Lab Matters Summer 2019 - Page 48

APHL 2019 POSTER ABSTRACTS Presenter: Alyssa Mattson, State Hygienic Laboratory at the University of Iowa, Coralville, IA, Establishing a Medical Cannabis Testing Program in Iowa M. Pendergast 1 , S. Dai 2 , D. May 1 , S. Dricken 1 , M. Pentella 1 ; 1 State Hygienic Laboratory at the University of Iowa, 2 University of Iowa HON. MENTION 2019 Beginning in May 2017, Iowa legalized medical cannabidiol and required testing of manufactured products for quality and safety. The legislation identified the State Hygienic Laboratory (SHL), Iowa’s public health laboratory, as a resource to provide testing services for these products. SHL immediately initiated a project charter to define the scope of work. Over the course of the next 18 months, SHL collaborated extensively with stakeholders to establish a testing program that was both fit for purpose and defensible while ensuring a quality product for public consumption. During the initial ten months, SHL collaborated with IDPH to draft the lab testing rules for content and contamination covering: sampling procedures, limits of quantitation, action levels, inventory tracking, waste disposal, and security. This initial phase of rulemaking involved 400 SHL staff hours, at an estimated labor cost of $15k. Concurrently with this rulemaking process, SHL conducted validation studies for eight methods covering four matrices. The validations determined the following: selectivity; LOD & LOQ; working and linear ranges; bias and recovery; intermediate precision; measurement uncertainty; and robustness. This phase spanned eight months, involved 16 staff members and 1000 SHL staff hours, at an estimated labor cost of $35k. The majority of the effort occurred during the final three months of this phase. In order to oversee testing of medical cannabidiol products, SHL developed a 46 LAB MATTERS Summer 2019 program aligning with the twelve quality system essentials. Program management for the establishment of testing required eight months and included: validation plan and study authorizations; document and record generation; document and record organization; and three process training exercises. This phase involved 18 staff members and 1300 SHL staff hours, at an estimated labor cost of $48k. Finally, in the last three months of 2018, after the development of rules governing testing, the validation of analysis methods, and the establishment of a quality management system, SHL received 181 samples and conducted 570 tests covering potency, pesticides, metals, solvents, total yeast and mold count, total aerobic microbial count, Shiga-toxin producing E. coli, and Salmonella. This testing required pre and post studies based on production by the manufacturer and four matrices (concentrate, capsules, cream, and tincture). This initial testing phase involved 16 staff members and 915 staff hours, at an estimated labor cost of $32k. The SHL’s success in establishing a medical cannabidiol testing program illustrates that public health laboratories possess unique expertise to help guide and establish complex programs. Additionally, the constraints and risks posed by these types of programs can be adequately addressed by following established project management principals and the quality system essentials. Presenter: Michael Pentella, State Hygienic Laboratory at the University of Iowa, Coralville, IA, Biomonitoring Pyrethroid Pesticides in the Four Corners States J. Patel 1 , G. Silva 2 , S. Chaudhuri 1 ; 1 Utah Public Health Laboratory, 2 New Mexico Scientific Laboratory Division Objective: The objective of this study is to develop and expand laboratory-based biomonitoring programs that address concerns common to the four corner states, to assess the extent and nature of human exposures to environmental toxicants that have the potential to cause harm, and to help prevent diseases resulting from such exposures. Pyrethroid pesticides are of concern as they are such toxicants that are widely used for mosquito and other household insect control in the four corner states of Utah, Arizona, Colorado, and New Mexico. Methods: The Four Corners States Biomonitoring Consortium comprised of laboratory and epidemiology program staff of the four states worked together to develop and implement pyrethroid biomonitoring in the four states. Laboratory workload for the study was undertaken by the public health laboratories of Utah and New Mexico. These laboratories utilized existing infra-structure and equipment from respective Chemical Threat programs to perform the analytical work needed for this study. The analytical methods utilize an extraction process followed by liquid chromatography-tandem mass spectrometry to measure concentrations of metabolites of pyrethroid pesticides in urine. Chemists from Utah and New Mexico laboratories received hands- on training at the Centers for Disease Control and Prevention (CDC) laboratory by CDC subject matter experts. On-going consultation and training was received by the same to troubleshoot method problems. PublicHealthLabs @APHL engaged 40 counties and their associated environmental health professionals across the state of Iowa to complete the successful collection of raw and treated water samples from approximately 1,200 private wells. Each raw water well sample was analyzed for total coliform bacteria, E. coli, nitrite + nitrate as nitrogen and total arsenic. Additionally, compounds of emerging concern for human health, such as neonicotinoid insecticides, selected herbicides and associated compounds and manganese, have also been identified and analyzed for these well samples. Results of analyses reinforce the position that public health concerns exist for many people consuming private well water in Iowa. Nitrate levels have reached a concentration as high as 69 mg/L with approximately 12% of wells sampled exceeding the EPA Maximum Contaminant Level (MCL) of 10 mg/L. Concentrations of total coliform bacteria and E. coli have been quantifiable at a rate of approximately 40% and 8% of wells sampled, respectively, all in exceedance of the MCL for those microbiological organisms. Arsenic is naturally occurring and quite prevalent in the north central region of Iowa and in other localized geographic formations in the state. Concentrations up to 0.39 mg/L were found among the wells sampled with approximately 3% exceeding the MCL of 0.01 mg/L. Water treatment systems in 290 of the homes sampled have not insured completely safe drinking water for the consumers with quantifiable results for all measured parameters present in treated water samples. These results illustrate the pressing concerns for the health of Iowans consuming private well water.