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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The Alphabet Soup of Food Safety (Part I)

FSMA. FSSC22000. GFSI. HAACP. SQF. Stop! My head hurts.

This is the likely reaction of anyone performing a deep dive into the intricacies of the world’s food safety standards. But understanding the acronyms of the various entities involved in food safety is well worth the time and effort if you are a food manufacturer or supplier. Why? Because the safety standards – a mix of voluntary, industry-led guidelines and government mandated regulations – will likely play an important, perhaps even decisive role in your business going forward.

What follows is the first of a two-part blog on helping food manufacturers and their suppliers – here and abroad – understand the key organizations and programs involved in safeguarding the global food supply.

Ready? Let’s jump in . . .

FSMA — This is the Food Safety Modernization Act of 2011 passed by Congress and signed into law by former President Barack Obama. It is watershed legislation because of its dramatic shift in focus from dealing with foodborne illness outbreaks after they occur to preventing them (as much as possible) from happening in the first place.

The rules and procedures in FSMA took regulators from the Food and Drug Administration more than five years to draw up and finalize. Much of the work (as this post demonstrates) was based upon already existing food safety procedures and guidelines. Implementation is now underway using compliance timetables generally related to the size of companies. FSMA applies to farmers and growers (but not cattle ranchers), manufacturers and processors, as well as shippers. Its provisions also apply to companies that http://www.sqfi.comimport food into the U.S.  Food, under FSMA, is both for humans and animals.

(In the U.S., government agencies and academia have teamed up to create the Food Safety Preventive Controls Alliance (FSPCA) to help train companies on how to meet FSMA’s regulations).

HAACPHazard Analysis and Critical Control Point (HACCP) is an internationally accepted management program for reducing potentially dangerous hazards in food. HAACP forms the basis of the new food safety act as well as voluntary food safety certification programs.

A HACCP System requires that potential hazards be identified and controlled at specific points in the manufacturing, storing and distribution process along the global food chain. This includes biological, chemical or physical hazards. Any company involved in the manufacturing, processing or handling of food products can use HACCP to minimize or eliminate food safety issues from occurring. (The language in FSMA refers to “preventive controls,” which largely build upon HAACP principles).

GFSIThe Global Food Safety Initiative is a Paris-based association of major food companies that promulgates food safety protocols (or “schemes) for food companies.  It was formed in 2000 in response to a series of serious food safety crises. GFSI is a voluntary organization. Industry-led committees and workgroups formulate schemes, which serve as benchmarks for companies that want to gain GFSI certification. Although it has a global reach, GFSI’s schemes have been adopted more internationally than in the U.S.

SQFThe Safe Food Quality Institute is a standard-setting, voluntary organization for the food industry, with a focus on U.S. based food retailers. The SQF Program is recognized by the Global Food Safety Initiative (GFSI) as a Food Safety Management Systems Certification program (see more below).

ISO The International Organization for Standards, based in Geneva, Switzerland, is an independent, non-governmental organization of some 163 national standard setting bodies. The standards, many thousands in all, cover a wide range of industries (including the human and animal food industry) through “best practice” specifications for products, services and systems. The standards are voluntary – they don’t carry the force of law – and are based on consensus of relevant national standard setting bodies.

Importantly, ISO itself does not provide certification that a company has met its standards; this is done by external certification bodies (such as SQF). Once certified, a company can promote its compliance with the ISO standard.

FSSC 22000 – This is a Food Safety Management System (FSMS) Certification Scheme. Certification is granted to retailers, manufacturers, suppliers and others when the companies have implemented prevention-based hazard food safety controls and a third-party auditor has audited the system to verify that it complies with its requirements.

FSSC 22000 is a certification program recognized by GFSI. In April, 2017, it issued its 15,000th certificate.

Whew! That’s a lot of information to absorb. The point is that taken as a whole, these organizations are all about establishing and maintaining worldwide food safety standards. In Part II, we’ll show you how these organizations compare to, and differ from, regulatory efforts via the new American food safety law, and why that law is both evolutionary and revolutionary in its scope and intent.

 

 

 

 

 

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With New Administration, Where Does FSMA Stand Now?

The Food Safety Modernization Act (FSMA) went mostly into effect last fall. Where do things stand now with a new Administration in the White House?

It’s hard to know for certain, in part because the Food and Drug Administration (FDA) which oversees FSMA, is hanging in limbo without a new Commissioner in place. Plus, with all the other issues and policy differences on the front burner right now, food safety has pretty much been pushed into the deep background of White House priorities. For now, the timetable for rollout and compliance remains in effect (see compliance schedule chart).

Yet careful observers should be able to spot some indicators of what might happen in the months ahead.

For one thing, the newly-approved head of the Department of Health and Human Services, former Georgia Rep. Tom Price, is well-known for his strong views against government regulation. HHS oversees the FDA (a relationship often overlooked), and with the new Republican regime hustling to assemble a new federal budget, it would hardly be surprising if FDA’s already slim budget for FSMA enforcement were cut back some more. Reducing the FDA’s budget for inspectors would create obvious enforcement problems. State governments were allocated federal budget dollars to support local inspectors; these funds also might be reduced or eliminated.

For another, while the major chunks of the sweeping new food safety act have been implemented, compliance with the new regulations was postponed for a year last September, except in cases of gross violations by food manufacturers or transporters. Between now and August, FDA is committed to “educating” the industry on the law’s many and complex requirements. As a result, the new Administration simply might extend the compliance deadline even further into the future; in effect, turning FSMA into a voluntary set of guidelines, not federal law backed by severe fines and even imprisonment for violations.

Finally, compliance on the part of small manufacturers was specifically postponed to give them more time to figure out how to cover the costs of the law’s requirements, such as creating a food safety manager at each plant site. Thus, it would be easy for the Administration to either delay compliance by small companies even farther into the future, or to exempt them from FSMA altogether.

The interesting factor in this is the influence of the major manufacturers towards the new law. The big brands who churn out thousands of manufactured food products every day got on board with FSMA early on, figuring that a position opposing food safety standards was a non-starter, but also because most of the companies felt that food safety was, in fact, a growing concern as the global supply chain grew in size and complexity.

Experience has taught manufacturers (and retailers, which aren’t under FSMA) that food contamination outbreaks and widespread product recalls can have a serious negative impact on sales and brand reputation. FSMA’s entire approach to regulation is aimed at preventing outbreaks by instilling a “safety first” mantra at every link in the food supply channel.

All of these factors point to the conclusion that the Food Safety Modernization Act, like many federal regulations enacted during the previous eight years, could face delays in actual compliance. While that may please those who object to government involvement in business, it may distress others in the food industry who see the need for across-the-board standards that promote a safe food production and transportation environment.

 

 

 

 

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FSMA and the Challenges for Small Business

FSMA BUSINESS COMPLIANCE DATES

April 30, 2017 — food safety verification for companies exporting product or ingredients to American-based small businesses;

August 30, 2017 — companies with fewer than 500 full-time employees;

August 30, 2018 — companies with annual sales of less than $1 million (for animal products, $2.5 million)

The big compliance date has come and gone, and food manufacturers and their suppliers are now subject to the Food Safety Modernization Act (FSMA).

Yet in many ways, the September 2016 deadline was only the start of a new countdown to compliance for small and and very small food companies and their suppliers, domestic and foreign.

Let’s take a look by examining what “compliance” actually means to the Food and Drug Administration, the agency that governs the food industry and manages FSMA:

  • ENFORCEMENT. Although FSMA is in effect for large-scale, multinational food companies, the FDA has offered industry a grace period in which education will take precedence over enforcement. Essentially, regulators are allowing manufacturers and their suppliers an extended period of time to implement the new safety law’s many requirements without fear of citation, license revocation or a mandated food recall. However — and this is a big caveat — the FDA will crack down on “egregious” FSMA violations, defined as activities that demonstrate that a food company is willfully failing to comply with the new law.
  • SMALL BUSINESS DEADLINES. The FDA’s rules offer a helping hand to small businesses in the food industry by extending compliance deadlines for nearly a year – to August 30, 2017. What constitutes a small business? Generally, the FDA says, a small business is one with less than 500 full time equivalent employees. There is also a “very small” business category, with a somewhat different definition: a company with average annual sales of less than $1 million, including the market value of inventory on hand. (For producers of animal food, the cutoff for compliance is annual sales of $2.5 million).
  • IMPORTERS. How to insure compliance for food importers is one of the trickiest aspects of FSMA. The overall intent of the law is clear: the United States wants foreign-based suppliers of food items or ingredients to be held to the same safety standards as American-based firms. Yet the various rules governing what the FDA calls the Foreign Supplier Verification Program (FSVP) have differing compliance dates tied to the size of the importing company, where it is domiciled, and what it is shipping to the U.S. Suffice it to say that if a small American company is importing food items from overseas, it must verify the foreign supplier’s compliance with FSMA standards by April 30, 2017.
  • TRAINING & ASSISTANCE. A baked-in assumption in FDA’s rules is that large manufacturers will already have been close to compliance, but that smaller firms many not possess the budget, personnel or access to training to meet FSMA’s tough new safety standards. One solution is the Food Safety Preventive Controls Alliance, comprised of government, industry and academic advisors who can assist small businesses understand FSMA’s requirements and schedules through seminars, distance learning and online and printed materials.

American manufacturing is by and large driven by small business. Of some 252,000 manufacturers of all types in 2013, according to the National Association of Manufacturers, the vast majority employed fewer than 500 people, the cutoff point for FDA compliance next year, not this year.

What these numbers suggest is that reaching the thousands upon thousands of employees and persuading them to make food safety a personal responsibility will take time, effort and patience. Thankfully, the FDA has recognized the scope of the task, and is rolling out FSMA compliance in a way that helps every business adjust to the new law.

 

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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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