Adopting Global Food Safety Standards (Part II)

Suppose you are a manufacturer’s rep for a product that is needed by food processors facing the government’s new compliance standards under the Food Safety Modernization Act (FSMA). The client’s procurement manager tells you that his company already is compliant and has the certificate from something called FSC22000 to prove it. So why, he asks, do we even need new government regulations?

The question causes your head to spin:

  • Is the procurement manager correct, or is he smoking something?
  • What is FSC2200, anyway, and is it a substitute for FSMA?
  • Does my product meet the various food safety standards currently covering the food industry?
  • Can someone clear things up for me?

If this is you, or if you currently work in the food business, the chances are pretty good that you’ll face just these kinds of questions even as FSMA continues to roll out across America. How to make sense of the situation is the purpose of this post.

Voluntary versus Required

The first matter to keep straight in your mind is that there are many voluntary food safety certification programs and standards, but only one mandated law – FSMA. So, even if the company your work for has met those voluntary standards, your firm will still have to meet the new food law’s stringent regulations. But before you go off in a rage, it’s important to know that the voluntary safety standards by and large complement, and in some instances are incorporated into, FSMA.  So things may not be as onerous as you think.

Here’s why: the global food industry has taken clear leadership in creating food safety guidelines and standards for manufacturers, processors, suppliers in the food chain and food retailers around the world. These standards are rigorous, comprehensive and peer reviewed. They also are completely voluntary.

FSMA adds another layer of required compliance standards that in many ways reflect the industry’s standards. But it also adds record-keeping requirements that will force companies and their suppliers to maintain detailed records of preventive controls, safety reviews and inspections, and communications up and down the food chain.

Similarities and Differences

The food industry’s safety standards generally are organized into what are called “schemes.” Think of these as protocols or standards for the various procedures and practices of the global food chain. Example: temperature controls for perishable products. Each of the industry certification recommendations includes a set of established good manufacturing programs to insure that producers, shippers and retailers maintain constant and adequate temperatures to avoid food spoilage. So does FSMA, which also requires detailed record-keeping of temperatures for review by government inspectors.

Other similarities between industry voluntary standards and government regulations:

  • HAACP controls are prominent throughout all the food safety programs. FSMA’s are slightly different than the industry standards, but by and large, managing forseeable problems and dealing with them is a core concept underlying both the new government regulations and the industry programs;
  • Although different nomenclature is used, both the industry programs and FSMA emphasize the critical importance for companies to assign experienced food safety professionals to manage implementation and compliance efforts. The federal law calls these individuals “Preventive Control Qualified Individuals,” or PCQIs; the various voluntary industry programs also call for such individuals. Training for such designated individuals is widely available.
  • Food safety training is key to both the industry certification programs and the federal food safety law. The FDA has authorized dozens of training experts to conduct training seminars. Internet Google search lists numerous programs available for companies and individuals;
  • Perhaps the most significant difference between the voluntary programs and the government food safety law involves record-keeping. The industry programs lay out suggested actions a company should take to demonstrate proof of its compliance. FSMA, by contrast, requires companies to set up and maintain detailed compliance records that must be available on short notice for Food and Drug Administration inspectors. In fact, FSMA’s record-keeping requirements arguably are among the most contentious duties of the law.
  • One other difference is worth pointing out: the voluntary industry programs issue certification to those who pass muster. The FDA, on the other hand, does not certify manufacturers or suppliers as “certified” or “in compliance.” Practically speaking, this means that the industry certification can be used in advertising or marketing, but there is no such thing as FDA endorsement or certification.

It is important to note that as companies scramble to achieve compliance with FSMA, certification from a voluntary program can be especially helpful if for no other reason than to demonstrate to regulators that the company is serious about maintaining a high level of food safety protocols in its operation.

The voluntary standards are high-minded and tough. FSMA is tough and comprehensive. In the end, these standards are the most encouraging development in the long struggle to maintain a safe food supply.  The outcomes for consumers worldwide should result in fewer foodborne illness outbreaks and contaminations. That’s to everyone’s benefit.

 

 

 

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Is the Nation’s New Food Safety Law on the Cutting Block?

Is the nation’s new food safety law on Congress’s cutting block?

The 2016 election results have the food industry and regulators scrambling to determine whether – or which – government programs may be affected once President-elect Trump and a new, Republican-controlled Congress take office in January.

The short answer is that nearly every program and agency in the federal budget likely will come under review, as is always the case each fiscal year but even more so when there’s a new Administration. Donald Trump and the GOP strongly advocate cutting government spending, so it is a safe bet that the Congressional budget and appropriations committees will be focusing renewed attention on by eliminating or trimming existing programs and regulations.

How will funding for the new Food Safety Modernization Act (FSMA) fare? Right now, an educated guess will have to suffice; much depends upon appropriations choices for the U.S. Department of Agriculture, the parent agency of the Food and Drug Administration, which oversees FSMA implementation.

What we do know is that in outgoing President Obama’s final budget submission to Congress (which was declared “dead on arrival by House Republicans), the Administration sought a $25 million increase in FDA’s food safety budget to a total of $1.195 billion FY 2017. That’s down from the FY 2016 budget in which the FDA received a $1.5 billion outlay, which was higher due to FDA’s FSMA implementation.

Beyond the bare numbers, which are sure to change, the following are for possible food safety budget reductions:

  • Food safety inspections of domestic and foreign manufacturing plants. FSMA envisions a preventive-based approach to food safety that is backed by extensive and strengthened inspection procedures carried out by the agency itself and by state agriculture or public health agencies. The food industry prefers voluntary compliance, and it is possible Congress will delay stepped-up inspection and rely on industry self-compliance.
  • Compliance deadlines. Although FSMA is now fully implemented, the agency plans to emphasize education over enforcement until August 2017. For budget reasons, as well as ongoing industry challenges in achieving compliance, it may be tempting for Congress to push back the compliance deadline even more into the future.
  • Food safety research and testing. Over the past several budget cycles, the FDA and the Centers for Disease Control (CDC) have spearheaded the use of emerging microbiological technologies to more quickly pinpoint the sources of food-borne illnesses. Yet the GOP Congress has long been skeptical about government research, preferring privately funded activities, and the new Congress could take a red pen to food safety research expenditures.

Of course, there is an alternative case to be made that Congress will leave FDA funding mostly alone. Food illness outbreaks always generate headlines and, at times, huge negative publicity when there are fatalities or indications of industry malfeasance. Food safety’s importance to consumers may thus prompt legislators to refrain from sizable budget reductions. Still, with the federal deficit at record highs and a majority political party eager to bring federal spending under control, the budget for food safety regulation may be vulnerable to cutbacks when FSMA’s full impact will be just getting underway.

 

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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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