Is Global Food Safety Possible, or a Pipedream?

Another food safety milestone went by a few weeks ago with little notice: food products for humans and animals imported into the United States must meet our strict new standards to prevent food contamination and illness outbreaks.

Sounds great, but is that really feasible? The U.S. imports tons of food annually from all over the world: tomatoes from Mexico, jams from England, fruit tarts from France, shrimp from Thailand . . .  and on and on.

In fact, an estimated 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.

80 Percent of Seafood in the U.S. is Imported

Moreover, as America’s population has become more diverse, imports of cultural or ethnic foods have skyrocketed in popularity. Much of these products come from countries in which food safety is at best irregular, and in some cases non-existent.

For decades, food imports could be blocked if they failed to meet American food safety standards, but in practice, only a tiny portion of foreign product was inspected. State and local public health departments also were overloaded and unable to keep up with foods coming from abroad.

But a substantial segment of the new Food Safety Modernization Act (FSMA) is intended to dramatically step up preventive controls on food imports.

That’s the promise of the Foreign Supplier Verification Program (FSVP), which took effect on May 30. More than anything, the FSVP extends the reach of the Food and Drug Administration and the U.S. Department of Agriculture well beyond our national borders to ensure that food items for export are safe. The basic regulations governing importers can be found here. But these are the game-changing aspects of the Foreign Supplier Verification Program:

  • All imported food must be certified as coming from sources that have verified their adherence to FSMA, most notably the law’s requirements for a preventive control plan at overseas manufacturing, processing, distribution and shipping facilities. Importers (or agents) also must verify in writing the safety of the items coming into the country.
  • Importers of fruits and vegetables must certify that pesticide residue levels fall below threshold standard established by the Environmental Protection Agency (EPA) or else be rejected.
  • FDA inspectors have the right to visit facilities on foreign soil to verify food-safe production, distribution and shipping protocols.
  • By requiring verification, the FSVP also enables food safety regulators to better track food borne illness outbreaks in other countries and siginificantly expand the global supply chain’s transparency.

Together, these requirements represent a great big WOW! Is it even possible to attempt to get a handle on the global food supply – one of the largest and most scattered industries in all the world? And if it were true for years that FDA couldn’t keep up with border inspection of food items flowing into the country, where in the world will the agency obtain funding to step up inspections not just domestically but also abroad.

The answer is that although FSMA’s intentions are clear, implementation and compliance are clearly going to present management challenges, not the least of which is sufficient budgets to support inspections.

On the matter of foreign suppliers verifying that they have preventive control plans in place, the FDA may give some ground. One proposal floating around would allow overseas suppliers meet the voluntary standards of GFSI – the Global Food Safety Initiative – which in many aspects closely parallels FSMA’s requirements. The looming question, of course, is whether voluntary standards will really have teeth, which perhaps explains why this part of the program remains up in the air.

FSMA and the foreign supplier veritifcation program are perfectly timed to the growing interest by consumers in understanding the “transparency” of the foods they eat. In addition to GMOs, and the presence of allergens, consumers want to know the country of origin of the grocery products they buy for themselves and their pets. Yet like so much of public attention to the business of regulation, interest and comment on the foreign supplier verification program has been largely confined to specialized trade publications, with scant mainstream media reporting.

That’s a shame, because the Foreign Supplier Verification Program is something of a watershed in food safety efforts. It is recognition of the global nature of the food chain, for one. It also aspires to put in place a preventive control protocol with enough check points and government oversight to put a serious dent in foodborne illness outbreaks around the world. However, a dose of reality is necessary: FSMA enforcement is seriously under-funded, and state governments are hardly in a position to make up the funding shortfall.

So, at this point, foreign supplier verification, and the entire Food Safety Modernization Act, can best be seen as codifying in the law aspirational goals.  It would be a good outcome if these measures ended up guaranteeing a safe food supply. But that’s unlikely given the huge size of the global food chain and the ever-present danger of human error and microbiological contamination. With perfection virtually impossible, food consumers will have to hope that the foods they are purchasing from anywhere in the world will be as good and as safe as advertised.

 

 

 

 

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FSMA’s Record-Keeping Challenge

 

Of the many new requirements in the Food Safety Modernization Act, one of the most challenging is maintaining detailed records of compliance with the new law.

It’s a requirement that going to be especially difficult for small food manufacturers, those that typically do not operate with large administrative staffs. Even though small businesses (defined as those with less than 500 FTE employees) have until August 30, 2017 to achieve compliance, they still face a challenge: who are they going to tap to manage the array of records FSMA requires?

In fact, industry experts point out, FSMA requires that companies assign a management-level person to handle the record keeping, as well as an internal auditor to insure that the records are accurate and honest.

This will be no small assignment. FSMA’s record keeping regulations will require constant attention, for one thing, because the law says FDA inspectors can ask to review the records on just 24-hour notice. For another, once the August grace period ends and enforcement begins, operators who don’t meet the record keeping requirements could face costly fines.

The Food and Drug Administration (FDA) justifies the records maintenance requirement as being cost-effective in the long run. “We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion,” FDA’s economic analysis of the rule explains.

Another wrinkle in FSMA is that the company’s records must be available whenever the FDA comes calling.  “Currently, the FDA only has broad records access in emergency situations when it uses authority granted by the Bioterrorism Act,” explained Maile Gradison Hermida, an Associate with the global law firm Hogan Lovells, in a 2015 Food Online blog post. “However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.”

Through contractors, the FDA is offering training sessions to help companies understand the breadth of what they’ll need to keep track of: from hazard analyses to safety plans to documentation of suppliers and transporters. Still, there are common sense procedures that small and medium-sized manufacturers can implement early in 2017 (if they haven’t already been put in place):

  • Undertake a company-wide audit of existing record-keeping procedures, including how they are stored, who does the compilation, and what data might be located on cloud-based servers;
  • Assemble a FSMA compliance team that includes representatives of senior management (or ownership), operations, IT, accounting, legal and marketing. Its role would be to oversee all aspects of food safety implementation, including record-keeping and tracking. To assure efficiency, someone with the requisite experience in records handling should be designated as the team leader.
  • Invest in new technologies that will ease the record-keeping burden. Manufacturing software that monitors products throughout the manufacturing process should be a top priority. Cloud-based technology will not only provide a cost-effective way to store digital documents, but also offer an array of predictive analytics that can unearth potential production issues and also preempt alarm and failure events.

The enthusiastic buy-in of senior management to place food safety at the pinnacle of production is essential. In a very real sense, FSMA is a risk management tool intended to help companies in food production to protect their brands while maintaining product quality and safety.

Managing risk, after all, is a fundamental necessity for any business. Now, under FSMA, it can be the spur to efficient, profitable – and safe – performance.

 

 

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A Safer Food Supply?

Will the nation’s food supply be safer under FSMA?

The new Food Safety Modernization Act, or FSMA, which takes full effect in September, has a multitude of goals, but foremost of these is insuring that the nation’s food supply (human and animal) is safe – safer than it already is. Will the new law do that?

That was certainly the motivation for passage of FSMA in 2011. Congress recognized that the vast American food supply from farm to table was very safe, but also persistently vulnerable to microbiological contamination, accidents, and terrorist threats. FSMA addresses these dangers directly and indirectly. Here are three of the primary goals behind the new food safety regulations.

  1. Responding to the new realities of a global food chain. America’s food supply throughout much of its history has been largely self-contained: American growers, ranchers and manufacturers accounted for the vast majority of food items available to consumers. But it was never 100% domestic: Coffee from Africa and Central America; winter produce from Mexico; Canadian wheat, spice from Southeast Asia. As the consumer palate has become more varied and reflective of diverse cultures, our food supply is incredibly global in scale. FSMA is intended to insure that all food items and ingredients coming from overseas are subject to stringent safety protocols.
  1. foodmfgPlacing more aggressive regulations on suppliers, not just manufacturers. If the world’s food supply were envisioned as an iceberg, the portion above the water line would represent manufacturers, processors, and retailers. The portion of the iceberg below water – by far the largest segment – would represent the thousands upon thousands of suppliers that play a pivotal but often overlooked role in food safety. It’s a supply chain that is both widespread and granular in scope: it includes makers of conveyor equipment, as well as suppliers of lubricants for that equipment.
  1. Preventing food safety issues rather than relying upon government intervention only when there’s a problem, is at the very heart of FSMA, and one that should have the most immediate and beneficial impact on food safety over time. That’s because, for the first time, food manufacturers and processors, along with their supply chain partners, have clear direction in preventing food contamination by creating and maintaining a food safe environment up and down the supply line. One requirement alone – having in place a comprehensive food safety plan – is perhaps the single most significant of all of FSMA’s many regulations.

Of course, maintaining a 100 percent safe food supply is literally impossible. But as an aspirational goal, FSMA represents forward thinking on the part of the government and the food industry, both of which have an obvious, vested interest in producing and selling products that are as safe as they can possibly be.

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FSMA and Hand Washing. Yes, Hand Washing

Embedded in the myriad rules and regulations of the Food Safety Modernization Act (FSMA) is a significant cultural shift in food manufacturing.

How so? The new law requires the food industry (and its many suppliers) to provide day-to-day management of all aspects of food safety, or suffer the consequences of government fines and public opprobrium. This represents a dramatic change from the largely voluntary approach of decades past amid a patchwork of vague, sometimes conflicting laws and regulations.

A perfect example of this transformation involves a simple procedure long associated with public health: hand washing. It’s long been standard practice (and a health code regulation) that employees working around or with food, whether in a restaurant, a growing field, or on a food manufacturing production line must wash their hands – thoroughly and regularly – while on the job.

handwashingPractically speaking, however, various studies over the years indicate that proper hand washing doesn’t occur as regularly or as thoroughly as needed or required. Even the ubiquitous hand sanitizer dispensers don’t offer the germ protection necessary to prevent contamination. Just as problematic is sketchy enforcement of hygiene. For food manufacturers and processors, hygienic requirements have always been nebulous. Many producers and processors have adopted the hand washing procedures outlined in the FDA Food Code or similar procedures. Yet the Food Code is only a set of recommendations and doesn’t carry the force of law.

With FSMA, these recommended procedures now become mandatory. Under FSMA’s required preventive controls,known by the acronym HARPC (Hazard Analysis and Risk-based Preventive Controls), manufacturers must create and maintain a thorough hygiene discipline throughout their facilities. Specifically, the new law says “management of covered facilities must ensure that all employees who manufacture, process, pack or hold food have the necessary education, training, and/or experience and ensure they receive training in the principles of food hygiene, food safety, and employee health and hygiene.” Such training includes thorough and regular briefings on proper hand washing protocols, as well as hand washing records available for FDA inspection.

Regulatory overkill? Perhaps. Hand washing seems like a such a small issue in the midst of a wholesale re-direction of food safety regulations under the Food Safety Modernization Act. Yet hand sanitation is a critical frontline technique to prevent the spread of harmful bacteria that can lead to outbreaks of Hepatitis and other illnesses. This has been the FDA’s intention for decades; now, with FSMA, proper hand washing carries the force of law.

That’s a clear cultural shift that will impact workers, managers, and manufacturers all along the food supply chain.

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The Challenge of FSMA Transparency

UPDATE

The critical importance of food transparency was underscored by the results of a recent global survey on consumer attitudes about overall food safety. Bottom line, confidence in food safety has declined, and consumers look to manufacturers and retailers to be proactive in preventing food contaminations and recalls. Read about the survey results here:

 

The new Food Safety Modernization Act (FSMA) presents food manufacturers and their suppliers with a significant challenge: how to efficiently filter FSMA preventative controls down the food supply chain to encompass the thousands of suppliers and vendors that will have to create and manage their own food safety plans?

The answer lies in a key section of FSMA, which codifies in its regulations the concept of “supply chain transparency.” Under the new regulations drawn up by the Food and Drug Administration (FDA), a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. In other words, at every step along the food chain from farm to table, manufacturers and producers must be fully cognizant of the safety controls of their suppliers – and have the records to prove it.

Actually, transparency has been around for several years in business-to-business circles. A series of disastrous food recalls traced to suppliers who either didn’t know what they were doing, or intentionally sold adulterated, unsafe product, prompted businesses here and abroad to begin putting their suppliers on notice: unsafe practices will not be tolerated. Under FSMA, manufacturers are obliged to hold their suppliers to the same food safety standards they must follow.

(Transparency and another descriptor, traceability, are often used interchangeably, but have slightly different meanings. Traceability usually describes the technical ability to verify the identity, history, location or application of an item, while transparency is used when talking about broader collaborations among trading partners in the food chain).

For the FDA, supply chain transparency is part of the agency’s new operating model that emphasizes strengthened collaboration and improved information sharing and gathering among trading partners, data-driven risk analytics, and the smart allocation of resources for food safety management.

food mfg close upThere are many places along the manufacturing production line where unintentional food adulteration may accidentally occur. Water used to hose down equipment may contain harmful bacteria. The lubricants used to keep the machines running at peak efficiency might touch the product as it whizzes by. And so on.

Suppliers of material used in manufacturing, such as lubricants, are required under FSMA to demonstrate that their products are properly formulated, labeled, stored and used to prevent compromising food safety, and that only “food grade” lubricants are allowed in those parts of the manufacturing facility where the food is produced. Lubricant manufacturers also must document their processes so that if a food safety problem arises, preventative control records and product formulations are readily accessible should a problem arise.

Over time, transparency will become second nature for manufacturers and their many supply chain partners. For the time being, however, companies all along the food chain are quickly realizing that the new way of doing business to prevent food contaminations will require time, attention and management focus not just inside their own operations, but also up and down the supply chain.

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