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Conne c ting to Audio: 3 Options Phone (be st sound quality)

1.Se le c t “Ca ll Me ”

• E

nte r yo ur pho ne numb e r

• 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

no w.

• Use c ha t fo r a ssista nc e .

For technical assistance, use chat.

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

DRAFT REPORT

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

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 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

• 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

C 17025 ac c r e ditation b y a se le c te d

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.

Next steps

Se e dra ft re po rt a t e c o lo g y.wa .g o v/ c a nna la b s

Feedback session

Oc to b e r 29 3 – 4 p.m. E c o lo g y He a dq ua rte rs 300 De smo nd Drive