Food Safety Modernization Act: What you Need to Know

IMG_4113By Mike Ebert

Coffee production has long been pushed aside in the world of food safety. Having run roasting plants for almost 30 years, I learned early on that any health inspector, from any level–local, state or federal–did not know what to look for with coffee, thought it was a waste of their time, and ultimately used protocols and procedures from other food manufacturing facilities, whether or not they made any sense just so they could “do their job.”

That’s changing fast, and coffee importers and roasters need to be aware of what is coming. On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA). This new law was aimed at ensuring the U.S. food supply is safe by shifting focus from responding to problems that have already occurred to preventing them in the first place.

Preventing contamination and health safety risks throughout our food chain in the U.S. is extremely important as a powerful risk management strategy.

How does this affect the coffee importer or roaster? Since December 12, 2003, all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S., as defined in 21 CFR 1.227, must register with FDA. Starting this year, registration must be renewed every two years or is considered expired. There are no small business exemptions or fees at the present time.

Coffee Handler with Beans from Coffee Cooperative
Photo: United Nations Photo

A written food safety plan is also required, which includes a Hazard Analysis & Critical Control Points (HACCP), Preventive Controls and Good Manufacturing Practices (GMPs). Larger roasters probably already have most, if not all of this in place.

In regards to FSMA, there are five major components of the new law:

  1. Preventive controls: For the first time, the FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.
  2. Inspection and compliance: The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food; thus, the law specifies how often the FDA should inspect food producers. The FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
  3. Imported food safety: The FDA has new tools to ensure that those imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and the FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  4. Response: The FDA will have mandatory recall authority for all food products. The FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors requests for voluntary recalls.
  5. Enhanced partnerships: The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign––to achieve our public health goals. For example, it directs the FDA to improve training of state, local, territorial and tribal food safety officials.

(Courtesy of

The most central component of the law was switching from remediation to prevention. This encompasses several current practices: the HACCP, preventive controls, GMPs and production of safety rules. The big concern here is that many have spent years writing the current plans, having to throw them all out to conform to something new that’s not defined.

One of the other requirements is verification of the effectiveness of preventive controls through scientific validation and documentation. Coffee is roasted and brewed at high temperatures that kill all microorganisms that could, although unlikely, be present in green coffee. So any “verification” of this is really just adding tedious testing and documentation that does nothing to assure the safety of coffee.

The record-keeping rules require that documentation of this verification must be kept for two years and accessible within 24 hours. All this does is add time and expense to the process, not ensure coffee safety.

Finally, under the law’s provisions, coffee could fall under produce safety rules, even though it cleary falls out of this category by two things: the first, it’s not consumed raw, and secondly, it goes through a “kill step” through roasting. However, as some of you may have encountered in dealing with certification of your roasting plant, this can be considered vague, and may require steps to be taken.

IMG_0450Luckily, we have some support on this issue. The NCA submitted comments to the FDA on the original law’s wording with ample supporting information. This past fall, they received a response in which many of the concerns were addressed. They sent a reply to this on December 15, 2014, agreeing with some of the proposed changes, but also with a more focused disagreement on various points. (Both can be found at

This is an ongoing process. At the minimum, there are steps every roaster needs to take now if you have not already done so. The final rules for FSMA will be announced by midyear, and with mandatory inspection being a critical component–high-risk every three years, low-risk every five–anyone without previous history will be considered a high-risk operation initially.

If you want to learn more, not only about new updates on the law, but more importantly, how to implement a food safety program at your facility, please attend my upcoming lecture on this subject at the SCAA Event this coming April in Seattle, titled “FSMA and the coffee roaster, what does it mean?” (View Lecture Offerings)

mikeMike Ebert is the founder of Firedancer Coffee Consultants, which he created to help specialty coffee companies achieve success in all facets of the specialty coffee supply chain. Mike is a past president of the SCAA, founding chair of the Roaster’s Guild, and current president of Coffee Kids, whose mission is to improve the lives of coffee-farming families worldwide.