Hemp & Cannabis Management System – US Regulations

DISCLAIMER: Due to the rapidly changing nature of regulations by each State and Federal Agency, QSE does not submit any of the content in this article as specific to the Laws and Regulations pertaining to Hemp/Cannabis based on requirements for your company and location. For specific requirements seek Legal consul or your State Department of Agriculture.

As stated in the disclaimer, rapid change is occurring at state and federal levels in regulations and oversight of the hemp and cannabis industries. These changes provide great opportunity and responsibility for organizations to provide safe, consistent, and beneficial production of these products.

The 2018 USDA Farm Fill implemented a new definition for Industrial Hemp applications that no longer consider it to be a controlled substance. Equally, many states have lifted restrictions on cannabis production. The result has been the need for regulations to ensure safety and consistency of production, but also confusion about the status dependent upon which state. Some states allow it to be used for medical purposes, smoking, edible product, or supplements; other states/areas may not accept all applications.

DEFINITIONS:

Industrial Hemp, processed from the family of plants – (2018 Farm Bill: Subtitle G – Sec. 297A. Definitions) The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”  – Hemp contains a low amount of THC but a high content of CBD delta-9 tetrahydrocannabinol concentration.

Benefits / Uses –

  • Fibers used for producing textiles, paper, bags, insulation/construction materials, twine, yarn, rope, cable, string, sackcloth (burlap), canvas, bags, and artificial sponges.
  • Oil from the seed used for paints, varnishes, soaps, cosmetic products, edible health food, CBD products, caged-bird feed, animal food, beverages including a milk substitute, and Hemp-derivative CBD. The oil contains magnesium and protein.

Cannabis – Dried leaves, flower portion, or chemicals containing delta-9 tetrahydrocannabinol concentration (THC) processed from the Cannabis sativa plant. The limit of THC may be much higher than hemp (Ex. Up to 10mg THC per package instead of the .3 percent limit on hemp).

Benefits / Uses –

  • Recreational – Smoking and edible marijuana products.
  • Medical – medical cannabis, drugs (such as Marinol, Syndros, & Cesamet to help control cancer treatment reactions of nausea and vomiting / Epidolex for seizures), and CBD oil.

Cannabidiol / CBD Oil (Some confusion exists due to the potential source of CBD from both non-psychoactive Hemp Derivatives or Cannabis) – A naturally occurring compound that is found naturally in the flower of the cannabis plant or a derivative processed from Hemp, having therapeutic capabilities.

Benefits / Uses –

  • Pharmaceutical Grade Product – Smoking, vaping, and edible marijuana products.
  • Unregulated Market Product – medical cannabis, drugs (such as Marinol, Syndros, & Cesamet to help control cancer treatment reactions of nausea and vomiting / Epidolex for seizures), and CBD oil.
  • CBD oil has been promoted as a non-addictive substance by multitudes of movie stars, athletes, and parents as a preventive health product and a cure-all for illness. It has therapeutic characteristics but does not create the physiological feelings (High) of THC.
  • QSE CAN HELP – A disciplined system produces consistent quality and responds to product variations impacting quality. QSE can assist:
    Pharmaceutical providers in meeting regulations and development of an effective, simplified management system.
    • Unregulated providers in receiving certification as a tremendous marketing tool and providing consistent quality products

Tetrahydrocannabinol (THC) – The chemical component (delta-9 tetrahydrocannabinol concentration) that can be processed form dried leaves or the flower of the cannabis plant that causes physiologically active reactions in humans. The THC content from cannabis can be much higher than that processed from hemp.

Benefits / Uses –

  • Delays release to provide relief of pain & stress.
  • Prohibited in some states due to high content levels or may require medical prescription

Industrial Hemp – The US Agricultural Improvement Act of 2018, known as the Farm Bill of 2018, signed December 20, 2018, makes provision for hemp to be allowed but does not override state law.

Restrictions on Hemp specify that products or derivatives must contain < 0.3% of THC based on a dry weight basis.

Cannabis & THC (Having levels > .3 / usually @ 10%) – Individual state mandates do not allow for full practical expansion of this presentation on legal requirements. States may allow sale of edible cannabis products and marijuana, disallow any non-medicinal sale, and everything in-between.

Each state has the authority to set testing/certification / licensing requirements for content levels potency, physical or chemical contamination, and which biological contaminants may require testing. There is no consistency between states and requires identification of your state’s restrictions. QSE is available to assist in making these determinations.

CANNABIDIOL (CBD) – Due to varied state regulations, the legality is difficult to determine without knowledge of your state law.

The FDA has determined that CBD is a drug regardless of its source and illegal for use in food or supplements. On a state by state basis, it may be illegal, available with a prescription. Available for recreational use and multiple other variations of requirements.

Regardless of state law, it is illegal to sell CBD to anyone in another state.

Opportunities have been identified that put the United States in an advantageous position to pursue sales and shipment to foreign countries. The largest provider to South American countries has been Canada who makes extensive sales, especially to Brazil.

Recently, Brazil has increased CBD products import from the US due to problems with delivery. Canada has categorized CBD as a controlled substance whereas the US can sell as supplements. Brazil has illegalized cultivation of medical marijuana. Add to this the prohibitive cost of delivery/purchase Canada, the US gains an advantage.

The window of opportunity for the United States is narrow however as South American countries having controlled methods of production begin to avail themselves of the Brazilian market. The main hindrance is consistency and speed of delivery as problems occur from US Customs confusion of regulations and delays.

Clarification of requirements and confidence in the logistic success may provide a more profitable market.

Testing Laboratories ensuring content and quality of Hemp / Cannabis products require accredited / proven capabilities to provide accurate service to the industry.

  • The National Cannabis Industry Association (NCIA) promotes the use of ISO/IEC 17025 Accredited Laboratories to ensure confidence and acceptance of test reports.
  • Common testing for Cannabinoid content includes testing of:
    • Levels of multiple chemical levels.
    • Evidence of pest or pesticide contamination.
    • Processing chemical contamination.
    • Microbiological contamination.
  • Any facility wanting to assure customers products are safely processed for the intended application and meet all regulatory requirements for content levels of ingredients.
  • Any facility desiring a strong marketing tool to showcase their commitment to meeting consumer and regulatory requirements for Hemp or Cannabis product as defined by federal and individual state requirements.
  • All businesses, operations, and organizations needing disciplines in place to ensure consistent production and testing levels to reduce the loss of viable products and maximize profit.
  • The process for getting certification to the Hemp & Cannabis Management System. (HCMS) starts with preparation of a well-developed Quality Control & Testing Plan.
  • Consultants proficiently qualified in developing a comprehensive, Hemp & Cannabis Management System (HCMS) to meet Federal and State Regulations.
  • QSE assists in selection of the proper utilization of ISO 17025 testing and analysis methods and implementation of a Quality Control & Testing Plan required to ensure that the organization can provide product that consistently achieves test results for all requirements.
  • Ensure that buildings, facilities, air quality, and equipment are secure to provide safe cultivation production, and processing to meet State and Federal regulations.
  • Management needs to ensure the facility is physically prepared to provide clean, cross-contamination free production.
  • QSE consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits/tests of product and systems to meet the State and Federal requirements.
  • Once prepared, select certification body.
    • Hemp/Cannabis cultivation & production facilities achieve GMP Certification.
    • Hemp Certification:
      • Multiple Certification Bodies are prepared and available to provide Hemp Certification.
    • Cannabis Certification: Only BRC providing for facilities in the USA.
  • Once the facility successfully passes the certification body compliance audit on requirements for a Hemp & Cannabis Management System, the certification body issues the compliance certificate to the organization.

 

  • Quality Management Consultants can prepare your facilities for Hemp & Cannabis related certification through implementation of a simplified, thorough Hemp & Cannabis Management System.
  • QSE can provide guidance for certification and in selection of the Testing Services that best fit your company needs and marketing strategy.
  • QSE Consultants are experienced in assisting small, medium and large organizations in developing, training, implementing, and maintaining a compliant / documented / consistent Hemp & Cannabis Management System designed specifically to fit your organizational needs.
  • Provision of internal audits to ensure product and system meets all requirements and employees prepared for certification and interfacing with auditor.
  • QSE consultants will ensure that certification is successfully achieved upon initial audit by the certification body.
  • QSE provides guidance in:
    • Implementation of Hemp & Cannabis applications for those providing only this type of product or those that produce multiple product lines requiring assurance that cross-contamination is controlled and risk contamination eliminated through identification of potential contamination points in processes and equipment.
    • Development of a rigorous Quality Control Plan that minimizes hazards and ultimately benefits both organization and consumer.
    • Implementation of testing at appropriate stages to prevent contamination.
    • Establishment of an employee training program that gives results.
      • Employee involvement to achieve successful implementation.
      • Education on control of cross-contamination, Good Manufacturing Practices (GMPs), and sanitation/cleaning.
      • Proper training in hazard assessment and application of testing for identified hazard.
      • Procedure for prevention of cross-contamination.
      • A robust system that trains and compels employees to understand and adhere to defined roles, responsibilities, procedures and controls.
  • A good consultant firm can provide detailed explanation on the intent and properly define and implement the system to meet requirements.
  • A comprehensive Hemp & Cannabis Management System can create confidence in customers and provide answers to all questions from product/process certification auditors.
  • An experienced Hemp & Cannabis consulting firm provides experience in the techniques for developing and implementing the HCMS.
  • Consulting firm such as QSE provides audit and testing services to help the facility verify the accuracy and adequacy of the system and provide accurate levels of THS in product.
  • Annual surveillance audits are conducted to ensure implementation effectiveness of the established HCMS.
  • Thoroughness of preparation and ease of Hemp & Cannabis certification achievement by utilizing all of QSE’s 10-Step Approach.
  • Quality Systems Enhancement Inc. (QSE) is a Premier Consulting, Auditing and Training firm with over 27 Years’ experience and capability for implementation of any Hemp & Cannabis Management System, ISO Standard, Sector Specific Standard, AISC Standard and all Food Safety
  • QSE provides On-Site and On-line Training for all Hemp & Cannabis Certifications to ensure Awareness of Requirements and Effective Implementation along with internal Product/System Auditing.
  • QSE’s Consultants have helped over 800 facilities to earn multiple ISO, Food Safety, Hemp & Cannabis, and many other certifications.
  • Over 98 % of QSE customers passed ISO certification audits with no nonconformity first time around. QSE has a 100 % success rate in obtaining certifications for its customers.
  • Unlike our competitors, QSE provides a unique, comprehensive, evidence based, simplified documentation system comprehensively encompassing all requirements to achieve Compliance which is easy to implement and provides product and system compliance results to earn
  • QSE Consultant’s Hemp and Cannabis Audits are an effective management tool to run any business processes to enhance Bottom-Line
  • QSE designed templates are tried and tested for thorough coverage of all standard requirements, accuracy and correctness and provide objective evidence during internal audits and certification / compliance audits.
  • QSE’s simplified System is evidence and result based, and is easy to implement, easy to use and easy to audit. If required the QSE System can be integrated with other ISO or Food Safety Management System Standards.
  • QSE ‘s evidence-based system with proven lists, forms and tables results in certification with minimum or no nonconformities.
  • QSE utilizes competent Hemp / Cannabis Auditors to conduct product and supply chain material audits

President QSE, Baskar Kotte is an original and an active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 50001 and  ISO 19011 the Guiding Standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO, ISO 14001:2015, ISO 45001:2018 family of Standards and ISO 19011:2018 revised standards.

  • Additional benefits not listed for each component are as follows;
    • Benefit through identification of hazard points and high-risk ingredients to manage the risk of cross contamination.
    • Discipline implemented to identify High-Risk items / Area / Equipment and implementation of a Quality Control Plan to control the risk.
    • Additional Requirements that vary based on State specific criteria.
    • An HCMS provides consistency and confidence in organizational ability to provide consistent Hemp & Cannabis related product.
    • Benefits of quality / compliant final product for the organization and the consumer.
    • Bottom Line Benefits to ensure satisfied customer and meeting needs of the organization.

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