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Issue s with T attoo and PMU Ink - T he AF DO T atto o I nk - - PowerPoint PPT Presentation

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Issue s with T attoo and PMU Ink - T he AF DO T atto o I nk and Pe rmane nt Make up L ab e ling Guide line s 2019 CE HA Annua l E duc a tion Confe re nc e Ke ystone , Colora do L a ure l Arrig o na Jo di Zimme rma n Re g ula to

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SLIDE 1

Issue s with T attoo and PMU Ink -

T he AF DO T atto o I nk and Pe rmane nt Make up L ab e ling Guide line s

2019 CE HA Annua l E duc a tion Confe re nc e Ke ystone , Colora do L a ure l Arrig o na Re g ula to ry, Ce utic a l L a b s AF DO BAC, Cha ir BAEA, Cha ir NE HA BAMC, Co mmitte e Me mb e r Jo di Zimme rma n E nviro nme nta l He a lth Spe c ia list II , E l Pa so Co unty Pub lic He a lth BAEA, Co mmitte e Me mb e r AF DO BAC, Co mmitte e Me mb e r

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SLIDE 2

As You Know -

T attooing is on the Rise

  • 2015 Ha rris Po ll sho we d tha t

a b o ut 29% o f Ame ric a ns ha ve a t le a st o ne ta tto o .

  • T

a tto o s a re mo re pre va le nt a mo ng yo ung e r Ame ric a ns, with ne a rly 50% o f mille nnia ls.

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SLIDE 3

T a ttooing a nd PMU Pr

  • c e dur

e s

Pra c tic e o f T a tto o ing a nd PMU Pro c e dure s

  • T

he pra c tic e o f ta tto o ing a nd PMU pro c e d ure s a re re g ula te d b y State and

L

  • c al jur

isdic tions, fo c using o n sa fe

pra c tic e s a t the ta tto o pa rlo rs a nd sa lo ns.

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SLIDE 4

In the Shop -

T a ttooing Re g ula tions Ac r

  • ss the Countr

y

► So me sta te s ha ve re g ula tio ns fo r e ntire sta te ► So me sta te s ha ve re g ula tio ns pe r c o unty o r c ity ► So me sta te s ha ve vo lunta ry pro g ra ms

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SLIDE 5

Pr

  • ble ms with the Cur

r e nt Shop Re gulations

► Co nsiste nc y ► I

nspe c tio ns a nd pra c tic e s within o ne jurisdic tio n

► I

nspe c tio ns a nd pra c tic e s within o ne sta te

► I

nspe c tio ns a nd pra c tic e s a c ro ss the c o untry

► E

duc a tio n re q uire me nts

► L

ic e nsing Re q uire me nts Ca use s

► Co nfusio n ► Adve rsia l re la tio ns b e twe e n industry a nd re g ula to rs ► I

nc o nsiste nt sho p inspe c tio ns

► Risk to a rtist a nd the pub lic

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SLIDE 6

F DA Re g ula te s T a ttoo Ink a nd PMU

Co sme tic s

  • Any pr
  • duc t inte nde d to be applie d to the human body for

c le ansing, be autifying, pr

  • moting attr

ac tive ne ss, or alte r ing the appe ar anc e . (F D&C Ac t, se c . 201(i))

Co lo r Additive

  • "a mate r

ial whic h ... is a dye , pigme nt, or

  • the r

substanc e made by a pr

  • c e ss of synthe sis or

similar ar tific e , or e xtr ac te d, isolate d,

  • r
  • the r

wise de r ive d, with or without inte r me diate or final c hange

  • f ide ntity, fr
  • m a ve ge table , animal, mine r

al, or

  • the r

sour c e , and ... [that] whe n adde d or applie d to a food, dr ug, or c osme tic ,

  • r

to the human body or any par t the r e of, is c apable (alone or thr

  • ugh r

e ac tion with [an]othe r substanc e ) of impar ting c olor the r e to ... T he te r m 'c olor ' inc lude s blac k, white , and inte r me diate gr ays..." (F D&C Ac t, se c . 201(t))

T a tto o I nks

  • “T

attoo inks” so ld a nd use d in the US a re c o nside re d a s

“Co sme tic s” c o nta ining “Co lo r Additive s”. As suc h the y fa ll unde r

F DA jur isdic tion.

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SLIDE 7

Pr

  • ble ms with the Pr
  • duc t Re gulations

► Ma ny in industry a rg ue a g a inst the c o sme tic re g s b e ing a pplie d to ta tto o ink a nd

PMU.

► No ne o f the c o lo r a dditive s a re a ppro ve d fo r the use . ► Histo ric a lly the re ha s b e e n little re g ula to ry a c tio n. ► Co nfusio n in industry a nd the pub lic ► I

f no t a s a c o sme tic , ho w sho uld ta tto o ink a nd PMU b e c la ssifie d?

► BAM 23 spe c s

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SLIDE 8

Ac knowle dg e me nt

  • T

he F DA Offic e o f Co sme tic s a nd Co lo rs ha ve g ive n the AF DO Bo dy Art Co mmitte e pe rmissio n to c o mmunic a te the info rma tio n the y pre se nte d a t the AF DO Annua l E duc a tio n Co nfe re nc e o f 2019.

  • T

he finding s pre se nte d b y F DA we re the re sult o f inspe c tio ns o f distrib uto rs a nd ma nufa c ture rs, ro utine surve ys o f ta tto o inks, a nd the sub se q ue nt mic ro b io lo g ic a l a na lysis o f ta tto o ink a va ila b le o n the Unite d Sta te s ma rke t.

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SLIDE 9

Adve r se E ve nts Re por te d to F DA fr

  • m 2004- 2016

► 363 fro m 2004-2016 ► So me re po rts re sulte d in

vo lunta ry re c a ll o f inks

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SLIDE 10

T a ttoo Ink a nd Pe rma ne nt Ma ke up Re c a lls, 2003- 2015

Br a nd Color Ink T ype Ye a r

  • f

Re c a ll Issue s Sour c e of Issue s

1 All Co lo rs PMU 2003, 2004 Alle rg ic Be nzimid a zo lo ne wa s susp e c te d a s a c a use

  • f a lle rg ic re a c tio n b ut no t c o nfirme d

2 Bla c k T a tto o 2004 Mic ro Pse ud o mo na s a e rug ino sa Mo ld : Ac re mo nium sp p . 3 Bla c k T a tto o 2011 Mic ro NT M: Myc o b a c te rium a b sc e ssus, M. c he lo na e 4 Gre y wa she s T a tto o 2012 Mic ro NT M: Myc o b a c te rium c he lo na e 5 Bla c k T a tto o 2014 Mic ro No c a rd ia . fa rc inic a a nd No c a rd ia sp p . 6 All c o lo rs T a tto o 2014 Mic ro Multip le Mic ro b e s: Sp hing o mo na s p a uc imo b ilis, Ba c illus sp p . 7 Gre y wa she s T a tto o 2015 Mic ro NT M: M. c he lo na e , Mo ld : Pe nic illium sp p ., a nd Cryp to c o c c us a lb id us

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SLIDE 11

Case Re por t: T attoo- Assoc iate d Nontube r c ulosis Myc obac te r ial Skin Infe c tions – 2011- 2012

► Oc t 2011 – A p e rso n (Ro c he ste r, Ne w Yo rk), p re se nte d with a p e rsiste nt

p a p ula r ra sh b e g inning 1 we e k a fte r b e ing ta tto o e d

► Ja n 2012 – T

he Mo nro e Co unty De p t. o f Pub lic He a lth (NY) inve stig a te d a n o utb re a k:

► M. c he lo na e wa s iso la te d fro m a skin b io psy ► 14 c o nfirme d with M. c he lo na e o ut o f a to ta l o f 19 infe c tio ns ► Co mpa ny A pre dilute d g ra y ink wa s use d ► M. c he lo na e wa s iso la te d fro m tissue spe c ime n, o ne o pe ne d a nd o ne

uno pe ne d b o ttle o f c o mpa ny A pre dilute d g ra y ink (indisting uisha b le )

► Wa te r a nd e nviro nme nta l sa mple s: ne g a tive fo r M. c he lo na e

► F

e b 2012 – CDC d isse mina te d a n E p i-X p ub lic he a lth a le rt:

► Ide ntifie d a dditio na l ta tto o -a sso c ia te d NT

M skin infe c tio ns fro m thre e sta te s (Wa shing to n, Io wa , a nd Co lo ra do )

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SLIDE 12

Nontube r c ulous Myc oba c te r ium (NT M)

► NT

M sp e c ie s (e .g . M. a b sc e ssus a nd M. c he lo na e )

► E

nviro nme nta l myc o b a c te rium (fo und in wa te r)

► NT

M c o nta mina tio n c a n o c c ur:

► During the ink ma nufa c turing pro c e ss a s a re sult o f using c o nta mina te d ra w ma te ria ls ► As a re sult o f dilutio n o f inks with no n-ste rile wa te r b y the ta tto o a rtist b e fo re use

► T

a tto o -a sso c ia te d NT M infe c tio ns

► Ra ng e fro m mild infla mma tio n to se ve re a b sc e sse s re q uiring e xte nsive a nd multiple surg ic a l

de b ride me nt

► Diffic ult to tre a t a nd c a n re q uire a minimum o f 4 mo nths o f tre a tme nt with a c o mb ina tio n o f two o r

mo re a ntib io tic s

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SLIDE 13

F DA’s T a ttoo Ink & Pe r ma ne nt Ma ke up Re se a r c h

► Co nduc te d multiple surve ys o f ta tto o a nd pe rma ne nt ma ke up inks

  • n the US ma rke t.

► NCT

R de ve lo pe d e ffe c tive de te c tio n me tho do lo g ie s fo r mic ro b ia l c o nta mina tio n o f ta tto o a nd pe rma ne nt ma ke up inks.

► T

his re se a rc h is pub lic ly a va ila b le .

► Pub lishe d in the Jo urna l o f Applie d Mic ro b io lo g y Ja nua ry 2018. ► “Mic ro b io lo g ic a l surve y o f c o mme rc ia l ta tto o a nd pe rma ne nt

ma ke up inks a va ila b le in the Unite d Sta te s”

Sur ve ys Ide ntify Pr

  • ble ms

Ac tion: Inspe c tions & Re c alls

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SLIDE 14

F DA’s T a ttoo Ink Sur ve y Re sults

Ye a r s / L a b Numbe r

  • f

Sa mple s Numbe r Positive BAM 23* Non- Complia nt

2013-2015, priva te 75 32 (43%) 12 (16%) 2015-2017, F DA 85 42 (49%) 16 (18%) 2017-2018, F DA 41 18 (44%) 10 (24%) T

  • ta l

201 92 (46%) 38 (19%) *Sa mple s we re e va lua te d fo llo wing Ba c te rio lo g ic a l Ana lytic a l Ma nua l, Cha pte r 23

  • BAM 23 Microbiological Methods for Cosmetics

○

E ye -a re a pro duc ts, no g re a te r tha n 500 CF U/ g

○

No n-e ye -a re a pro duc ts, no g re a te r tha n 1000 CF U/ g

Sur ve ys

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SLIDE 15

Wha t Wa s L e a r ne d F r

  • m the Sur

ve ys

► Muc h o f the ta tto o a nd PMU inks a va ila b le in the US tha t

we re a sse sse d we re c o nta mina te d with Mic ro .

► So me ha d hig h le ve ls o f mic ro o rg a nisms, mo re tha n 1000

CF U/ mL (CF U/ g ) (e .g ., 16 o ut o f 42 c o nta mina te d ta tto o inks).

► So me we re o ppo rtunistic huma n pa tho g e ns.

► Hig he r risk fo r pe o ple with we a ke ne d immune syste ms Ide ntify Pr

  • ble ms
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SLIDE 16

F DA Ac tion: T attoo Inspe c tion and Sampling

► F

  • c use d o n firms ide ntifie d during re c a ll

inve stig a tio ns

► 12 firms inspe c te d ► 61 sa mple s te ste d ► 31 sa mple s po sitive (51%) ► 7 o f 31 sa mple s re sulte d in the ne e d fo r a

vo lunta ry re c a ll (23%)

Ac tion: Inspe c tions & Re c alls

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SLIDE 17

T a ttoo Ink Re c a lls 2017-2019

Brand L

  • c ation

Re c all Initiation Date Colors Issue s Sourc e of Issue s

1 T X 11/ 14/ 2017 Blue , Gre e n, Ora ng e , Purp le Mic ro Multip le Mic ro o rg a nisms 2 CA 12/ 12/ 2017 L ining Bla c k Mic ro Ba c illus a ltitud inis, Pa e nib a c illus sp p . 3 F L 5/ 15/ 2018 Ora ng e Mic ro Ba c illus p umilus a nd Ba c illus lic he nifo rmis 4 NJ 6/ 26/ 2018 Re d , Blue Mic ro Ba c illus ha lo sa c c ha ro vo ra ns, Bra c hyb a c te rium c o ng lo me ra tum, Pse ud o mo na s a nd e rso nii, P. b a le a ric a 5 MI 9/ 25/ 2018 Re d , Blue Mic ro Ba c illus c o hnii, Pse ud o mo na s a nd e rso nii, L ysinib a c illus fusifo rmis 6 NY 2/ 22/ 2019 Bla c k Mic ro Pse ud o mo na s a e rug ino sa , Bre vib a c illus c ha shine nsis, Clo strid ium b utyric um/ c lo strid io fo rme , o the rs 7 F L 3/ 12/ 2019 Bla c k Mic ro Ba c illus c e re us 8 F L 3/ 20/ 2019 Re d Mic ro Clo stridium c lo stridio fo rme , C. ramo sum & Clo stridium spp., o the rs

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SLIDE 18

F DA Inspe c tion Conc lusions

► Ind ustry is no t a d d re ssing c o nta mina tio n issue s ► ”Ste riliza tio n” no t va lid a te d o r c o ntro lle d ► Ga mma le ve ls use d o nly le tha l to ve g e ta tive b a c te ria ,

no t spo re s

► A sta nd a rd fo r ta tto o ink ste riliza tio n is ne e d e d

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SLIDE 19

“Ste r ile ” T a ttoo Ink

► 31 sa mple s we re la b e le d “ste rile ” ► 15 ta tto o inks la b e le d a s “ste rile ” we re fo und to c o nta in

mic ro o rg a nisms (48%)

► Ma nufa c ture rs no t fo llo wing a va lid a te d pro c e d ure ► Va lid a te d pro c e d ure is no t c urre ntly re q uire d . ► Ste rility o f inks is no t c urre ntly re q uire d . ► If the pro d uc t is la b e le d a s “ste rile ,” it ne e d s to b e ste rile .

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SLIDE 20

Cur r e nt Situa tion

► Co nta mina tio n is fo und in a ll c o lo rs, no t just b la c k a nd g re ywa sh ► Hig h pla te c o unts o r pre se nc e o f kno wn pa tho g e ns is “a dulte ra tio n” ► Ste rility la b e ling a nd ste riliza tio n me tho ds a re a c o nc e rn ► I

nks la b e le d “ste rile ” b ut c o nta in mic ro o rg a nisms b e lo w BAM 23 limits a re misb ra nde d.

► I

f a pro duc t is la b e le d “ste rile ” it must b e fre e o f mic ro o rg a nisms

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SLIDE 21

Public He a lth Impa c ts of Sur ve ys

► Surve ys a re use d to he lp a sse ss pre va le nc e o f the c o nta mina te d inks o n

the US ma rke t.

► T

he surve y re sults pro vide sc ie ntific e vide nc e to de ve lo p po lic ie s.

► He lps F

DA unde rta ke a ppro pria te e nfo rc e me nt a c tivitie s in o rde r to re mo ve unsa fe pro duc ts fro m the ma rke t.

► Re c e nt ta tto o ink re c a lls pro te c t c o nsume rs fro m po te ntia lly se rio us

a dve rse e ve nts c a use d b y c o nta mina te d inks.

► F

DA’ s ta tto o ink surve ys a nd re g ula to ry a c tio ns inc re a se a wa re ne ss in the ta tto o a nd PMU industrie s a nd with the c o nsume rs a b o ut the risk.

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SLIDE 22

Safe ty

  • Additional , foc use d assignme nts
  • Monitor

ing Adve r se E ve nts

  • De te r

mine he alth e ffe c ts of e ndotoxin

Me thods

  • NT

M me thod (Multi-lab validation)

  • E

ndotoxin Assay

  • Ste r

ility te sting

Guide line s/ Polic ie s

  • Guidanc e for

Industr y

  • Polic y De ve lopme nt

Colla bora tion

  • Wor

king with L

  • c al/ State Jur

isdic tion

  • De ve lop ste r

ilization pr

  • toc ol for

tattoo ink with industr y/ AF DO

E duc ation

  • E

duc ation for tattoo ar tists, public , and he alth pr

  • fe ssionals

F DA’s F utur e Dir e c tion

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SLIDE 23

Safe ty

  • Monitor

ing and c ommunic ating adve r se e ve nts, r e c alls, pr

  • duc t spe c ific war

nings, he alth r isks

  • De te r

mine he alth e ffe c ts of pigme nts

Me thods

  • Standar

d Analytic al and Mic r

  • Me thodology for

pr

  • duc ts
  • Color

Additive Pe titions for Appr

  • val of Color

s for use

Guide line s/ Polic ie s

  • L

abe ling guide line s

  • Ste r

ilization standar d

  • Polic y De ve lopme nt
  • E

stablishme nt inspe c tion standar ds

Colla bora tion

  • Wor

king with L

  • c al/ State Jur

isdic tions

  • Wor

king with F DA

  • Wor

king with NE HA

  • Wor

king with Industr y

E duc ation

  • E

duc ation for tattoo ar tists, public , and he alth pr

  • fe ssionals

How Can the AF DO Body Ar t Committe e He lp?

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SLIDE 24

T a ttoo Ink a nd Pe r ma ne nt Ma ke - Up L a be ling Guide

► Pro vide s g uida nc e fo r industry, pro fe ssio na ls, a nd

re g ula to rs with c o mplia nc e to U.S. la ws a nd re la te d re g ula tio ns.

► Co nsiste nt la b e ling ► Whe re po ssib le use d e sta b lishe d industry

no me nc la ture

► Co nsiste nt with o the r c urre nt e sta b lishe d re g s - BAMC

► Pre se nts

► Info rma tio n re q uire d o n la b e ls pe r re g ula tio ns ► Sug g e ste d b e st pra c tic e s

► I

nc lude s a c he c klist

► Ava ila b le fo r fre e www.a fdo .o rg / pub lic a tio ns

► AF

DO Po dc a st

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SLIDE 25

► L

a b e l info re q uire d fo r sa fe use , re c a lls, a nd inve stig a tio ns.

► Ge ne ra l ► PDP Spe c s ► Pro duc t Ide ntity

► Co nspic uo us wa rning sta te me nt a b o ut

unsub sta ntia te d sa fe ty

► Ne t q ua ntity ► Ma te ria l fa c ts ► Wa rning s ► Ma nufa c ture r/ distrib uto r info ► Ing re die nts/ pro fe ssio na l use ► Dire c tio ns fo r sa fe use

T a ttoo Ink a nd Pe r ma ne nt Ma ke - Up L a be ling Guide

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SLIDE 26

► L

a b e l info sug g e ste d fo r sa fe use , re c a lls, a nd inve stig a tio ns.

► L

  • t/ b a tc h numb e rs

► Use b y da te ► Do no t dilute ► Sto ra g e a nd ha ndling info ► Alle rg y sta te me nts ► Pre g na nc y wa rning ► K

e e p o ut o f re a c h o f c hildre n

► Do no t re use ► Bro ke n se a l wa rning

T a ttoo Ink a nd Pe r ma ne nt Ma ke - Up L a be ling Guide

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SLIDE 27

Ho w c a n yo u g e t invo lve d?

► Asso c ia tio n o f F

  • o d a nd Drug Offic ia ls (AF

DO)

► Bo dy Art E

duc a tio n Allia nc e (BAEA)

► Na tio na l E

nviro nme nta l He a lth Asso c ia tio n (NE HA)

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SLIDE 28

AF DO Bo dy Art Co mmitte e

► Cha rg e s fo r the ye a r: ► Co lo r Ad ditive Pe titio n fo r T

ita nium Dio xide fo r Intra de rma l T a tto o ing

► Bo dy Art E

sta b lishme nt Inspe c tio n Guide a nd Che c klist

► T

a tto o Ink a nd PMU Ste riliza tio n Be st Pra c tic e s

► Syste m to a ssist in e xpe ditio us re spo nse to b o dy a rt

re la te d pub lic he a lth risks

► Guida nc e fo r Co nsume rs ► Ag e nda fo r 2020 AF

DO AE C

► Pho ne c a ll 2nd T

hursda y o f the mo nth

► Cha irs: ► K

C Ste ve nso n – kc ste ve nso n@ c e utic a lla b s.c o m

► L

a ure l Arrig o na – la rrig o na @ c e utic a lla b s.c o m

► Sa ra h Ro b b in – sa ra hro b b n1@ g ma il.c o m

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SLIDE 29

Bo dy Art E duc a tio n Allia nc e

► Co lla b o ra tio n b e twe e n AF

DO, NE HA, APP, APT , SPCP, CT S, F DA, a nd o the r industry a nd re g ula to ry g ro ups

► T

ra ining mo dule s fo r b o dy a rt e sta b lishme nts a nd re g ula to rs

► I

nspe c tio n Ba sic s o f Bo dy Art E sta b lishme nts

► Pho ne c a ll 3rd F

rida y o f e ve ry mo nth

► Cha irs: ► K

C Ste ve nso n – kc ste ve nso n@ c e utic a lla b s.c o m

► L

a ure l Arrig o na – la rrig o na @ c e utic a lla b s.c o m

► Ma tt Ba vo ug ia n –

m.b a vo ug ia n@ g ma il.c o m

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SLIDE 30

Bo dy Art E duc a tio n Allia nc e

Org a niza tio ns Re pre se nte d Sta te s a nd Co untrie s Re pre se nte d

AF DO AF DOSS NE HA MCAF DO APP GE HA APT NE HA (Ne br aska) SPCP CE HA (Color ado) CT S CE HA (Califor nia) F DA F E HA WAF DO ME HA (Montana) ME HA (Missour i) CCDE H BA T AC Alaska L

  • uisiana

Or e gon Califor nia Mic higan Pe nnsylvania Color ado Minne sota T e xas Conne c tic ut Missour i Washington F lor ida Montana We st Vir ginia Ge or gia Ne br aska Wisc onsin Illinois Ne w Je r se y Canada Iowa Ne w Yor k Kansas Ohio

E sta b lishe d in 2018 b y me mb e rs o f AF DO, NE HA, APP, APT , SPCP, CT S, F DA

slide-31
SLIDE 31

Que stions a nd Conc e r ns?

► L

a ure l Arrig o na

► la rrig o na @ c e utic a lla b s.c o m ► 972-241-8374 ► Jo di Zimme rma n ► jo dizimme rma n@ e lpa so c o .c o m ► 719-433-3685