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.

 

 

 

Share

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.

 

 

 

 

Share

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.

 

 

Share

Blowing the Whistle on Dangerous Food

The new national food safety law extends whistleblower protections to employees who uncover food safety problems at their workplace. This is the first time such protection has applied to food safety issues, according to an analysis by the national law firm Thompson Coburn LLP.

food-production-workersWith little fanfare, the whistleblower provisions took effect immediately upon FSMA’s passage in 2011. The rules cover companies in food manufacturing, processing, packing, distribution, holding, importation and transportation. (Whistleblower complaints actually are managed for the FDA by the Occupational Health & Safety Administration (OSHA), which manages whistleblower actions for more than 20 federal departments). In its first three years, 144 food industry whistleblower complaints were submitted.

The protections afforded whistleblowers are straightforward: employers are prohibited from firing or discriminating against any employee who speaks up about potential or ongoing safety issues, whether publicly or privately. FSMA’s Section 402 specifically prohibits employer actions such as termination or demotion, and also protects workers from any form of reprisal that might dissuade other employees from engaging in similar activity.

Section 402 is especially relevant to food scientists and technologists, who have the scientific training in food contamination and are the individuals typically assigned to oversee food safety protocols for manufacturers, notes the Canadian-based International Union of Food Science and Technology (UoFST). Protection from reprisals against these employees is especially important, UoFST notes. This may become more of an issue in the future as larger food manufacturers bring on trained microbiologists and researchers to help pinpoint food safety vulnerabilities.

What about importers? Do these whistleblower provisions apply to overseas workers in the same way that FSMA’s safety rules directly impact foreign exporters and manufacturers whose products are sold in the U.S.?

The answer is the proverbial “it depends.” The UoFST points out that whistleblower protections outside the U.S. are uneven in effectiveness. The United Kingdom prohibits retaliation against whistleblowers under its Public Interest Disclosure Act (1998). Japan and South Africa both have dedicated legislation on whistleblower protection. But, writes Gerald Moy, a retired World Health Organization executive, many whistleblower laws worldwide are limited in scope to anticorruption. Other countries may not have the regulatory infrastructure in place to handle such complaints.

By contrast, Moy notes, the inclusion of these protections in the U.S. food safety law is another demonstration of the government’s commitment to head off food safety problems before they lead to costly recalls, consumer illness (or death) and negative news reports of “unsafe” food.

The FDA wants the industry to become prevention-oriented, but instead of purely voluntary compliance, the agency has written tough new rules into the new law requiring a host of procedures to insure safe food production and holding management personally responsible for any violations.

So, in answer to what happens next at the bakery, here’s a checklist for employers under FSMA:

  1. Make certain food safety training has been implemented throughout the organization as part of an overall management food safety system;
  2. Train supervisors to deal promptly with complaints, “shop talk” or rumors of potential food safety problems;
  3. Maintain records of logged complaints and follow-up actions;
  4. Resist the temptation to punish or criticize any employee who spots a problem.

With FSMA now the law of the land, and food-borne illness prevention the guiding regulatory goal, food manufacturs just might want to reward employees who speak up with a bonus check for a job well done.

Share

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.

 

# # #

Share