~"
TheCommonwealth ofMassachusetts
Executive Office ofHealth andHuman Services
Department ofPublic Health
250Washington Street, Boston," MA02108-4619
CHARLES D.BAKER
GovernorMARYLOU SUDDERS
secretary
KARYN E.POLITO
Lieutenant GovernorMONICA BHAREL. MD. MPH
Commissioner
Tel:617-624-6000
www.mass.gov/dph
NOTICE OFPUBLIC HEARING
Notice ishereby given pursuant toM.G.L. c.30A,§2,thattheDepartment ofPublic Health will
holdapublic hearing ontheemergency promulgation of105CMR 801.000, Severe Lung
Disease Associated with Vaping Products.
Thisregulation is.adopted toaddress theGovernor's Declaration ofEmergency Detrimental to
thePublic Health made pursuant toM.G.L. c.17,§2A,andM.G.L. c.Ill,§§1-3,5, &6,dueto
'severe lungdisease associated withtheuseofe-cigarettes andvaping products inthe
Commonwealth. OnSeptember 24,2019, theCommissioner ofPublic Health" withapproval of
theGovernor andthePublic Health Council, issued Orders toeffectuate theDeclaration. This
regulation prohibits thesaleofvapingproducts intheComrrioriwealth andauthorizes astanding
order fornicotine replacement therapy.
Since theDeclaration, reports ofsuspected vaping-related disease inMassachusetts residents
haveincreased to204andthenumber ofconfirmed casesroseto20.There havebeentwo
fatalities fromvaping-related disease occurring intheCommonwealth. Todate,nospecific
vaping product hasbeenlinked toallcases.
Thisregulation waspromulgated asanemergency regulation because observance ofthe
requirements ofnotice andapublic hearing would becontrary tothepublic interest. Although
allreported cases ofsevere lungdisease associated withvaping products demonstrate ahistory .
ofvaping andahistory ofvaping products containing tetrahydrocannabinol, nicotine, ora
combination ofboth,thecause ofthedisease remains unknown. Todate,nospecific vaping
product, including therelated devices andliquids, orothersubstance, hasbeenidentified as
linked toallcases. Delayed implementation oftheregulations inorder tocomply withthe
requirements ofnotice andtoholdapublic hearing would result inadditional individuals
becoming sick,hospitalized andpotentially evendying fromvaping related pulmonary illness.
TheDepartment found thatimmediate adoption wasnecessary topreserve public health, safety,
orgeneral welfare, duetotheincreasing instances ofsevere lungdisease associated withtheuse . .
ofe-cigarettes .andvaping products intheCommonwealth. Asrequired byM.G.L. c.30A,§2,
theDepartment nowintends toholdapublic hearing regarding thisregulation.
Thepublic hearing willbeheldonFriday, November 22,2019, at10:30 AMinthePublic
Health Council Room, Second Floor, Department" ofPublic Health, 250Washington Street,
Boston, MA,20108.
38
Speakers arerequested toprovideacopy oftheiroraltestimony. TheDepartment encourages all
interested parties tosubmit testimony electronically tothefollowing address:
Reg.Testimony@state:ma.us. Please submit electronic testimony asanattached Word document
orastextwithin thebodyofanemail andtype"Vaping products regulation" inthesubject line.
Allsubmissions mustinclude thesender's fullname andaddress. TheDepartment willpostall
electronic testimony thatcomplies withtheseinstructions onitswebsite. Parties whoareunable
tosubmit electronic testimony should mailsubmissions toWilliam Anderson, Office ofthe
General Counsel, Department ofPublic Health, 250Washington Street, Boston, MA02108. All
written ororalcomments submitted totheDepartment maybeposted ontheDepartment's
website andreleased inresponse toarequest forpublic records. Alltestimony mustbe
submitted by5:00·p.m. onFriday, November 29,2019.
Acopyoftheproposed amendments maybeviewed ontheDepartment's website orobtained
fromtheOffice oftheGeneral Counsel at617-624-5220.
39
CMR No:105CMR 801
Estimate oftheNumber ofSmall Businesses Impacted bytheRegulation:
Thisregulation isadopted toaddress theGovernor's Declaration ofEmergency Detrimental tothePublic Health due
tosevere lungdisease associated withtheuseofe-cigarettes andvaping products intheCommonwealth andismade
pursuant toM.G.L. c.17,§2A,andM;G.L. c.111,§§1-3,5, &6.OnSeptember 24,2019, theCommissioner of
Public Health, withapproval oftheGovernor andthePublic Health Council, issued Orders toeffectuate the
Declaration. Thisregulation prohibits thesaleofvaping products intheCommonwealth andauthorizes astanding
order fornicotine replacement therapy.
Since theDeclaration, reports ofsuspected vaping-related disease inMassachusetts residents haveincreased to204
andthe'number ofconfirmed cases roseto20.There havebeentwofatalities fromvaping-related disease occurring in
theCommonwealth. Todate;nospecific vaping product hasbeenlinked toallcases.
Thisregulation waspromulgated asanemergency regulation because observance oftherequirements ofnotice anda
public hearing would becontrary tothepublic interest. Although allreported cases ofsevere lungdisease associated
withvaping products demonstrate ahistory ofvapingandahistory ofvapingproducts containing
tetrahydrocannabinol, nicotine, oracombination ofboth,thecause ofthedisease remains unknown. Todate,no
specific vaping product, including therelated devices andliquids, orother substance, hasbeenidentified aslinked to
allcases. Delayed implementation oftheregulations inordertocomply withtherequirements ofnotice andtoholda
public hearing would result inadditional individuals becoming sick,hospitalized andpotentially evendying from
vaping related pulmonary illness. TheDepartment found thatimmediate adoption wasnecessary topreserve public
health, safety.or general welfare, duetotheincreasing instances ofsevere lungdisease associated withtheuseofe-
cigarettes andvaping products intheCommonwealth. Asrequired byM.G.L. c.30A, §2,theDepartment nowintends
toholdapublic hearing regarding thi~regulation.
105CMR 801directly impacts anybusiness thatsellsordisplays vaping products inMassachusetts, including vaping
product retailers, convenience stores, gasstations, andmedical andretail marijuana dispensaries. Theemergency
regulation ~ayindirectly impact those businesses thatproduce ormanufacture vaping products and/or thecomponents
thereof, including cultivators, producers, manufacturers anddistributors. Notanoftheimpacted businesses meetthe
definition ofsmall business, noraretheynecessarily subject totheemergency regulation, found atG.L.c.30A,§
I(5A)and13.C.F.R. §121.201.
. .Inorder toascertain thenumber ofsmall businesses potentially subject totheemergency regulation, theDepartment
consulted theU.S.Small Business Administration'S online searchable database ofself-certified small businesses and
searched bythefollowing North American Industry Classification Systems codes:
453991 Tobacco Stores (zeroresults inMassachusetts)
445120 Convenience Stores (zero results inMassachusetts)
453998 AllOther Miscellaneous Retail Stores (except Tobacco Stores) (31results inMassachusetts) (note: theindex
ofNAICS liststhiscodewithreference toElectronic Cigarette Stores)
447110 Gasoline Stations withConvenience Stores (fiveresults inMassachusetts)
Searching theindex ofNAICS codes (2017) forthewords vapor, nicotine, cannabis, andhemp didnotidentify any
relevant codes.
Alternatively, theDepartment conducts apricing survey ofalltobacco retailers intheCommonwealth. Ofthose
tobacco retailers, approximately 4,000 report selling nicotine vapor products. Thesurvey doesnotcollect information
about thenumber ofemployees, andtherefore theDepartment isnotabletodetermine 'whether ornotthese retailers
meetthedefinition ofasmall business.
There arealsoapproximately 70entities intheCommonwealth withadultuselicenses fromtheCannabis Control
Commission, andapproximately 50entities withmedical uselicenses. Those numbers arenotexclusive, andincludes
licenses forcultivation andmanufacture aswellassale,sothose numbers include some entities notdirectly affected
bytheemergency regulation. TheDepartment doesnothaveinformation about thenumber ofemployees and
therefore isnotabletodetermine whether ornotthese businesses meetthedefinition ofasmall business.
Select YesorNoandBriefly Explain
Yes NoWillsmall businesses havetocreate, file,orissueadditional reports?
0 ~
Theemergency regulation doesnotinclude areporting requirement.
Yes NoWillsmall businesses havetoimplement additional recordkeeping procedures?
0 ~
Theemergency regulation doesnotinclude arecordkeeping requirement.
Yes NoWillsmall businesses havetoprovide additional administrative oversight?
0 ~
Theemergency regulation doesnotinclude arequirement thatsmall businesses willhavetoprovide
administrative oversight provision.
Yes NoWillsmall businesses havetohireadditional employees inorder tocomply withtheproposed
0 ~ regulation?
TheDepartment doesnotanticipate thatadditional employees willneedtobehired. Pursuant tothe
requirements G.L.c.30Ass.2,3,and5,and950CMR 20.04(2), theDepartment willfileanamended
regulation andanamended Small Business Impact Statement addressing thisquestion following receipt
.ofcomments, thepublic hearing scheduled forNovember 22,2019, andthesubsequent Public Health
Council meeting.
Yes NoDoes compliance withtheregulation require small businesses tohireother professionals (e.g.alawyer,
0 ~ accountant, engineer, etc.)?
TheDepartment doesnotanticipate thatsmall businesses willrequire professional services tocomply
withtheemergency regulation. Pursuant totherequirements G.L.c.30Ass.2,3,and5,and950CMR
20.04(2), theDepartment willfileanamended regulation andanamended Small Business Impact
Statement addressing thisquestion following receipt ofcomments, thepublic hearing scheduled for
November 22,2019, andthesubsequent Public Health Council meeting.
Yes NoDoes theregulation require small businesses topurchase aproduct ormake anyother capital
0 ~ investments inorder tocomply withtheregulation?
Theemergency regulation doesnotrequire thatsmall businesses purchase anyproduct ormake any
capital investments inorder tocomply withtheemergency regulation. Pursuant totherequirements
G.L.c.30Ass.2,3,and5,and950CMR 20.04(2), theDepartment willfileanamended regulation and
41
anamended Small Business Impact Statement addressing thisquestion following receipt ofcomments,
thepublic hearing scheduled forNovember 22,2019, andthesubsequent Public Health Council
meeting.
Yes :No Areperformance standards more appropriate thandesign/operational standards toaccomplish the
0 18I regulatory objective?
(Performance standards express requirements interms ofoutcomes, giving theregulated party
flexibility toachieve regulatory objectives anddesign/operational standards specify exactly what
actions regulated parties musttake.)
Thisquestion isnotapplicable asthisemergency regulation doesnotrequire design/operational
standards.
Yes No Doanyother regulations duplicate orconflict withtheproposed regulation?
0 18I
Apriorregulation oftheCannabis Control Commission (CCC), 935CMR 501.100(I)(c), stated that
registered marijuana dispensaries "must make vaporizers available forsaletoregistered qualifying
patients." However, thisprovision hasbeenremoved fromregulation filedbytheCCCwiththe
Secretary onOctober 18,2019, which willbecome effective onNovember 1,2019. See935CMR
50l.100 (version filedOct.18,2019).
Other CCCregulations filedwiththeSecretary onOctober 18,2019, permit incertain circumstances,
butdonotrequire, thesaleofvaporizers atmedical marijuana treatment centers (MTCs), andthe
teaching oftheuseofvaporizers atMTCs. 935CMR 501.105(19)(g), (h).
Accordingly, there isnoconflict between theCCCregulation andtheemergency regulation.
Yes No Does theregulation require small businesses tocooperate withaudits; inspections orothe!regulatory
18I 0enforcement activities?
Small businesses subject tothisemergency regulation mustcooperate withmunicipal board ofhealth or
Department ofPublic Health inspections.
Yes No Does theregulation require small businesses toprovide educational services tokeepuptodatewith
0 t8I regulatory requirements?
There isnorequirement intheemergency regulation foreducational services.
Yes No Is~eregulation likely todeter theformation ofsmall businesses inMassachusetts?
18I D.
Thisemergency regulation maydetertheformation ofsmall businesses thatintend tolimittheir
business exclusively orprimarily tothesaleordisplay forthepurpose ofselling vaping products while
theemergency regulation isineffect. Pursuant totherequirements G.L.c.30Ass.2,3,and5,and950
CMR 20.04(2), theDepartment willfileanamended regulation andanamended Small Business Impact
Statement addressing thisquestion following receipt ofcomments, thepublic hearing scheduled for
November 22,2019, andthesubsequent Public Health Council meeting.
Yes No Istheregulation likely toencourage theformation ofsmall businesses inMassachusetts?
0 t8I
TheDepartment doesnotanticipate thattheemergency regulation willencourage theformation of
42
small businesses inMassachusetts. Pursuant totherequirements G.L.c.30Ass.2,3,and5,and950
CMR 20.04(2), theDepartment willfileanamended regulation andanamended Small Business Impact
Statement addressing thisquestion following receipt ofcomments, thepublic hearing scheduled for
November 22,2019, andthesubsequent Public Health Council meeting.
Yes No Does theregulation provide forlessstringent compliance orreporting requirements forsmall
0 181 businesses?
Theemergency regulation imposes atemporary banonthesaleanddisplay ofallvaping products; the
regulation imposes thesame compliance requirements onallbusinesses regardless ofsize. Itisnot
possible t~protect thepublic health. inanymanner thatislessstringent.
Yes No Does theregulation establish lessstringent schedules ordeadlines forcompliance orreporting
0 ~ requirements forsmall businesses?
Theemergency regulations impose atemporary banonthesaleanddisplay ofallvaping products; the
regulations impose thesame compliance requirements onallbusinesses regardless ofsize. Itisnot
possible toprotect thepublic health inanymanner thatislessstringent.
Yes No Didtheagency consolidate orsimplify compliance orreporting requirements forsmall businesses?
0 181
Theemergency regulations impose atemporary banonthesaleanddisplay ofallvaping products; the
regulations impose thesame compliance requirements onallbusinesses regardless ofsize. Itisnot
possible toprotect thepublic health inanymanner thatislessstringent.
Yes No Canperformance standards forsm~ll businesses replace design oroperational standards without
0 181 hindering delivery oftheregulatory objective? ..
Thisquestion isnotapplicable asthisemergency regulation doesnotestablish design oroperational
standards.
Yes No Aretherealternative regulatory methods thatwould minimize theadverse impact onsmall businesses?
0 181
Theemergency regulations impose atemporary banonthesaleanddisplay ofallvaping products; the
regulations impose thesame compliance requirements onanbusinesses regardless ofsize. Itisnot
possible to'protect thepublic health inanymanner thatislessstringent.
43