Vitale Scientific Associates Hires Industry Expert to Spearhead Cannabis Services Program

Shannon Swantek joins Vitale Scientific Associates, LLC (VSA) as a Senior Quality Scientist with extensive knowledge of the environmental and cannabis industries.  She has a robust regulatory background that includes 8 years of experience performing audits nationally to the 2009 TNI1 Standard and ISO 17025:2005 Standards in environmental, food, agricultural, and cannabis laboratories.

Ms. Swantek was the Cannabis Program Manager for the Oregon Environmental Laboratory Accreditation Program (ORELAP), the state accreditation body required for all compliance cannabis laboratories in Oregon, and provided cannabis laboratory compliance training to state cannabis regulations and the 2009 TNI Standard.  She developed a cannabis-specific “in-matrix” proficiency testing program and multiple policies addressing the complexities of compliant implementation.  She trained the ORELAP Team on auditing, testing, and sampling of cannabis and organized the audits of 22 cannabis laboratories as an ORELAP Lead Assessor.

Ms. Swantek is uniquely qualified to perform the cannabis-related services offered by VSA.  An overview of those services is provided below.

Cannabis Services Overview

  • Laboratory management, inter-laboratory program management, analytical program design and management, sampling and analysis planning, and quality assurance (QA) project planning needed to meet state and local regulations.
    • Auditing and mock audits
    • Assessments
    • Training
  • Development of cGMP/ISO 9001-compliant Integrated Management Systems for extract and cannabis-product processors.
  • Performance of due diligence, compliance, and gap audits of processors, laboratories, and sampling organizations to various ISO standards, cGMP requirements, and state regulations.
  • Analytical QA and quality control (QC), including working under regulatory standards.
  • Laboratory facility planning, design and construction oversight.
  • Laboratory operational readiness reviews (ORRs) in preparation for state medical marijuana testing program requirements.
  • Management of laboratory procurements including drafting and issuing technical specification manuals; design, planning and execution of performance evaluation (PE) studies; and the evaluation of laboratory proposals.
  • Laboratory data review and data validation.
  • Analytical method development and validation.
  • Chemical, microbiological, and physical testing analytical experimental design, management, and evaluation of laboratory studies involving medical cannabis products, cannabis-infused products, finished plant material, cannabis resin, cannabis concentrates, cannabis oils, environmental grow media, water sources and other materials.
  • Experimental design, management, evaluation of laboratory studies in the cannabis industry for the following:
    • Cannabinoid Profile Testing for Major and Minor Cannabinoids
      • Δ9 –THC, THCA-A, CBD, CBDA, CBN, THCV, CBG, CBC, Δ8 –THC
    • Terpenoid Profile Testing for Major and Minor Terpenoids
      • Monoterpenoids, Sesquiterpenoids and Flavonoids
    • Testing for Natural Contaminants and Adulterants
      • Pesticides, metals, residual solvents, microbes (bacteria and fungi) and growth enhancers
    • Testing for Degradation Products and Artifacts
      • Cannabicyclol- (CBL-) type phytocannabinoids, Cannabinodiol- (CBND-) type phytocannabinoids and other synthetic cannabinoid-like compounds
    • Analytical characterization of drug compounds and drug products.
    • Beyond-use dating (BUD).

We are proud to have Ms. Swantek on our team.  During her time at ORELAP, she also participated in ORELAP efforts to promote cooperative, rather than punitive, assessments in air toxics, environmental, drinking water, whole effluent toxicity, radiochemistry, and microbiology laboratories by providing technical assistance and cooperative training.  This holistic approach resulted in the program doubling in size, and ORELAP became the primary accrediting body to laboratories from South Korea, Fiji, Canada, and various states including Colorado, Arizona, Hawaii, and most laboratories in the California National Environmental Laboratory Accreditation Program (NELAP).

Ms. Swantek served on the Cannabis Testing Rules Advisory Committee (RAC), which advised on the testing legislation for both the Oregon Health Authority (OHA) for medical cannabis and the Oregon Liquor Control Commission (OLCC) for adult-use cannabis sampling and analysis.  She chaired the cannabis sampling sub-committee and participated in the pesticide sub-committee providing associated sections of the legislation.

As a cannabis industry expert, she assisted the Oregon Department of Justice (ODOJ), Oregon Department of Agriculture (ODA), OHA, and OLCC by regularly advising on policy in all parts of the cannabis-industry legislation pertaining to testing, labeling, processing, and cultivation.  She participated in industry education efforts – speaking at processor, dispensary, and cultivator meetings on the changing legislation, working with the laboratories, and educating on process control.  She also coordinated with other state public health officials in an effort to standardize state efforts and spoke on state regulatory panels in industry conferences such as the Emerald Conference and the Cannabis Quality Summit.  She remains engaged in state and national efforts to support the cannabis industry as well as provide laboratory development services to help elevate the industry’s standards for credible and high-quality scientific data.

For more information on VSA’s Cannabis Services, contact Shannon Swantek at 865.376.7590 ext.806.

1 The NELAC Institute

Global Certification for Food Science Professional David I. Thal

David I. Thal, Director of Vitale Scientific Associates, LLC, has been notified by the Institute of Food Technologists (IFT) that he has met all requirements and is now designated a Certified Food Scientist (CFS). The IFT notes that this credential is the only global certification for food science professionals. Unlike any other certifications, the CFS designation recognizes the applied scientific knowledge and skills of global food professionals and provides a universal way to identify, cultivate, and retain top talent. The certification helps ensure that food science and technology professionals are up to date on the latest developments in food science to address global food and consumer needs. This is especially important as the global food system evolves to address increasingly complex challenges.

Mr. Thal is also recognized by the American Society for Quality as a Certified Quality Auditor. These certifications in combination with more than 25 years’ experience conducting and supervising quantitative laboratory science make him a valuable resource for ensuring your food testing program is scientifically sound, compliant, and effective. He can be contacted at dthal@envstd.com.

FSMA Drives the Need for Data Quality Management

FDA Food Safety Modernization Act: Driving the Need for Data Quality ManagementOver the last decade, high-profile outbreaks of foodborne illness and data showing that such illnesses strike almost 20% of Americans each year have caused a widespread recognition that we need a new, modern food safety system. The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011 and it is the most sweeping legislation for regulating the food industry in over 70 years.  It aims to ensure the US food supply is safe by shifting the focus of federal regulators to be proactive rather than reactive, from responding to outbreaks to preventing food safety problems before they occur.

Food Safety Modernization Act FSMA Drives the Need for Data Quality Management

The requirements for preventive controls for food include current good manufacturing practice and hazard analysis and risk-based preventive controls, which would apply to many domestic and foreign firms that manufacture, process, pack, or hold food. These firms would be required to evaluate hazards, identify and implement preventive controls to address these hazards, verify that the preventive controls are adequate to control the hazards identified, take corrective action when needed, and maintain a written plan and documentation.  It is clear that the need for high-quality scientific data collection and management will intensify as these evaluations and subsequent control policies are contemplated.  Because the decision to release foods to the marketplace will be made on the basis of hazard identifications and controls, the need for data of known quality and statistical power is obvious.  A data quality program to support these needs will include statistically-informed sampling design, coupled with more rigorous protocols and uncertainty analysis.  Data validation and performance evaluation studies for contract and internal laboratories are important tools to gain control of the overall analytical process.

The proposed rule also contains requirements relating to auditing and certification of food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health. To ensure the safety of food, the most effective preventative programs focus on quality assurance and quality control, which includes developing protocols of well documented and appropriate levels of accuracy, precision, sensitivity, and specificity.  The proper implementation of quality programs must be assessed and this is typically performed through third-party audits.  The combined requirements for monitoring, oversight, and notification are needed to give the FDA, consumers, and other stakeholders confidence in the program.

If you have questions about how FSMA will impact your company, contact James Markwiese or David Thal at 865.376.7590.

House Approves New Farm Bill

The House of Representatives passed a bill on January 29, 2014, authorizing nearly $1 trillion in spending on farm subsidies and nutrition programs, setting the stage for final passage of a new five-year farm bill that has been stalled for more than two years.

Negotiators from the House and Senate spent several weeks working out their differences on issues in the legislation, including cuts to food stamps, income caps on farm subsidies and a price support program for dairy farmers. The bill is expected to save about $16.6 billion over the next 10 years.

As noted in a recent Food Safety News article, the bill calls for scientific and economic analysis of the produce safety rule issued under the Food Safety Modernization Act (FSMA), along with a plan to systematically evaluate the impact of the final rule on farming and ranching operations and evaluate and respond to business concerns. This final version eliminated the House provision prohibiting enforcement of the regulation and now simply requires that an analysis of the information used in promulgating the rule be released alongside the final rule.

The bill passed the House by a vote of 251 to 166. The Senate is expected to take up the bill later this week.

California Proposition 65: Omnibus Consumer Product Enforcement Act

California Proposition 65 LawThe California law known as Proposition 65, formally titled “The Safe Drinking Water and Toxic Enforcement Act of 1986,” can accurately be thought of as “Omnibus Consumer Product Enforcement Act.”  The law was enacted to improve public health by reducing exposure to toxic chemicals.  More specifically, Proposition 65 controls a growing list of chemicals and substances believed to have the potential to cause cancer, birth defects, or other reproductive adverse effects.  It is administered by the Office of Environmental Health Hazard Assessment, which is part of the California Environmental Protection Agency.  Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment.  These chemicals can include ingredients or additives in household or workplace products and foods, and can even include byproducts of chemical processes.

Since it was first published in 1987, the list has grown to include approximately 800 chemicals. For carcinogens, the toxicity of a chemical is based on no more than one excess cancer risk in 100,000 individuals exposed to that concentration of the chemical over 70 years.  For non-carcinogens, an additional 1000-fold margin of safety is applied to the more conventional benchmark for toxicity that is based on an exposure concentration shown to have no effect on humans or, more often, laboratory animals.

Once a chemical is listed, businesses have a year to comply with listing requirements, including posting warnings about toxic chemicals associated with their operations.  The warning requirement states that, “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”  Suppliers of food, water, and other exposure media are required to show that a properly applied method of detection and analysis was followed, where “method of detection and analysis” means a specific analytical testing procedure appropriate for detecting a particular chemical in a particular matrix such as air, water, soil, or food that is applied for the purpose of detecting the chemical or measuring its concentration (Section 12900 ARTICLE 9. MISCELLANEOUS, 22 CCR 12900).  This vague, circular language is an insufficient basis for identifying a concrete, technically valid testing regimen.  The supplier will likely need assistance from specialists to address this requirement.

Proposition 65 has established safety thresholds, also called safe harbor numbers, for some 300 listed chemicals based on conservative exposure assumptions, leaving about 500 chemicals currently without safe harbor numbers.  If a chemical is not listed, companies using such chemicals have the onus of developing exposure information.  Here again, the supplier will need assistance from specialists versed in the finer points of exposure assessment and analytical validity.  Vitale Scientific Associates, LLC provides expertise in the evaluation of sampling and analytical methodology.  We have assisted in litigation and laboratory evaluation for Proposition 65 cases and stand ready to support our clients through this challenging process.  A copy of the current Proposition 65 list can be found here.

For more information, please contact Quality Assurance Specialist David Thal at dthal@vitalescientific.com.

Toxicity Testing Quality Assurance: Strengths and Weaknesses (Part 3 of 3)

This article is the third in a series of three by Senior Scientist James Markwiese, Ph.D., discussing the quality control and quality assurance measures for state-of-the-practice toxicity testing.  The series focuses on mechanisms to facilitate the establishment and documentation of quality procedures for toxicity testing laboratories. The first article in this series is available here.  The second article in this series is available here.

Toxicity Testing Quality Assurance: Strengths and Weaknesses

To date, we have considered consequences of mischaracterizing (over- or underestimating) the toxicity of a test material (foods, ingredients, raw materials finished products) and the role of laboratory audits in ensuring the quality of toxicity testing results.  This final segment will highlight the strengths and weaknesses of toxicity testing to highlight what can be expected regarding the use of toxicity test results for decision making.

Toxicity testing represents a powerful line of evidence for assessing impacts from trace-level chemical contaminants in the test material.  Toxicity test results are more realistic than basing conclusions on literature values because they incorporate synergistic, antagonistic, and kinetic features of the particular medium. Additionally, toxicity testing can provide transparent scientific input to decision-makers regarding certainty (vs. uncertainty), importance, and significance of results.  For example, literature-based estimates are typically based on exposures to single chemicals.  But because contaminated media typically represents a mixture of chemicals, bioassays can integrate effects from multiple stressors using the specific test material being studied.

While there are many benefits from toxicity testing, there are also many hurdles to proper implementation.  Shortcomings associated with toxicity testing are myriad and include the following:

  • insistence on using only standardized toxicity tests
  • conducting testing because it is possible, not because it will provide necessary information/answer the questions that need answering
  • endpoints may be limited
  • test taxa may not be the same or even similar to those in the real world (different sensitivities)
  • failure to apply data quality objectives

Appropriate quality assurance and quality control can also be employed to reduce uncertainty and increase test acceptability.

If you have questions about toxicity testing quality assurance, please contact James Markwiese, Ph.D. at 865.376.7590.

Toxicity Testing Quality Assurance: The Role of Laboratory Audits (Part 2 of 3)

This article is the second in a series of three by Senior Scientist James Markwiese, PhD, discussing the quality control and quality assurance measures for state-of-the-practice toxicity testing.  The series focuses on mechanisms to facilitate the establishment and documentation of quality procedures for toxicity testing laboratories. The first article in this series is available here.  The third article in this series is available here.

Toxicity Testing Quality Assurance: The Role of Laboratory Audits

A laboratory must actively ensure that its quality system is being properly implemented and that it is achieving the required standard of quality.  Quality control measures, such as a method-specific demonstration of bioassay capability, can provide feedback on the quality system but are not enough to ensure quality results.  Audits are designed to provide an objective and thorough evaluation of quality issues affecting a laboratory and cover the entirety of the quality system.  Routine audits of toxicity testing laboratories can detect actual or potential non-conformances before they impact data quality and can even identify possible future problems.  Where there are no problems, the audit provides a record that the quality assurance system has been thoroughly evaluated and found to be acceptable.

The quality assurance elements reviewed in a toxicity testing audit include:

  • quality documents such as quality management plans, study plans including quality assurance sections and standard operating procedures;
  • records including technician training, Chain-of-Custody, equipment calibration such as dosimetry, pH, salinity and light meters, test conditions, toxicity test data and reports and corrective actions;
  • and methodology including test implementation and performance.

These topics can be covered in any order, but typically begin with an evaluation of documentation and records and end with method/ test performance review.

The most important, and perhaps most difficult to gauge, aspect of the latter involves evaluating competence of laboratory personnel for routine maintenance, such as culture of test organisms.  For confidence in bioassay results, it is imperative to demonstrate that the organism is responding to the test substance and/or conditions and not some confounding factor (lack of acclimation to test conditions, disease, etc.). Validity of results can be evaluated on a test-specific basis and efforts are underway to gauge long-term performance of testing laboratories.  Although audits typically only last from one to several days, and therefore represent a narrow window for gauging year-round laboratory operations, they offer an unparalleled means for evaluating a laboratory’s implementation of its quality assurance system.

Connect with Dr. Markwiese on LinkedIn or at jmarkwiese@vitalescientific.com.

Ensuring The Quality Of Toxicity Test Results (Part 1 of 3)

This is the first in a series of articles discussing the quality control and quality assurance measures for state-of-the-practice toxicity testing by Senior Scientist James Markwiese, PhD.  The series will focus on mechanisms to facilitate the establishment and documentation of quality procedures for toxicity testing laboratories. The second article in this series is available here.  The third article in this series is available here.

Ensuring the Quality of Toxicity Test Results

Toxicity tests are used to determine whether materials containing multiple constituents can induce effects upon living organisms.  The liability associated with inadequate characterization of toxicity (either over- or under-estimating actual toxicity) can be enormous and the quality of toxicity testing is, therefore, of great importance.  While rigorous quality assurance evaluations such as data validation are routine for chemical characterization of samples, analogous toxicity testing quality assurance measures are limited; this lack of QA can present a vulnerability to our clients. Vitale Scientific Associates is taking the necessary steps to ensure that only high-quality and defensible toxicity data are provided.

Successful toxicity testing laboratories need to employ quality management systems to help meet toxicity test acceptability requirements and ensure quality results.  Critical components of quality management systems for toxicity testing programs include:

  • emphasis on analyst training (particularly with regard to culture and maintenance of test organisms).
  • maintenance of standardized operating procedures.
  • maintenance of required test conditions.
  • use of standard reference toxicants.
  • testing multiple control or reference samples with each batch of toxicity tests.
  • detailed record-keeping.
  • appropriate statistical analyses.
  • routine laboratory audits.

Connect with Dr. Markwiese on LinkedIn or at jmarkwiese@vitalescientific.com.