FSMA: The Food Safety Modernization Act
It is the responsibility of everyone in the coffee industry to keep coffee safe for consumption. The Food Safety Modernization Act (FSMA) is legislation initially enacted in 2011 enforced by the Food and Drug Administration (FDA) to keep food safe by preventing outbreaks of food-borne illnesses through regulation of the facilities where food is manufactured.
As a green coffee importer, Ally Coffee complies with the requirements of the Foreign Supplier Verification Program (FSVP) portion of FSMA. For roasters, the main FSMA requirement is to write and follow a comprehensive Food Safety Plan. To guide roasters and coffee professionals towards the completion of this crucial task, Ally offers Essential Food Safety for Roasting Operations, a course on compliance, written and taught by Ildi Revi, our Director of Learning.
A course is not required to write and implement a valid food safety plan, but being a preventative controls qualified individual (PCQI)is required by the FDA. A class that walks through FSMA requirements step by step may be the best way to understand the requirements of the law, operate legally compliant facilities, and make coffee that is verifiably food safe. FDA manuals are available in full, for free, online here, and the Final Rule for Preventative Controls in Human Food factsheet gives a good summary, but the documents are daunting to sift through.
Taking the Essential Food Safety for Roasting Operations course at Ally is one way for an employee of a roasting company to become a PCQI; the course includes guiding the participant through the development of their company’s own plan.
Special Food Safety Considerations for Cold Brew
In the preliminary draft of Cold Brew Coffee: Recommendations for Industry; Product Description, Food Safety, & Stability Evaluation, the National Coffee Association (NCA) in New York states that, “Cold brew coffee has unique food safety considerations. By identifying the extensive and evolving range of product formats in the marketplace, we can better understand the industry’s food safety and quality needs and develop educational and resource tools to aid in compliance with standards and regulations.” The report was open for industry comment through May 2018 and the full updated version will soon be released, for free, on the NCA’s website.
While cold brewed coffee (coffee extracted at ambient temperature rather than with boiling water) can take many forms and become many final beverages — coffee only, concentrate, with milk, with sugar, with flavor, with nitro, with carbonation, with citrus — cold brew is precisely that: a cold beverage that is premade and served ready to drink. Very quickly cold brew has catapulted coffee businesses into the realm of manufacturing a product with inherently higher risk than roasted coffee destined to be prepared with boiling water.
Liquids represent different levels and types of risk than roasted beans. Ildi outlines major risks, explaining, “Some species of bacteria (and fungi) can survive hostile environments as spores, dormant and indestructible forms that come to life when conditions improve. The pathogen Listeria monocytogenes can hang out in cold conditions, and the Clostridium botulinum spores can survive boiling water. Botulism is a serious paralytic illness caused by toxins produced by Clostridium botulinum, an anaerobic bacterium that thrives without oxygen, in environments like a bottle or nitrogenated can. The spores of this pathogen don’t germinate at low temperatures, but if the cold chain is broken, like a keg at an outdoor festival or in a hot car, the risk goes up.”
Cold brew can and should be safe, but to ensure it is requires starting the food safety process as soon as green coffee enters the roasting, brewing, and packing facility.
Ildi also notes that, “Yeast and bacteria are active in soils on farms and are necessary during coffee processing, impacting quality both positively and negatively.[i], [ii] Some of these remain on the green coffee and can cause illness in humans. Also, coffee production environments are perfect for development of mold, and most green coffee carries spores from origin to its new home in the roastery.[iii]”
Writing a food safety plan, especially one for a cold brewing facility, means taking a close look at potential hazards, their respective consequences, and they likelihood that they will occur. The food safety plan needs to explain each step and component of the creation of the cold brew product from start to finish, demonstrating how the hazards will be prevented with validation and verification, explaining how problems will be corrected, and delineating how the product will be recalled, if necessary.
Ildi lists important questions for cold brewers to consider. “Are you adding anything to your cold brew that might be an allergen? If you are bottling your cold brew, how are the bottles and lids sanitized — with a chemical (what kind? is it approved?) or with hot water? The EPA has rules for water that impact food processors both concerning microbes and disinfection byproducts — how do you demonstrate your water is compliant? These are just a few of the questions that need to be answered in the written plan.”
Consulting a food safety professional while building out a cold brew facility is the best way to keep the category safe and ensure that coffee, at all temperatures, remains a product consumers trust as safe.
Key Terms to Know by the Food Safety Preventive Controls Alliance
Good Manufacturing Practices: The conditions and practices the regulated food industry must follow for processing safe food under sanitary conditions, including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels considerations.
Critical limit: The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process preventive control.
Defect action level: A level of a non‐hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.
HACCP: Hazard Analysis and Critical Control Point: Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.
HARPC: Hazard Analysis and Risk-Based Preventive Controls: Systematic preventive approach to food safety designed to prevent, reduce to acceptable levels, or eliminate the microbial, chemical, and physical hazards associated with food production. (Side note: The key difference with HARPC and HACCP is the incorporation of risk-based preventive controls.)
Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore must be addressed in the HACCP or Food Safety Plan.
Known or reasonably foreseeable hazard: A biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.
PCQI: Preventive Controls Qualified Individual: A qualified individual who has successfully completed training in the development and application of risk‐based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.