Implementation of the Food Safety Modernization Act is mostly in the rearview mirror, but industry members are still working on getting up to speed with the new regulations.

Overall, FSMA’s rollout at the grocery retail and commissary/central kitchen levels is going well, says Hilary Thesmar, chief food and product safety officer and senior vice president of food safety programs for the Arlington, Virginia-based Food Marketing Institute.

“FDA has been very thoughtful in how it’s been rolled out,” Thesmar says. “They knew it was a heavy lift and they gave the industry time to implement it.”

Commissaries and central kitchens have probably been more impacted by FSMA than retail stores themselves, Thesmar says. Compliance with FSMA depends on the type of facility, and retailers, because they’re under local and state jurisdiction, are exempt from much of the law’s reach.

“There’s little retail has to do to comply with FSMA, but distribution centers and commissaries are under FSMA,” Thesmar says. “If a facility is not attached to retail, it’s regulated by FDA and does have to be regulated by FSMA.”

The good news is, commissaries are for the most part up to speed when it comes to compliance, she says. “From what we’re hearing, they’re ready for it and all is going well. We’re not hearing of violations, so that’s good news.”

Because it applies to FDA regulated products, FSMA does not apply to the vast majority of meat and poultry products. But Sarah Little, vice president of communications for the Washington, D.C.-based North American Meat Institute, says there are some products containing meat and poultry that are FDA regulated.

“Some Meat Institute members are dual jurisdiction, regulated by both the USDA and the FDA. The transition has been fairly easy for the meat industry, which has been employing the Hazard Analysis and Critical control point system (HACCP) for over 20 years and are experienced in food safety, traceability, and sanitation.”


Commissaries, suppliers get breathing room to adjust to adulteration rule

This summer, the last of the FSMA regulations, FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration (Intentional Adulteration Rule), had its compliance date, says Rasma Zvaners, vice president of regulatory and technical services for the Washington, D.C.-based American Bakers Association.

In April, meanwhile, the FDA announced that it will begin routine inspections to verify compliance with its Intentional Adulteration rule in March 2020.  This rule is designed to protect the food supply from a person or group of people who are intentionally doing something to the food to cause harm on a large scale.

“FDA is still working to complete its guidance document related to this final rule,” Zvaners says. “ABA has commented on the first two portions of the FDA guidance and will plan to comment on the remaining portion as well.”

Commissaries are affected by the adulteration regulation because of the large among of food-making on site that involves adding different ingredients, Thesmar says.

FMI’s members in general are ready, they’re expecting it, and so when inspectors come in, everything tends to go smoothly, Thesmar says. And if there is a problem, they’re able to correct it quickly.

Little says the majority of meat and poultry establishments have had food defense plans in place for years and are ahead of the game on preventing intentional adulteration. 

The baking industry continues working towards meeting its food safety obligations under the FSMA structure, she adds. According the FDA data, during the 2018 calendar year the top 5 FDA observations issued in 483s included:

·          Lack of food safety plans

·          Insufficient monitoring of sanitation and water

·          Pest activity of contamination

·          Lacked proper controls for holding/processing foods (allergens, micro etc.)

·          Clean and sanitary plant maintenance inadequate

FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations, Zvaners says.


Retailers that import gear up for new regs

While retailers are largely exempt from FSMA because they’re under other regulatory jurisdictions, those who bring in certain products from overseas do fall under the law’s purview, Thesmar says.

“What we’re finding is that retailers who import, say, specialty cheeses from France or prosciutto from Italy, and other specialty products, have to comply under FSMA’s foreign supplier verification program under FSMA.”

Produce safety regulations in FSMA are another area that can affect retailers, Thesmar says, and those are among the later regulations to be implemented.

“We’re hearing a lot about that now. It really impacts growers of produce.”

Yet to be implemented in the fresh produce category are agricultural water provisions whose compliance date has been pushed back to 2022.

FSMA also has a transportation piece that affects drivers, loaders, receivers, truckers and others who make sure product gets to stores. The direct impact on retailers, however, is minimal, Thesmar says.

Overall, the rollout of FSMA has been slower than the industry has expected, and it’s had more of an impact than anticipated, Thesmar says.

“One line of regulation creates a lot of work for a company to implement. Some regulations were more than retailers expected and took more time to implement.”

For example, the preventive control measures at distribution centers and commissaries have created a lot of work.

“While retailers have supported the concept, the legislation in 2010 when it went through, thinking through it, I don’t think it sunk in like it should have,” Thesmar says. “There were some surprises when regulations came out about how much work had to happen to accomplish what was required for compliance.”

Most rules come with some kind of training requirement, and a  lot of employees throughout the industry have taken on additional responsibilities. And of course implementing new regulations is always very expensive.

“It’s a lot more work. It’s document-heavy, it takes time. Even if you’re doing electronic record keeping it’s expensive.”

That said, industry members know it’s time and money well spent.

“Our industry knows how important food safety is, and that’s why they’ve supported regulations from the beginning, and they still support it. They hope it will make our food supply safe in the long term.”


No new legislation on the horizon

No current legislation affecting the baking industry is pending, but of course regulations remain, Zvaners says. ABA’s members, for instance, are working to meet their obligations under the USDA’s Agricultural Marketing Service (AMS) rule implementing the National Bioengineered Food Disclosure Standard (NBFDS).

The NBFDS preempts state and local genetic engineering labeling requirements and charges AMS with developing a national mandatory standard for disclosing the presence of bioengineered (BE) food. Implementation is phased in, with a January 1, 2020, compliance date for most and a mandatory compliance date by January 1, 2022.  ABA members are also working towards the Nutrition Facts Label compliance date of January 2020.

Looking ahead, ABA does not foresee any new legislation in the food safety arena, Zvaners says.  The association does anticipate ongoing guidance documents that are related to the FDA’s implementation of its food safety regulations.  These include guidance for the Preventive Controls rule as it relates to “ready to eat/ not ready to eat’; allergens and recall plans. 

“Most importantly FDA has signaled that it’s revisiting its Appendix 1 of the Preventive Controls Guidance Document,” she says. “Industry continues to stress that guidance documents are intended as guidance and should not serve as ‘check lists’ for inspectors during their visits.  We also anticipate that the agency will be moving forward over the next year to look more closely at traceability.” 

ABA’s Food Technical Regulatory Affairs professional group continues to be a great forum for the baking sector to come together to discuss and seek solutions for both food safety and nutrition related items, Zvaners says.