What’s being touted as one of the most monumental pieces of legislation in the United States food industry by producers, legislators and undefined
lawyers alike is now in full force – finally.
In January 2011, US President Barack Obama signed into law the FDA’s Food Safety Modernization Act (colloquially pronounced “fizz-ma”) in the hopes of driving down the incidence of foodborne illness in the US.
More importantly, the goal of FSMA is to establish a “culture” of food safety, shifting from a reactionary approach to a preventive one. Despite the “monumental” move, it took the FDA more than five years to finalise the legislation that would greatly impact the US food industry, including coffee.
“This is the biggest change in the country’s food safety system since the early 1900s,” says Joe DeRupo, External Relations and Communications Director for the National Coffee Association. “The industry is going crazy. Companies are struggling with how to comply; even the FDA is struggling.”
In August, the FDA revised seven rules under FSMA that require new and updated food safety programs in line with its goal of preventing foodborne illness and other food safety issues.
Depending on the size of the business, compliance dates are staggered over the next four years, with smaller businesses generally allotted more time than big businesses (those with more than 500 employees). The first of the deadlines for big businesses occurred in September.
Says Joann Givens, co-chair of the FSMA Operations Team Steering Committee and Director of the FDA’s Food and Feed Program in the Office of Regulatory Affairs, “The goal … is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes and practices that we know will minimise the risk of serious illness or death”.
Considering there are about 48 million cases of foodborne illness in the US annually, the FDA took its time to truly evaluate the project at hand, involving a diverse pool of food safety stakeholders. In the past five years, FDA teams have been involved in nearly 600 meetings, presentations, webinars, feedback sessions, farm tours and facility visits. Among those were discussions with the NCA on behalf of the US coffee industry.
During 2014, NCA President and CEO William Murray shared a dozen comment letters with the FDA in hopes of providing industry insight as the administration developed the legislation. Among the changes that came out of those letters was coffee’s exemption from various rules, considering coffee is rarely consumed raw and is also exposed to high, bacteria-killing temperatures during roasting.
Because coffee is considered low risk, Mike Ebert, coffee industry veteran and founder of Firedancer Coffee Consultants, doesn’t see food safety being an issue in the industry. “The FDA just didn’t know how to treat it, so it has gone under the radar.”
Considering coffee’s uniqueness in the greater food industry, Ebert hopes the industry will eventually bring people and resources together to create a coffee industry-specific food safety program, with related definitions and best practices.
Under the FSMA header there are seven regulations with mandates surrounding food safety and preventative issues, but not all of them directly or significantly apply to coffee. The first two rules concern hazard analysis and risk-based preventative controls for human and animal food, the former obviously being the one applicable to the coffee industry.
“What that regulation is doing fundamentally is requiring any facility that processes, packs or holds food to develop a food safety plan,” explains Maile Gradison Hermida, partner at global law firm Hogan Lovells.
“Companies need to look at what the potential hazards are, and then implement controls, monitor them and then engage in corrective actions when necessary.” She and her team are focused on food law, with a special dedication to FSMA for more than five years. Hermida also regularly works with the NCA, having conducted a webinar on FSMA’s role in the coffee industry last year.
The requirement for a written food safety plan is different than requiring Hazard Analysis & Critical Control Points (HACCP) plans, which many large coffee companies may already have. Hermida advises that a HAACP alone is not sufficient to meet the rule but can be used as a foundation for the food safety plan.
Similar to the mandate for a safety plan is the Foreign Supplier Verification Program (FSVP). It requires importers to perform risk-based evaluations of foreign suppliers and their activities to ensure the imported foods are as safe as those manufactured in the United States. Basically, US importers are responsible for holding their suppliers to US food safety standards. This can mean going deep into their supply chain to conduct similar risk analyses of their overseas suppliers.
Considering the US is the number-one importer of coffee beans, according to industry research firm IBISWorld, and most of its beans are imported, this rule under FSMA is anticipated to have a significant impact on the US coffee industry.
Understanding who is responsible under this rule is important, Hermida tells Global Coffee Report. “FSVP will affect the people in the business of getting coffee into the country, whether they’re producers who import beans or retailers who import coffee products. They have to verify the product’s safety, and if in the hazard analysis the ‘importer’ concludes there are hazards that require control at the farm level, I see potential traceability challenges.”
Another challenge she sees with this particular rule is the fact that it applies to a segment of the industry that hasn’t had previous obligations with regards to food safety. In general, US coffee producers have a good handle on product quality within their own four walls, but they’ve never had to manage foreign suppliers at this level of detail before.
“FSVP is going to be very different than what some of these companies have done before,” says Hermida. “The regulations on this are very detailed and very prescriptive, so it’ll require adequate time and effort.”
The coffee industry’s complex supply chain may also pose challenges at the manufacturing stage in regards to the FSMA rule for preventing intentional adulteration. Food facilities are required to prepare food defence plans to help prevent any tampering of or malicious interactions with food in their facilities. Similar to the food safety plan that identifies potential hazards and implements preventive controls, this plan must identify any vulnerabilities in the facility and its processes and then create mitigation strategies.
“This regulation is fundamentally centred around preventing terrorist activity,” Hermida tells GCR. “It’s a complicated rule, and of all of them, it’s the most different from current industry practices.” In light of that, the compliance deadline is three years out, giving the FDA more time to iron out details and companies more time to prioritise other upcoming FSMA deadlines.
The cost of compliance
So now that rules and deadlines have been solidified and plans are (ideally) under way, US coffee companies are wondering how much compliance is going to cost.
“It’s going to be a time cost more than a money cost,” says Ebert, citing costs related to the extra work for employees, as well as those for educational courses and certifications. There will also be costs for hiring and training those employees. FSMA requires food safety plans to be written by a “qualified individual”; though Ebert says there isn’t a clear definition of what that means.
If coffee companies don’t already have thorough recordkeeping and data management systems in place, FSMA may be the catalyst. “As part of preventive controls, the FDA has more access to records than ever,” explains Hermida, “so records need to be accessible, complete and clear. Good recordkeeping is an art, so training on this is particularly important.” Companies should implement a comprehensive system for documenting processes and recording related data because the FDA requires documentation to be kept for two years and be accessible within 24 hours.
Fortunately, many of these compliance costs will only be imposing at the outset, at implementation – as long as noncompliance issues don’t arise that could potentially impose fines and hold up operations or goods.
Additionally, it’s an area where companies can leverage automation and technology. Where a task was originally done manually, they can potentially save money in the longer term through greater efficiency, fewer employees and lower incidence of human error.
Still, cost remains a concern, especially when US coffee companies already have a difficult time accurately estimating input costs due to volatile and increasing coffee bean prices, according to IBISWorld research.
Add new compliance costs, and coffee producers, distributors and retailers will be looking to reduce operational costs where possible.
Fortunately, IBISWorld reports that profit in the US coffee production industry is relatively high and increasing, allowing any additional costs associated with compliance to be absorbed without a significant impact on the bottom line.
The Future of Compliance in Coffee
As the FDA proved during the past five years, food safety measures are not to be rushed. As such, compliance deadlines for the remaining FSMA regulations will occur during the next three years. Furthest out? Food defence plans for intentional adulteration will be due in July 2020 from small businesses, while large businesses’ food defence plans are due in July 2019.
Next up is the sanitary transportation compliance deadline for big businesses, in April 2017. A month later, foreign supplier verification programs are due from most businesses. Considering the latter’s significant implications on the coffee industry, coffee companies will be busy during the next six months.
Fortunately, the FDA has produced numerous webinars and guidance documents to help food businesses through these compliance phases. And there are many more to come over the next few years, according to Givens. “We intend to continue this dialogue and collaboration with the industry to ensure that everyone understands and engages in their respective roles in food safety … We are very committed to educating while we regulate to align understanding and expectations.”
And that’s what players in the coffee industry are most focused on at the moment, according to DeRupo. “What I’m hearing from NCA members is that the reality of compliance is really starting to hit. More so than cost, the question I’m getting is ‘How do I comply?’”
As mentioned, aside from striving to reduce foodborne illness, the FDA hopes to shift the food industry’s approach to more proactive and less reactive.
“[Companies] should look at the big picture, at areas where they could be vulnerable and proactively take action,” adds Givens. “Promptly responding to problems even if they aren’t yet violations can prevent them from getting to the point where there is a concern about the safety of the food.”
Says Hermida, “The FDA wants companies to police themselves. It has increasingly come to expect a food safety culture, where the need for food safety is driven from the top. Companies should be empowering everyone [in the business] to do the right thing for food safety, rather than cutting corners in food safety to increase the bottom line.” GCR