are working to achieve parity between our oversight of domestic and foreign foods.

We have systems recognition arrangements in place with New Zealand, Australia and Canada, and are actively working on a similar arrangement with Europe, which is more challenging because of the 28 member states. 

Last month we issued a proposed determination regarding shellfish equivalence with the European Union; a separate process is underway by the EU for the U.S.  These determinations, if finalized, are important to allow the resumption of trade across the Atlantic in this commodity category. 

Let me next turn to Intentional Adulteration (IA), the only foundational FSMA rule that has yet to reach a compliance date. 

The rule requires companies, primarily large ones whose products reach many people, to prepare and implement a food defense plan that identifies vulnerabilities to deliberate contamination and ways to minimize risks.

The IA rule reflects the realities of today’s world.  One in which there are people and groups out there who are intent on carrying out acts of terrorism meant to harm and kill many people.

Some in the food industry have raised concerns about the costs and burdens associated with this rule.  We know many companies have made significant efforts to reduce their vulnerabilities to intentional acts.  And I applaud them. 

For these companies, the costs and burden of the IA rule should be minimal.  And there is a great deal of flexibility in the rule that will enable companies to tailor their food defense plans in a way that is cost effective and works best for them.

We’ve been engaged in an extended dialogue with industry over the IA rule, including their interpretation of the requirements and ours as the regulators.  I’ve visited a number of facilities to specifically learn more about the concerns. 

I’ve indicated that many of these concerns will hopefully be clarified and allayed when the promised draft guidance on the rule is issued, hopefully soon.  We do have some time, since the initial compliance date is not until July 2019.  And we intend to take the same “educate before and while we regulate” approach to this rule that we’ve taken with the others. 

Two other subjects that I know are of great interest to you are inspections and recalls.

Inspections

Continued training of federal and state regulators to conduct consistent, effective inspections is a priority this year.  Even as this effort is underway, we have moved forward with inspections of both foreign and domestic food producers.

In Fiscal Year 2017, there were more than 1,200 preventive controls, CGMP and FSVP inspections domestically and almost 150 in other countries.  In just the first half of FY 2018, we’ve already exceeded those numbers, with more than 1,600 domestic inspections and 150 foreign inspections conducted. 

The feedback we’ve received from industry about their experiences with FSMA inspections has been generally positive.  In the few instances where problems have been brought to our attention, we’ve worked to quickly remedy them through feedback to inspectors. 

We are also looking to enhance efficiencies. 

One example is what we refer to as two-tiered inspections.  This can be done when certain food safety activities are managed at the corporate level and not at the facility level.  Recalls or supply chain are examples. 

In those situations, we can do that part of the review at headquarters only, simplifying the inspection at the facility.  We plan to pilot this approach soon. 

Another pilot in several states will evaluate the possibility of conducting unitary federal inspections at dairy facilities which process both Grade A and non-Grade A products.  Currently, these facilities undergo separate inspections, resulting in multiple visits from federal regulators.

Another way to streamline activities for regulators and for industry is to integrate FSVP and Sanitary Transportation inspections into inspections being performed for the preventive controls provisions.

There will be more to come on all these streamlining ideas.  

Recalls

As you know, FSMA gave FDA new enforcement tools such as facility registration suspension and mandatory recall authority.  You also know that FDA has used these tools sparingly, as we know voluntary recalls are often the quickest and most effective way to get a potentially contaminated product off the market.  

However, on April 2nd, FDA ordered a mandatory recall for the first time, although it’s not the first time we’ve threatened to invoke that authority. In the previous two instances, the threat was sufficient to initiate a voluntary recall. 

But in this case, the company refused to initiate a voluntarily recall of food products containing powdered kratom after samples tested positive for Salmonella.
So when the company in this case did not comply with our request for a voluntary recall, we moved quickly to remove these products from the marketplace.  That’s how the system should work. 

We also have several other concerns about kratom, including the current outbreak of salmonellosis from kratom products, which now numbers 135 reported cases and many hospitalizations.

We have also continued to make advances to improve our food recall process since the Department of Health and Human Services’ Inspector General first brought to our attention concerns about the timeliness and effectiveness of our recall procedures. 

This includes putting in place the SCORE (Strategic Coordinated Oversight of Recall Execution) team of senior leaders to oversee complicated, unusual, or problematic recall situations.  It also includes enhanced transparency, including timely information sharing with the public.  And when necessary to help effectuate a recall, retail distribution information, as we recently did with bulk shredded coconut. 

Another game-changer when it comes to recalls is whole genome sequencing (WGS).  Its impact on food safety response and prevention has been significant. 

FDA has established a national and international network of laboratories called the GenomeTrakr.  This system now has over 167,000 gene sequences of foodborne pathogens and the database is growing at roughly 5,000 isolates each month, 

We’ve now had two recent situations where the use of this technology has allowed us to find what I refer to as "reverse outbreaks." 

In these situations, an outbreak was recognized leading to product sampling.  This sampling then identifies other pathogens (in both instances different Salmonella serotypes), which are then sequenced.  These sequences were then shared with CDC, and were then linked to human illnesses without an identified source.  Re-interviews of these patients then link them to the initial outbreak, akin to a “cold case” investigation.

This occurred with a June 2017 papaya-related outbreak as well as the current kratom outbreak.  I don’t think these are isolated instances and I’m sure we will see more of these as our experience with this technology grows. 

Nutrition

In the remaining time, I’d like to touch on several nutrition issues.  Just a few weeks ago, Commissioner Scott Gottlieb introduced FDA’s multi-year Nutrition Innovation Strategy.  This new strategy takes a fresh look at what can be done to reduce preventable death and disease related to poor nutrition.  Areas that we plan to work on, among others, include standards of identity, ingredient lists, and health claims. 

The plan also involves things that are already underway. 

Probably the two most immediate issues are the Nutrition Facts label and the menu labeling provisions. 

Regarding the other NFL, we proposed to extend the initial compliance date from May of this year to January 1, 2020 to give industry more time to develop the new labels once additional guidance was available. 

This date was also chosen to reduce the time period when both the old and new labels were in the market, since we know that about 10% of current products on store shelves, or about 25,000 products, already carry the new format labels. 

We are working to finalize the compliance date regulation.  We also recently released a bundle of final and draft guidances on issues such as fibers, serving sizes, and the added sugars provisions. 

Menu labeling

Less than four weeks from today, covered eating establishments, including chain restaurants, grocery stores, and convenience stores with 20 or more outlets, will be required to post calorie counts to help consumers have more information about their meal choices. 
We’ve reached this milestone after a series of compliance date delays, including in May of last year. 

I feel these delays have helped to address many questions around compliance and have led to added flexibility on how to meet the requirements. 

Last fall we issued a draft supplemental guidance to provide more flexibility, recognizing the many variety of business models covered by this regulation and how what works in one setting may not work in another.   We hope to finalize that guidance very soon. 

We’ve announced that we’ll be launching an educational campaign focused on better understanding daily caloric requirements and how to make healthy swaps, so that consumers can make the most of the new information.

Time does not permit me to talk about many other issues, such as biotechnology regulation, especially gene editing of plants and animals, traceability through innovations like block chain technology and how it can also benefit areas like food fraud, regulation of synthetic meats and fish, standards of identity for complicated areas like dairy products, ready-to-eat versus non-ready to eat foods, dietary supplements, antimicrobial resistance and antibiotic use in food producing animals, and many others. 

If I covered all of those, we’d be here most of the day.  And I know you have a very exciting agenda to cover, including talks by other FDA presenters. 

So I’ll end with another Yogi Berra quote.  He said "It gets late early out here."  Meaning I’ve talked far too long – but it went by fast. 

I thank you for your attention, and for what you do.  I would be happy to entertain questions now or afterwards.