NOTICES OF PROPOSED RULES DAR File No. 40207
INTERESTED PERSONS MAY PRESENT THEIR VIEWS ON  
THIS RULE BY SUBMITTING WRITTEN COMMENTS NO  
LATER THAN AT 5:00 PM ON 03/31/2016
THIS RULE MAY BECOME EFFECTIVE ON:  04/07/2016
AUTHORIZED BY:  Bryce Bird, Director
R307.  Environmental Quality, Air Quality.
R307-841.   Residential  Property  and  Child-Occupied  Facility  
Renovation.
R307-841-8.   Renovator  Certification  and  Dust  Sampling  
Technician Certification.
(1)  Renovator certification and dust sampling technician  
certification.
(a)   To  become  a  certified  renovator  or  certified  dust  
sampling  technician,  an  individual  must  successfully  complete  an  
initial lead-based paint renovator or dust-sampling technician course  
accredited by the director under R307-842-1, the EPA under 40 CFR  
745.225, or a state or tribal program that has been authorized by EPA  
pursuant to subpart Q of 40 CFR 745.
(b)   Individuals  who  have  successfully  completed  an  
accredited abatement worker or supervisor course, or individuals who  
have successfully completed a director,  EPA, HUD,  or EPA/HUD  
model renovation training course before October 4, 2011, but no later  
than  the  training  course  expiration  date  found  on  that  training  
certificate, may take an accredited refresher renovator training course  
in lieu of the initial renovator training course to become a certified  
renovator.
(c)   Individuals  who  have  successfully  completed  an  
accredited lead-based paint inspector or risk assessor course before  
October 4, 2011, but no later than the training course expiration date  
found on that training certificate, may take an accredited refresher dust  
sampling technician course in lieu of the initial training to become a  
certified  dust  sampling  technician.   Individuals  who  are  currently  
certified as lead-based paint inspectors or risk assessors may act as  
certified dust sampling technicians without further training.
(d)  To maintain renovator certification or dust sampling  
technician certification, an individual must complete a renovator or  
dust sampling technician refresher course accredited by the director  
under R307-842-1, the EPA under 40 CFR 745.225, or by a state or  
tribal program that is authorized under subpart Q of 40 CFR 745  
within 5 years of the date the individual completed the initial course  
described in paragraph (1)(a) of this section.  If the individual does not  
complete a refresher course within this time, the individual must re-
take the initial course to become certified again.   Individuals who 
complete a renovator course accredited by the director under R307-
842-1, the EPA or an EPA authorized program on or before March 31,  
2010, must complete a renovator refresher course accredited by the  
director under R307-842-1, the EPA or an EPA authorized program on  
or  before  March  31,  2016,  to  maintain  renovator  certification.  
Individuals  who  completed  a  renovator  course  accredited  by  the  
director under R307-842-1, the EPA or an EPA authorized program  
between April 1, 2010 and March 31, 2011, will have one year added  
to their original 5-year certification.   
(2)  Renovator  responsibilities.   Certified  renovators  are  
responsible  for  ensuring  compliance  with  R307-841-5  at  all  
renovations to which they are assigned.  A certified renovator:(a)  Must perform all of the tasks described in R307-841-
5(2) and must either perform or direct workers who perform all of the  
tasks described in R307-841-5(1);
(b)  Must provide training to workers on the work practices  
required by R307-841-5(1) that they will be using in performing their  
assigned tasks;
(c)  Must be physically present at the work site when the  
signs required by R307-841-5(1)(a) are posted, while the work area  
containment required by R307-841-5(1)(b) is being established, and  
while  the  work  area  cleaning  required  by  R307-841-5(1)(e)  is  
performed;
(d)  Must regularly direct work being performed by other  
individuals to ensure that the work practices required by R307-841-
5(1) are being followed, including maintaining the integrity of the  
containment barriers and ensuring that dust or debris does not spread  
beyond the work area;
(e)  Must be available, either on-site or by telephone, at all  
times that renovations are being conducted;
(f)  When requested by the party contracting for renovation  
services,  must  use  an  acceptable  test  kit  to  determine  whether  
components to be affected by the renovation contain lead-based paint;
(g)  Must have with them at the work site their current Utah  
Lead-Based Paint Renovator certification card; and
(h)  Must prepare the records required by R307-841-6(2)(a)
(ii), (iii), and (f).
(3)   Dust  sampling  technician  responsibilities.   When  
performing optional dust clearance sampling under R307-841-5(3), a  
certified dust sampling technician:
(a)  Must collect dust samples in accordance with R307-842-
3(5)(h), must send the collected samples to a laboratory recognized by  
EPA under TSCA Section 405(b), and must compare the results to the  
clearance levels in accordance with R307-842-3(5)(h); and
(b)  Must have with them at the work site their current Utah  
Lead-Based Paint Dust Sampling Technician certification card.
KEY:  paint, lead-based paint, lead-based paint renovation
Date of Enactment or Last Substantive Amendment:  [ May 3, 
2012]2016  
Notice of Continuation:  February 5, 2015
Authorizing, and Implemented or Interpreted Law:  19-2-104(1)(i)
Health, Disease Control and  
Prevention, Health Promotion
R384-415
Electronic-Cigarette Substance  
Standards
NOTICE OF PROPOSED RULE
(Amendment)
DAR FILE NO.:  40210
FILED:  02/16/2016
RULE ANALYSIS
PURPOSE  OF  THE  RULE  OR  REASON  FOR  THE  
CHANGE:   The  amendments  are  intended  to  clarify  
8 UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5DAR File No. 40210 NOTICES OF PROPOSED RULES
requirements of the rule and also to alleviate some of the  
fiscal  burden  the  rule  could  impose  on  Utah  small  
businesses.
SUMMARY OF THE RULE OR CHANGE:  Under Section  
R384-415-10,  a  provision  has  been  clarified  to  read  that  
retailers will be expected to have access to the documents in  
that  section  for  a  period  of  two  years  after  the  retailer  
purchases the electronic-cigarette substance.  The required  
size of the safety warning statement has been reduced from  
30 percent of the principle display panel to 20 percent.  Also,  
the  maximum  allowed  nicotine  content  for  these  products  
have been increased from 240mg per container to 360mg.  
However,  the  maximum  nicotine  concentration  has  stayed  
that same at 24mg/mL.  Language has been added to the  
provision requiring child resistant packaging on all electronic-
cigarette substance containers.  The new language makes  
reference  to any federal  standards  that might  be  put  into  
place.  This addition has been made to recognize the recently  
signed  "Child  Nicotine  Poisoning  Prevention  Act"  at  the  
federal level.  Finally, nonsubstantive grammatical changes  
have been made.
STATUTORY OR CONSTITUTIONAL AUTHORIZATION FOR  
THIS  RULE:   Section  26-57-103  and  Subsection  59-14-
803(5)
ANTICIPATED COST OR SAVINGS TO:
♦ THE STATE BUDGET:  The amendments to the rule will not  
change  the  implementation  of  enforcement  by  the  Utah  
Department  of  Health  (UDOH).   The  same  enforcement  
apparatus and cost that was to be used for the original rule  
will  accommodate  these  amendments.   As  such,  UDOH  
expects to experience no additional costs or savings.  The  
original rule anticipated that there would be savings to the  
state by reducing the number of calls to the Utah Poison  
Control Center.  In 2014, there were 131 poison control calls  
in  Utah  associated  with  electronic-cigarette  substances.  
Each  of  these  calls  cost  the  state  approximately  $65.  
However, amendments to the rule that increase the allowed  
nicotine  per  container  and  reduce  the  size  of  the  safety  
warning statement could reduce the positive effects of this  
rule.  Therefore, compared to original rule, this amendment  
may reduce the savings to the state due to an increase in  
poison  control  calls.   However  it  is  difficult  to  provide  a  
specific  amount.   Also,  because  the  amendments  may  
increase the number of poisonings (compared to the original  
rule)  there  may  also  be  a  reduced  savings  to  the  Utah  
Medicaid  Program.   Poisonings  among  Medicaid-covered  
individuals  would  increase  medical  bills.   It  has  been  
estimated  that  the medical costs  associated  with  a  single  
poisoning is $15,000 for in-hospital treatment and $3,000 for  
an emergency room visit.  Though UDOH cannot determine  
the number of electronic-cigarette related poisoning among  
Medicaid patients (and thus the total savings), it is expected  
that by increasing the allowed nicotine content and reducing  
the size of the warning statement that there would be reduced  
savings to Medicaid.  Since the amendments will be made  
before enforcement of the rule, there will be no noticeable  cost to state agencies and the overall net effect will likely be  
savings.  However, the amended rule does reflect a potential  
opportunity cost when compared to the original language in  
the  rule.   (DAR NOTE:  The  original  proposed  new Rule  
R384-415 was published in the October 15, 2015, Bulletin  
under DAR No. 39797 and is effective as of 12/29/2015.)
♦ LOCAL GOVERNMENTS:  The amendments to the rule will  
not change the implementation of  enforcement by UDOH.  
The same enforcement apparatus and cost that was to be  
used  for  the  original  rule  will  accommodate  these  
amendments.  As such, no additional costs or savings are  
anticipated.
♦  SMALL  BUSINESSES:   UDOH  anticipates  that  small  
businesses  will  experience  reduced  costs  because  of  the  
amendments  to  the  rule.   Industry  representatives  have  
estimated  that the amended rule  will  cost small specialty-
businesses  $12,500 to $1,600,000  during the first year  of  
enforcement  due  to  either  a  loss  in  sales  or  required  
improvements to their operations.  However, representatives  
have also estimated that these amendments have reduced  
the cost of compliance by $1,500 to $160,000.  UDOH cannot  
estimate cost or savings to the industry as a whole because  
the number of small specialty-businesses is unknown.  The  
wide range in the cost estimate perhaps reflects the large  
variability in product quality that exists in the industry.  Much  
of  the  responsibility  to  comply  with  the  rule  will  fall  on  
manufacturers  who  sell  to  Utah  retailers.   Industry  
representatives estimate that the amended rule will cost a  
Utah small-manufacturer approximately $15,500 to $266,000  
over the first year of enforcement.  However, representatives  
also have estimated that the amendments to increase the  
allowed nicotine content and decrease the size of the safety  
warning  statement  have  reduced  the  cost  to  comply  by  
$17,000  to  $35,000.   UDOH  cannot  estimate  the  cost  or  
savings to the industry as a whole because the number of  
small manufacturers is unknown.  The manufacturer could  
also face non-fiscal costs.  Prescribing manufacturer labeling  
requirements may be perceived as an infringement of the  
manufacturer's freedom of speech.  Also, the manufacturer  
may  face  a  perceived  infringement  on  their  intellectual  
property if product information is requested by the enforcing  
agency.  These perceived non-fiscal costs may be somewhat  
alleviated by the amendments.  The small specialty-retailer  
will also face costs and savings because of the rule.  Industry  
representatives estimate that the amended rule will cost a  
small specialty-retailer approximately $46,350 to $1,600,000  
during the first year of enforcement due largely to a loss in  
sales.  This cost estimate is based on the assumption that  
consumers would not purchase an alternative product if their  
selection of products was limited.  The small specialty-retailer  
may incur come small costs to educate staff on compliance  
with the rule.  It is not possible to predict these costs due to  
varying circumstances, but to reduce this burden the state  
and local health department will provide support.  However,  
representatives also estimate that the amendments allowing  
for a higher nicotine content and smaller warning statements  
have reduced the cost to comply by $1,500 to $160,000.  The  
amendments will allow retailers to keep more of their current  
products on the market, hence reducing the potential loss in  
UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5 9NOTICES OF PROPOSED RULES DAR File No. 40210
sales and the potential of local fines.  UDOH cannot estimate  
the cost and savings to the industry as a whole because the  
number  of  small  specialty-businesses  is  unknown.   It  is  
expected  that  small  general-retailers  will  incur  little  cost  
through  the  enforcement  of  the  rule.   General  retailers  
typically  sell  manufacturer-sealed  electronic-cigarette  
substances,  which  are  exempt  from  the  rule.   General  
retailers may experience some cost through educating staff  
on  the  rule  or  through  incurring  local  enforcement  fines.  
However, because the number of small general-retailers who  
sell these products is unknown, UDOH cannot estimate the  
total cost they will incur.
♦  PERSONS  OTHER  THAN  SMALL  BUSINESSES,  
BUSINESSES,  OR  LOCAL  GOVERNMENTAL  ENTITIES:  
These amendments will decrease the cost of compliance to  
businesses in the state.  Those savings can be passed on to  
consumers  in  the  price  of  electronic  cigarette  products.  
UDOH cannot estimate the total savings to the consumer due  
to varying circumstances of the individual retailers.  However,  
the amendment to increase the allowed amount of nicotine  
and decrease the required warning statement may impose  
costs on other members of the public.  The average medical  
bill associated with a poisoning is approximately $15,000 for  
inpatient treatment and $3,000 in emergency room fees.  The  
cost  of  a  poisoning  in  terms  of  lost  productivity  is  
approximately  $2,600  per  poisoning  if  the  victim  is  
hospitalized.  It is difficult to estimate a population level cost.  
There  is  evidence  that  suggests  that  electronic-cigarettes  
among youth may be connected to using traditional tobacco.  
If this is the case, the amendments of the rule may increase  
future  tobacco-related  medical  costs.   The  Centers  for  
Disease Control and Prevention has estimated that in Utah,  
residents  as  a  whole  experience  $542,000,000  annually  
because  of  tobacco  products.   General  retailers  may  
experience some cost through educating staff on the rule or  
through incurring local enforcement fines.  However, because  
the number of general retailers who sell these products is  
unknown, UDOH cannot estimate the total cost they will incur.
COMPLIANCE COSTS FOR AFFECTED PERSONS:  UDOH  
has sought comment from representatives in the electronic-
cigarette industry.  It is estimated that an individual small-
manufacturer will incur approximately $15,500 to $266,000 in  
compliance costs during the first year of rule enforcement.  It  
is expected that the majority of these costs will come from  
redesigning  labels, and sales  lost through limiting nicotine  
content.  Therefore, this industry estimate is based on the  
assumption  that  the  consumer  would  not  purchase  an  
alternate product if their selection was restricted.  The small-
specialty  retailer  will  also  incur  compliance  costs.   It  is  
estimated that a single, small specialty-retailer will need to  
pay approximately $46,400 to $1,600,000 to comply with the  
rule.  It is expected that the majority of these costs will come  
from sales lost through not being able to sell products from  
out-of-state that don’t comply with the rule.  However, this  
industry cost estimate is based on the assumption that the  
consumer would not purchase an alternate product if their  
selection was restricted.  It is expected that general retailers  
will incur little compliance cost because the majority of the  products  they  sell  are  exempt  from  the  rule.   The  small  
portion of general retailers that will come under regulation  
may experience:  1) a negligible loss in sales; 2) some cost  
through educating staff; and 3) potential fines through local  
enforcement.   However,  because  the  number  of  general  
retailers who sell these products is unknown, UDOH cannot  
estimate what individual compliance cost they will incur.
COMMENTS  BY  THE  DEPARTMENT  HEAD  ON  THE  
FISCAL IMPACT THE RULE MAY HAVE ON BUSINESSES:  
The  proposed  amendment  clarifies  Subsection  R384-415-
10(a)  that  retailers  will  be  expected  to  retain  the  records  
required in that section for two years after the purchase of the  
e-cigarette substance.  It also reduces the size of the safety  
warning statement from 30 percent of the display panel to 20  
percent and increase the maximum allowed nicotine content  
from 240mg per container to 360mg per container.  Business  
will  see  a  positive  fiscal  impact  because  the  proposed  
amendment reduces a business's cost of compliance to this  
rule.
THE  FULL TEXT  OF  THIS  RULE  MAY BE  INSPECTED,  
DURING REGULAR BUSINESS HOURS, AT:
HEALTH
DISEASE CONTROL AND PREVENTION,
HEALTH PROMOTION
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY , UT 84116-3231
or at the Division of Administrative Rules.
DIRECT QUESTIONS REGARDING THIS RULE TO:
♦ Luke Chalmers by phone at 801-538-6260, or by Internet E-
mail at tpcprules@utah.gov
INTERESTED PERSONS MAY PRESENT THEIR VIEWS ON  
THIS RULE BY SUBMITTING WRITTEN COMMENTS NO  
LATER THAN AT 5:00 PM ON 03/31/2016
THIS RULE MAY BECOME EFFECTIVE ON:  04/07/2016
AUTHORIZED BY:  Joseph Miner, MD, Executive Director
R384.  Disease Control and Prevention, Health Promotion.
R384-415.  Electronic-Cigarette Substance Standards.
R384-415-1.  Authority and Purpose.
(1)  This rule is authorized by Section 26-57-103 and  
Subsection 59-14-803(5).
(2)  This rule establishes standards for labeling, nicotine  
content,  packaging,  and  product  quality  for  electronic-cigarette  
substances for the regulation of electronic-cigarettes.
(3)  This rule does not apply to a manufacturer-sealed  
electronic-cigarette substance.
(4)  A product in compliance with this rule is not endorsed  
as safe.
R384-415-2.  Definitions.
As used in this rule:
10 UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5DAR File No. 40210 NOTICES OF PROPOSED RULES
(1)  "Artificial coloring" means the same as the term is  
defined in 21 C.F.R. 101.22(a)(4) (April 1, 2015) and as the term  
"color additive" is defined in 21 C.F.R 70.3(f) (April 1, 2015).
(2)  "Artificial flavoring" means the same as the term is  
defined in 21 C.F.R 101.22(a)(1) (April 1, 2015).
(3)  "Batch number" means the same as the term "lot  
number, control number, or batch number" is defined in 21 C.F.R.  
210.3(b)(11) (April 1, 2015).
(4)   "Business"  means  any  sole  proprietorship,  
partnership, joint venture, corporation, association, or other entity  
formed for profit or non-profit purposes.
(5)  "Child resistant" means the same as the term "special  
packaging" is defined in 16 C.F.R 1700.1(a)(4) (January 1, 2015)  
and is tested in accordance with the method described in 16 C.F.R.  
1700.20 (January 1, 2015).
(6)  "Department" means the Utah Department of Health.
(7)  "Electronic-cigarette" means the same as the term is  
defined in Subsections 26-38-2(1) and 59-14-802(2).
(8)  "Electronic-cigarette Product" means the same as the  
term is defined in Subsection 59-14-802(3).
(9)  "Electronic-cigarette substance" means the same as  
the term is defined in Subsection 59-14-802(4).
(10)  "EP standards" means the standards established for  
medicines by the European Pharmacopeia, the European equivalent  
of  the  United  States  Pharmacopeia.  The  EP  standards  define  
requirements  for  the  qualitative  and  quantitative  composition  of  
medicines,  and  the  tests  that  are  to  be  used  on  medicines,  
substances, and materials used in their production.
(11)  "Generally Recognized As Safe" means an United  
States Food and Drug Administration designation that a substance  
added  to  food  is  generally  recognized,  by qualified  experts,  as  
having been adequately shown to be safe under the conditions of its  
intended use, as found in 21 C.F.R. 170.30 (April 1, 2015). Such a  
substance  is  exempted  from the usual Federal  Food,  Drug,  and  
Cosmetic Act, 21 U.S.C. Sec. 301 et sq. (2013).
(12)  "Local health department" means the same as the  
term is defined in Subsection 26A-1-102(5).
(13)   "Manufacture"  means  the  same  as  the  term  is  
defined in Subsection 26-57-102(5).
(14)   "Manufacturer"  means  the  same  as  the  term  is  
defined in Subsection 26-57-102(6).
(15)  "Mg/mL" means milligrams per milliliter, a ratio for  
measuring  an  ingredient,  in  liquid  form,  where  accuracy  is  
measured in milligrams per milliliter, or a percentage equivalent.
(16)  "Natural flavoring" means the same as the term is  
defined in 21 C.F.R 101.22(a)(3) (April 1, 2015).
(17)  "Nicotine" means the same as the term is defined in  
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 387(12)  
(2013).
(18)  "Manufacturer-sealed electronic-cigarette substance"  
means the same as the term defined is in Subsection 26-57-102(6).
(19)  "Pharmaceutical" means a compound manufactured  
for use as a medicinal drug.
(20)  "Retailer" means any person who sells, offers for  
sale,  or  offers  to  exchange  for  any  form  of  consideration,  an  
electronic-cigarette  substance  to  a  consumer.  This  definition  is  
without regard to the quantity of an electronic-cigarette substance  
sold, offered for sale, exchanged, or offered for exchange.(21)   "Retailing"  means  involvement  in  any  of  the  
activities listed in Subsection R384-415-2(20).  This definition is  
without regard to the quantity of an electronic-cigarette substance  
sold, offered for sale, exchanged, or offered for exchange.
(22)  "Straight color" means a color additive approved for  
human consumption in food and drugs as listed in 21 C.F.R. 73.1  
through  21  C.F.R.  73.1991  (April  1,  2015),  21  C.F.R.  74.101  
through 21 C.F.R.  74.1711 (April 1,  2015),  and 21 C.F.R.  81.1  
(April 1, 2015), and includes substances as are permitted by the  
specifications for such color.
(23)   "Tamper-evident"  means  the  packaging  uses  an  
indicator or barrier to entry that is distinctive by design, or must  
employ an identifying characteristic.
(24)  "Transaction statement" means a statement, in paper  
or electronic form, which the manufacturer transferring ownership  
of the product certifies that the electronic-cigarette substance is in  
compliance with the standards in this rule.
(25)  "USFDA Food Standards" means the United States  
Food and Drug Administration's common designation for standards  
of identity, standards of quality, and standards of fill of container  
promulgated under the Federal Food, Drug & Cosmetics Act, 21  
U.S.C. Sec. 301 et seq. (2013)and as contained in 21 C.F.R. 130  
through 21 C.F.R. 169 (April 1, 2015).
(26)  "USP-NF standards" means the standards for drug  
products  established  by  the  United  States  Pharmacopeia  and  
National Formulary.  The USP-NF standards include standards for  
chemical  and  biological  drug  substances,  dosage  forms,  
compounded preparations, excipients, medical devices, and dietary  
supplements.
R384-415-3.  General Labeling.
(1)  The retailer shall ensure that a container holding an  
electronic-cigarette  substance  offered  for  sale  to  the  consumer  
conforms to the following labeling standards:
(a)  the label is smear resistant; and
(b)  the label clearly displays:
(i)  the nicotine content in mg/mL or percent by volume;
(ii)  the manufacturer name;
(iii)  the batch number;
(iv)  the ingredients, as required in Section R384-415-4;
(v)   a  tamper-evident  warning,  which  meets  the  
requirements of Section R384-415-5; and
(vi)  a safety warning, which meets the requirements of  
Section R384-415-6.
R384-415-4.  Labeling of Ingredients.
(1)  The retailer shall ensure that:
(a)  an ingredient of an electronic-cigarette substance is  
listed on the label of the container holding an electronic-cigarette  
substance, except as provided for in Subsection R384-415-4(1)(c)
(i).
(b)  An artificial coloring ingredient is listed on the label  
using  the  classification  system  that  best  applies.  Classification  
systems include:
(i)   Food,  Drug,  and  Cosmetic  color  designation  and  
number;
(ii)  Drug and Cosmetic color designation and number; or
UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5 11NOTICES OF PROPOSED RULES DAR File No. 40210
(iii)  the generic straight color name, if the artificial color  
is not classified under the systems found in Subsection R384-415-
4(1)(b)(i) or Subsection R384-415-4(1)(b)(ii).
(c)(i)   An  ingredient  included  in  the  manufacturer's  
proprietary mixture of flavorings is exempt from being listed on the  
label by name.
(ii)   An  ingredient  included  in  the  manufacturer's  
proprietary mixture of flavorings is listed on the label under the  
generic term of artificial flavoring, natural flavoring, or both.
R384-415-5.  Labeling of Tamper-Evident Warning.
(1)   The  retailer  shall  ensure  that  the  label  of  an  
electronic-cigarette  substance  displays  a  tamper-evident  warning  
alerting the consumer to the tamper-evident feature of the packaging
(2)   The  retailer  shall  ensure  that  the  tamper-evident  
warning:
(a)  is prominently displayed to consumers;
(b)  is placed on the label so that it would be unaffected if  
the tamper-evidence feature is removed; and
(c)  lists the type of tamper-evident feature used with the  
product.
R384-415-6.  Labeling of Safety Warning.
(1)  The retailer shall ensure that an electronic-cigarette  
substance offered for sale to the consumer features a safety warning  
stating  "nicotine  is  addictive  and  poisonous.  Keep  away  from  
children and pets".
(2)  The retailer shall ensure that the safety warning:
(a)  occupies at least [30]20 percent of the largest panel of  
the container and any additional immediate packaging;
(b)  is in capitalized letters;
(c)  has a font size that occupies the maximum amount of  
the area described in Subsection R384-415-6(2)(a);
(d)  uses the Helvetica, Arial, or Univers font; and
(e)  uses either a black font on a white background or a  
white font on a black background.
R384-415-7.  Nicotine Content.
(1)  The retailer shall comply with the following nicotine  
content standards regarding an electronic-cigarette substance sold to  
the consumer:
(a)   The  nicotine  content  for  an  electronic-cigarette  
substance is limited to [ 240]360 mg per container, and does not  
exceed a 24mg/mL concentration.
(b)   The  nicotine  level  for  an  electronic-cigarette  
substance is limited to a 10% variation in mg/mL above the content  
level indicated on the label.
(c)  An electronic-cigarette substance labeled 0 mg/mL or  
0% by volume contains no nicotine.
R384-415-8.  Packaging.
(1)  The retailer shall ensure that the packaging of an  
electronic-cigarette substance intended for sale to a consumer;
(a)   is  certified  as  child  resistant ,  and  compliant  with 
federal  standards  and  law  concerning  child  nicotine  poisoning  
prevention;
(b)  does not leak at the time of sale; and
(c)  utilizes a tamper-evident feature by means of one or  
more of the following:(i)  a bubble pack;
(ii)  a heat shrink band;
(iii)  a breakable cap; or
(iv)  an inner-seal.
R384-415-9.  Product Quality.
(1)   The  retailer  shall  ensure  that  an  ingredient  in  an  
electronic-cigarette  substance  is  compliant  with  either  USP-NF  
standards, EP standards, USFDA Food Standards, or is Generally  
Recognized As Safe at the time of sale.
(2)   The  retailer  shall  be  prohibited  from  selling  an  
electronic-cigarette substance that contains :
(a)  vitamins or other additives that create the impression  
that an electronic-cigarette substance has a health benefit or presents  
reduced health risks;
(b)  pharmaceuticals;
(c)  caffeine or taurine or other additives and stimulant  
compounds that are associated with energy and vitality;
(d)   illegal  or  controlled  substances  as  identified  in  
Section 58-37-3; and
(e)  additives having coloring properties for emissions.
R384-415-10.  Record Keeping and Testing.
(1)   The  retailer  shall  provide  the  electronic-cigarette  
substances transaction statement to the [ department]Department or 
the local health department within five working days of a request.  
The  retailer  shall  ensure  that  the  transaction  statement  includes  
manufacturer certifications that:
(a)   the  nicotine  content  of  an  electronic-cigarette  
substance is compliant with Section R384-415-7;
(b)  the packaging of an electronic cigarette-substance is  
child-resistant; and
(c)  an ingredient used in an electronic-cigarette substance  
meets the appropriate standard found in Section R384-415-9.
(2)(a)  The retailer shall have a system in place to trace  
production of an electronic-cigarette substance through the labeled  
batch number to the ingredients used in manufacturing.
(b)  The retailer shall provide documents produced from  
batch tracing to the enforcing agency within five working days of a  
request.
(c)  The retailer shall ensure that documents produced  
through batch tracing provide evidence in support of the electronic-
cigarette substances transaction statement.
(3)(a)  The  retailer  shall  [maintain]have  access  to the 
documents  described  in  Subsections  R384-415-10(1)  and  R384-
415-10(2) for a period of two years after the retailer purchases the  
electronic-cigarette substance.
                 (b)  the retailer shall provide the documents described in   
Subsections  R384-415-10(1)  and  R384-415-10-(2)  to  the  
Department or the local health department within 5 working days of  
a request.
R384-415-11.  Enforcement.
(1)  The [department]Department may enforce and seek 
penalties  for  the  violation  of  public  health  rules  including,  the  
standards for electronic cigarettes set forth in this rule as prescribed  
in Sections 26-23-1 through 26-23-10.
(2)   A local  health  department  may  enforce  and  seek  
penalties for the violation of the standards for electronic cigarettes  
12 UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5DAR File No. 40210 NOTICES OF PROPOSED RULES
set forth in this rule.  A local health department shall have authority  
to enforce and seek penalties for violations of public health law  
including this rule as is found in Sections 26-23-1 through 26-23-
10, 26A-1-108, 26A-1-114(1) and 26A-1-123.
(3)   The  [department]Department or  local  health 
department is responsible to make a determination as to if a person  
holding a Utah  State Tax Commission  license to  sell electronic  
cigarettes  has  violated  the  standards  of  this  rule.   If  the  
[department]Department or local health department makes such a  
determination  it shall notify the Utah  State Tax Commission  to  
revoke the person's license as provided in Subsection 59-14-803(5).
(4)  Administrative or civil enforcement of this rule by the  
[department]Department or  local  health  departments  does  not  
preclude criminal enforcement by a law enforcement agency and  
prosecution of any violation of the standards in this rule that can  
constitute a criminal offense under state law.
KEY:   electronic  cigarettes,  nicotine,  standards,  Electronic  
Cigarette Regulation Act
Date  of  Last  Substantive  Amendment:   [ December  29, 
2015]2016
Authorizing, and Implemented of Interpreted Law:  26-57-103;  
59-14-803(5)
Human Services, Child and Family  
Services
R512-42
Adoption by Relatives
NOTICE OF PROPOSED RULE
(Amendment)
DAR FILE NO.:  40195
FILED:  02/08/2016
RULE ANALYSIS
PURPOSE  OF  THE  RULE  OR  REASON  FOR  THE  
CHANGE:  The purpose of this rule modification is to bring  
the rule in line with current statute and practice.
SUMMARY OF THE RULE OR CHANGE:  This rule change  
is intended to make the rule technically correct with current  
practice.
STATUTORY OR CONSTITUTIONAL AUTHORIZATION FOR  
THIS RULE:  Section 62A-4a-102 and Section 78A-6-307 and  
Section 78B-6-102 and Section 78B-6-117 and Section 78B-
6-128 and Section 78B-6-133 and Section 78B-6-137
ANTICIPATED COST OR SAVINGS TO:
♦ THE STATE BUDGET:  There will be no increase in cost or  
savings to the state budget because these proposed changes  
do not increase workload that would require additional staff or  
other costs.
♦  LOCAL GOVERNMENTS:   Local  governments  have  no  
responsibility  for  services  offered  by  Child  and  Family  Services and are, therefore, not affected by this rule and will  
have no fiscal impact.
♦  SMALL  BUSINESSES:   Small  businesses  have  no  
responsibility  for  services  offered  by  Child  and  Family  
Services and are, therefore, not affected by this rule and will  
have no fiscal impact.
♦  PERSONS  OTHER  THAN  SMALL  BUSINESSES,  
BUSINESSES,  OR  LOCAL  GOVERNMENTAL  ENTITIES:  
There is no expected fiscal impact for "persons other than  
small businesses, businesses, or local government entities"  
because funding requests for services offered by Child and  
Family Services come out of already-existing budgets.
COMPLIANCE COSTS FOR AFFECTED PERSONS:  Child  
and  Family  Services  determined  that  there  will  be  no  
compliance costs for affected persons because there are no  
specific costs involved with the changes being made to this  
rule.
COMMENTS  BY  THE  DEPARTMENT  HEAD  ON  THE  
FISCAL IMPACT THE RULE MAY HAVE ON BUSINESSES:  
This rule will have no fiscal impact on businesses.
THE  FULL TEXT  OF  THIS  RULE  MAY BE  INSPECTED,  
DURING REGULAR BUSINESS HOURS, AT:
HUMAN SERVICES
CHILD AND FAMILY SERVICES
195 N 1950 W
SALT LAKE CITY , UT 84116
or at the Division of Administrative Rules.
DIRECT QUESTIONS REGARDING THIS RULE TO:
♦ Carol Miller by phone at 801-557-1772, by FAX at 801-538-
3993, or by Internet E-mail at carolmiller@utah.gov
♦ Julene Robbins by phone at 801-538-4521, by FAX at 801-
538-3942, or by Internet E-mail at jhjonesrobbins@utah.gov
INTERESTED PERSONS MAY PRESENT THEIR VIEWS ON  
THIS RULE BY SUBMITTING WRITTEN COMMENTS NO  
LATER THAN AT 5:00 PM ON 03/31/2016
THIS RULE MAY BECOME EFFECTIVE ON:  04/07/2016
AUTHORIZED BY:  Brent Platt, Director
R512.  Human Services, Child and Family Services.
R512-42.  Adoption by Relatives.
R512-42-1.  Purpose and Authority.
(1)  The purpose of this rule is to specify requirements for  
relatives to adopt a child in the custody of [ the Division of ]Child and 
Family Services[ (Child and Family Services) ].
(2)  This rule is authorized by Section s 62A-4a-102, 78A-6-
307, 78B-6-128, and 78B-6-133 .
R512-42-2.  Definitions.  
                 (1)  "Child and Family Services" means the Division of   
Child and Family Services.   
                 (2)  "Relative" is defined in Section 78A-6-307.      
UTAH STATE BULLETIN , March 01, 2016, V ol. 2016, No. 5 13