From The Editor | January 12, 2017

Food Safety 2017: What To Expect

Sam Lewis

By Sam Lewis

2016 is behind us, and last year’s unresolved food safety challenges have joined the list of issues to face in the new year. But, what is currently challenging the food and beverage industry in terms of food safety? This column will discuss three topics that will impact nearly every manufacturer in 2017.

The FDA, FSMA, And Donald Trump
Back in 2011, President Obama signed FSMA into law, bringing sweeping changes to U.S. food safety regulations. But, with Donald Trump’s upcoming inauguration, should U.S. food makers expect to stay the course or prepare for more changes to regulations? Or will there be a complete deregulation of the FDA?

It’s no secret Donald Trump has been critical of the FDA, even going as far as calling for the elimination of food safety regulations back in September. “The FDA Food Police dictates how the federal government expects farmers to produce fruits and vegetables, even dictates the nutritional value of dog food,” says Trump. “The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperature, and even what animals can roam which fields and when. It also greatly increased inspections of food facilities and levies new taxes to pay for this inspection overkill.” While radical, this statement should come as no surprise as Trump believes federal regulations can put a major burden on the U.S. economy.

However, back in October, Dr. David Acheson, formerly of the FDA and founder of industry consultant agency The Acheson Group, addressed this specific notion. “Would a Republican Administration deregulate the FDA?” asks Dr. Acheson. “Frankly, I believe those remarks were rhetoric. I think it was a shoot-from-the-hip, tongue-in-cheek statement, to be honest with you. Short of a major crisis, I really don’t see any changes to the U.S.’s current plan for food safety as there is no obvious need for it.”

These are two very different opinions on the same topic. So what’s a food company to do? To traverse the FSMA uncertainty that Trump’s administration may bring, the best course of action for a food company is to stick to FSMA’s current groundwork. Before FSMA reached the President’s desk, the Senate unanimously passed the bill. Further, it was approved by the House of Representatives by a 215 – 144 vote. FSMA is a bipartisan effort and there seems to be no indication that either party cares to deconstruct it.

Here’s a brief recap of FSMA’s seven pillars and their compliance dates:

  • The General Compliance deadline for the Preventive Controls (PC) Rules, August 30, 2016, has come and gone. Small businesses (fewer than 500 total employees) are expected to comply with the PC rules by August 30, 2017. Large businesses should already have their food safety plans in place to be compliant with the rules, while small businesses should currently be finalizing food safety plans for compliance.
  • The Sanitary Transportation Rule was made final in March 2016 with the General Compliance Period ending on March 31, 2017. Food makers with 500 or more employees must be compliant with this deadline, while small businesses will have until March 31, 2018 to reach compliance.
  • Compliance with The Foreign Supplier Verification (FSVP) Rule becomes a bit more convoluted. Importers not subject to PC rules or FSMA’s Produce Safety Rule will have until May 30, 2017 to reach compliance. Importers with foreign suppliers who are required to comply with the PC Rule For Human Food will  be broken into several categories: 
  • Small business deadline is March 19, 2018
  • Very-small business deadline is March 18, 2019
  • Suppliers subject to the Pasteurized Milk Ordinance must comply by March 18, 2019
  • All other business suppliers must be compliant by May 30, 2017

For further details regarding FSVP compliance, visit the FDA’s Compliance Dates for the Final Rule on FSVP.

  • FSMA’s Food Defense Rule became final on May 31, 2016. The General Compliance Period ends on July 31, 2017, with Small Businesses expected to comply by July 31, 2018 and very-small businesses by July 31, 2019.
  • The Produce Safety Rule became final on October 31, 2015 with the General Compliance Period ending on December 31, 2017. Small Businesses must be compliant by December 31, 2018, and very-small businesses by December 31, 2019. Businesses subject to this year’s deadline should currently have a general sense of what the rule requires and begin making necessary changes for compliance.
  • The Final Rule for Accredited Third-Party Accreditation and Certification (3PAC) became final on October 31, 2015. This rule establishes a voluntary program for accrediting third-party auditors (certification bodies) to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA. More information of 3PAC can be found here.

FDA guidance documents for some of FSMA’s rules have also been released and are available here.

Is WGS The Future Of Food Safety?
Whole Genome Sequencing (WGS) is essentially the process of determining the complete DNA sequence of an organism at once. This advancement has provided the food industry with accelerated identification and detection of microorganisms, which, in turn, has allowed for food illness outbreak response times to become faster, more efficient, and more targeted.

When WGS was first discovered, its use was cost prohibitive for the food industry. However, its value has been realized. Heavy investments have been made into it. And because of the realization and investments, it has been made much more cost efficient. According to Melanie Neumann, J.D. M.S., at Neumann Risk Services, affordable WGS is an enormous breakthrough for food safety in both the manufacturing and regulatory world. “WGS is being leveraged as the future key consumer protection tool used by regulatory agencies,” says Neumann. “This tool is now almost fully implemented in many regulatory laboratories in many states. For example, those who did not implement WGS in 2016 have plans to do so in 2017, 2018 at the latest. This change will mean laboratories will be moving from its current PFGE (Pulsed Field Gel Electrophoresis) technology, which has some limits, compared to WGS.”

The technology has certainly led to an increase in food recalls due to microbial pathogens. However, this is not completely unexpected, as WGS is identifying and detecting pathogens that previously slipped through the cracks. Those closest to the technology, such as Neumann, hope WGS will advance far enough to eliminate food illness outbreaks.

FDA’s Nutrition Facts Label Changes Quickly Approach
In May 2016, the FDA announced new Nutrition Facts label for packaged foods to reflect new scientific information. The changes should make it easier for consumers to make better informed food choices. Food manufacturers will be required to use the new label by July 26, 2018, but companies with less than $10 million in annual sales will be given an additional year for compliance.

Compliance with the FDA’s labeling changes may be more than a year away, however, according to the Grocery Manufacturers Association’s Kimberly Wingfield, food manufacturers need to begin preparing for the new labeling requirements. They can do this by:

  • Gathering updated nutrient data from ingredient suppliers
  • Working with software vendors to obtain updates for nutrition labeling programs
  • Developing a comprehensive understanding of the new rules
  • Submitting technical questions regarding uncertainties in the rules to the FDA using their inbox
  • Updating nutrition databases with new data from ingredient suppliers
  • Conducting analytical testing on ingredients and finished products

The new label will include serving per container in larger, bolder type; updated serving sizes; calories per serving in larger, bolder type; updated daily values; added sugars; changes to the nutrients window; actual amounts (in percentages) of nutrients per serving; and a footnote explaining Daily Values (DV) in a serving according to a 2,000 calorie/day diet.