Edibles Entrepreneurs in Oregon: Invest in Food Safety Details

Edibles Entrepreneurs in Oregon: Invest in Food Safety Details

Flickr / Dank Depot / CC BY 2.0

This is the first in a series of articles to help you quickly get up to speed on food safety and ensure you invest in the most important details when planning and during construction or revising existing production and processing facilities in Oregon.


By Rachel Montgomery

Are you going to be able to claim your market share as edibles boom in the marijuana market? Oregon is already seeing a trend in edibles as indicated by a report from the Oregon Legislative Revenue Office; and according to Mazen Malik, senior economist at the OLRC, economists expect the edibles market to continue to increase marijuana sales in Oregon. This is consistent with the first year of legal retail sales in Colorado when retail units trumped medical and captured almost 60% of the total edibles market.

With “early start” recreational sales at registered medical marijuana dispensaries coming to an end on Dec. 31, 2016, the Oregon Liquor Control Commission announced via email on Nov. 17 that it’s anticipating an influx of applications from prospective recreational marijuana businesses. If you hope to become a licensed recreational processor and want to avoid delays in having your application processed, compliance is critical.

To stake your claim, you must manufacture your edibles and related components according to the same food safety standards as traditional foods, and this means being licensed by the Oregon Department of Agriculture. Even though medical and recreational marijuana fall under the Oregon Health Authority and the OLCC, respectively, it is the ODA who is responsible for regulating the production, processing and distribution of food products in the state. This means a pre-operational inspection by ODA Food Safety must occur before you can begin operations.


Start With the End in Mind

On Aug. 30, OLCC sent email notifications with ODA information on “Cannabis and Food Safety.” ODA encourages starting the OHA or OLCC license process and then ODA can start the plan review process from a food safety standpoint. Bottom line: Start with the end in mind and pass the pre-operational inspection by ODA Food Safety.

Preparing a business for a food safety inspection can be quite a challenge for those supply chain links that have not been involved in traditional foods and are not familiar with food safety regulations. This may apply to those producing extracts and concentrates which can now be used in food products.

The ODA has provided a checklist to prepare facilities for the ODA inspection. The document indicates that facilities may need other licenses, plus potentially needing to meet additional city and county requirements. The checklist, “Cannabis and Food Safety,” is an excellent tool for checking facility requirements, but do you and your key personnel understand the rationale for these checks?


Smooth Surface, Easily Cleanable and Adequate Space

Take a look at Oregon’s Food Safety Plan Requirements in OAR-603-025-0020 and -0030 and though there are a number of requirements, three key details related to cleaning will emerge. Interestingly, but not surprisingly, this same approach is needed to comply with the FDA’s brand new Preventive Controls rule, 21 CFR Part 117, which as of Sept. 19, 2016, replaced the 53-year-old 21 CFR Part 110 which covered only Good Manufacturing Practices.

Preventing contamination is the basis for food safety, and contamination has many sources, including personnel, materials, and the environment, and especially related to cleaning. These three key details will help you design and construct/remodel your edibles facility to ensure appropriate cleaning and the prevention of contamination in the near and distant future.

This attention is required for passing your ODA food safety inspection. Just as importantly, attention to these details in design and construction will ensure ongoing production without risk to your edibles, your reputation and your bottom line.

So what are these three key cleaning-related details? Smooth surface, easily cleanable and adequate space. All of these require careful attention as you design your floor plan and plan construction materials and equipment design according to the Food Safety Plan requirements issued by the ODA’s Food Safety Division, and also according to FDA’s FSMA.

Why mention FDA? Isn’t FSMA a federal regulation? Yes, but FSMA is applicable because the ODA also has encouraged food processors and food safety professionals “to educate themselves about the federal Food Safety Modernization Act” because it affects processed food. The ODA points out that “the goal of FSMA is to step up prevention of food-borne illnesses, in addition to responding to foodborne illness outbreaks.”

The ODA website provides links to those final rules and fact sheets. Training is required by FSMA for GMP and Hazard Analysis & Risk-based Preventive Controls. Other new requirements under FSMA will be discussed in this series, along with some of the ODA specified food safety plan requirements, including the new FSMA requirements for prevention of allergen cross-contact and the cleaning of non-food-contact surfaces.

Because of the depth and breadth of food safety standards, this first article focuses on the first two details, “smooth surface and easily cleanable,” only for non-food-contact surfaces. If you want to pass the pre-approval inspection by ODA, the type of materials you use for these surfaces must be considered early—when designing construction of a new facility or remodeling an existing facility.

In fact, one of the added requirements in the new GMP rules under FDA’s FSMA is “Sanitation of non-food-contact surfaces.” As indicated in Part 117, Section 35, the new GMPs require that these non-food contact surfaces be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces and food-packaging materials.


Smooth and Easily Cleanable: Non-food Contact Surfaces

Smooth surface and easily cleanable are not always written together, but they inherently go together and prevent contamination. Contamination occurs from having a food source available for microbial growth and non-food contact surfaces can cross-contaminate food surfaces. It may seem simple to choose materials with a smooth surface that will be easily cleanable, but consider that you want the surface to be smooth for many years to come.

Non-food contact surfaces apply to floors, ceilings, walls and exterior surfaces of equipment. This means floors in an edibles facility must be constructed to withstand the frequent chemical cleaning needed in a food plant. And floors must withstand the type of traffic that will occur in each particular area, whether personnel or equipment traffic or both. Also consider what tools are going to be used in a given area and what a single nick in a floor can do to its “smooth surface.” It is virtually impossible to clean surfaces that have surface indentations and abrasions; pathogenic microorganisms including Listeria and Salmonella can persist and cross-contaminate your food product.

Invest in the most durable floors possible to minimize downtime for repair and to avoid significant down-time for floor replacement and resurfacing. Moreover, use a contractor experienced in installing floors in food plants that will guarantee sloping to drains and avoid standing water, a source of contamination.

Walls and ceilings are also included in the category of non-food-contact surfaces. ODA requires that walls and ceilings be smooth and easily cleanable and FSMA requires the cleaning “protect against allergen cross-contact and against contamination.” Consider how you will clean those surfaces before you install them, and design and install accordingly to prevent costly upgrades and the down-time likely involved in making changes.

In planning and during construction, be sure to follow the ODA requirements for doors and windows, lighting and ventilation, and realize that surfaces related to those areas also fall under the FSMA GMPs “non-food-contact surfaces” and require cleaning. All of these surfaces have to be cleanable; moreover, consider how you will access these surfaces to be able to clean them.

It goes without saying that restrooms must have surfaces that are easily cleanable and will not be an easy harbor for microorganisms. The ODA requirements also cover garbage: “Garbage containers, dumpsters, and compactor systems located outside shall be stored on or above a smooth surface of nonabsorbent material such as concrete or machine-laid asphalt that is kept clean and maintained in good repair.” The wastewater is required to flow into a sanitary sewer and not into storm sewers.

The next article will provide details for cleaning food contact surfaces as you plan to purchase or upgrade your processing equipment in preparation for producing cannabis edibles, followed by an article on space considerations for planning construction or upgrade of an edibles facility.



Rachel Montgomery is founder and principal of Simple Compliance Solutions LLC. Montgomery has 36 years of industrial experience in FDA compliance in the fermentation and contract manufacturing industries and holds the FSPCA certificate for Lead Instructor for conducting the Preventive Controls for Human Food training course.
Simple Compliance Solutions is currently registering individuals for additional public and private company training courses in mid-2016 through early 2017. If readers of MJINews would like a promotional code to receive a discount on one of the scheduled courses, contact Rachel Montgomery at (843) 888-9358, RMontgomerySCS@gmail.com or on LinkedIn.

Guest Contributor designates a writer who is guest publishing content with MJINews.

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