APHL 2019 POSTER ABSTRACTS
Presenter: Alyssa Mattson, State Hygienic Laboratory at the
University of Iowa, Coralville, IA, [email protected]
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
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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, [email protected]
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
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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.