Our webinar will begin soon Conne c ting to Audio: 3 Options Phone - PowerPoint PPT Presentation

Our webinar will begin soon Conne c ting to Audio: 3 Options Phone (be st sound quality) 1.Se le c t “Ca ll Me ” o E nte r yo ur pho ne numb e r o Yo u will b e c a lle d b a c k 2.Or se le c t “I Will Ca ll I n” a nd dia l the numb e r pro vide d 3.Se le c t “Ca ll Using Co mpute r” a nd fo llo w dire c tio ns

Use chat for technical help • Our we b ina r is no w b e g inning . • Use sho uld b e a b le to he a r us For technical assistance, use chat. no w. • Use c ha t fo r a ssista nc e .

Facilitators Ca mille St. Ong e & Ruth F ro e se Co mmunic a tio ns Presenter Je ssic a Arc he r Se c tio n Ma na g e r, E nviro nme nta l Asse ssme nt Pro g ra m Author Sa ra Se ke ra k Se nio r Che mist a nd Pro je c t Ma na g e r, E nviro nme nta l Asse ssme nt Pro g ra m

Webinar Format • All a tte nde e s a re in liste n o nly mo de . • T he pre se nta tio n will b e ma de a va ila b le o n E c o lo g y’ s we b site . • E c o lo g y will ho ld a fe e db a c k se ssio n o n Oc to b e r 29.

LEGISLATIVE ASSIGNMENT & REPORT PROCESS

Senate Bill 6032 PR E L IMINAR Y R E COMME NDAT IONS Be g in c o nduc ting re se a rc h a nd de ve lo ping pre limina ry re c o mme nda tio ns fo r pro to c o ls a nd a c c re dita tio n sta nda rds fo r c a nna b is te sting la b o ra to rie s.

Report process

Legislative Report Cannabis Lab Accreditation Je ssic a Arc he r Se c tio n Ma na g e r, E nviro nme nta l Asse ssme nt Pro g ra m

ACCREDITATION & ECOLOGY’S ROLE

What is accreditation? • Ac c re dita tio n is the fo rma l re c o g nitio n tha t a la b o ra to ry ha s the te c hnic a l c o mpe te nc e a nd the syste ms in pla c e to pe rfo rm a n ide ntifie d sc o pe o f wo rk, de fine d b y re g ula tio ns, a nd is the re fo re c a pa b le o f pro duc ing a c c ura te a nd de fe nsib le a na lytic a l da ta .

Ecology’s role in accreditation • Ac c re dits ~500 la b o ra to rie s • Pro vide s initia l a nd c o ntinuing a c c re dita tio n • Ac c re dits to the pa ra me te r • E c o lo g y g ra nts, re vo ke s, o r suspe nds a c c re dita tio n

Re po rt sc o pe a nd initia l re se a rc h DRAFT REPORT

Scope Be g in c o nduc ting re se a rc h a nd de ve lo ping pre limina ry re c o mme nda tio ns fo r pro to c o ls a nd a c c re dita tio n sta nda rds fo r c a nna b is te sting la b o ra to rie s.

Problems with Scope

Research • Ga the re d a c c re dita tio n da ta • Re vie we d c urre nt po lic ie s a nd pra c tic e s • L o o ke d to o the r sta te s • De ve lo pe d pre limina ry re c o mme nda tio ns

CRITICAL CHALLENGES MUST BE ADDRESSED

Critical Analytical Gaps & Challenges • Me tho ds o f a na lysis • Me tho d va lida tio n • Pe rfo rma nc e c rite ria • Pro fic ie nc y te sting • Sa mpling • Ho mo g e niza tio n • Pre pa ra tio n pro c e dure s

Cannabis Science Workgroup • Ca nna b is Sc ie nc e Wo rkg ro up: – Do c to rs, to xic o lo g ists, c he mists, mic ro b io lo g ists, pub lic he a lth e xpe rts, fo o d & a g te sting me tho ds, DOH a nd WSDA, industry no n-g o ve rnme nta l sc ie ntists – De te rmine me tho ds, pro to c o ls, q ua lity sta nda rds – Sc ie nc e -b a se d upda te s to la ng ua g e in WAC re g a rding QA, sa mpling , ho mo g e niza tio n, QA te sting , PT , la b pra c tic e s, a c tio n limits, pro duc t c o mplia nc e ,

American Herbal Pharmacoepeia Monograph Ac c o rding to WAC 314-55-0995, • Ce rtifie d la b s must fo llo w the a na lytic a l re q uire me nts [in the ] mo st c urre nt ve rsio n o f the Cannabis I nflo re sc e nc e and L e af Mo no graph pub lishe d b y the Ame ric an He rbal Pharmac o po e ia o r no tify the WSL CB o r its de sig ne e wha t a lte rna tive sc ie ntific a lly va lid te sting me tho do lo g y the la b is fo llo wing fo r e a c h q ua lity a ssura nc e te st.

The Good Laboratory Practices Checklist • E va lua te to we a k a nd insuffic ie nt q ua lity sta nda rds • L a b s a c c re dite d to c rite ria in SOPs tha t the y wro te the mse lve s. • L a b s no t re q uire d to imple me nt spe c ific QA/ QC due to we a k WAC q ua lity sta nda rds. • No t a n e ffe c tive a c c re dita tio n me c ha nism

Proficiency Testing • I nte g ra l pa rt o f la b o ra to ry a c c re dita tio n • Re q uire d pre -a c c re dita tio n in a ll ma jo r te sting pro g ra ms • Appro pria te PT pro vide rs no t a va ila b le in WA • Ro und Ro b in inte rla b c o mpa riso ns ma y b e a ppro pria te • Sta te pro g ra m o r priva te c o mpa ny c o uld so urc e a nd spike pro duc t

Sample Procedures • L a c k o f g uida nc e ma y le a d to b ia se d sa mple s • No na tio na lly o r inte rna tio na lly re c o g nize d sta nda rd me tho ds • I nsuffic ie nt pro c e ss in WAC 314-55-101 • Bia s intro duc e d a t this sta g e will pe rsist thro ug h pro c e ss • Sa mpling pro to c o ls ne e de d • No t a sse sse d a s pa rt o f la b o ra to ry a c c re dita tio n

Sample Homogenization • L e ft to la b o ra to ry disc re tio n • Ma y le a d to va ria b le , no n-re pre se nta tive re sults • No t no rma lly pa rt o f a c c re dita tio n a c tivitie s unle ss pa rt o f a na lysis me tho d o r in a pre p SOP

Widely Accepted Protocols & Methods Do Not Exist • Va lida ting & de ve lo ping me tho ds ta ke mo nths – ye a rs to de ve lo p • Multiple ma tric e s, e a c h re q uiring diffe re nt pro to c o ls

Options for Protocols & Methods • Ado pt (a nd a da pt) me tho ds fro m o the r te sting pro g ra ms • Use me tho ds fro m o the r sta te s, c o untrie s, instrume nt ma nufa c ture rs, o r the industry • Ado pt (o r a da pt) pe rfo rma nc e c rite ria o r va lida tio n pro to c o ls to use with no n-sta nda rd la b me tho ds • Ca na da

MODELS OF ACCREDITATION EVALUATED

Model 1 • E c o lo g y’ s L a b o ra to ry Ac c re dita tio n Unit (L AU) a ssume s the ro le o f a c c re diting b o dy, a nd la b o ra to rie s a re e va lua te d using a ppro ve d me tho ds, e sta b lishe d pe rfo rma nc e c rite ria , a nd o the r c ritic a l e le me nts ne c e ssa ry to a sse ss c o mpe te nc y a nd a b ility to g e ne ra te c o nsiste ntly a c c ura te a nd de fe nsib le da ta

Model 2 • An ISO/ IE e ditation b y a se le c te d C 17025 ac c r I nte rna tio na l L a b o ra to ry Ac c re dita tio n Co o pe ra tio n (I L AC) Mutua l Re c o g nitio n Ag re e me nt (MRA) pro vide r

The ISO/IEC 17025 Accreditation Standard Is Not Enough • Ge ne ra l re q uire me nts, spe c ific a tio ns, a nd g uide line s • Se rve s b ro a d a rra y o f disc ipline s b y no t inc o rpo ra ting spe c ific de ta ils • Va g ue a nd g e ne ra l unle ss pa ire d with spe c ific a tio ns o r po lic y a nd a do ptio n o f o the r re g ula to ry, industry, o r c o nse nsus sta nda rds

Model 3 • E c o lo g y’ s L AU a ssume s the ro le a s the a c c re dita tio n b o dy a nd a c c re dit c a nna b is te sting la b o ra to rie s to a r e vise d ve rsio n o f the GL P Che c klist (WAC 314-55-103) a nd r e vise d la b o ra to ry c e rtific a tio n a nd a c c re dita tio n re q uire me nts (WAC 314-55-0995), a t a minimum

Model 4 • E c o lo g y’ s L a b o ra to ry Ac c re dita tio n Unit (L AU) a ssume s the ro le a s the a c c re dita tio n b o dy a nd a c c re dits c a nna b is te sting la b o ra to rie s to the c urre nt “a s is” Go o d L a b o ra to ry Pra c tic e (GL P) Che c klist in Wa shing to n Administra tive Co de (WAC) 314-55-103.

RECOMMENDATIONS

(1) Develop protocols and quality standards to achieve established product standards. • Ca nna b is Sc ie nc e Wo rkg ro up: – Do c to rs, to xic o lo g ists, c he mists, mic ro b io lo g ists, pub lic he a lth e xpe rts, fo o d & a g te sting me tho ds, DOH a nd WSDA, industry no n-g o ve rnme nta l sc ie ntists – De te rmine me tho ds, pro to c o ls, q ua lity sta nda rds – Sc ie nc e -b a se d upda te s to la ng ua g e in WAC re g a rding QA, sa mpling , ho mo g e niza tio n, QA te sting , PT , la b pra c tic e s, a c tio n limits, pro duc t c o mplia nc e ,

(2) Revise Chapter 314-55 WAC to adopt the new protocols and quality standards. • L a b o ra to ry c e rtific a tio n a nd a c c re dita tio n re q uire me nts (WAC 314-55-0995) • Qua lity a ssura nc e te sting (WAC 314-55-102) • Qua lity a ssura nc e s sa mpling pro to c o ls (WAC 314-55-101) • Pro fic ie nc y te sting (WAC 314-55-1025) • L a b o ra to ry c e rtific a tio n – suspe nsio n a nd re vo c a tio n (314- 55-1035) • Se c tio ns within ma rijua na pro duc t c o mplia nc e (WAC 314- 55-107 a nd Cha pte r 246-70 WAC) • Additio na lly, this o ptio n ma y re q uire re visio n o f la ng ua g e in pe stic ide a c tio n le ve ls (WAC 314-55-108

(3) Maintain the current private accreditation provider until the new protocols and quality standards are in place.

(4) Adopt a new accreditation provider after new standards are in place. • De sig na te E c o lo g y’ s L a b o ra to ry Ac c re dita tio n Unit a s the a c c re dita tio n pro vide r fo r Wa shing to n c a nna b is te sting la b o ra to rie s.