MEETING PACKET JULY 2012 1 .. .. ..
CITY OF SALEIVI; NLASSr1CHUSETTS
BOARD or.F-IEALTi-i
blicHea .
120 DV�kSHINGTON STREET,Ott,FL(:)C)R PC lthtrevrnt.trummc:Proles.
Tti:(978)7414800 FAx (978)745-0343 .
{ KIMBERLEY DRISCbLL likAdirt o 01ein.com
MAYOR...: L\Il Rl'RAKDIN,RS/RI_,t.TS,C;i HE.A1 t'iiAGPNT
NOTICE OF MEETING
You are hereby notified that the Salem Board of Health will hold its,regularly.scheduled meeting
Tuesday, July 10, 2012 at 7.00 PM
City Hall Annex, 120 Washington St Room 311
i
. . . . . . . MEETING AGENDA
j
1. Call to
2. Approval.of Minutes from June 19, 2012
3. Chairperson Announcements
.4. Public.Health Announcements/Reports/Updates
r
a. :Health Agent
b. Public Health Nurse:Report
c. Administrative
d. . Council Liaison
S. Tobacco Regulations.Hearing.
1
6. Miscellaneous
7. Adjournment
Larry Ramdin
Health Agent
cc: Mayor Kimberley Driscoll, Board of Health, City Councilors
Next regularly scheduled meeting is July.24,2012 at 7pm at City Hall Annex 120
Washington Street Room311
Know your rights under the open meeting law MGL Chapter 39 Section 23B and City
Ordinance section:2-2028 through 2-2033
It
• JUSTINA POLVERE
SALEM BOARD Of HEALTH
PUBLIC HEALTH NURSE
PUBLIC HEALTH NURSE REPORT
JULY 2012 ACTIVITIES
Disease Prevention
• Investigated 4 reportable diseases and reported case information to MDPH.
• In contact with North Shore Pulmonary Clinic on current active cases, and case
contacts.
■ DOT for 1 active TB cases
Meetings/Clinics
• Met with 1 TB case contacts privately to PPD skin test /give results
-Home visits of 3 Salem residents with David Greenbaum. Met with 1 elderly male
resident and checked on living status/offered services; will be checking back with
him in 2 weeks.
* (Other 2 home visits were unsuccessful because residents were either not home
or did not answer on multiple occasions).
-Attended two day ICS 400 training and received certificate for the course.
-Inspected Leggs Hill YMCA summer camp with David Greenbaum — permitted to
open for 2012 season
-Inspected Children's Island summer camp with Elizabeth Gagakis- permitted to
• open for 2012 season
•Inspected Campfire summer camp with David Greenbaum- permitted to open for •
2012 season
Inspected Salem Boys and Girls club summer camp with Elizabeth Gagakis
permitted to open for 2012 season
•Inspected Naumkeag summer camp with Elizabeth Gagakis- permitted to open
for 2012 season
•Inspected Salem YMCA summer camps with Elizabeth Gagakis- permitted to
open for 2012 season
Inspected Salem State College summer camp with Elizabeth Gagakis- permitted
to open for 2012 season
•Inspected Rebel Shakespeare summer camp with Elizabeth Gagakis-permitted to
open for 2012 season
Monthly Report of Communicable Disease •
May 2012
Disease # Of Cases New Carry Over Discharged
Reported
campylobacter 2 2 0 1
Salmonella 0 0 0 0
Pertussis 0 0 0 0
HGA 1 1 0 0
Tuberculosis 2 0 2 0
•
J
• Summary of Communicable Diseases for July 2012
Campylobacteriosis:
Case #1: During incubation period case ate at many restaurants on her vacation in
Florida, no suspect food or restaurant. Zero animal contact. Pt. is not a food
handler and does not work in daycare setting (nor does any close contacts) No
one else around her is or became ill. Pt. recovered.
Case #2: Currently being investigated
Human Granulocytic Anaplasmosis (Ehrlichiosis):
Currently being further investigated; contacting case in progress. Case denied tick
bite to physician. Presented with mild symptoms; case recovered.
• Food Bourne Illness
(Unidentified)
Case became very ill 2 hours after eating at New Yorker Deli. Pt. did not seek
medical attention and no diagnosis was made. Conducted 72 hour food history
and an investigation of New Yorker Deli in progress because case believes what he
ate from there caused this. He is not a food handler. No one around has any
similar symptoms and is not sick. Case recovered.
J Health x ,.Human Services
. R ;
SUMMARY OF THE
IPAA PRIVACY RULE
wm�
_
HIPAA Compliance Assistance
•
SUMMARY OF •
THE HIPAA PRIVACY RULE
Contents
Introduction......................................................................................................................... I
Statutory&Regulatory Background................................................................................... I
Who is Covered by the Privacy Rule..................................................................................2
BusinessAssociates.............................................................................................................3
What Information is Protected............................................................................................3
General Principle for Uses and Disclosures........................................................................4
Permitted Uses and Disclosures..........................................................................................4
Authorized Uses and Disclosures........................................................................................9
Limiting Uses and Disclosures to the Minimum Necessary.............................................10 •
Notice and Other Individual Rights ..................................................................................11
Administrative Requirements............................................................................................ 14
OrganizationalOptions ..................................................................................................... 15
Other Provisions: Personal Representatives and Minors .................................................. 16
StateLaw...........................................................................................................................17
Enforcement and Penalties for Noncompliance................................................................17
ComplianceDates .............................................................................................................18
Copies of the Rule& Related Materials............................................................................ 18
EndNotes.......................................................................................................................... 19
•
i
SUMMARY OF
THE HIPAA PRIVACY RULE
Contents
Introduction..........................................................................................................................1
Statutory&Regulatory Background...................................................................................l
Who is Covered by the Privacy Rule..................................................................................2
BusinessAssociates.............................................................................................................3
What Information is Protected....................................................... .................................3
General Principle for Uses and Disclosures........................................................................4
Permitted Uses and Disclosures..........................................................................................4
Authorized Uses and Disclosures...............................................................................:......:.9
Limiting Uses and Disclosures to the Minimum Necessary............................................. 10
Notice and Other Individual Rights..................:...............................................................11
Administrative Requirements............................................................................................ 14
OrganizationalOptions ......'...............................................................................................15
Other Provisions:Personal Representatives and Minors.................................................. 16
StateLaw. .........................................................................................................................17
Enforcement and Penalties for Noncompliance................................................................17
ComplianceDates .............................................................................................................18
Copies of the Rule&Related Materials...........................................................I.................18
EndNotes..........................................................................................................................19
i
• SUMMARY OF
THE HIPAA PRIVACY RULE
Introductilon The Standards for Privacy of Individually Identifiable Health Information ("Privacy
Rule") establishes, for the first time, a set of national standards for the protection of
certain health information. The U.S. Department of Health and Human Services
("HHS") issued the Privacy Rule to implement the requirement of the Health
Insurance Portability and Accountability Act of 1996("HIPAA").1 The Privacy Rule
standards address the use and disclosure of individuals' health information—called
"protected health information" by organizations subject to the Privacy Rule—called
"covered entities," as well as standards for individuals' privacy rights to understand
and control how their health information is used. Within HHS, the Office for Civil
Rights ("OCR") has responsibility for implementing and enforcing the Privacy Rule
with respect to voluntary compliance activities and civil money penalties.
A major goal of the Privacy Rule is to assure that individuals' health information is
properly protected while allowing the flow of health information needed to provide
and promote high quality health care and to protect the public's health and well being.
The Rule strikes a balance that permits important uses of information, while
protecting the privacy of people who seek care and healing. Given that the health
care marketplace is diverse, the Rule is designed to be flexible and comprehensive to
cover the variety of uses and disclosures that need to be addressed.
• This is a summary of key elements of the Privacy Rule and not a complete or
comprehensive guide to compliance. Entities regulated by the Rule are obligated to
comply with all of its applicable requirements and should not rely on this summary as
a source of legal information or advice. To make it easier for entities to review the
complete requirements of the Rule,provisions of the Rule referenced in this summary
are cited in notes at the end of this document. To view the entire Rule, and for other
additional helpful information about how it applies, see the OCR website:
http://www.hhs.gov/ocr/hioaa. In the event of a conflict between this summary
and the Rule,the Rule governs.
Links to the OCR Guidance Document are provided throughout this paper.Provisions
of the Rule referenced in this summary are cited in endnotes at the end of this
document. To review the entire Rule itself, and for other additional helpful
information about how it applies, see the OCR website:
http://www.hhs.gov/ocr/hioaa.
Statutory & The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public
Law 104-191,was enacted on August 21, 1996. Sections 261 through 264 of HIPAA
Regulatory require the Secretary of HHS to publicize standards for the electronic exchange,
]Badieround privacy and security of health information. Collectively these are known as the
Administrative Simplification provisions.
HIPAA required the Secretary to issue privacy regulations governing individually
• identifiable health information, if Congress did not enact privacy legislation within
OCR Privacy Rule Summary 1 Last Revised 05/03
three years of the passage of HIPAA. Because Congress did not enact privacy •
legislation, HHS developed a proposed rule and released it for public comment on
November 3, 1999. The Department received over 52,000 public comments. The
final regulation,the Privacy Rule,was published December 28,2000.2
In March 2002, the Department proposed and released for public comment
modifications to the Privacy Rule. The Department received over 11,000 comments.
The final modifications were published in final form on August 14, 2002.3 A text
combining the final regulation and the modifications can be found at 45 CFR Part
160 and Part 164, Subparts A and E on the OCR website:
htlp://www.hhs.jzov/oci-/hipaa.
Who TS The Privacy Rule, as well as all the Administrative Simplification rules, apply to
health plans, health care clearinghouses, and to any health care provider who
Covered b the
3' transmits health information in electronic form in connection with transactions for
PI'iVaCy Rule - which the Secretary of HHS has adopted standards under HIPAA (the "covered
entities"). For helpin determining whether you are covered use the decision tool at:
g
htt ://www.cros.hhs. ov/hi aa/hi aa2/su ort/tools/decisionsu ort/default.as .
P � P p PP Pp p
Health Plans. Individual and group plans that provide or pay the cost of medical l
care are covered entities.4 Health plans include health, dental, vision, and
prescription drug insurers, health maintenance organizations ("HMOs"), Medicare,
Medicaid, Medicare+Choice and Medicare supplement insurers, and long-term care
insurers (excluding nursing home fixed-indemnity policies). Health plans also
include employer-sponsored group health plans, government and church-sponsored •
health plans, and multi-employer health plans. There are exceptions—a group health
plan with less than 50 participants that is administered solely by the employer that
established and maintains the plan is not a covered entity. Two types of government-
funded programs are not health plans: (1) those whose principal purpose is not
providing or paying the cost of health care, such as the food stamps program; and(2)
those programs whose principal activity is directly providing health care, such as a
community health center,5 or the making of grants to fund the direct provision of
health care. Certain types of insurance entities are also not health plans, including
entities providing only workers' compensation, automobile insurance, and property
and casualty insurance.
Health Care Providers. Every health care provider, regardless of size, who
- electronically transmits health information in connection with certain transactions, is
a covered entity. These transactions include claims, benefit eligibility inquiries,
referral authorization requests, or other transactions for which HHS has established
standards under the HIPAA Transactions Rule.b Using electronic technology, such as
email, does not mean a health care provider is a covered entity;the transmission must
be in connection with a standard transaction. The Privacy Rule covers a health care
provider whether it electronically transmits these transactions directly or uses a
billing service or other third party to do so on its behalf. Health care providers
include all "providers of services" (e.g., institutional providers such as hospitals) and
"providers of medical or health services" (e.g., non-institutional providers such as
physicians, dentists and other practitioners) as defined by Medicare, and any other
person or organization that furnishes,bills,or is paid for health care.
•
OCR Privacy Rule Summary 2 Last Revised 05/03
160 anart 164, - Subparts A and E on the OCR websi
• htty://ww s.gov/ocr/hil2aa.
_ b 1S The Privacy Rule, as well as all the Administrative Simplification rules, apply to
health plans, health care clearinghouses, and to any health care provider who
Covered b. the
y transmits health information in electronic form in connection with transactions for
Pl'1vaCy Rtlk which the Secretary of HHS has adopted standards under HIPAA (the "covered
entities"). For help in determining whether you are covered, use the decision tool at:
httD://www.cros.hhs. og v/hipaa/hipaa2/support/tools/decisionsupport/default asp.
Health Plans. Individual and group plans that provide or pay the cost of medical
care are covered entities.4 Health plans include health, dental, vision, and
prescription drug insurers, health maintenance organizations ("HMOs"), Medicare,
Medicaid, Medicare+Choice and Medicare supplement insurers, and long-term care
insurers (excluding nursing home fixed-indemnity policies). Health plans also
include employer-sponsored group health plans, government and church-sponsored
health plans,and multi-employer health plans. There are exceptions—a group health
plan with less than 50 participants that is administered solely by the employer that
established and maintains the plan is not a covered entity. Two types of government-
funded programs are not health plans: (1) those whose principal purpose is not
providing or paying the cost of health care, such as the food stamps program; and(2)
those programs whose principal activity is directly providing health care, such as a
community health center,' or the making of grants to fund the direct provision of
health care. Certain types of insurance entities are also not health plans, including
entities providing only workers' compensation, automobile insurance, and property
and casualty insurance.
Health Care Providers.
Every health care provider, regardless of size, who
electronically
transmits health information in connection with certain transactions, is
a covered entity. These transactions include claims, benefit eligibility inquiries,
referral authorization requests, or other transactions for which.HHS has established
standards under the HIPAA Transactions Rule 6 Using electronic technology, such as
email, does not mean a health care provider is a covered entity; the transmission must
be in connection with a standard transaction. The Privacy Rule covers a health care
provider whether it electronically transmits these transactions directly or uses a
billing service or other third party to do so on its behalf. Health care providers
�` include all "providers of services"(e.g., institutional providers such as hospitals) and
"providers of medical or health services" (e.g., non-institutional providers such as
physicians, dentists and other practitioners) as defined by Medicare, and any other
person or organization that furnishes,bills,or is paid for health care.
OCR Privacy Rule Summary 2 Last Revised 05/03
• Health Care Clearinghouses. Health care clearinghouses are entities that process
nonstandard information they receive from another entity into a standard (i.e.,
standard format or data content), or vice versa. 7 In most instances, health care
clearinghouses will receive individually identifiable health information only when
they are providing these processing services to a health plan or health care provider as
a business associate.In such instances,only certain provisions of the Privacy Rule are
applicable to the health care clearinghouse's uses and disclosures of protected health
informations Health care clearinghouses include billing services, repricing
companies, community health management information systems, and value-added
networks and switches if these entities perform clearinghouse functions.
BUS1rieSS Business Associate Defined. In general, a business associate is a person or
organization, other than a member of a covered entity's workforce, that performs
ASSOC1ateS certain functions or activities on behalf of, or provides certain services to, a covered
entity that involve the use or disclosure of individually identifiable health
information. Business associate functions or activities on behalf of a covered entity
include claims processing, data analysis, utilization review, and billing.9 Business
associate services to a covered entity are limited to legal, actuarial, accounting,
consulting, data aggregation, management, administrative, accreditation, or financial
services. However, persons or organizations are not considered business associates if
their functions or services do not involve the use or disclosure of protected health
information, and where any access to protected health information by such persons
would be incidental, if at all. A covered entity can be the business associate of
• another covered entity.
Business Associate Contract. When a covered entity uses a contractor or other non-
workforce member to perform "business associate" services or activities, the Rule
requires that the covered entity include certain protections for the information in a
business associate agreement(in certain circumstances governmental entities may use
alternative means to achieve the same protections). In the business associate contract,
a covered entity must impose specified written safeguards on the individually
identifiable health information used or disclosed by its business associates.10
Moreover, a covered entity may not contractually authorize its business associate to
make any use or disclosure of protected health information that would violate the
Rule. Covered entities that have an existing written contract or agreement with
business associates prior to October 15,2002,which is not renewed or modified prior
to April 14, 2003, are permitted to continue to operate under that contract until they
renew the contract or April 14, 2004, whichever is first." Sample business associate
contract language is available on the OCR website at:
http://www.hhs.aov/ocr/Iiipaa/contractprov.litml. Also see OCR "Business
Associate"Guidance.
What Protected Health Information. The Privacy Rule protects all "individually
identifiable health information"held or transmitted by a covered entity or its business
Information 15 associate, in any form or media,whether electronic,paper, or oral. The Privacy Rule
Protected calls this information"protected health information (PHI)."12
•
OCR Privacy Rule Summary 3 Last Revised 05/03
"Individually identifiable health information" is information, including demographic •
data,that relates to:
• the individual's past, present or future physical or mental health or
condition,
• the provision of health care to the individual,or
• the past, present, or future payment for the provision of health care to the
individual,
and that identifies the individual or for which there is a reasonable basis to believe
can be used to identify the individual.13 Individually identifiable health information
includes many common identifiers (e.g., name, address, birth date, Social Security
Number).
The Privacy Rule excludes from protected health information employment records
that a covered entity maintains in its capacity as an employer and education and
certain other records subject to, or defined in, the Family Educational Rights and
Privacy Act,20 U.S.C. §1232g.
De-Identified Health Information. There are no restrictions on the use or
disclosure of de-identified health information.14 De-identified health information
neither identifies nor provides a reasonable basis to identify an individual. There are
two ways to de-identify information; either: 1) a formal determination by a qualified
statistician; or 2) the removal of specified identifiers of the individual and of the
individual's relatives, household members, and employers is required, and is
adequate only if the covered entity has no actual knowledge that the remaining
information could be used to identify the individual.15
General Basic Principle. A major purpose of the Privacy Rule is to define and limit the
• circumstances in which an individual's protected heath information may be used or
Tn'nc>< le for.
1� disclosed by covered entities. A covered entity may not use or disclose protected
Uses'Ind health information,except either:(1)as the Privacy Rule permits or requires;or(2)as
•' the individual who is the subject of the information (or the individual's personal
Disclosures: 16
representative)authorizes in writing.
Required Disclosures. A covered entity must disclose protected health information
in only two situations: (a) to individuals (or their personal representatives)
specifically when they request access to, or an accounting of disclosures of, their
protected health information; and (b) to HHS when it is undertaking a compliance
investigation or review or enforcement action." See OCR "Government Access"
Guidance.
Perim ttefl USCs : Permitted Uses and Disclosures. A covered entity is permitted, but not required, to
use and disclose protected health information, without an individual's authorization,
-and D kWC ures for the following purposes or situations: (1) To the Individual (unless required for
access or accounting of disclosures); (2) Treatment, Payment, and Health Care
Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise
permitted use and disclosure;(5)Public Interest and Benefit Activities; and
I •
OCR Privacy Rule Summary 4 Last Revised 05/03
• includes common identifiers (e.g., name, address, birth date, Social Sec
Number).
The Privacy Rule excludes from protected health information employment records
` that a covered entity maintains in its capacity as an employer and education and
R F certain other records subject to, or defined in, the Family Educational Rights and
r Privacy Act,20 U.S.C. §1232g.
5 t; tF De-Identified Health Information. There are no restrictions on the use or
disclosure of de-identified health information.14 De-identified health information
neither identifies nor provides a reasonable basis to identify an individual. There are
two ways to de-identify information; either: 1) a formal determination by a qualified
j statistician; or 2) the removal of specified identifiers of the individual and of the
individual's relatives, household members, and employers is required, and is
ade uate only if the covered entity has no actual knowledge that the remaining
w q y ' ty g g
information could be used to identify the individual.15
z Basic Principle. A ma purpose of the Privacy Rule is to define and limit the
or
General P J P rP Y
circumstances in which an individual's protected heath information may be used or
IT e for FT
disclosed by covered entities. A covered entity may not use or disclose protected
ITSeSw6aind ' health information,except either:(1)as the Privacy Rule permits or requires;or(2)as
aN the individual who is the subject of the information (or the individual's personal
"Nitogil 16
representative)authorizes in writing.
Y
Required Disclosures. A covered entity must disclose protected health information
in only two situations: (a) to individuals (or their personal representatives)
r specifically when they request access to, or an accounting of disclosures of, their
protected health information; and (b) to HHS when it is undertaking a compliance
y investigation or review or enforcement action." See OCR "Government Access"
Guidance.
PermYtted-;U5e:S Permitted Uses and Disclosures. A covered entity is permitted, but not required, to
#cn 5
use and disclose protected health information, without an individual's authorization,
andD><Selosures for the following purposes or situations: (1) To the Individual (unless required for
access or accounting of disclosures); (2) Treatment, Payment, and Health Care
Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise
`- permitted use and disclosure;(5)Public Interest and Benefit Activities;and
OCR Privacy Rule Summary 4 Last Revised 05/03
• (6) Limited Data Set for the purposes of research, public health or health care
operations.18 Covered entities may rely on professional ethics and best judgments in
deciding which of these permissive uses and disclosures to make.
(1)To the Individual. A covered entity may disclose protected health information to
the individual who is the subject of the information.
(2) Treatment, Payment, Health Care Operations. A covered entity may use and
disclose protected health information for its own treatment, payment, and health care
operations activities.19 A covered entity also may disclose protected health
information for the treatment activities of any health care provider, the payment
activities of another covered entity and of any health care provider, or the health care
operations of another covered entity involving either quality or competency assurance
activities or fraud and abuse detection and compliance activities, if both covered
entities have or had a relationship with the individual and the protected health
information pertains to the relationship. See OCR"Treatment, Payment, Health Care
Operations"Guidance.
Treatment is the provision, coordination, or management of health care and
related services for an individual by one or more health care providers,
including consultation between providers regarding a patient and referral of a
patient by one provider to another.20
Payment encompasses activities of a health plan to obtain premiums,
determine or fulfill responsibilities for coverage and provision of benefits,
• and furnish or obtain reimbursement for health care delivered to an
individual21 and activities of a health care provider to obtain payment or be
reimbursed for the provision of health care to an individual.
Health care operations are any of the following activities: (a) quality
assessment and improvement activities, including case management and care
coordination; (b) competency assurance activities, including provider or
health plan performance evaluation, credentialing, and accreditation; (c)
conducting or arranging for medical reviews, audits, or legal services,
including fraud and abuse detection and compliance programs; (d) specified
insurance functions, such as underwriting, risk rating, and reinsuring risk; (e)
business planning, development, management, and administration; and (f)
business management and general administrative activities of the entity,
including but not limited to: de-identifying protected health information,
creating a limited data set, and certain fundraising for the benefit of the
covered entity zz
Most uses and disclosures of psychotherapy notes for treatment, payment, and health
care operations purposes require an authorization as described below.23
Obtaining "consent" (written permission from individuals to use and disclose their
protected health information for treatment, payment, and health care operations) is
optional under the Privacy Rule for all covered entities 24 The content of a consent
form,and the process for obtaining consent,are at the discretion of the covered entity
electing to seek consent.
OCR Privacy Rule Summary 5 Last Revised 05/03
(3) Uses and Disclosures with Opportunity to Agree or Object. Informal •
permission may be obtained by asking the individual outright, or by circumstances
that clearly give the individual the opportunity to agree, acquiesce, or object. Where
the individual is incapacitated, in an emergency situation, or not available, covered
entities generally may make such uses and disclosures, if in the exercise of their
professional judgment, the use or disclosure is determined to be in the best interests
of the individual.
It is a common practice in man health care facilities
_ Facility Directories. ,
t1' P Y
such as hospitals, to maintain a directory of patient contact information. A
covered health care provider may rely on an individual's informal permission
to list in its facility directory the individual's name, general condition,
religious affiliation, and location in the provider's facility.25 The provider
may then disclose the individual's condition and location in the facility to
anyone asking for the individual by name, and also may disclose religious
affiliation to clergy. Members of the clergy are not required to ask for the
individual by name when inquiring about patient religious affiliation.
For Notification and Other Purposes. A covered entity also may rely on an
individual's informal permission to disclose to the individual's family,
relatives, or friends, or to other persons whom the individual identifies,
protected health information directly relevant to that person's involvement in
the individual's care or payment for care. 26 This provision, for example,
allows a pharmacist to dispense filled prescriptions to a person acting on
behalf of the patient. Similarly, a covered entity may rely on an individual's •
informal permission to use or disclose protected health information for the
purpose of notifying (including identifying or locating) family members,
personal representatives, or others responsible for the individual's care of the
individual's location, general condition, or death. In addition, protected
health information may be disclosed for notification purposes to public or
private entities authorized by law or charter to assist in disaster relief efforts.
(4) Incidental Use and Disclosure. The Privacy Rule does not require that every
risk of an incidental use or disclosure of protected health information be eliminated.
A use or disclosure of this information that occurs as a result of, or as "incident to,"
an otherwise permitted use or disclosure is permitted as long as the covered entity has
adopted reasonable safeguards as required by the Privacy Rule, and the information
being shared was limited to the "minimum necessary," as required by the Privacy
Rule?' See OCR"hncidental Uses and Disclosures"Guidance.
(5) Public Interest and Benefit Activities. The Privacy Rule permits use and
disclosure
1 re of protected health information without an individual's authorization or
z
. These disclosures are permitt
ed,permission, for 12 national priority purposes
although not required,by the Rule in recognition of the important uses made of health
information outside of the health care context. Specific conditions or limitations
apply to each public interest purpose, striking the balance between the individual
privacy interest and the public interest need for this information.
Required by Law. Covered entities may use and disclose protected health
information without individual authorization as required by law(including by
•
OCR Privacy Rule Summary 6 Last Revised 05/03
• (3) Uses and Disclosures with Opportunity to Agree or Object. Informal
permission may be obtained by asking the individual outright, or by circumstances
that clearly give the individual the opportunity to agree, acquiesce, or object. Where
the individual is incapacitated, in an emergency situation, or not available, covered
entities generally may make such uses and disclosures, if in the exercise of their
professional judgment, the use or disclosure is determined to be in the best interests
of the individual.
Facility Directories. It is a common practice in many health care facilities,
such as hospitals, to maintain a directory of patient contact information. A
rr� covered health care provider may rely on an.individual's informal permission
to list in its facility directory the individual's name, general condition,
religious affiliation, and location in the provider's facility 25 The provider
may then disclose the individual's condition and location in the facility to
yr T anyone asking.for the individual by name, and also may disclose religious
affiliation to clergy. Members of the clergy are not required to ask for the
individual by name when inquiring about patient religious affiliation.
SrY � ForNoti Notification and OtherPur Purposes. A covered entity also may rely on an
s P tY Y Y
' x individual's informal permission to disclose to the individual's family,
q # = relatives, or friends, or to other persons whom the individual identifies,
protected health information directly relevant to that person's involvement in
the individual's care or payment for care. 26 This provision, for example,
allows a pharmacist to dispense filled prescriptions to a person acting on
• behalf of the patient. Similarly, a covered entity may rely on an individual's
informal permission to use or disclose protected health information for the
purpose of notifying (including identifying or locating) family members,
personal representatives, or others responsible for the individual's care of the
m individual's location, general condition, or death. In addition, protected
health information may be disclosed for notification purposes to public or
F private entities authorized by law or charter to assist in disaster relief efforts.
r (4) Incidental Use and Disclosure. The Privacy Rule does not require that every
risk of an incidental use or disclosure of protected health information be eliminated.
A use or disclosure of this information that occurs as a result of, or as "incident to,"
an otherwise permitted use or disclosure is permitted as long as the covered entity has
adopted reasonable safeguards as required by the Privacy Rule, and the information
being shared was limited to,the "minimum necessary," as required by the Privacy
Rule?' See OCR"Incidental Uses and Disclosures"Guidance.
(5) Public Interest and Benefit Activities. The Privacy Rule permits use and
disclosure of protected health information, without an individual's authorization or
permission, for 12 national priority purposes.Z$ These disclosures are permitted,
although not required,by the Rule in recognition of the important uses made of health
information outside of the health care context. Specific conditions or limitations
apply to each public interest purpose, striking the balance between the individual
x fr privacy interest and the public interest need for this information.
Required by Law. Covered entities may use and disclose protected health
- information without individual
authorization asre required by law(including din
g by
OCR Privacy Rule Summary 6 Last Revised 05/03
• statute,regulation,or court orders).
Public Health Activities. Covered entities may disclose protected health
information to: (1) public health authorities authorized by law to collect or
receive such information for preventing or controlling disease, injury, or
disability and to public health or other government authorities authorized to
receive reports of child abuse and neglect; (2) entities subject to FDA
regulation regarding FDA regulated products or activities for purposes such
as adverse event reporting, tracking of products, product recalls, and post
marketing surveillance; (3) individuals who may have contracted or been
exposed to a communicable disease when notification is authorized by law;
and (4) employers, regarding employees, when requested by employers, for
information concerning a work-related illness or injury or workplace related
medical surveillance,because such information is needed by the employer to
comply with the Occupational Safety and Health Administration (OHSA),
the Mine Safety and Health Administration (MHSA), or similar state law 30
See OCR "Public Health" Guidance; CDC Public Health and HIPAA
Guidance.
Victims of Abuse,Neglect or Domestic Violence. In certain circumstances,
covered entities may disclose protected health information to appropriate
government authorities regarding victims of abuse, neglect, or domestic
violence.31
Health Oversight Activities. Covered entities may disclose protected health
• information to health oversight agencies(as defined in the Rule)for purposes
of legally authorized health oversight activities, such as audits and
investigations necessary for oversight of the health care system and
government benefit programs.32
Judicial and Administrative Proceedings. Covered entities may disclose
protected health information in a judicial or administrative proceeding if the
request for the information is through an order from a court or administrative
tribunal. Such information may also be disclosed in response to a subpoena
or other lawful process if certain assurances regarding notice to the individual
or a protective order are provided.33
Law Enforcement Purposes. Covered entities may disclose protected health
information to law enforcement officials for law enforcement purposes under
the following six circumstances, and subject to specified conditions: (1) as
required by law (including court orders, court-ordered warrants, subpoenas)
and administrative requests; (2) to identify or locate_a suspect, fugitive,
material witness, or missing person; (3) in response to a law enforcement
official's request for information about a victim or suspected victim of a
crime; (4)to alert law enforcement of a person's death, if the covered entity
suspects that criminal activity caused the death; (5) when a covered entity
believes that protected health information is evidence of a crime that
occurred on its premises; and (6) by a covered health care provider in a
medical emergency not occurring on its premises, when necessary to inform
law enforcement about the commission and nature of a crime,the location of
• the crime or crime victims,and the perpetrator of the crime 34
OCR Privacy Rule Summary 7 Last Revised 05/03
Decedents. Covered entities may disclose protected health information to •
funeral directors as needed,and to coroners or medical examiners to identify
a deceased person,determine the cause of death, and perform other functions
authorized by law.31
Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or
disclose protected health information to facilitate the donation and
transplantation of cadaveric organs,eyes,and tissue.36
Research. "Research" is any systematic investigation designed to develop or
contribute to generalizable knowledge.37 The Privacy Rule permits a covered
entity to use and disclose protected health information for research purposes,
without an individual's authorization, provided the covered entity obtains
either: (1) documentation that an alteration or waiver of individuals'
authorization for the use or disclosure of protected health information about
them for research purposes has been approved by an Institutional Review
Board or Privacy Board; (2) representations from the researcher that the use
or disclosure of the protected health information is solely to prepare a
research protocol or for similar purpose preparatory to research, that the
researcher will not remove any protected health information from the covered
entity, and that protected health information for which access is sought is
necessary for the research; or(3)representations from the researcher that the
use or disclosure sought is solely for research on the protected health
information of decedents, that the protected health information sought is
necessary for the research, and, at the request of the covered entity, •
documentation of the death of the individuals about whom information is
sought.38 A covered entity also may use or disclose, without an individuals'
authorization, a limited data set of protected health information for research
purposes (
u oses see discussion below).39 cc See OCR Research" Guidance; N IH
Protecting PHI in Research.
Serious Threat to Health or Safety. Covered entities may disclose protected
health information that they believe is necessary to prevent or lessen a serious
is made
r n r thepublic, when suc
h disclosure
and imminent threat to a person 0
P
to someone they believe can prevent or lessen the threat(including the target
of the threat). Covered entities may also disclose to law enforcement if the
information is needed to identify or apprehend an escapee or violent
criminal.ao
Essential Government Functions. An authorization is not required to use or
disclose protected health information for certain essential government
functions. Such functions include: assuring proper execution of a military
mission, conducting intelligence and national security activities that are
authorized by law, providing protective services to the President, making
medical suitability determinations for U.S. State Department employees,
protecting the health and safety of inmates or employees in a correctional
institution,and determining eligibility for or conducting enrollment in certain
government benefit programs."
OCR Privacy Rule Summary 8 Last Revised 05/03
I -
Decedents. Covered entities may disclose protected health information to
funeral directors as needed,and to coroners or medical examiners to identify
a deceased person,determine the cause of death, and perform other functions
authorized by law.ss
Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or
disclose protected health information to facilitate the donation and
transplantation of cadaveric organs,eyes,and tissue.36
Research. "Research" is any systematic investigation designed to develop or
contribute to generalizable knowledge.37 The Privacy Rule permits a covered
entity to use and disclose protected health information for research purposes,
without an individual's authorization, provided the covered entity obtains
either: (1) documentation that an alteration or waiver of individuals'
authorization for the use or disclosure of protected health information about
them for research purposes has been approved by an Institutional Review
Board or Privacy Board; (2) representations from the researcher that the use j
or disclosure of the protected health information is solely to prepare a
research protocol or for similar purpose preparatory to research, that the
researcher will not remove any protected health information from the covered
entity, and that protected health information for which access is sought is
necessary for the research; or(3)representations from the researcher that the
use or disclosure sought is solely for research on the protected health
• information of decedents, that the protected health information sought is
necessary for the research, and, at the request of the covered entity,
documentation of the death of the individuals about whom information is
sought.38 A covered entity also may use or disclose, without an individuals'
authorization, a limited data set of protected health information for research
purposes (see discussion below).39 See OCR "Research" Guidance; NIH
Protecting PHI in Research.
Serious Threat to Health or Safety. Covered entities may disclose protected
health information that they believe is necessary to prevent or lessen a serious
and imminent threat to a person or the public, when such disclosure is made
to someone they believe can prevent or lessen the threat(including the target
of the threat). Covered entities may also disclose to law enforcement if the
information is needed to identify or apprehend an escapee or violent
criminal ao
Essential Government Functions. An authorization is not required to use or
disclose protected health information for certain essential government
functions. Such functions include: assuring proper execution of a military
mission, conducting intelligence and national security activities that are
authorized by law, providing protective services to the President, making
medical suitability determinations for U.S. State Department employees,
protecting the health and safety of inmates or employees in a correctional
institution,and determining eligibility for or conducting enrollment in certain
government benefit programs.a'
OCR Privacy Rule Summary 8 Last Revised 05/03
• Workers' Compensation. Covered entities may disclose protected health
information as authorized by, and to comply with, workers' compensation
laws and other similar programs providing benefits for work-related injuries
or illnesses.42 See OCR"Workers' Compensation"Guidance.
(6) Limited Data Set. A limited data set is protected health information from which
certain specified direct identifiers of individuals and their relatives, household
members, and employers have been removed43 A limited data set may be used and
disclosed for research, health care operations, and public health purposes, provided
the recipient enters into a data use agreement promising specified safeguards for the
protected health information within the limited data set.
Authorized Authorization. A covered entity must obtain the individual's written authorization
:.1 andfor any use or disclosure of protected health information that is not for treatment,
payment or health care operations or otherwise permitted or required by the Privacy
DISCIOSure5 Rule. 4 A. covered entity may not condition treatment, payment, enrollment, or
benefits eligibility on an individual granting an authorization, except in limited
circumstances.as
An authorization must be written in specific terms. It may allow use and disclosure
of protected health information by the covered entity seeking the authorization, or by
a third party. Examples of disclosures that would require an individual's
authorization include disclosures to a life insurer for coverage purposes, disclosures
• to an employer of the results of a pre-employment physical or lab test, or disclosures
to a pharmaceutical firm for their own marketing purposes.
All authorizations must be in plain language, and contain specific information
regarding the information to be disclosed or used, the person(s) disclosing and
receiving the information, expiration, right to revoke in writing, and other data. The
Privacy Rule contains transition provisions applicable to authorizations and other
express legal permissions obtained prior to April 14,2003.46
Psychotherapy Notes47. A covered entity must obtain an individual's authorization
to use or disclose psychotherapy notes with the following exceptions48:
• The covered entity who originated the notes may use them for treatment.
• A covered entity may use or disclose, without an individual's authorization,
the psychotherapy notes, for its own training, and to defend itself in legal
proceedings brought by the individual, for HHS to investigate or determine
the covered entity's compliance with the Privacy Rules,to avert a serious and
imminent threat to public health or safety, to a health oversight agency for
lawful oversight of the originator of the psychotherapy notes, for the lawful
activities of a coroner or medical examiner or as required by law.
Marketing. Marketing is any communication about a product or service that
encourages recipients to purchase or.use the product or service49 The Privacy Rule
carves out the following health-related activities from this definition of marketing:
• Communications to describe health-related products or services, or payment
•
OCR Privacy Rule Summary 9 Last Revised 05/03
for them, provided by or included in a benefit plan of the covered entity •
making the communication;
• Communications about participating providers in a provider or health plan
network, replacement of or enhancements to a health plan, and health-related
products or services available only to a health plan's enrollees that add value
to butp
are not art of,the benefits plan;
•
and
mm nications for treatment of the individual;
Co u
• Communications for case management or care coordination for the
individual, or to direct or recommend alternative treatments, therapies,
health care providers, or care settings to the individual.
Marketing also is an arrangement between a covered entity and any other entity
whereby the covered entity discloses protected health information, in exchange for
direct or indirect remuneration, for the other entity to communicate about its own
products or services encouraging the use or purchase of those products or services.
A covered entity must obtain an authorization to use or disclose protected health
information for marketing, except for face-to-face marketing communications
between a covered entity and an individual, and for a covered entity's provision of
promotional gifts of nominal value. No authorization is needed, however, to make a
communication that falls within one of the exceptions to the marketing definition.
An authorization for marketing that involves the covered entity's receipt of direct or
indirect remuneration from a third party must reveal that fact. See OCR "Marketing"
Guidance.
Limiting Uses Minimum Necessary. A central aspect of the Privacy Rule is the principle of •
minimum necessary�, use and disclosure. A covered entity must make reasonable
:'and Disclosures efforts to use, disclose, and request only the minimum amount of protected health
t0 the information needed to accomplish the intended purpose of the use, disclosure, or
Minimum request 50 A covered entity must develop and implement policies and procedures to
reasonably limit uses and disclosures to the minimum necessary. When the minimum
Necessary necessary standard applies to a use or disclosure, a covered entity may not use,
disclose, or request the entire medical record for a particular purpose, unless it can
specifically justify the whole record as the amount reasonably needed for the purpose.
See OCR"Minimum Necessary"Guidance.
The minimum necessary requirement is not imposed in any of the following
circumstances: (a) disclosure to or a request by a health care provider for treatment;
(b) disclosure to an individual who is the subject of the information, or the
: individual's personal representative; (c) use or disclosure made pursuant to an
authorization; (d) disclosure to HHS for complaint investigation, compliance review
or enforcement; (e) use or disclosure that is required by law; or (f) use or disclosure
required for compliance with the HIPAA Transactions Rule or other HIPAA
Administrative Simplification Rules.
Access and Uses. For internal uses, a covered entity must develop and implement
policies and procedures that restrict access and uses of protected health information
based on the specific roles of the members of their workforce. These policies and
procedures must identify the persons, or classes of persons, in the workforce who
need access to protected health information to carry out their duties,the categories of •
OCR Privacy Rule Summary 10 Last Revised 05/03
• for them, provided by or included in a benefit plan of the covered entity
making the communication;
• Communications about participating providers in a provider or health plan
network, replacement of or enhancements to a health plan, and health-related
products or services available only to a health plan's enrollees that add value
to,but are not part of,the benefits plan;
• Communications for treatment of the individual;and
• Communications for case management or care coordination for the
individual, or to direct or recommend alternative treatments, therapies,
health care providers, or care settings to the individual.
Marketing also is an arrangement between a covered entity and any other entity
whereby the covered entity discloses protected health information, in exchange for
direct or indirect remuneration, for the other entity to communicate about its own
products or services encouraging the use or purchase of those products or services.
A covered entity must obtain an authorization to use or disclose protected health
information "for marketing, except for face-to-face marketing communications
between a covered entity and an individual, and for a covered entity's provision of
promotional gifts of nominal value. No authorization is needed, however, to make a
communication that falls within one of the exceptions to the marketing definition.
An authorization for marketing that involves the covered entity's receipt of direct or
indirect remuneration from a third party must reveal that fact. See OCR"Marketing,"
'' Guidance.
• ,L><m><hng Minimum Necessary. A central aspect of the Privacy Rule is the principle of
Uses.
"minimum necessary" use and disclosure. A covered entity must make reasonable
and Disclosures efforts to use, disclose, and request only the minimum amount of protected health
t0 the information needed to accomplish the intended purpose of the use, disclosure, or
request 50 A covered entity must develop and implement policies and procedures to
Mlllllllllill reasonably limit uses and disclosures to the minimum necessary. When the minimum
NeCeSsal`y necessary standard applies to a use or disclosure, a covered entity may not use,
disclose, or request the entire medical record for a particular purpose, unless it can
specifically justify the whole record as the amount reasonably needed for the purpose.
See OCR"Minimum Necessary"Guidance.
The minimum necessary requirement is not imposed in any of the following
circumstances: (a) disclosure to or a request by a health care provider for treatment;
(b) disclosure to an individual who is the subject of the information, or the
individual's personal representative; (c) use or disclosure made pursuant to an
authorization; (d) disclosure to HHS for complaint investigation, compliance review
or enforcement; (e) use or disclosure that is required by law; or (f) use or disclosure
required for compliance with the HIPAA Transactions Rule or other HIPAA
Administrative Simplification Rules.
Access and Uses. For internal uses, a covered entity must develop and implement
policies and procedures that restrict access and uses of protected health information
based on the specific roles of the members of their workforce. These policies and
procedures must identify the persons, or classes of persons, in the workforce who
• need access to protected health information to carry out their duties,the categories of
OCR Privacy Rule Summary 10 Last Revised 0510
• protected health information to which access is needed, and any conditions under
which they need the information to do their jobs.
Disclosures and Requests for Disclosures. Covered entities must establish and
implement policies and procedures (which may be standard protocols) for routine,
recurring disclosures, or requests for disclosures, that limits the protected health
information disclosed to that which is the minimum amount reasonably necessary to
achieve the purpose of the disclosure. Individual review of each disclosure is not
required. For non-routine, non-recurring disclosures, or requests for disclosures that
it makes, covered entities must develop criteria designed to limit disclosures to the
information reasonably necessary to accomplish the purpose of the disclosure and
review each of these requests individually in accordance with the established criteria.
Reasonable Reliance. If another covered entity makes a request for protected health
information, a covered entity may rely, if reasonable under the circumstances, on the
request as complying with this minimum necessary standard. Similarly, a covered
entity may rely upon requests as being the minimum necessary protected health
information from: (a) a public official, (b) a professional (such as an attorney or
accountant)who is the covered entity's business associate, seeking the information to
provide services to or for the covered entity; or (c) a researcher who provides the
documentation or representation required by the Privacy Rule for research.
NOt1Ce and Privacy Practices Notice. Each covered entity, with certain exceptions, must
provide a notice of its privacy practices 51 The Privacy Rule requires that the notice
Other
• contain certain elements. The notice must describe the ways in which the covered
Individual entity may use and disclose protected health information. The notice must state the
R><ghtS covered entity's duties to protect privacy, provide a notice of privacy practices, and
abide by the terms of the current notice. The notice must describe individuals' rights,
including the right to complain to HHS and to the covered entity if they believe their
privacy rights have been violated. The notice must include a point of contact for
further information and for making complaints to the covered entity. Covered entities
must act in accordance with their notices. The Rule also contains specific
distribution requirements for direct treatment providers, all other health care
providers,and health plans. See OCR"Notice"Guidance.
• Notice Distribution. A covered health care provider with a direct treatment
relationship with individuals must deliver a privacy practices notice to
patients starting April 14,2003 as follows:
o Not later than the first service encounter by personal delivery (for
patient visits), by automatic and contemporaneous electronic
response(for electronic service delivery), and by prompt mailing(for
telephonic service delivery);
o By posting the notice at each service delivery site in a clear and
prominent place where people seeking service may reasonably be
expected to be able to read the notice; and
o In emergency treatment situations, the provider must furnish its
notice as soon as practicable after the emergency abates.
•
OCR Privacy Rule Summary 11 Last Revised 05/03
Covered entities, whether direct treatment providers or indirect treatment •
providers (such as laboratories)or health plans must supply notice to anyone
on request.52 A covered entity must also make its notice electronically
available on any web site it maintains for customer service or benefits
information.
The covered entities in an organized health care arrangement may use ajoint
privacy practices notice, as long as each agrees to abide by the notice content
with respect to the protected health information created or received in
connection with participation in the arrangement.53 Distribution of a joint
notice by any covered entity participating in the organized health care
arrangement at the first point that an OHCA member has an obligation to
provide notice satisfies the distribution obligation of the other participants in
the organized health care arrangement.
A health plan must distribute its privacy practices notice to each of its
enrollees by its Privacy Rule compliance date. Thereafter, the health plan
must give its notice to each new enrollee at enrollment, and send a reminder
to every enrollee at least once every three years that the notice is available
upon request. A health plan satisfies its distribution obligation by furnishing
the notice to the "named insured," that is, the subscriber.for coverage that
also applies to spouses and dependents.
• Acknowledgement of Notice Receipt. A covered health care provider with
a direct treatment relationship with individuals must make a good faith effort
to obtain written acknowledgement from patients of receipt of the privacy •
practices notice.54 The Privacy Rule does not prescribe any particular content
for the acknowledgement. The provider must document the reason for any
failure to obtain the patient's written acknowledgement. The provider is
relieved of the need to request acknowledgement in an emergency treatment
situation.
Access. Except in certain circumstances, individuals have the right to review and
obtain a copy of their protected health information in a covered entity's designated
record set.55 The "designated record set" is that group of records maintained by or
for a covered entity that is used, in whole or part, to make decisions about
individuals, or that is a provider's medical and billing records about individuals or a
health plan's enrollment, payment, claims adjudication, and case or medical
management record systems.56 The Rule excepts from the right of access the
following protected health information: psychotherapy notes, information compiled
for legal proceedings, laboratory results to which the Clinical Laboratory
Improvement Act (CLIA) prohibits access, or information held by certain research
laboratories. For information included within the right of access, covered entities
may deny an individual access in certain specified situations,such as when a health
care professional believes access could cause harm to the individual or another. In
such situations, the individual must be given the right to have such denials reviewed
by a licensed health care professional for a second opinion.57 Covered entities may
impose reasonable,cost-based fees for the cost of copying and postage.
Amendment. The Rule gives individuals the right to have covered entities amend
their protected health information in a designated record set when that information-Ls-
OCR Privacy Rule Summary 12 Last Revised 05/03
i
• Covered entities, whether direct treatment providers or indirect treatment
providers(such as laboratories)or health plans must supply notice to anyone
on request.52 A covered entity must also make its notice electronically
available on any web site it maintains for customer service or benefits
information.
The covered entities in an organized health care arrangement may use a joint
privacy practices notice,as long as each agrees to abide by the notice content
with respect to the protected health information created or received, in
connection with participation in the arrangement.53 Distribution of a joint
notice by any covered entity participating in the organized health care
arrangement at the first point that an OHCA member has an obligation to
provide notice satisfies the distribution obligation of the other participants in
the organized health care arrangement.
A health plan must distribute its privacy practices notice to each of its
enrollees by its Privacy Rule compliance date. Thereafter, the health plan
must give its notice to each new enrollee at enrollment, and send a reminder
to every enrollee at least once every three years that the notice is available
upon request. A health plan satisfies its distribution obligation by furnishing
the notice to the "named insured," that is, the subscriber.for coverage that
also applies to spouses and dependents.
• Acknowledgement of Notice Receipt. A covered health care provider with
• a direct treatment relationship with individuals must make a good faith effort
to obtain written acknowledgement from patients of receipt of the privacy
practices notice.54 The Privacy Rule does not prescribe any particular content
for the acknowledgement. The provider must document the reason for any
failure to obtain the patient's written acknowledgement. The provider is
relieved of the need to request acknowledgement in an emergency treatment
situation.
Access. Except in certain circumstances, individuals have the right to review and
obtain a copy of their protected health information in a covered entity's designated
record set.55 The "designated record set" is that group of records maintained by or
for a covered entity that is used, in whole or part, to make decisions about
individuals, or that is a provider's medical and billing records about individuals or a
health plan's enrollment, payment, claims adjudication, and case or medical
management record systems.56 The Rule excepts from the right of access the
following protected health information: psychotherapy notes, information compiled
for legal proceedings, laboratory results to which the Clinical Laboratory
Improvement Act (CLIA) prohibits access, or information held by certain research
laboratories. For information included within the right of access, covered entities
may deny an individual access in certain specified situations,such as when a health
care professional believes access could cause harm to the individual or another. In
such situations, the individual must be given the right to have such denials reviewed
by a licensed health care professional for a second opinion.57 Covered entities may
impose reasonable,cost-based fees for the cost of copying and postage.
Amendment. The Rule gives individuals the right to have covered entities amend
• their protected health information in a designated record set when that information is
OCR Privacy Rule Summary 12 Last Revised 05/03
• inaccurate or incomplete. If a covered entity accepts an amendment request,it must
make reasonable efforts to provide the amendment to persons that the individual has
identified as needing it, and to persons that the covered entity knows might rely on
the information to the individual's detriment 59 If the request is denied, covered
entities must provide the individual with a written denial and allow the individual to
submit a statement of disagreement for inclusion in the record. The Rule specifies
processes for requesting and responding to a request for amendment. A covered
entity must amend protected health information in its designated record set upon
receipt of notice to amend from another covered entity.
Disclosure Accounting. Individuals have a right to an accounting of the disclosures
of their protected health information by a covered entity or the covered entity's
business associates.60 The maximum disclosure accounting period is the six years
immediately preceding the accounting request, except a covered entity is not
obligated to account for any disclosure made before its Privacy Rule compliance date.
The Privacy Rule does not require accounting for disclosures: (a) for treatment,
payment, or health care operations; (b) to the individual or the individual's personal
representative; (c) for notification of or to persons involved in an individual's health
care or payment for health care, for disaster relief, or for facility directories; (d)
pursuant to an authorization; (e) of a limited data set; (f) for national security or
intelligence purposes; (g)to correctional institutions or law enforcement officials for
certain purposes regarding inmates or individuals in lawful custody; or(h)incident to
otherwise permitted or required uses or disclosures. Accounting for disclosures to
health oversight agencies and law enforcement officials must be temporarily
• suspended on their written representation that an accounting would likely impede
their activities.
Restriction Request. Individuals have the right to request that a covered entity
restrict use or disclosure of protected health information for treatment, payment or
health care operations, disclosure to persons involved in the individual's health care
or payment for health care,or disclosure to notify family members or others about the
individual's general condition, location, or death 61 A covered entity is under no
obligation to agree to requests for restrictions. A covered entity that does agree must
comply with the agreed restrictions,except for purposes of treating the individual in a
medical emergency.62
Confidential Communications Requirements. Health plans and covered health
care providers must permit individuals to request an alternative means or location for
receiving communications of protected health information by means other than those
that the covered entity typically employs. 3 For example, an individual may request
that the provider communicate with the individual through a designated address or
phone number. Similarly, an individual may request that the provider send
communications in a closed envelope rather than a post card.
Health plans must accommodate reasonable requests if the individual indicates that
the disclosure of all or part of the protected health information could endanger the
individual. The health plan may not question the individual's statement of
endangerment. Any covered entity may condition compliance with a confidential
communication request on the individual specifying an alternative address or method
• of contact and explaining how any payment will be handled.
OCR Privacy Rule Summary 13 Last Revised 05/03
Administrative HHS recognizes that covered entities range from the smallest provider to the largest, •
multi-state health plan. Therefore the flexibility and scalability of the Rule are
Requirements intended to allow covered entities to analyze their own needs and implement
solutions appropriate for their own environment. What is appropriate for a particular
covered entity will depend on the nature of the covered entity's business, as well as
the covered entity's size and resources.
Privacy Policies and Procedures. A covered entity must develop and implement
written privacy policies and procedures that are consistent with the Privacy Rule.64
Privacy Personnel. A covered entity must designate a privacy official responsible
for developing and implementing its privacy policies and procedures, and a contact
person or contact office responsible for receiving complaints and providing
individuals with information on the covered entity's privacy practices.61
Workforce Training and Management. Workforce members include employees,
volunteers, trainees, and may also include other persons whose conduct is under the
direct control of the entity (whether or not they are paid by the entity).66 A covered
entity must train all workforce members on its privacy policies and procedures, as
necessary and appropriate for them to carry out their functions. 7 A covered entity
must have and apply appropriate sanctions against workforce members who violate
its privacy policies and procedures or the Privacy Rule.68
Mitigation. A covered entity must mitigate, to the extent practicable, any harmful
effect it learns was caused by use or disclosure of protected health information by its •
workforce or its business associates in violation of its privacy policies and procedures
or the Privacy Rule.69
Data Safeguards. A covered entity must maintain reasonable and appropriate
administrative, technical, and physical safeguards to prevent intentional or
unintentional use or disclosure of protected health information in violation of the
Privacy Rule and to limit its incidental use and disclosure pursuant to otherwise
permitted or required use or disclosure.70 For example, such safeguards might
include shredding documents containing protected health information before
discarding them, securing medical records with lock and key or pass code, and
limiting access to keys or pass codes. See OCR "Incidental Uses and Disclosures"
Guidance.
Complaints. A covered entity must have procedures for individuals to complain
about its compliance with its privacy policies and procedures and the Privacy Rule."
The covered entity must explain those procedures in its privacy practices notice.'Z
Among other things, the covered entity must identify to whom individuals can submit
complaints to at the covered entity and advise that complaints also can be submitted
to the Secretary of HHS.
Retaliation and Waiver. A covered entity may not retaliate against a person for
exercising rights provided by the Privacy Rule, for assisting in an investigation by
HHS or another appropriate authority, or for opposing an act or practice that the
person believes in good faith violates the Privacy Rule.73 A covered entity may not •
OCR Privacy Rule Summary 14 Last Revised 05/03
HHS recognizes that covered entities range from the smallest provider to the largest,Admin>istra>hve _ gn� p g ,
multi-state health plan. Therefore the flexibility and scalability of the Rule are
Requirements intended to allow covered entities to analyze their own needs and implement
solutions appropriate for their own environment. What is appropriate for a particular
covered entity will depend on the nature of the covered entity's business, as well as
the covered entity's size and resources.
Privacy Policies and Procedures. A covered entity must develop and implement
written privacy policies and procedures that are consistent with the Privacy Rule.64
Privacy Personnel. A covered entity must designate a privacy official responsible
for developing and implementing its privacy policies and procedures, and a contact
person or contact office responsible for receiving complaints and providing
individuals with information on the covered entity's privacy practices.65
Workforce Training and Management. Workforce members include employees,
volunteers, trainees, and may also include other persons whose conduct is under the
direct control of the entity(whether or not they are paid by the entity)66 A covered
entity must train all workforce members on its privacy policies and procedures, as
necessary and appropriate for them to carry out their functions. 7 A covered entity
must have and apply appropriate sanctions against workforce members who violate
` its privacy policies and procedures or the Privacy Rule.68
• Mitigation. A covered entity must mitigate, to the extent practicable, any harmful
effect it learns was caused by use or disclosure of protected health information by its
workforce or its business associates in violation of its privacy policies and procedures
or the Privacy Rule 69
Data Safeguards. A covered entity must maintain reasonable and appropriate
administrative, technical, and physical safeguards to prevent intentional or
unintentional use or disclosure of protected health information in violation of the
Privacy Rule and to limit its incidental use and disclosure pursuant to otherwise
permitted or required use or disclosure.70 For example, such safeguards might
include shredding documents containing protected health information before
discarding them, securing medical records with lock and key or pass code, and
limiting access to keys or pass codes. See OCR "Incidental Uses and Disclosures"
Guidance.
Complaints. A covered entity must have procedures for individuals to complain
- about its compliance with its privacy policies and procedures and the Privacy Rule.71
The covered entity must explain those procedures in its privacy practices notice.'Z
Among other things,the covered entity must identify to whom individuals can submit
complaints to at the covered entity and advise that complaints also can be submitted
to the Secretary of HHS.
Retaliation and Waiver. A covered entity may not retaliate against a person for
exercising rights provided by the Privacy Rule, for assisting in an investigation by
HHS or another appropriate authority, or for opposing an act or practice that the
• person believes in good faith violates the Privacy Rule.73 A covered entity may not -�
OCR Privacy Rule Summary 14 Last Revised 05/03
• require an individual to waive any right under the Privacy Rule as a condition for
obtaining treatment,payment,and enrollment or benefits eligibility.74
Documentation and Record Retention. A covered entity must maintain, until six
years after the later of the date of their creation or last effective date, its privacy
policies and procedures, its privacy practices notices, disposition of complaints, and
other actions, activities, and designations that the Privacy Rule requires to be
documented.75
Fully-Insured Group Health Plan Exception. The only administrative obligations
with which a fully-insured group health plan that has no more than enrollment data
and summary health information is required to comply are the (1) ban on retaliatory
acts and waiver of individual rights,and(2)documentation requirements with respect
to plan documents if such documents are amended to provide for the disclosure of
protected health information to the plan sponsor by a health insurance issuer or HMO
that services the group health plan.76
-Organizational The Rule contains provisions that address a variety of organizational issues that may
Options affect the operation of the privacy protections.
Hybrid Entity. The Privacy Rule permits a covered entity that is a single legal entity
and that conducts both covered and non-covered functions to elect to be a "hybrid
entity."77 (The activities that make a person or organization a covered entity are its
"covered functions.,78) To be a hybrid entity, the covered entity must designate in
• writing its operations that perform covered functions as one or more "health care
components."After making this designation,most of the requirements of the Privacy
Rule will apply only to the health care components. A covered entity that does not
make this designation is subject in its entirety to the Privacy Rule.
Affiliated Covered Entity. Legally separate covered entities that are affiliated by
common ownership or control may designate themselves (including their health care
components) as a single covered entity for Privacy Rule compliance.79 The
designation must be in writing. An affiliated covered entity that performs multiple
covered functions must operate its different covered functions in compliance with the
Privacy Rule provisions applicable to those covered functions.
Organized Health Care Arrangement. The Privacy Rule identifies relationships in
which participating covered entities share protected health information to manage and
benefit their common enterprise as"organized health care arrangements."80 Covered
entities in an organized health care arrangement can share protected health
information with each other for the arrangement's joint health care operations.$'
Covered Entities With Multiple Covered Functions. A covered entity that
performs multiple covered functions must operate its different covered functions in
compliance with the Privacy Rule provisions applicable to those covered functions 82
The covered entity may not use or disclose the protected health information of an
individual who receives services from one covered function (e.g., health care
provider) for another covered function (e.g., health plan) if the individual is not
involved with the other function.
•
OCR Privacy Rule Summary 15 Last Revised 05/03
•
Group Health Plan disclosures to Plan Sponsors. A group health plan and the
health insurer or HMO offered by the plan may disclose the following protected
health information to the "plan sponsor"—the employer, union, or other employee
organization that sponsors and maintains the group health plan83:
• Enrollment or disenrollment information with respect to the group health
plan or a health insurer or HMO offered by the plan.
• If requested by the plan sponsor, summary health information for the plan
sponsor to use to obtain premium bids for providing health insurance
coverage through the group health plan, or to modify, amend, or terminate
the group health plan. "Summary health information" is information that
summarizes claims history, claims expenses, or types of claims experience of
the individuals for whom the plan sponsor has provided health benefits
through the group health plan, and that is stripped of all individual identifiers
other than five digit zip code (though it need not qualify as de-identified
protected health information).
• Protected health information of the group health plan's enrollees for the plan
sponsor to perform plan administration functions. The plan must receive
certification from the plan sponsor that the group health plan document has
been amended to impose restrictions on the plan sponsor's use and disclosure
of the protected health information. These restrictions must include the
representation that the plan sponsor will not use or disclose the protected
health information for any employment-related action or decision or in
connection with any other benefit plan. •
Other Personal Representatives. The Privacy Rule requires a covered entity to treat a
'personal representative" the same as the individual, with respect to uses and
Provisions: disclosures of the individual's protected health information, as well as the
Personal individual's rights under the Rule.84 A personal representative is a person legally
authorized to make health care decisions on an individual's behalf or to act for a
Representatives
deceased individual or the estate. The Privacy Rule permits an exception when a
and Minors covered entity has a reasonable belief that the personal representative may be abusing
or neglecting the individual, or that treating the person as the personal representative
could otherwise endanger the individual.
Special case: Minors. In most cases, parents are the personal representatives for
their minor children. Therefore, in most cases,parents can exercise individual rights,
such as access to the medical record, on behalf of their minor children. In certain
exceptional cases, the parent is not considered the personal representative. In these
situations, the Privacy Rule defers to State and other law to determine the rights of
parents to access and control the protected health information of their minor children.
If State and other law is silent concerning parental access to the minor's protected
health information, a covered entity has discretion to provide or deny a parent access
to the minor's health information, provided the decision is made by a licensed health
care professional in the exercise of professional judgment. See OCR "Personal
Representatives"Guidance.
•
OCR Privacy Rule Summary 16 Last Revised 05/03
• uested by the plan sponsor, summary health information for the
• Wor to use to obtain premium bids for providing health insuraW
coverage through the group health plan, or to modify, amend, or terminate
the group health plan. "Summary health information" is information that
summarizes claims history, claims expenses,or types of claims experience of
the individuals for whom the plan sponsor has provided health benefits
through the group health plan, and that is stripped of all individual identifiers
other than five digit zip code (though it need not qualify as de-identified
protected health information).
• Protected health information of the group health plan's enrollees for the plan
sponsor to perform plan administration functions. The plan must receive
certification from the plan sponsor that the group health plan document has
been amended to impose restrictions on the plan sponsor's use and disclosure
of the protected health information. These restrictions must include the
representation that the plan sponsor will not use or disclose the protected
health information for any employment-related action or decision or in
connection with any other benefit plan.
Other Personal Representatives. The Privacy Rule requires a covered entity to treat a
'personal representative" the same as the individual, with respect to uses and
PrOvisions:. disclosures of the individual's protected health information, as well as the
PerSOilal individual's rights under the Rule.84 A personal representative is a person legally
' . authorized to make health care decisions on an individual's behalf or to act for a
Re resentat><ves
P,:> deceased individual or the estate. The Privacy Rule permits an exception when a
and Minors covered entity has a reasonable belief that the personal representative may be abusing
or neglecting the individual, or that treating the person as the personal representative
could otherwise endanger the individual
Special case: Minors. In most cases, parents are the personal representatives for
their minor children. Therefore, in most cases,parents can exercise individual rights,
such as access to the medical record, on behalf of their minor children. In certain
exceptional cases, the parent is not considered the personal representative. In these
situations, the Privacy Rule defers to State and other law to determine the rights of
parents to access and control the protected health information.of their minor children.
If State and other law is silent concerning parental access to the minor's protected
health information, a covered entity has discretion to provide or deny a parent access
to the minor's health information, provided the decision is made by a licensed health
care professional in the exercise of professional judgment. See OCR "Personal
Representatives"Guidance.
OCR Privacy Rule Summary 16 Last Revised 05/03
• State Law Preemption. In general, State laws that are contrary to the Privacy Rule are
preempted by the federal requirements, which means that the federal requirements
will apply.85 "Contrary" means that it would be impossible for a covered entity to
comply with both the State and federal requirements, or that the provision of State
law is an obstacle to accomplishing the full purposes and objectives of the
Administrative Simplification provisions of HIPAA.86 The Privacy Rule provides
exceptions to the general rule of federal preemption for contrary State laws that (1)
relate to the privacy of individually identifiable health information and provide
greater privacy protections or privacy rights with respect to such information, (2)
provide for the reporting of disease or injury, child abuse, birth, or death, or for
public health surveillance, investigation, or intervention, or (3) require certain health
plan reporting, such as for management or financial audits.
Exception Determination. In addition, preemption of a contrary State law will not
occur if HHS determines, in response to a request from a State or other entity or
person,that the State law:
• Is necessary to prevent fraud and abuse related to the provision of or payment
for health care,
• Is necessary.to ensure appropriate State regulation of insurance and health
plans to the extent expressly authorized by statute or regulation,
• Is necessary for State reporting on health care delivery or costs,
• Is necessary for purposes of serving a compelling public health, safety, or
• welfare need, and, if a Privacy Rule provision is at issue, if the Secretary
determines that the intrusion into privacy is warranted when balanced against
the need to be served; or
• Has as its principal purpose the regulation of the manufacture, registration,
distribution, dispensing, or other control of any controlled substances (as
defined in 21 U.S.C. 802), or that is deemed a controlled substance by State
law.
Enforcement Compliance. Consistent with the principles for achieving compliance provided in
the Rule, HHS will seek the cooperation of covered entities and may provide
and Penalties technical assistance to help them comply voluntarily with the Rule$' The Rule
for provides processes for persons to file complaints with HHS, describes the
Noncompliance responsibilities of covered entities to provide records and compliance reports and to
cooperate with, and permit access to information for, investigations and compliance
reviews.
Civil Money Penalties. HHS may impose civil money penalties on a covered entity
of$100 per failure to comply with a Privacy Rule requirement.$$ That penalty may
not exceed $25,000 per year for multiple violations of the identical Privacy Rule
requirement in a calendar year. HHS may not impose a civil money penalty under
specific circumstances, such as when a violation is due to reasonable cause and did
not involve willful neglect and the covered entity corrected the violation within 30
days of when it knew or should have known of the violation.
•
OCR Privacy Rule Summary 17 Last Revised 05/03
Criminal Penalties. A person who knowingly obtains or discloses individually •
identifiable health information in violation of HIPAA faces a fine of$50,000 and up
to one-year imprisonment89 The criminal penalties increase to $100,000 and up to
five years imprisonment if the wrongful conduct involves false pretenses, and to
$250,000 and up to ten years imprisonment if the wrongful conduct involves the
intent to sell, transfer, or use individually identifiable health information for
commercial advantage, personal gain, or malicious harm. Criminal sanctions will be
enforced by the Department of Justice.
COIIlplia.11Ce+ Compliance Schedule. All covered entities, except "small health plans," must be
compliant with the Privacy Rule by April 14, 2003.90 Small health plans, however,
Dates have until April 14,2004 to comply.
Small Health Plans. A health plan with annual receipts of not more than $5 million
is a small health plan 91 Health plans that file certain federal tax returns and report
receipts on those returns should use the guidance provided by the Small Business
Administration at 13 Code of Federal Regulations (CFR) 121.104 to calculate annual
receipts. Health plans that do not report receipts to the Internal Revenue Service
(IRS), for example, group health plans regulated by the Employee Retirement Income
Security Act 1974 (ERISA) that are exempt from filing income tax returns, should
use proxy measures to determine their annual receipts.92
See What constitutes a small health pan?
iti •
;COp1eS Of the:. The entire Privacy Rule, as well as guidance and additional materials y ma be found
on our website,http://www.hhs.gov/ocr/hipaa.
Rule A.Related
Materials
OCR Privacy Rule Summary 18 Last Revised 05/03
• Criminal Penalties: A person who knowingly obtains or discloses individually p g y dually
_ identifiable health information in violation of HIPAA faces a fine of$50,000 and up
to one-year imprisonment.89 The criminal penalties increase to $100,000 and up to
five years imprisonment if the wrongful conduct involves false pretenses, and to
$250,000 and up to ten years imprisonment if the wrongful conduct involves the
intent to sell, transfer, or use individually identifiable health information for
commercial advantage, personal gain, or malicious harm. Criminal sanctions will be
enforced by the Department of Justice.
Compliance Compliance Schedule. All covered entities, except "small health plans," must be
compliant with the Privacy Rule by April 14, 2003.90 Small health plans, however,
1)ate5 have until April 14,2004 to comply.
R
Small Health Plans. A health plan with annual receipts of not more than $5 million
is a small health plan 91 Health plans that file certain federal tax returns and report
receipts on those returns should use the guidance provided by the Small Business
Administration at 13 Code of Federal Regulations(CFR) 121.104 to calculate annual
receipts. Health plans that do not report receipts to the Internal Revenue Service
(IRS),for example,group health plans regulated by the Employee Retirement Income
Security Act 1974 (ERISA) that are exempt from filing income tax returns, should
92
use proxy measures to determine their annual receipts.
See What constitutes a small health plan?
•
CO lea Of the The entire Privacy Rule, as well as guidance and additional materials, may be found
p _ on our website'http://www.hhs.gov/ocr/1-iii)aa.
Rule & Related��
Materials
OCR Privacy Rule Summary 18 Last Revised 05/03
End Notes
'Pub.L. 104-191.
2 65 FR 82462.
'67 FR 53182.
4 45 C.F.R.§§ 160.102, 160.103.
5 Even if an entity, such as a community health center, does not meet the definition of a health
plan, it may, nonetheless,meet the definition of a health care provider, and, if it transmits health
information in electronic form in connection with the transactions for which the Secretary of HHS
has adopted standards under HIPAA,may still be a covered entity.
6 45 C.F.R. §§ 160:102, 160.103;see Social Security Act§ 1172(a)(3),42 U.S.C. § 1320d-l(a)(3).
The transaction standards are established by the HIPAA Transactions Rule at 45 C.F.R.Part 162.
'45 C.F.R.§ 160.103.
'45 C.F.R. § 164.500(b).
9 45 C.F.R. § 160.103.
10 45 C.F.R.§§ 164.502(e), 164.504(e).
" 45 C.F.R. § 164.532
12 45 C.F.R. § 160.103.
• "45 C.F.R.§ 160.103
14 45 C.F.R.§§ 164.502(d)(2), 164.514(a)and(b).
15 The following identifiers of the individual or of relatives,employers,or household members of
the individual must be removed to achieve the "safe harbor" method of de-identification: (A)
Names; (B) All geographic subdivisions smaller than 'a State, including street address, city,
county,precinct,zip code,and their equivalent geocodes,except for the initial three digits of a zip
code if, according to the current publicly available data from the Bureau of Census (1) the
geographic units formed by combining all zip codes with the same three initial digits contains
more than 20,000 people; and(2)the initial three digits of a zip code for all such geographic units
containing 20,000 or fewer people is changed to 000; (C) All elements of dates(except year)for
dates directly related to the individual,including birth date,admission date,discharge date,date of
death;and all ages over 89 and all elements of dates(including year)indicative of such age,except
that such ages and elements may be aggregated into a single category of age 90 or older; (D)
Telephone numbers;(E)Fax numbers;(F)Electronic mail addresses: (G)Social security numbers;
(H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K)
Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate
numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators
(URLs); (0) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger
and voice prints; (Q)Full face photographic images and any comparable images; and®any other
unique identifying number, characteristic, or code, except as permitted for re-identification
purposes provided certain conditions are met. In addition to the removal of the above-stated
identifiers,the covered entity may not have actual knowledge that the remaining information could
be used alone or in combination with any other information to identify an individual who is
subject of the information. 45 C.F.R. § 164.514(b).
16 45 C.F.R. § 164.502(a).
• "45 C.F.R. § 164;502(a)(2).
OCR Privacy Rule Summary 19 Last Revised 05/03
'$45 C.F.R. § 164.502(a)(1). •
19 45 C.F.R. § 164.506(c).
20
45 C.F.R. § 164.501.
2' 45 C.F.R.§ 164.501.
22 45 C.F.R. § 164.501.
23 45 C.F.R. § 164.508(a)(2)
24 45 C.F.R. § 164.506(b).
2s 45 C.F.R. § 164.510(a).
26 45 C.F.R. § 164.510(b).
27 45 C.F.R. §§ 164.502(a)(1)(iii).
28 See 45 C.F.R. § 164.512.
29 45 C.F.R.§ 164.512(a).
30 45 C.F.R.§ 164.512(b).
31 45 C.F.R. § 164.512(a),(c).
32 45 C.F.R. § 164.512(d).
33 45 C.F.R. § 164.512(e).
34 45 C.F.R. § 164.512(f).
35 45 C.F.R. § 164.512(g). •
36 45 C.F.R. § 164.512(h).
3' The Privacy Rule defines research as, "a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to generalizable
knowledge."45 C.F.R. § 164.501.
38 45 C.F.R.§ 164.512(i).
39 45 CFR§ 164.514(e).
4°45 C.F.R.§ 164.5120).
4' 45 C.F.R. § 164.512(k).
42 45 C.F.R. § 164.512(1).
43 45 C.F.R. § 164.514(e). A limited data set is protected health information that excludes the
following direct identifiers of the individual or of relatives, employers, or household members of
the individual: (i)Names; (ii) Postal address information, other than town or city, State and zip
code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses: (vi) Social
security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix)
Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers,
including license plate numbers; (xii)Device identifiers and serial numbers; (xiii)Web Universal
Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric
identifiers, including finger and voice prints; (xvi) Full face photographic images and any
comparable images. 45 C.F.R. § 164.514(e)(2).
44 45 C.F.R.§ 164.508.
45 A covered entity may condition the provision of health care solely to generate protected health
information for disclosure to a third party on the individual giving authorization to disclose the
•
OCR Privacy Rule Summary 20 Last Revised 05/03
'$45 C.F.R.§ 164.502(a)(1). )
19 45 C.F.R.§ 164.506(c).
2'
45 C.F.R.§ 164.501.
2' 45 C.F.R.§ 164.501.
22 45 C.F.R. § 164.501.
23 45 C.F.R.§ 164.508(a)(2)
24 45 C.F.R. § 164.506(b).
2s 45 C.F.R. § 164.510(a).
26 45 C.F.R.§ 164.510(b).
2'45 C.F.R.§§ 164.502(a)(1)(iii).
26 See 45 C.F.R. § 164.512.
29 45 C.F.R.§ 164.512(a).
30 45 C.F.R.§ 164.512(b).
31 45 C.F.R.§ 164.512(a),(c).
32 45 C.F.R.§ 164.512(d).
33 45 C.F.R. § 164.512(e).
sa 45 C.F.R.§ 164.512(f).
• ss 45 C.F.R.§ 164.512(g).
36 45 C.F.R.§ 164.512(h).
3' The Privacy Rule defines research as, "a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to generalizable
knowledge."45 C.F.R. § 164.501.
38 45 C.F.R.§ 164.512(i).
39 45 CFR§ 164.514(e).
40 45 C.F.R.§ 164.5126).
41 45 C.F.R.§ 164.512(k).
42 45 C.F.R.§ 164.512(l).
43 45 C.F.R. § 164.514(e). A limited data set is protected health information that excludes the
following direct identifiers of the individual or of relatives, employers, or household members of
the individual: (i)Names; (ii) Postal address information, other than town or city, State and zip
code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses: (vi) Social
security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix)
Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers,
including license plate numbers; (xii)Device identifiers and serial numbers;,(xiii)Web Universal
Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric
identifiers, including finger and voice prints; (xvi) Full face photographic images and any
comparable images. 45 C.F.R. § 164.514(e)(2).
as 45 C.F.R. § 164.508.
45 A covered entity may condition the provision of health care solely to generate protected health
information for disclosure to a third party on the individual giving authorization to disclose the
OCR Privacy Rule Summary 20 Last Revised 05/03
• information to the third party. For example,a covered entity physician may condition the
provision of a physical examination to be paid for by a life insurance issuer on an individual's
authorization to disclose the results of that examination to the life insurance issuer. A health plan
may condition enrollment or benefits eligibility on the individual giving authorization,requested
before the individual's enrollment,to obtain protected health information(other than
psychotherapy notes)to determine the individual's eligibility or enrollment or for underwriting or
risk rating. A covered health care provider may condition treatment related to research(e.g.,
clinical trials)on the individual giving authorization to use or disclose the individual's protected
health information for the research. 45 C.F.R.508(b)(4).
46 45 CFR§ 164.532.
4'"Psychotherapy notes"means notes recorded(in any medium)by a health care provider who is
a mental health professional documenting or analyzing the contents of conversation during a
private counseling session or a group,joint, or family counseling session and that are separated
from the rest of the of the individual's medical record. Psychotherapy notes excludes medication
prescription and monitoring, counseling session start and stop times, the modalities and
frequencies of treatment furnished, results of clinical tests, and any summary of the following
items: diagnosis,functional status,the treatment plan, symptoms,prognosis,and progress to date.
45 C.F.R.§ 164.501.
48 45 C.F.R.§ 164.508(a)(2).
49 45 C.F.R.§§ 164.501 and 164.508(a)(3).
so 45 C.F.R. §§ 164.502(b)and 164.514(d).
51 45 C.F.R. §§ 164.520(a)and(b). A group health plan,or a health insurer or HMO with respect
to the group health plan, that intends to disclose protected health information (including
• enrollment data or summary health information) to the plan sponsor, must state that fact in the
notice. Special statements are also required in the notice if a covered entity intends to contact
individuals about health-related benefits or services, treatment alternatives, or appointment
reminders,or for the covered entity's own fundraising.
12 45 C.F.R. §164.520(c).
"45 C.F.R. § 164.520(d).
14 45 C.F.R.§ 164.520(c).
ss 45 C.F.R.§ 164.524.
16 45 C.F.R. § 164.501.
57 A covered entity may deny an individual access,provided that the individual is given a right to
have such denials reviewed by a licensed health care professional(who is designated by the
covered entity and who did not participate in the original decision to deny),when a licensed health
care professional has determined,in the exercise of professional judgment,that: (a)the access
requested is reasonably likely to endanger the life or physical safety of the individual or another
person;(b)the protected health information makes reference to another person(unless such other
person is a health care provider)and the access requested is reasonably likely to cause substantial
harm to such other person;or(c)the request for access is made by the individual's personal
representative and the provision of access to such personal representative is reasonably likely to
cause substantial harm to the individual or another person.
A covered entity may deny access to individuals,without providing the individual an opportunity
for review,in the following protected situations: (a)the protected health information falls under
an exception to the right of access;(b)an inmate request for protected health information under
certain circumstances;(c)information that a provider creates or obtains in the course of research
that includes treatment for which the individual has agreed not to have access as part of consenting
•
OCR Privacy Rule Summary 21 Last Revised 05/03
to participate in the research(as long as access to the information is restored upon completion of •
the research);(d)for records subject to the Privacy Act,information to which access may be
denied under the Privacy Act,5 U.S.C.§552a;and(e)information obtained under a promise of
confidentiality from a source other than a health care provider,if granting access would likely
reveal the source. 45 C.F.R. § 164.524.
58 45 C.F.R. § 164.526.
59 Covered entities may deny an individual's request for amendment only under specified
circumstances. A covered entity may deny the request if it: (a)may exclude the information from
access by the individual; (b) did not create the information (unless the individual provides a
reasonable basis to believe the originator is no longer available),---(c)--determines--that-the
information is accurate and complete;or(d)does not hold the information in its designated record
set. 164.526(a)(2).
60 45 C.F.R. § 164.528.
61 45 C.F.R. § 164.522(a).
62 45 C.F.R. § 164.522(a). In addition, a restriction agreed to by a covered entity is not effective
under this subpart to prevent uses or disclosures permitted or required under §§ 164.502(a)(2)(ii),
164.510(a)or 164.512.
63 45 C.F.R. § 164.522(b).
64 45 C.F.R. § 164.530(i).
66 45 C.F.R. § 164.530(a).
66 45 C.F.R. §160.103.
67 45 C.F.R. § 164.530(b). •
68 45 C.F.R. § 164.530(e).
69 45 C.F.R. § 164.530(f).
70 45 C.F.R. § 164.530(c).
" 45 C.F.R. § 164.530(d).
'Z 45 C.F.R. § 164.520(b)(1)(vi).
73 45 C.F.R. § 164.530(g).
74 45 C.F.R. § 164.530(h).
75 45 C.F.R. § 164.5300).
76 45 C.F.R. § 164.530(k).
" 45 C.F.R. §§ 164.103,164.105.
78 45 C.F.R. § 164.103.
79 45 C.F.R. §164.105. Common ownership exists if an entity possesses an ownership or equity
interest of five percent or more in another entity; common control exists if an entity has the direct
or indirect power significantly to influence or direct the actions or policies of another entity. 45
C.F.R. §§ 164.103.
80 The Privacy Rule at 45 C.F.R. § 160.103 identifies five types of organized health care
arrangements:
• A clinically-integrated setting where individuals typically receive health care from more
than one provider.
• An organized system of health care in which the participating covered entities hold
themselves out to the public as part of a joint arrangement and jointly engage in •
OCR Privacy Rule Summary 22 Last Revised 05/03
to participate in the research(as long as access to the information is restored completion upon of
P
the research);(d)for records subject to the Privacy Act,information to which access may be
denied under the Privacy Act,5 U.S.C.§552a;and(e)information obtained under a promise of
confidentiality from a source other than a health care provider,if granting access would likely
reveal the source. 45 C.F.R.§ 164.524.
58 45 C.F.R.§ 164.526.
59 Covered entities may deny an individual's request for amendment only under specified
circumstances. A covered entity may deny the request if it: (a)may exclude the information from
access by the individual; (b) did not create the information (unless the individual provides a
reasonable basis to believe the originator is no longer available);-(c)—determines--that---the
information is accurate and complete;or(d)does not hold the information in its designated record
set. 164.526(a)(2).
60 45 C.F.R. § 164.528.
6' 45 C.F.R. § 164.522(a).
62 45 C.F.R. § 164.522(a). In addition, a restriction agreed to by a covered entity is not effective
under this subpart to prevent uses or disclosures permitted or required under§§ 164.502(a)(2)(ii),
164.510(a)or 164.512.
63 45 C.F.R.§ 164.522(b).
64 45 C.F.R.§ 164.530(i).
6s 45 C.F.R. § 164.530(a).
66 45 C.F.R. §160.103.
• 67 45 C.F.R. § 164.530(b).
68 45 C.F.R. § 164.530(e).
69 45 C.F.R. § 164.530(f).
70 45 C.F.R. § 164.530(c).
71 45 C.F.R. § 164.530(d).
7245 C.F.R.§ 164.520(b)(1)(vi).
73 45 C.F.R. § 164.530(g).
74 45 C.F.R. § 164.530(h).
75 45 C.F.R.§ 164.5300).
76 45 C.F.R.§ 164.530(k).
77 45 C.F.R. §§ 164.103,164.105.
78 45 C.F.R.§ 164.103.
79 45 C.F.R. §164.105. Common ownership exists if an entity possesses an ownership or equity
interest of five percent or more in another entity;common control exists if an entity has the direct
or indirect power significantly to influence or direct the actions or policies of another entity. 45
C.F.R. §§ 164.103.
80 The Privacy Rule at 45 C.F.R.§ 160.103 identifies five types of organized health care
arrangements:
• A clinically-integrated setting where individuals typically receive health care from more
than one provider.
• An organized system of health care in which the participating covered entities hold
themselves out to the public as part of a joint arrangement and jointly engage in
OCR Privacy Rule Summary 22 Last Revised 05/03
• utilization review,quality assessment and improvement activities,or risk-sharing
payment activities.
• A group health plan and the health insurer or HMO that insures the plan's benefits,with
respect to protected health information created or received by the insurer or HMO that
relates to individuals who are or have been participants or beneficiaries of the group
health plan.
• All group health plans maintained by the same plan sponsor.
• All group health plans maintained by the same plan sponsor and all health insurers and
HMOs that insure the plans'benefits,with respect to protected health information created
or received by the insurers or HMOs that relates to individuals who are or have been
participants or beneficiaries in the group health plans.
81 45 C.F.R. § 164.506(c)(5).
az 45 C.F.R. § 164.504(g).
as 45 C.F.R.§ 164.504 .
sa 45 C.F.R.§ 164.502(g).
ss 45 C.F.R. §160.203.
86 45 C.F.R.§ 160.202.
87 45 C.F.R.§ 160.304
s8 Pub.L. 104-191;42 U.S.C. §1320d-5.
s9 Pub.L. 104-191;42 U.S.C. §1320d-6.
90 45 C.F.R. § 164.534.
• 9i 45 C.F.R. § 160.103.
92 Fully insured health plans should use the amount of total premiums that they paid for health
insurance benefits during the plan's last full fiscal year. Self-insured plans, both funded and
unfunded,should use the total amount paid for health care claims by the employer,plan sponsor or
benefit fund,as applicable to their circumstances, on behalf of the plan during the plan's last full
fiscal year. Those plans that provide health benefits through a mix of purchased insurance and
self-insurance should combine proxy measures to determine their total annual receipts.
OCR Privacy Rule Summary 23 Last Revised 05/03
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Pagel of 5
f
Centers for Disease Control and Prevention Morbidi and
CDC 24/7,Savhg lives_Protecting P ple.Th9 Mortality Weekly
Report (MMWR)
Updated Recommendations for Use of Tetanus Toxoid,
Reduced Diphtheria Toxoid, and Acellular Pertussis
(Tdap) Vaccine in Adults Aged 65 Years and Older —
Advisory Committee on Immunization Practices (ACIP),
2012
..................................................................................................................................................................................................................................................................................................................................................................
Weekly
June 29, 2012/ 61(25);468-470
Since 2005,the Advisory Committee on Immunization Practices (ACIP)has recommended a
tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap)vaccine booster dose.
for all adolescents aged 11 through 18 years (preferred at 11 through 12 years) and for those
adults aged 19 through 64 years who have not yet received a dose (1,22). In October 2010,
despite the lack of an approved Tdap vaccine for adults aged 65 years and older,ACIP
recommended that unvaccinated adults aged 65 years and older be vaccinated with Tdap if in
• close contact with an infant, and that other adults aged 65 years and older may receive Tdap
(3). In July 2011,the Food and Drug Administration (FDA) approved expanding the age
indication for Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) to aged 65 years and
older (4). In February 2012,ACIP recommended Tdap for all adults aged 65 years and older.
This recommendation supersedes previous Tdap recommendations regarding adults aged 65
years and older.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population. The Work Group also considered
safety and immunogenicity data from clinical trials and observational studies on the use of
Tdap in adults aged 65 years and older (3).
The two Tdap vaccines available in the United States, Boostrix and Adacel (Sanofi Pasteur,
Toronto, Canada), differ in composition and approved age for use Table). Only Boostrix is
approved for adults aged 65 years and older;however,ACIP discussed the use of Adacel in this
age group. On February 22, 2012,ACIP approved use of Tdap for all adults aged 65 years and
older. This report summarizes data considered and conclusions made by ACIP and provides
guidance for implementing the recommendation.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population. The Work Group also considered
• safety and immunogenicity data from clinical trials and observational studies on the use of
Tdap in adults aged 65 years and older (3). The Work Group then presented policy options for
consideration to the full ACIP.
http://www.cdc.gov/mmwr/preview/minwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 2 of 5
It
Epidemiology of Pertussis in Older Adults
Because pertussis is underdiagnosed and underreported substantially in all age groups, the •
actual burden of disease in adults aged 65 years and older is unknown (5). During 2000-2010,
an annual average of 318 pertussis cases (range: 71-719 cases) in adults aged 65 years and
older were reported each year through the National Notifiable Diseases Surveillance System
(CDC, unpublished data, 2011). Challenges to diagnosing and reporting pertussis in all adults
include 1) underrecognition of pertussis as a cause for cough illness, 2) atypical presentation of
symptoms in adults, and 3) a low index of suspicion among providers (6,7). Few studies are
focused on the burden of pertussis in adults aged 65 years and older.Among reported
prospective studies,the calculated pertussis incidence ranged from 66 to 50o cases per
loo,000 persons per year(8-11). Reported pertussis incidence ranges from one to five cases
per 100,00o in adults of similar age ranges (CDC,unpublished data, 2011);this 70-fold to loo-
fold difference suggests that actual pertussis incidence in older adults is much higher than
reported (CDC,unpublished data, 2011). ACIP supported the conclusion that the actual burden
of pertussis in adults aged 65 years and older likely is at least loo times greater than that
reported.
Cost Effectiveness Analysis
ACIP reviewed two unpublished cost-effectiveness models, developed independently by
GlaxoSmithKline and CDC (12,13). Both models were developed to assess the epidemiologic
and economic impact of Tdap vaccination in adults aged 65 years and older and demonstrated
that a dose of Tdap for older adults resulted in a moderate decrease in the number of cases and
outcomes (e.g., outpatient visits, hospitalizations, and deaths),which might represent a cost-
effective intervention. Model results were most sensitive to incidence of pertussis; however, •
sensitivity analyses showed that even with a range of underreporting of incidence,Tdap
vaccination might be cost-effective in this population. Reassured by the concordance between
the two cost-effectiveness models,ACIP's interpretations were that the cost per case averted
and cost per quality-adjusted life-year saved were modest, and pertussis incidence estimates
accounting for underreporting were reasonable based on limited data and expert opinion.
Tdap Products in the United States
Safety and immunogenicity data of Tdap administered to adults aged 65 years and older were
reviewed by ACIP in October 2010 and in February 2012 (q). Published and unpublished data
from clinical trials of Boostrix (N = 1,104) and Adacel (N = 1,170) on the safety and
immunogenicity of Tdap in adults aged 65 years and older who received vaccine were provided
by G1axoSmithKline and Sanofi Pasteur.
Safety. For both Tdap products,the frequency and severity of adverse events in persons aged
65 years and older were comparable to those among persons aged less than 65 years. No
increase in local or generalized reactions in Tdap recipients was observed, compared with
persons who received Td. No serious adverse events were considered related to vaccination (3).
Postmarketing data from the Vaccine Adverse Event Reporting System (VAERS) suggest that
the safety profile of Tdap vaccine in adults aged 65 years and older was comparable to that of
Td vaccine (14).
Boostrix immunogenicity. For diphtheria and tetanus, immune responses to Boostrix were
noninferior to the immune responses elicited by a comparator Td vaccine (15). Immune •
responses to pertussis antigens (i.e.,pertussis toxin [PT],filamentous hemagglutinin [FHA],
and pertactin [PRN])were noninferior to those observed following a 3-dose primary DTaP
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 2 of 5
Epidemiology of Pertussis in Older Adults
4PBecause pertussis is underdiagnosed and underreported substantially in all age groups, the
actual burden of disease in adults aged 65 years and older is unknown (5). During 2000-2010,
an annual average of 318 pertussis cases (range: 71-719 cases) in adults aged 65 years and
older were reported each year through the National Notifiable Diseases Surveillance System
(CDC,unpublished data, 2011). Challenges to diagnosing and reporting pertussis in all adults
include 1) underrecognition of pertussis as a cause for cough illness, 2) atypical presentation of
symptoms in adults,and 3) a low index of suspicion among providers (6,7). Few studies are
focused on the burden of pertussis in adults aged 65 years and older.Among reported
prospective studies,the calculated pertussis incidence ranged from 66 to 05_o cases per
100,00o persons per year(8-11). Reported pertussis incidence ranges from one to five cases
per 100,00o in adults of similar age ranges (CDC,unpublished data, 2011);this 70-fold to 100-
fold difference suggests that actual pertussis incidence in older adults is much higher than
reported (CDC,unpublished data, 2011).ACIP supported the conclusion that the actual burden
of pertussis in adults aged 65 years and older likely is at least too times greater than that
reported.
Cost Effectiveness Analysis
ACIP reviewed two unpublished cost-effectiveness models, developed independently by
G1axoSmithKline and CDC (12,13). Both models were developed to assess the epidemiologic
and economic impact of Tdap vaccination in adults aged 65 years and older and demonstrated
that a dose of Tdap for older adults resulted in a moderate decrease in the number of cases and
outcomes (e.g.,outpatient visits, hospitalizations; and deaths),which might represent a cost-
effective intervention. Model results were most sensitive to incidence of pertussis; however,
sensitivity analyses showed that even with a range of underreporting of incidence,Tdap
vaccination might be cost-effective in this population. Reassured by the concordance between
the two cost-effectiveness models,ACIP's interpretations were that the cost per case averted
and cost per quality-adjusted life-year saved were modest, and pertussis incidence estimates
accounting for underreporting were reasonable based on limited data and expert opinion.
Tdap Products in the United States
Safety and immunogenicity data of Tdap administered to adults aged 65 years and older were
reviewed by ACIP in October 2010 and in February 2012 (3). Published and unpublished data
from clinical trials of Boostrix(N = i,1o4) and Adacel (N = 1,170) on the safety and
immunogenicity of Tdap in adults aged 65 years and older who received vaccine were provided
by GlaxoSmithKline and Sanofi Pasteur.
Safety. For both Tdap products,the frequency and severity of adverse events in persons aged
65 years and older were comparable to those among persons aged less than 65 years. No
increase in local or generalized reactions in Tdap recipients was observed,compared with
persons who received Td. No serious adverse events were considered related to vaccination ( .
Postmarketing data from the Vaccine Adverse Event Reporting System (VAERS) suggest that
the safety profile of Tdap vaccine in adults aged 65 years and older was comparable to that of
Td vaccine (14).
Boostrix immunogenicity. For diphtheria and tetanus, immune responses to Boostrix were
• noninferior to the immune responses elicited by a comparator Td vaccine (15). Immune
responses to pertussis antigens (i.e.,pertussis toxin [PT],filamentous hemagglutinin [FHA],
and pertactin [PRN])were noninferior to those observed following a 3-dose primary DTaP
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 3 of 5
I
series with Infanrix (G1axoSmithKline),according to predefined criteria discussed with and
agreed to by FDA before study initiation (16). Boostrix contains the same three pertussis
• antigens as Infanrix,but in reduced quantities. The geometric mean concentrations for
antibodies to PT, FHA, and PRN after Boostrix administration increased 7.4-fold to 13.7-fold
over baseline levels (15).
Adacel immunogenicity. Antibody responses to diphtheria and tetanus toxoids in Adacel
were noninferior to a comparator Td vaccine. Because a limited quantity of sera remained from
infant efficacy trials, immune responses to three of the four pertussis antigens (FHA, PRN, and
fimbriae [FIM]) in Adacel were bridged to a 3-dose DTaP (Daptacel [Sanofi Pasteur])series,
and PT was bridged to a 4-dose series. Immune responses were observed to all Adacel pertussis
antigens but some did not meet predefined noninferiority criteria as agreed upon by FDA and
Sanofi Pasteur (16); however, a 4.4-fold to 15.1-fold increase in anti-pertussis antibodies,
depending on the antigen, was observed. Multiple other countries,including Canada,Australia,
and European Union members have approved Adacel for use in persons aged 65 years and
older.ACIP concluded that Adacel likely would provide protection in adults aged 65 years and
older.
Guidance for Use
Tdap use in adults. ACIP recommends that all adults aged 19 years and older who have not
yet received a dose of Tdap should receive a single dose. Tdap should be administered
regardless of interval since last tetanus or diphtheria toxoid-containing vaccine.After receipt of
Tdap, persons should continue to receive Td for routine booster immunization against tetanus
and diphtheria, according to previously published guidelines (1,2). Currently,Tdap is
• recommended only for a single dose across all age groups.ACIP will begin discussions on the
need for additional doses of Tdap and timing of revaccination of persons who have received
Tdap previously.
Tdap products in adults aged 65 years and older. Providers should not miss an
opportunity to vaccinate persons aged 65 years and older with Tdap. Therefore, providers may
administer the Tdap vaccine they have available.When feasible, Boostrix should be used for
adults aged 65 years and older; however,ACIP concluded that either vaccine administered to a
person 65 years or older is immunogenic and would provide protection. A dose of either
vaccine may be considered valid.
Tetanus prophylaxis in wound management for adults. As part of standard wound
management care to prevent tetanus, a tetanus toxoid—containing vaccine might be
recommended for wound management in adults aged 1g years and older if 5 years or more
have elapsed since last receiving Td. If a tetanus booster is indicated, Tdap is preferred over Td
for wound management in adults aged 19 years and older who have not received Tdap
previously.
References
1. CDC. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus
toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of
the Advisory Committee on Immunization Practices (ACIP). MMWR 20o6;55(No. RR-3).
2. CDC. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid,
• reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the
Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP,
http://www.edc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 4 of 5
t
supported by the Healthcare Infection Control Practices Advisojy Committee HICPAC
for use of Tdap among health-care personnel. MMWR 20o6;55(No. RR-17).
3. CDC Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and •
acellular pertussis(Tdap)vaccine from the Advisory Committee on Immunization
Practices, 2010. MMWR 2011;6o:13-5.
4. CDC FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria
toxoid and acellular pertussis vaccine. MMWR 2011;6o:1279-80.
5. Cherry JD, Grimpref E, Guiso N, Heininger U, Mertsola J. Defining pertussis
epidemiology: clinical,microbiologic and serologic perspectives. Pediatr Infect Dis J
2005;24(5 Suppl):S25-34•
6. Hoffait M, Hanlon D, Benninghoff B, Calcoen S. Pertussis knowledge, attitude and
practices among European health care professionals in charge of adult vaccination. Hum
Vaccin 2011;7:197-201. .
. Cornia PB Hersh AL Lis BA Newman TB Gonzales R. Does this coughing
7 � Lipsky g g
adolescent or adult patient have pertussis?JAMA 2010;304:89o-6.
8. Lasserre A, Laurent E, Turbelin C, Hanslik T, Blanchon T, Guiso N. Pertussis incidence
among adolescents and adults surveyed in general practices in the Paris area, France,
May 20o8 to March 20o9. Euro Surveill 2011;16.
9. Ward JI, Cherry JD, Chang SJ, et al. Efficacy of an acellular pertussis vaccine among
adolescents and adults. N Engl J Med 2005;353:1555-63•
1o. Strebel P, Nordin J, Edwards K, et al. Population-based incidence of pertussis among
adolescents and adults, Minnesota, 1995-1996. J Infect Dis 2001;183:1353-9•
11. Nennig ME, Shinefield HR, Edwards KM, Black SB, Fireman BH. Prevalence and
incidence of adult pertussis in an urban population. JAMA 1996;275:1672-4.
12. Acosta A. Cost-effectiveness of Tdap substitution for Td in prevention of pertussis in
adults 65 years and older. Presented to the Advisory Committee on Immunization
Practices (ACIP), February 22, 2012. Atlanta, GA: US Department of Health and Human •
Services, CDC; 2012.
13. Krishnarajah G. Cost-effectiveness analysis of Boostrix (tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine, adsorbed) among individuals >_65 years
of age in prevention of pertussis. Presented to the Advisory Committee on Immunization
Practices (ACIP), February 22, 2012. Atlanta, GA: US Department of Health and Human
Services, CDC; 2012.
14. Moro PL,Yue X, Lewis P, Haber P, Broder K. Adverse events after tetanus toxoid,
reduced diphtheria toxoid and acellular pertussis (Tdap)vaccine administered to adults
65 years of age and older reported to the Vaccine Adverse Event Reporting System
(VAERS), 2005-2010. Vaccine 2011;29:9404-8•
15. Weston WM, Friedland LR, Wu X, Howe B.Vaccination of adults 65 years of age and
older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
(Boostrix): results of two randomized trials.Vaccine 2012;30:1721-8.
16. Center for Biologics Evaluation and Research, Food and Drug Administration.Vaccines
and Related Biological Products Advisory Committee (day one). Bethesda, MD: US
Department of Health and Human Services, CDC, Food and Drug Administration; 1997•
Available at http://www.fda.gov/ohrms/dockets/ac/97/transcpt ooti.pdf" EY .
Accessed June 26, 2012.
TABLE. Composition and approved age for use of tetanus toxoid, reduced
diphtheria toxoid, and acellular pertussis (Tdap) vaccines,by trade name —
United States, 2012
http://www.edc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
ter•-� �.. •w vatuaa�liva�lvu� W1 V JG Ul 1 GLMUS 1 oxola, xeaucea Dipntnena Toxoid, and ... Page 4 of 5
suDDorted by the Healthcare Infection Control Practices Advisory Committee (HICPAC) 3
for use of Tdap among health-care personnel MMWR 20o6;5 No RR 17)
3. CDC. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and
• acellular pertussis a vaccine from the Adviso Committee on Immunization
Practices, 2010 MMWR 2011;6o•13-5.
4. CDC. FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria
toxoid and acellular pertussis vaccine MMWR 2011;6o•1279 80
5. Cherry iol Grimprel E, Guiso N, Heininger U, Mertsola J. Defining pertussis
epidemiology: clinical, microbiologic and serologic perspectives. Pediatr Infect Dis J
2005;24(5 SuPPl):S25-34.
6. Hoffait M, Hanlon D, Benninghoff B, Calcoen S. Pertussis knowledge, attitude and
practices among European health care professionals in charge of adult vaccination: Hum
Vaccin 20117197-201. .
7. Cornia PB, Hersh AL, Lipsky BA, Newman TB, Gonzales R. Does this coughing
adolescent or adult patient have pertussis?JAMA 2010;304:89o-6.
8. Lasserre A, Laurent E, Turbelin C, Hanslik T, Blanchon T; Guiso N. Pertussis incidence
among adolescents and adults surveyed in general practices in the Paris area, France,
May 20o8 to March 20o9. Euro Surveill 2011;16.
9. Ward JI, Cherry JD, Chang SJ, et al. Efficacy of an acellular pertussis vaccine among
adolescents and adults. N Engl J Med 2005;353:1555-63•
1o. Strebel P, Nordin J, Edwards K, et al. Population-based incidence of pertussis among
adolescents and adults, Minnesota, 1995-1996.J Infect Dis 2001;183:1353-9•
11. Nennig ME, Shinefield HR, Edwards KM, Black SB, Fireman BH. Prevalence and
incidence of adult pertussis in an urban population.JAMA 1996;275:1672-4.
12. Acosta A. Cost-effectiveness of Tdap substitution for Td in prevention of pertussis in
adults 65 years and older. Presented to the Advisory Committee on Immunization
Practices (ACIP), February 22, 2012. Atlanta, GA: US Department of Health and Human
Services, CDC; 2012.
13. Krishnarajah G. Cost-effectiveness analysis of Boostrix(tetanus toxoid,reduced
diphtheria toxoid and acellular pertussis vaccine, adsorbed) among individuals >65 years
of age in prevention of pertussis. Presented to the Advisory Committee on Immunization
Practices (ACIP), February 22, 2012.Atlanta, GA: US Department of Health and Human
Services, CDC; 2012.
14. Moro PL,Yue X, Lewis P, Haber P, Broder K.Adverse events after tetanus toxoid,
reduced diphtheria toxoid and acellular pertussis (Tdap)vaccine administered to adults
65 years of age and older reported to the Vaccine Adverse Event Reporting System
(VAERS), 2005-2010. Vaccine 2011;29:9404-8•
15. Weston WM, Friedland LR, Wu X, Howe B.Vaccination of adults 65 years of age and
older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
(Boostrix): results of two randomized trials.Vaccine 2012;30:1721-8.
16. Center for Biologics Evaluation and Research, Food and Drug Administration.Vaccines
and Related Biological Products Advisory Committee (day one). Bethesda, MD: US
Department of Health and Human Services, CDC, Food and Drug Administration; 1997•
Available at httP://www.fda.gov/ohrms/dockets/ac/97/transcptt/33oot1 pdf"; .
Accessed June 26, 2012.
TABLE. Composition and approved age for use of tetanus toxoid, reduced
diphtheria toxoid, and acellular pertussis (Tdap)vaccines,by trade name —
United States, 2012
http://www.cdc.gov/mmwr/preview/nlmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 5 of 5
Trade Manufacturer FDA- Pertussis antigens Diphtheria Tetanus
name approved (µg) toxoid (Lf) toxoid
age for (Lf)
use* (yrs) PT FHA PRN FIM
Boostrix G1axoSmithKline io and 8 8 2.5 — 2.5 5
Biologicals older
Adacel Sanofi Pasteur ii through 2.5 5 3 5t 2 5
64
Abbreviations:FDA=Food and Drug Administration;PT=pertussis toxin;FHA=filamentous hemagglutinin;PRN=
peitactin;FIM=fimbriae;Lf=limit of floccuation units.
*Indicated as a single dose.
t Types 2 and 3.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S.
Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or
imply endorsement of these organizations or their programs by CDC or the U.S.Department of Health and
Human Services.CDC is not responsible for the content of pages found at these sites.URL addresses listed in
MMWR were current as of the date of publication.
• All MMWR HTML versions of articles are electronic conversions from typeset documents.This conversion might
result in character translation or format errors in the HTML version.Users are referred to the electronic PDF
version(http://www.cdc.gov/mmwr)and/or the original MMWR paper copy for printable versions of official text,
figures,and tables.An original paper copy of this issue can be obtained from the Superintendent of Documents,
U.S.Government Printing Office(GPO),Washington,DC 20402-9371;telephone: (202)512-1800.Contact GPO
for current prices.
**Questions or messages regarding errors in formatting should be addressed to
mmwra Pcdc gov.
.......................................................................................................................................................................................................................................................................................................................................................:..........
Page last reviewed:June 29,2012
Page last updated:June 29,2012
Content source:Centers for Disease Control and Prevention
I--............................................................................................_.....................................................................................................................................................................................................................................................
Centers for Disease Control and Prevention 1600 Clifton Rd.Atlanta,GA 30333,USA
800-CDC-INFO(8o0-232-4636)TTY:(888)232-6348-cdcinfo(a)cdc.gov
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 1 of 5
Centers for Disease Control and Prevention Morbidi
• CDC 24/7:Saying:Lives. Protecting People.m Mortality Weekly •
Report MMWR)
..........................................................................................................................................................................................................................................................................................................................................I.......................
Updated Recommendations for Use of Tetanus Toxoid,
Reduced Diphtheria Toxoid, and Acellular Pertussis
(Tdap) Vaccine in Adults Aged 65 Years and Older —
Advisory Committee on Immunization Practices (ACIP),
2012
.....................................................................................................................................................................................................................................................................................................................................-..........................
Weekly
June 29, 2oi2/ 61(25);468-470
Since 2005,the Advisory Committee on Immunization Practices (ACIP)has recommended a
tetanus toxoid,reduced diphtheria toxoid, and acellular pertussis (Tdap)vaccine booster dose
for all adolescents aged 11 through 18 years (preferred at 11 through 12 years) and for those
adults aged 19 through 64 years who have not yet received a dose (1,2). In October 2010,
despite the lack of an approved Tdap vaccine for adults aged 65 years and older,ACIP
recommended that unvaccinated adults aged 65 years and older be vaccinated with Tdap if in
close contact with an infant, and that other adults aged 65 years and older may receive Tdap •
(3). In July 2011,the Food and Drug Administration (FDA) approved expanding the age
indication for Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) to aged 65 years and
older (4). In February 2012,ACIP recommended Tdap for all adults aged 65 years and older.
This recommendation supersedes previous Tdap recommendations regarding adults aged 65
years and older.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population. The Work Group also considered
safety and immuno enici data from clinical trials and observational studies on the use of
g ty
Tdap in adults aged 65 years and older O.
The two Tdap vaccines available in the United States, Boostrix and Adacel (Sanofi Pasteur,
Toronto, Canada), differ in composition and approved age for use Gable . Only Boostrix is
approved for adults aged 65 years and older;however,ACIP discussed the use of Adacel in this
age group. On February 22, 2012,ACIP approved use of Tdap for all adults aged 65 years and
older. This report summarizes data considered and conclusions made by ACIP and provides
guidance for implementing the recommendation.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population. The Work Group also considered
safety and immunogenicity data from clinical trials and observational studies on the use of
Tdap in adults aged 65 years and older (3). The Work Group then presented policy options for
consideration to the full ACIP.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Centers for Disease Control and prevention Morbidity and
CDC 24/7:Saving Lives. Protecting P@*ple.T" Mortality Weekly
Report (MMWR)
....................................................................................................................................................................................._......................................................................................._..................................................................................
Updated Recommendations for Use of Tetanus Toxoid,
Reduced Diphtheria Toxoid, and Acellular Pertussis
(Tdap) Vaccine in Adults Aged 65 Years and Older —
Advisory Committee on Immunization Practices (ACIP),
2012
..............................................................................................................................................................................................................................................................................................................................................
Weekly
June 29, 2012/ 61(25);468-470
Since 2005,the Advisory Committee on Immunization Practices (ACIP)has recommended a
tetanus toxoid,reduced diphtheria toxoid, and acellular pertussis (Tdap)vaccine booster dose
for all adolescents aged 11 through 18 years (preferred at ii through 12 years) and for those
adults aged 19 through 64 years who have not yet received a dose (1,2). In October 2010,
despite the lack of an approved Tdap vaccine for adults aged 65 years and older,ACIP
recommended that unvaccinated adults aged 65 years and older be vaccinated with Tdap if in
•close contact with an infant, and that other adults aged 65 years and older may receive Tdap
(3). In July 2011,the Food and Drug Administration(FDA) approved expanding the age
indication for Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) to aged 65 years and
older (4). In February 2012,ACIP recommended Tdap for all adults aged 65 years and older.
This recommendation supersedes previous Tdap recommendations regarding adults aged 65
years and older.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population. The Work Group also considered
safety and immunogenicity data from clinical trials and observational studies on the use of
Tdap in adults aged 65 years and older( ).
The two Tdap vaccines available in the United States, Boostrix and Adacel (Sanofi Pasteur,
Toronto, Canada), differ in composition and approved age for use Table . Only Boostrix is
approved for adults aged 65 years and older;however,ACIP discussed the use of Adacel in this
age group. On February 22, 2012,ACIP approved use of Tdap for all adults aged 65 years and
older.This report summarizes data considered and conclusions made by ACIP and provides
guidance for implementing the recommendation.
The Pertussis Vaccines Work Group of ACIP reviewed the epidemiology of pertussis in adults
aged 65 years and older and two cost-effectiveness models to assess the epidemiologic and
economic impact of pertussis vaccination in this population.The Work Group also considered
osafety and immunogenicity data from clinical trials and observational studies on the use of
Tdap in adults aged 65 years and older( ). The Work Group then presented policy options for
consideration to the full ACIP.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 2 of 5
Epidemiology of Pertussis in Older Adults
• Because pertussis is underdiagnosed and underreported substantially in all age groups, the
actual burden of disease in adults aged 65 years and older is unknown (5). During 2000-2010,
an annual average of 318 pertussis cases (range: 71-719 cases) in adults aged 65 years and
older were reported each year through the National Notifiable Diseases Surveillance System
(CDC, unpublished data, 2011). Challenges to diagnosing and reporting pertussis in all adults
include 1) underrecognition of pertussis as a cause for cough illness, 2) atypical presentation of
symptoms in adults, and 3) a low index of suspicion among providers (6,7). Few studies are
focused on the burden of pertussis in adults aged 65 years and older.Among reported
prospective studies,the calculated pertussis incidence ranged from 66 to 590 cases per
100,00o persons per year (8-11). Reported pertussis incidence ranges from one to five cases
per loo,000 in adults of similar age ranges (CDC,unpublished data, 2011);this 70-fold to loo-
fold difference suggests that actual pertussis incidence in older adults is much higher than
reported (CDC,unpublished data, 2011). ACIP supported the conclusion that the actual burden
of pertussis in adults aged 65 years and older likely is at least loo times greater than that
reported.
Cost Effectiveness Analysis
ACIP reviewed two unpublished cost-effectiveness models, developed'independently by
G1axoSmithKline and CDC (12,13). Both models were developed to assess the epidemiologic
and economic impact of Tdap vaccination in adults aged 65 years and older and demonstrated
that a dose of Tdap for older adults resulted in a moderate decrease in the number of cases and
outcomes (e.g., outpatient visits,hospitalizations, and deaths), which might represent a cost-
effective intervention. Model results were most sensitive to incidence of pertussis; however,
• sensitivity analyses showed that even with a range of underreporting of incidence,Tdap
vaccination might be cost-effective in this population. Reassured by the concordance between
the two cost-effectiveness models,ACIP's interpretations were that the cost per case averted
and cost per quality-adjusted life-year saved were modest, and pertussis incidence estimates
accounting for underreporting were reasonable based on limited data and expert opinion.
Tdap Products in the United States
Safety and immunogenicity data of Tdap administered to adults aged 65 years and older were
reviewed by ACIP in October 2010 and in February 2012 (3). Published and unpublished data
from clinical trials of Boostrix (N = 1,104) and Adacel (N = 1,170) on the safety and
immunogenicity of Tdap in adults aged 65 years and older who received vaccine were provided
by G1axoSmithKline and Sanofi Pasteur.
Safety. For both Tdap products,the frequency and severity of adverse events in persons aged
65 years and older were comparable to those among persons aged less than 65 years. No
increase in local or generalized reactions in Tdap recipients was observed,compared with
persons who received Td. No serious adverse events were considered related to vaccination ( ).
Postmarketing data from the Vaccine Adverse Event Reporting System (VAERS) suggest that
the safety profile of Tdap vaccine in adults aged 65 years and older was comparable to that of
Td vaccine (14).
Boostrix immunogenicity. For diphtheria and tetanus, immune responses to Boostrix were
• noninferior to the immune responses elicited by a comparator Td vaccine (15). Immune
responses to pertussis antigens (i.e., pertussis toxin [PT],filamentous hemagglutinin [FHA],
and pertactin [PRN])were noninferior to those observed following a 3-dose primary DTaP
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 3 of 5
1
series with Infanrix (G1axoSmithICine), according to predefined criteria discussed with and
agreed to by FDA before study initiation (16). Boostrix contains the same three pertussis
antigens as Infanrix,but in reduced quantities. The geometric mean concentrations for •
antibodies to PT, FHA, and PRN after Boostrix administration increased 7.4-fold to 13.7-fold
over baseline levels (15).
Adacel immunogenicity. Antibody responses to diphtheria and tetanus toxoids in Adacel
were noninferior to a comparator Td vaccine. Because a limited quantity of sera remained from
infant efficacy trials, immune responses to three of the four pertussis antigens (FHA, PRN, and
fimbriae [FIM]) in Adacel were bridged to a 3-dose DTaP (Daptacel [Sanofi Pasteur])series,
and PT was bridged to a 4-dose series. Immune responses were observed to all Adacel pertussis
antigens but some did not meet predefined noninferiority criteria as agreed upon by FDA and
Sanofi Pasteur (16); however, a 4.4-fold to 15.1-fold increase in anti-pertussis antibodies,
depending on the antigen, was observed. Multiple other countries,including Canada Austra
lia,
>
and European Union members have approved Adacel for use in persons aged 65 years and
older.ACIP concluded that Adacel likely would provide protection in adults aged 65 years and
older.
Guidance for Use
Tdap use in adults. ACIP recommends that all adults aged 19 years and older who have not
yet received a dose of Tdap should receive a single dose. Tdap should be administered
regardless of interval since last tetanus or diphtheria toxoid-containing vaccine. After receipt of
Tdap, persons should continue to receive Td for routine booster immunization against tetanus
and diphtheria, according to previously published guidelines (1,2 . Currently, Tdap is
recommended only for a single dose across all age groups.ACIP will begin discussions on the •
need for additional doses of Tdap and timing of revaccination of persons who have received
Tdap previously.
Tdap products in adults aged 65 years and older. Providers should not miss an
opportunity to vaccinate persons aged 65 years and older with Tdap. Therefore, providers may
administer the Tdap vaccine they have available. When feasible, Boostrix should be used for
adults aged 65 years and older; however,ACIP concluded that either vaccine administered to a
person 65 years or older is immunogenic and would provide protection. A dose of either
vaccine may be considered valid.
Tetanus prophylaxis in wound management for adults. As part of standard wound
management care to prevent tetanus, a tetanus toxoid—containing vaccine might be
recommended for wound management in adults aged 19 years and older if 5 years or more
have elapsed since last receiving Td. If a tetanus booster is indicated,Tdap,is preferred over Td
for wound management in adults aged 19 years and older who have not received Tdap
previously.
References
1. CDC. Preventing tetanus diphtheriaand pertussis among adolescents: use of tetanus
toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of
the Advisory Committee on Immunization Practices (ACIP). MMWR 20o6;55(No. RR-3).
2. CDC. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid,
reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the •
Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP,
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 3 of 5
i
series with Infanrix (G1axoSmithKline), according to predefined criteria discussed with and
agreed to by FDA before study initiation (16). Boostrix contains the same three pertussis
• antigens as Infanrix,but in reduced quantities. The geometric mean concentrations for -�
antibodies to PT, FHA, and PRN after Boostrix administration increased 7.4-fold to 13.7-fold
over baseline levels (15).
Adacel immunogenicity. Antibody responses to diphtheria and tetanus toxoids in Adacel
were noninferior to a comparator Td vaccine. Because a limited quantity of sera remained from
infant efficacy trials, immune responses to three of the four pertussis antigens (FHA, PRN, and
fimbriae [FIM])in Adacel were bridged to a 3-dose DTaP (Daptacel [Sanofi Pasteur])series,
and PT was bridged to a 4-dose series. Immune responses were observed to all Adacel pertussis
antigens but some did not meet predefined noninferiority criteria as agreed upon by FDA and
Sanofi Pasteur (16); however, a 4.4-fold to 15.1-fold increase in anti-pertussis antibodies,
depending on the antigen,was observed. Multiple other countries,including Canada,Australia,
and European Union members have approved Adacel for use in persons aged 65 years and
older.ACIP concluded that Adacel likely would provide protection in adults aged 65 years and
older.
Guidance for Use
Tdap use in adults.ACIP recommends that all adults aged 19 years and older who have not
yet received a dose of Tdap should receive a single dose.Tdap should be administered
regardless of interval since last tetanus or diphtheria toxoid-containing vaccine. After receipt of
Tdap, persons should continue to receive Td for routine booster immunization against tetanus
and diphtheria,according to previously published guidelines (1,2. Currently, Tdap is j
• recommended only for a single dose across all age groups.ACIP will begin discussions on the
need for additional doses of Tdap and timing of revaccination of persons who have received
Tdap previously.
Tdap products in adults aged 65 years and older. Providers should not miss an
opportunity to vaccinate persons aged 65 years and older with Tdap. Therefore, providers may
administer the Tdap vaccine they have available. When feasible, Boostrix should be used for
adults aged 65 years and older; however,ACIP concluded that either vaccine administered to a
person 65 years or older is immunogenic and would provide protection.A dose of either
vaccine may be considered valid.
Tetanus prophylaxis in wound management for adults. As part of standard wound
management care to prevent tetanus, a tetanus toxoid—containing vaccine might be
recommended for wound management in adults aged 19 years and older if 5 years or more
have elapsed since last receiving Td. If a tetanus booster is indicated,Tdap is preferred over Td
for wound management in adults aged 19 years and older who have not received Tdap,
previously.
References
1. CDC. Preventing tetanus, diphtheria,and pertussis among adolescents: use of tetanus
toxoid, reduced diphtheria toxoid and acellular pertussis vaccines Recommendations of
the Advisory Committee on Immunization Practices (ACIP) MMWR 20o6;55(No RR �)
2. CDC. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid.
• reduced diphtheria toxoid and acellular pertussis vaccine Recommendations of the
Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 4 of 5
supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC),
for use of Tdap among health-care personnel. MMWR 20o6,55(No RR-17)
• 3. CDC. Updated recommendations for use of tetanus toxoid reduced diphtheria toxoid and
acellular pertussis (Tdap)vaccine from the Advisory Committee on Immunization
Practices,, 2010. MM"2011;60.13-5
4. CDC FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria
toxoid, acellular pertussis vaccine MMWR 2011i6o•1279-8o
5. Cherry JD, Grim prel E, Guiso N, Heininger U, Mertsola J. Defining pertussis
epidemiology: clinical, microbiologic and serologic perspectives. Pediatr Infect Dis J
2005;24(5 Suppl):S25-34.
6. Hoffait M, Hanlon D, Benninghoff B, Calcoen S. Pertussis knowledge, attitude and
practices among European health care professionals in charge of adult vaccination. Hum
Vaccin 2011;7:197-201.
7. Cornia PB, Hersh AL, Lipsky BA, Newman TB, Gonzales R. Does this coughing
adolescent or adult patient have pertussis?JAMA 2010;304:89o-6.
8. Lasserre A, Laurent E, Turbelin C, Hanslik T, Blanchon T, Guiso N. Pertussis incidence
among adolescents and adults surveyed in general practices in the Paris area, France,
May 20o8 to March 20o9. Euro Surveill 2011;16.
9. Ward JI, Cherry JD, Chang SJ, et al. Efficacy of an acellular pertussis vaccine among
adolescents and adults. N Engl J Med 2005;353:1555-63•
1o. Strebel P, Nordin J, Edwards K, et al. Population-based incidence of pertussis among
adolescents and adults, Minnesota, 1995-1996. J Infect Dis 2001;183:1353-9•
11. Nennig ME, Shinefield HR, Edwards KM, Black SB, Fireman BH. Prevalence and
incidence of adult pertussis in an urban population. JAMA 1996;275:1672-4.
12. Acosta A. Cost-effectiveness of Tdap substitution for Td in prevention of pertussis in
adults 65 years and older. Presented to the Advisory Committee on Immunization
• Practices (ACIP), February 22, 2012. Atlanta, GA: US Department of Health and Human
Services, CDC; 2012.
13. Krishnarajah G. Cost-effectiveness analysis of Boostrix (tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine, adsorbed) among individuals >_65 years
of age in prevention of pertussis. Presented to the Advisory Committee on Immunization
Practices (ACIP), February 22, 2012. Atlanta, GA: US Department of Health and Human
Services, CDC; 2012.
14. Moro PL,Yue X, Lewis P, Haber P, Broder K. Adverse events after tetanus toxoid,
reduced diphtheria toxoid and acellular pertussis (Tdap)vaccine administered to adults
65 years of age and older reported to the Vaccine Adverse Event Reporting System
(VAERS), 2005-2010. Vaccine 2011;29:9404-8•
15. Weston WM, Friedland LR, Wu X, Howe B.Vaccination of adults 65 years of age and
older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
(Boostrix): results of two randomized trials.Vaccine 2012;30:1721-8.
16. Center for Biologics Evaluation and Research, Food and Drug Administration. Vaccines
and Related Biological Products Advisory Committee (day one). Bethesda, MD: US
Department of Health and Human Services, CDC, Food and Drug Administration; 1997.
Available athttp://www.fda.gov/ohrms/dockets/ac/97/transcpt/.13ootl.pdf V .
Accessed June 26, 2012.
TABLE. Composition and approved age for use of tetanus toxoid, reduced
diphtheria toxoid, and acellular pertussis (Tdap)vaccines,by trade name -
United States, 2012
http://www.cdc.gov/mmwr/preview/mmwrhtnfl/mm6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 5 of 5
Trade Manufacturer FDA- Pertussis antigens Diphtheria Tetanus
name approved (µg) toxoid (Lf) toxoid
age for (Lf) •
use* (yrs) PT FHA PRN FIM
Boostrix G1axoSmithKline 10 and 8 8 2.5 — 2.5 5
Biologicals older
Adacel Sanofi Pasteur 11 through 2.5 5 3 5t 2 5
64
Abbreviations:FDA=Food and Drug Administration;PT=pertussis toxin;FHA=filamentous hemagglutinin;PRN=
pertactin;FIM=fimbriae;Lf=limit of floccuation units.
*Indicated as a single dose.
t Types 2 and 3.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S.
Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or
imply endorsement of these organizations or their programs by CDC or the U.S.Department of Health and
Human Services.CDC is not responsible for the content of pages found at these sites.URL addresses listed in
MMWR were current as of the date of publication.
All MMWR HTML versions of articles are electronic conversions from typeset documents.This conversion might •
result in character translation or format errors in the HTML version.Users are referred to the electronic PDF
version(http://www.cdc.gov/mmwr)and/or the original MMWR paper copy for printable versions of official text,
figures, and tables.An original paper copy of this issue can be obtained from the Superintendent of Documents,
U.S.Government Printing Office(GPO),Washington,DC 20402-9371;telephone: (202)512-1800.Contact GPO
for current prices.
"Questions or messages regarding errors in formatting should be addressed to
mmwrq(&cdc.g_ov.
..................................................................................................................................................................................................................................................................................................................................................................
Page last reviewed:June 29,2012
Page last updated:June 29,2012
Content source:Centers for Disease Control and Prevention
..................................................................................................................................................................................................................................................................................................................................................................
Centers for Disease Control and Prevention 1600 Clifton Rd.Atlanta,GA 30333,USA
800-CDC-INFO(8o0-232-4636)TTY:(888) 232-6348-cdcinfo(@cdc.gov
•
http://www.cdc.gov/mmwr/preview/mmwrhtml/niin6l25a4.htm 7/5/2012
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and ... Page 5 of 5
Trade Manufacturer FDA- Pertussis antigens Diphtheria Tetanus
name approved (µg) toxoid (Lf) toxoid
• age for (Lf)
use* (yrs) PT FHA PRN FIM
Boostrix G1axoSmithKline io and 8 8 2.5 — 2.5 5
Biologicals older
Adacel Sanofi Pasteur li through 2.5 5 3 5t 2 5
64
Abbreviations:FDA=Food and Drug Administration;PT=pertussis toxin;FHA=filamentous hemagglutinin;PRN=
pertactin;FIM=fimbriae;Lf=limit of floccuation units.
*Indicated as a single dose.
t Types 2 and 3.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S.
Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or
imply endorsement of these organizations or their programs by CDC or the U.S.Department of Health and
Human Services.CDC is not responsible for the content of pages found at these sites.URL addresses listed in
MMWR were current as of the date of publication.
• All MMWR HTML versions of articles are electronic conversions from typeset documents.This conversion might
result in character translation or format errors in the HTML version.Users are referred to the electronic PDF
version(http//www.cdc.gov/mmwr)and/or the original MMWR paper copy for printable versions of official text,
figures,and tables.An original paper copy of this issue can be obtained from the Superintendent of Documents,
U.S.Government Printing Office(GPO),Washington,DC 20402-9371;telephone: (202)512-1800.Contact GPO
for current prices.
**Questions or messages regarding errors in formatting should be addressed to
mmM Pcdc.gov.
.................._....................................................................................._................................................................................................................................................................_............................_.............................................
.......
Page last reviewed:June 29,2012
Page last updated:June 29,2012
Content source:Centers for Disease Control and Prevention
................................._................................................................................................................................................._.. _......................................................................................._...................................................................
Centers for Disease Control and Prevention 1600 Clifton Rd.Atlanta,GA 30333,USA
800-CDC-INFO(8o0-232-4636)TTY:(888)232-6348-cdcinfona cdc.gov
1
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6125a4.htm 7/5/2012
Administration Monthly Report
June-12
Burial Permits @ $25.00 $800.00
Permits $2,930.00
Certificate of Fitness@$50.00 $3,250.00
Fines
Total Monies Collected = $6,980.00
Annual Budget Expended
Available Balance
Total Salary/Longevity $344,000.00 $314,827.79 $29,172.21
Annual Budget Expended Available Balance
Non-Personnel $19,600.00 $19,600.00 $0.00
Regulation of the City of Salem Board of Health
• Restricting the Sale and Use of Tobacco Products & Nicotine Delivery
Products
FINAL DRAFT
A. Statement of Purpose:
Whereas there exists conclusive evidence that tobacco smoke causes cancer,respiratory
and cardiac diseases,negative birth outcomes, irritations to the eyes, nose and throat
(Centers for Disease Control and Prevention(hereinafter "CDC'), Health Effects of Cigarette Smoking
Fact Sheet, (January 2012)); whereas among the 15.7%of students nationwide who currently
smoked cigarettes and were aged less than eighteen(18)years '14.1%usually obtained
their own cigarettes by buying them in a store (i.e., convert enc--store, supermarket, or
discount store) or gas station during the thirty(30)days before the survey(CDC, Youth Risk
Behavior,Surveillance Summaries.2009, MMWR 2010:59(NO:SS-55)`at 11);whereas nationally in
2000, sixty-nine (69%)percent of middle school,ag6 children who smoke'at least once a
month were not asked to show proof of age whei;purchasing cigarettes (CDC_Youth
Tobacco,Surveillance Summaries. 2000, MMWR 2001 50 N—ISS-04)),whereas the U.S".
Department of Health and Human Services has concided"that nicotine is as addictive as
cocaine Or heroin(U.S. Department of Health and Human Services,How Tobacco Smoke Causes
Disease: The Biology and Behavioral Basis for;Smoking-Attributable:Disease:A Report of the Surgeon
General,Atlanta, GA: U.S.Department of Health and Human Services Centers.for Disease Control and
Prevention, National Center for Chronic Disease Prevention-and Health Promotion, Office on Smoking
• and Health, 2010.); whereas despite state laws prohibiting the sale of tobacco products to
minors, access by minors;to-tobacco produets:ls a major—pro
blem;whereas according to
the CDC, cigarette price increases reduce the demand for cigarettes and thereby reduce
smoking prevalence, cigarette consumption, and youth initiation of smoking (U.S.
Department of Health and-Human Services.Reducing Tobacco Use:A Report of the Surgeon General.
Atlanta, GA. U.S. Department of Health,and Human Services, Centers for Disease Control and Prevention,
National Center for Chronic Disease,Preveiition and=Flealth Promotion, Office on Smoking and Health,
2000 at 358)
Whereasthe 2012 U.S. Surgeon General's Report on Preventing Tobacco Use Among
Youth and Xoung Adults,reports that in 2005 Ringel,Wasserman, &Andreyeva(U.S.
Department of Health andHumai,,Services,Nicotine Addiction,Atlanta, GA: U.S.Department of Health
and Human Services,CDC,National Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Healfh,=.1988) Conducted logistic regression analyses to examine whether
increased cigar prices a d state tobacco control policies affected the rate of cigar use.
(U.S.Department of Health and Human Services. Preventing Tobacco Use Among Youth and Young
Adults,Atlanta, GA: U.S.Department of Health and Human Services, Centers for Disease Control and
Prevention,National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking
and Health, 2012 at 706). Using the 1999 and 2000 iterations of the National Youth Tobacco
Survey, Ringel and colleagues analyzed data from 33,632 adolescent participants aged
nine to seventeen. They found that increased cigar prices significantly decreased the
probability of male adolescent cigar use and found that a 10%increase in cigar prices
would reduce the sample's cigar use by 3.4%(Ringel JS, Wasserman J,Andreyeva T,Effects of
Public Policy on Adolescents'Cigar Use:Evidence From the National Youth Tobacco Survey, 95 Am.J.
• Pub. Health 995-8(June 1, 2005); whereas according to the CDC's youth risk behavior
surveillance system,the percentage of high school students in Massachusetts who
reported the use of cigars within the past 30 days went from 11.8% in 2003 to 14.9% in
2009 (CDC, Youth Risk Behavior. Surveillance Summaries, 2009. MMWR 2010;59(No. SS-55)at 72;
CDC, Youth Risk Behavior. Surveillance Summaries,2003.MMWR 2004;53(No. SS-02)at 54);whereas •
nicotine levels in cigars are generally much higher than nicotine levels in cigarettes. (Nat'l
Cancer Institute at the Nat'1 Inst. of Health, Questions and Answers About Cigar Smoking and Cancer
(Oct. 27, 2010));
Whereas commercial Roll Your Own(RYO)machines enable loose, unpackaged tobacco
to be poured into a machine and placed into empty,unpackaged cigarette tubes to be
inhaled by individuals who smoke them. This procedure provides risk of contamination
of the tobacco and unsanitary conditions in the machine and is injurious to public health;
whereas commercial Roll Your Own (RYO)machines located in retail stores enable
retailers to sell cigarettes without paying the federal and state excise,taxes that are
imposed on conventionally manufactured cigarettes (RYO FILLING STATION,
www.wofllingstation.com (Feb. 27,2012). High excise taxes encourage adult smokers to quit
and deter youth from starting (Kenneth E. Warner, Smoking and.-Health lmplications of a Change in
the Federal Cigarettte Excise Tax,255 J.AM. MED.Ass 1028.(1980),Frank'J=Chaloupka&Rosalie
Liccardo Pacula, The Impact of Price on Youth Tobacco Use,,irF=1s4 SMOKING AND-TOBACCO
CONTROL MONOGRAPHS:CHANGING ADOLESCENT SMOKING PREVALENCE 1 Q3(U.S. Dep't
Health and Human Services et al. eds., 2001)). Therefore, inexpensive cigarettes;-like those
produced from RYO machines, promote the use of tobacco,resulting in a negative impact
on public health and increased health care costs, and;sever_'ely undercut the evidence-
based public health benefit of imposing high excise taxes on tobacco,
Whereas the sale of tobacco products and nicotine delivery products are incompatible
with the mission of healthcare institutions because_they are detrimental to the public
health and undermine efforts to educate patients on the safe,and effective use of •
medication;
Whereas educational;institutions:-sell tobacco`products to a younger population,which is
particularly at risk for becoming smokers and such sale of tobacco products and nicotine
delivery products.are incompatible with the mission of educational institutions that
educate a:;younger::population out social; environmental and health risks and harms;
Now;therefore it is the rntention of the City of Salem Board of Health to regulate the
access of tobacco productk.and nicotine delivery products.
B. Authority:
This regulation is promulgated pursuant to the authority granted to the City of Salem
Board of Health by Massachusetts General Laws Chapter 111, Section 31 that 'Boards of
Health may make reasonable health regulations".
C. Definitions:
For the purpose of this regulation, the following words shall have the following
meanings:
•
1
2009(CDC, Youth Risk Behavior. Surveillance Summaries, 2009. MMWR 2010;59(No. SS-55)at 72;
• CDC, Youth Risk Behavior.Surveillance Summaries,2003. MAI"2004,53(No. SS-02)at 54);whereas
nicotine levels in cigars are generally much higher than nicotine levels in cigarettes. (Nat'l
Cancer Institute at the Nat 7Inst. of Health, Questions and Answers About Cigar Smoking and Cancer
(Oct.27, 2010));
Whereas commercial Roll Your Own(RYO)machines enable loose,unpackaged tobacco
to be poured into a machine and placed into empty,unpackaged cigarette tubes to be
inhaled by,individuals who smoke them. This procedure provides risk of contamination
of the tobacco and unsanitary conditions in the machine and is injurious to public health;
whereas commercial Roll Your Own (RYO)machines located in retail stores enable
retailers to sell cigarettes without paying the federal and state excise taxes that are
imposed on conventionally manufactured cigarettes (RYO FILLING STATION,
www.ryofillingstation.com(Feb. 27,2012). High excise taxes encourage adult smokers to quit
and deter youth from starting(Kenneth E. Warner,Smoking and-Realfh Implications of a Change in
the Federal Cigarettte Excise Tax,255 J.AM.MED.Ass 1028.(19*,Frank!X Chaloupka&Rosalie
Liccardo Pacula, The Impact of Price on Youth Tobacco Use,itk=14:,S1 iOKING AND-TOBACCO
CONTROL MONOGRAPHS:CHANGING ADOLESCENT.S1lOKING PREVALENCE 193(U.S.Dept
Health and Human Services et al. eds.,2001)). Therefore, inexpensive cigarettes -i those
produced from RYO machines,promote the use of�tobacco,;;resulting in a negative impact
on public health and increased health care costs, and-isevezely undercut the evidence-
based public health benefit of imposing high excise taxes on tobacco;
Whereas the sale of tobacco products antl=niootine delivery pr-oducts are incompatible
with the mission of health care institutio because they are.detrimental to the public
• health and undermine efforts to educate patiients..on the,safe:and effective use of
medication;
Whereas educational institutions sell tobacco products to a younger population,which is
particularly at risk for becoming smokers and sbh sale of tobacco products and nicotine
delivery products__are incoiripatible with:the mission of educational institutions that
educate a younger population about social, environmental and health risks and harms;
Now,therefore it is the intention of the City of Salem Board of Health to regulate the
access of tobbacco products-aiid nicotine delivery products..
B. Authority:
This regulation is promulgated pursuant to the authority granted to the City of Salem
Board of Health by Massachusetts General Laws Chapter 111, Section 31 that 'Boards of
Health may make reasonable health regulations".
C. Definitions:
For the purpose of this regulation,the following words shall have the following
meanings:
1
i
Blunt Wrap: Any tobacco product manufactured or packaged as a wrap or as a hollow
• tube made wholly or in part from tobacco that is designed or intended to be filled by the
consumer with loose tobacco or other fillers.
Business Agent: An individual who has been designated by the owner or operator of any
establishment to be the manager or otherwise in charge of said establishment.
Cigar: Any roll of tobacco that is wrapped in leaf tobacco or in any substance containing
tobacco with or without a tip or mouthpiece not otherwise defined as a cigarette under
Massachusetts General Law, Chapter 64C, Section 1, Paragraph 1.
Commercial Roll-Your-Own(RYO)machine: A mechanical device, by whatever
manufacturer made and by whatever name known, that is designed to roll and wrap
tobacco into products. RYO machines located in a private home,used for personal
consumption, are not Commercial Roll-Your-Own machines.
E-Cigarette: Any electronic Nicotine Delivery Product composed of a mouthpiece,
heating element,battery and/or electronic circuits that provides a vapor of liquid nicotine
to the user, or relies on vaporization of solid nicotine or any-liquid. This term'shall
include such devices whether they are manufactured' s e-cigarettes, e-cigars,e-pipes or
under any other product name.
Educational Institution: Any public or private college, schdoi;professional school,
scientific or technical institution,university Or other institution famishing a program of
• higher education.
Employee: Any individual who performs services for an employer.
Employer: Any individual,partnership, association; corporation, trust or other organized
group of individuals that uses the services of one(1)or more employees.
Health Care Institution: An individual,partnership, association, corporation or trust or
any person or group of persons that provides health care services and employs health care
providers licensed, or subject to licensing,by the Massachusetts Department of Public
Health under M.G.L. c. 112 or a retail establishment that provides pharmaceutical goods
and services and subject to the provisions of 247 CMR 6.00. Health care institution
includes, but is not limited to,hospitals, clinics,health centers,pharmacies, drug stores,
doctor offices and dentist offices.
Minor: Any individual who is under the age of eighteen(18).
Nicotine Delivery Product: Any manufactured article or product made wholly or in part
of a tobacco substitute or containing nicotine that is expected or intended for human
consumption,but not including a tobacco substitute prescribed by a licensed physician or
a product that has been approved by the United States Food and Drug Administration for
sale as a tobacco use cessation or harm reduction product or for other medical purposes
and which is being marketed and sold solely for that approved purpose. Nicotine delivery
• product includes, but is not limited to, e-cigarettes.
2
Permit Holder: Any person engaged in the sale or distribution of tobacco or nicotine
delivery products directly to consumers who applies for and receives a tobacco and •
nicotine delivery product sales permit or any person who is required to apply for a
tobacco and nicotine delivery product sales permit pursuant to these regulations, or his or
her business agent.
Tobacco Product: Cigarettes, cigars, chewing tobacco,pipe tobacco, bidis, snuff or
tobacco in any of its forms.
Vending Machine: Any automated or mechanical self-service device, which upon
insertion of money, tokens or any other form of payment, dispenses or makes cigarettes,
any other tobacco product or Nicotine Delivery Product.
D. Tobacco and Nicotine Delivery Product Sales to Minors Prohibited:
1.No person shall sell tobacco or nicotine delivery products or permit tobacco or nicotine
delivery products to be sold to a minor; or not being the minor's parent or legal guardian,
give tobacco or nicotine delivery products to a minor.
2. Required Signage
a. In conformance with and in addition to Massachusetts General Law, Chapter 270,
Section 7, a copy of Massachusetts General Laws, Chapter.270, Section 6, shall
be posted conspicuously by the owner or=other person in charge thereof in the
shop or other place used to sell tobacco products at retail. The notice shall be •
provided by the Massachusetts Department of Public Health and made available
from the City of-Salem Board of Health. The notice shall be at least 48 square
inches and shall be posted conspicuously by the permit holder in the retail
establishment or.other place in such a manner so that it may be readily seen by a
person standing at or approaching the cash register. The notice shall directly face
the purchaser and shall-not be obstructed from view or placed at a height of less
than four(4)feet:or greater than nine(9) feet from the floor. The owner or other
person in charge of a shop-or other place used to sell tobacco products at retail
shall conspicuously'post any additional signs required by the Massachusetts
Department of Public Health.
b. The owner or other person in charge of a shop or other place used to sell tobacco
products at retail'shall conspicuously post signage provided by the City of Salem
board of health that discloses current referral information about smoking
cessation.
c. The owner or other person in charge of a shop or other place used to sell nicotine
delivery products at retail shall conspicuously post a sign stating that"The sale of
nicotine delivery products to minors under 18 years of age is prohibited."The
owner or other person in charge of a shop or other place used to sell e-cigarettes at
retail shall conspicuously post a sign stating that"The use of e-cigarettes at indoor
establishments may be prohibited by local law."The notices shall be no smaller
than 8.5"by 11"and shall be posted conspicuously in the retail establishment or •
other place in such a manner so that they may be readily seen by a person
standing at or approaching the cash register. These notices shall directly face the
3
Permit Holder: Any person engaged in the sale or distribution of tobacco or nicotine
delivery products directly to consumers who applies for and receives a tobacco and
nicotine delivery product sales permit or any person who is required to apply for a
tobacco and nicotine delivery product sales permit pursuant to these regulations, or his or
her business agent.
Tobacco Product: Cigarettes, cigars, chewing tobacco,pipe tobacco, bidis, snuff or
tobacco in any of its forms.
Vending Machine: Any automated or mechanical self-service device,which upon
insertion of money,tokens or any other form of payment, dispenses or makes cigarettes,
any other tobacco product or Nicotine Delivery Product.
D. Tobacco and Nicotine Delivery Product Sales to Minors Prohibited:
1.No person shall sell tobacco or nicotine delivery products or permit tobacco or nicotine
delivery products to be sold to a minor; or not being the minor's parent or legal guardian,
give tobacco or nicotine delivery products to a minor.
2. Required Signage
a. In conformance with and in addition to Massachusetts General Law, Chapter 270,
Section 7, a copy of Massachusetts_General Laws, Chap4er.270, Section 6, shall
be posted conspicuously by the owner or other persontn.charge thereof in the
• shop or other place used to sell tobacco products at retail. The notice shall be
provided by the Massachusetts Department of Public Health and made available
from the City of'Saleri Board of Health. The notice shall be at least 48 square
inches and shall be posted conspicuously by the permit holder in the retail
establishment or.other place in such a manner so that it may be readily seen by a
person standing at or approaching the cash register. The notice shall directly face
the.purchaser and shallmot be obstructed from view or placed at a height of less
than four(4)Teet or greater,than nine(9) feet from the floor. The owner or other
person in charge of a shop brother place used to sell tobacco products at retail
shall conspicuously"post any additional signs required by the Massachusetts_
Department of Public Health.
b. The owner or other person in charge of a shop or other place used to sell tobacco
products at retail shall conspicuously post signage provided by the City of Salem
board of health that discloses current referral information about smoking
cessation.
c. The owner or other person in charge of a shop or other place used to sell nicotine
delivery products at retail shall conspicuously post a sign stating that"The sale of
nicotine delivery products to minors under 18 years of age is prohibited."The
owner or other person in charge of a shop or other place used to sell e-cigarettes at
retail shall conspicuously post a sign stating that"The use of e-cigarettes at indoor
establishments may be prohibited by.local law."The notices shall be no smaller
• than-8.5"by 11"and shall be posted conspicuously in the retail establishment or
other place in such a manner so that they may be readily seen by a person
standing at or approaching the cash register. These notices shall directly face the
3
purchaser and shall not be obstructed from view or placed at a height of less than
• four(4) feet or greater than nine (9) feet from the floor.
3. Identification: Each person selling or distributing tobacco or nicotine delivery products
shall verify the age of the purchaser by means of valid government-issued photographic
identification containing the bearer's date of birth that the purchaser is 18 years old or
older. Verification is required for any person under the age of 27.
4. All retail sales of tobacco or nicotine delivery products must be face-to-face between
the seller and the buyer.
E. Tobacco and Nicotine Delivery Product Sales Permit:
1.No person shall sell or otherwise distribute tobacco or nicotine delivery products at
retail within the City of Salem without first obtaining a Tobacco and Nicotine Delivery
Product Sales Permit issued annually by the City of Salem Board of Health. Only owners
of establishments with a permanent, non-mobile location in Salem are eligible to apply
for a permit and sell tobacco products or nicotine delivery products at the specified
location in Salem.
2. As part of the Tobacco and Nicotine Delivery Product Sales Permit application
process,the applicant will be provided with the City of Salem Board of Health regulation.
Each applicant is required to sign a statement declaring that the applicant has read said
regulation and that the applicant is responsible:for-instructing any and all employees who
• will be responsible for tobacco and nicotine delivery product sales regarding both state
laws regarding the sale of.tobacco and this regulation.
3. Each applicant who sells tobacco is requiredao provide proof of a current tobacco sales
license issued by the Massachusetts Department of Revenue before a Tobacco and
Nicotine Delivery Product Sales Permit can be-issued.
4. The fee for a Tobacco:and Nicotine Delivery Product Sales Permit shall be determined
by the City of Salem Board of Health:annually. All such permits shall be renewed
annually.
5. A separate permit is required for each retail establishment selling tobacco or nicotine
delivery products.
6. Each Tobacco and Nicotine Delivery Product Sales Permit shall be displayed at the
retail establishment in a conspicuous place.
7. No Tobacco and Nicotine Delivery Product Sales Permit holder shall allow any
employee to sell tobacco products or nicotine delivery products until such employee
reads this regulation and state laws regarding the sale of tobacco and signs a statement, a
copy of which will be placed on file in the office of the employer, that he/she has read the
regulation and applicable state laws.
• 8.A Tobacco and Nicotine Delivery Product Sales Permit is non-transferable. A new
owner of an establishment that sells tobacco or nicotine delivery products must apply for
4
a new permit.No new permit will be issued unless and until all outstanding penalties
incurred by the previous permit holder are satisfied in full. •
9. Issuance of a Tobacco and Nicotine Delivery Product Sales Permit shall be conditioned
on an applicant's consent to unannounced, periodic inspections of his/her retail
establishment to ensure compliance with this regulation.
10. Issuance and holding of a Tobacco and Nicotine Delivery Product Sales Permit shall
be conditioned on an applicant's on-going compliance with current Massachusetts
Department of Revenue requirements and policies including, but not limited to, minimum
retail prices of tobacco products.
11. A Tobacco and Nicotine Delivery Product Sales Permit will'not be renewed if the
permit holder has failed to pay all fines issued and the time:perod to appeal the fines has
expired and/or has not satisfied any outstanding permit suspensions.
12. Maximum Number of Tobacco and Nicotine Delivery Product Sales"Permits.
At any given time, there shall be no more'than 60 Tobacco and Nicotine Delivery
Product Sales Permits issued in City of Salem;No-permit renewal will be denied
based on the requirements of this subsection except any permittee who has failed
to renew their current permit within(30)days of expiration will be treated as a
first-time permit applicant. Applicants who purchase_a business that holds a
current Tobacco and Nicotine Delivery Product Sales Permit at the time of the
sale of said business may apply, within sixty(60)days of such sale, for the permit •
held by the Seller if..the Buyer intends.to sell tobacco products and/or Nicotine
Delivery Products. New applicants for permits who are applying at a time when
the maximuminumber of permits have been issued will be placed on a waiting list
and will be eligible to apply for a permit_-on a"first-come, first-serve"basis as
issued permits are either notrenewed or are returned to the Board.
F. mar Sales Regulated:
1.No retailer, retail establishment, or other individual or entity shall sell or distribute or
cause to be sold or distributed a cigar unless the cigar is contained in an original package
of at least four(4).cigars.
2. This Section shall not apply to:
a. The sale or distribution of any cigar having a retail price of more than two dollars
and fifty cents ($2.50).
b. A person or entity engaged in the business of selling or distributing cigars for
commercial purposes to another person or entity engaged in the business of
selling or distributing cigars for commercial purposes with the intent to sell or
distribute outside the boundaries of City of Salem.
3. The Board of Health may adjust from time to time the amounts specified in this •
Section to reflect changes in the applicable Consumer Price Index by amendment of this
regulation.
5
• retail prices of tobacco pro*. •
11. A Tobacco and Nicotine Delivery Product Sales Permit will:not be renewed if the
permit holder has failed to pay all fines issued and the time.per od to appeal the fines has
expired and/or has not satisfied any outstanding permit suspensions.
12. Maximum Number of Tobacco and Nicotine Delivery Product Sales Permits.
At any given time, there shall be no more.-:than 60 Tobacco and Nicotine Delivery
Product Sales Permits issued in City of Salem: No:permit renewal will be denied
based on the requirements of this subsection except any permittee who has failed
to renew their current permit within(30) days of expiration will be treated as a
first-time permit applicant. Applicants who purchase a:business that holds a
current Tobacco and Nicotine Delivery Pro duct Sales Permit at the time of the
sale of said business may apply, within sixty,(6U:)..days of such sale, for the permit
held by the Seller if-the Buyer intends-40 sell tobacco products and/or Nicotine
Delivery Products. New applicants for permits who are applying at a time when
the maximumpumber of-permits have been issued will be placed on a waiting list
and will be eligible to apply for a permit-on a"first-come, first-serve"basis as
issued permits are either not'renewed or are returned to the Board.
F. Cigar Sales Re lug_ated.-
1.No retailer,retail establishment,.'or other individual or entity shall sell or distribute or
cause to be sold or distributed a cigar unless the cigar is contained in an original package
of at least four`(4).cigars.
2. This Section shall not apply to:
a. The sale or distribution of any cigar having a retail price of more than two dollars
and fifty cents ($2.50).
b. A person or entity engaged in the business of selling or distributing cigars for
commercial purposes to another person or entity engaged in the business of
selling or distributing cigars for commercial purposes with the intent to sell or
distribute outside the boundaries of City of Salem.
3. The Board of Health may adjust from time-to time the amounts specified in this
Section to reflect changes in the applicable Consumer Price Index by amendment of this
regulation.
5
• G. Prohibition of the Sale of Blunt Wraps
No person or entity shall sell or distribute blunt wraps within the City of Salem.
H. Free Distribution and Coupon Redemption:
No person shall distribute, or cause to be distributed, any free samples of tobacco
products or nicotine delivery products. No means, instruments or devices that allow for
the redemption of tobacco products for free or at a reduced price below the minimum
retail price determined by the Massachusetts Department of Revenue shall be accepted by
any permittee.
I. Out-of-Package Sales:
No person may sell or cause to be sold or distribute or cause to be distributed, any
cigarette package that contains fewer than twenty(20)cigarettes, including single
cigarettes.
J. Self-Service Displays:
All self-service displays of tobacco products and/or nicotine delivery products are
prohibited. All humidors including, but-not limited to,walk*in must be locked.
K. Vending?Machines:
•
All tobacco and/or nicotine delivery product vending machines are prohibited.
L. Commercial Roll-Your-Own Machines
All commercial Roll-Your-Own machines are prohibited.
M. Prohibition of the Sale of Tobacco and Nicotine Delivery Products by Health Care
Institutions:
No health care institution located in City of Salem shall sell or cause to be sold tobacco
or nicotine delivery products. No retail establishment that operates or has a health care
institution within it,such as a pharmacy or drug store, shall sell or cause to be sold
tobacco products or nicotine delivery products.
N. Prohibition of the Sale of Tobacco and Nicotine Delivery Products by Educational
Institutions:
No educational institution located in City of Salem shall sell or cause to be sold tobacco
or nicotine delivery products. This includes all educational institutions as well as any
retail establishments that operate on the property of an educational institution.
• O. E-Cigarette Use:
6
The use of e-cigarettes is prohibited wherever smoking is prohibited per M.G.L. Ch.270,
§22 and the Salem Environmental Tobacco Smoke(ETS)regulation. •
P. Violations:
1. It shall be the responsibility of the establishment,permit holder and/or his or her
business agent to ensure compliance with all sections of this regulation pertaining to his
or her distribution of tobacco and/or nicotine delivery products. The violator shall
receive:
a. In the case of a first violation, a fine of one hundred dollars ($100.00).
b. In the case of a second violation within 36 months of the date of the current
violation, a fine of two hundred dollars ($200.00) and.t'he Tobacco and Nicotine
Delivery Product Sales Permit shall be suspended+for seven.(7)consecutive
business days.
c. In the case of three or more violations within a 36 month period, a fine of three
hundred dollars ($300.00) and the Tobacco and Nicotine Delivery Product Sales
Permit shall be suspended for thirty(30)consecutive business days.
2. Refusal to cooperate with inspections pursuant to this regulation shall result.in the
suspension of the Tobacco and Nicotine.Delivery Product Sales Permit for thirty(30)
consecutive business days.
3. In addition to the monetary fines set above, any permitholder who engages in the sale •
or distribution of tobacco or nicotine delivery products directly to a consumer while his
or her permit is suspended shall;be subject to the suspension of all board of health issued
permits for thirty (30)consecutive business days.
4. The City of Salem Board of Health shall=provide notice of the intent to suspend a
Tobacco:and Nicotine Delivery Product Sales Permit,which notice shall contain the
reasons'therefor and establish a time.and date for a hearing which date shall be no earlier
than seven(7)days after the date of said notice. The permit holder or its business agent
shall have an opportunity to be heard at such hearing and shall be notified of the Board of
Health's decision and the reasons therefore in writing. After a hearing, the City of Salem
Board of Health shall suspend the Tobacco and Nicotine Delivery Product Sales Permit if
the Board finds that a sale to a minor occurred. For purposes of such suspensions, the
Board shall make the determination notwithstanding any separate criminal or non-
criminal proceedings brought in court hereunder or under the Massachusetts General
Laws for the same offense. All tobacco products and nicotine delivery products shall be
removed from the retail establishment upon suspension of the Tobacco and Nicotine
Delivery Product Sales Permit. Failure to remove all tobacco and nicotine delivery
products shall constitute a separate violation of this regulation.
Q.Non-Criminal Disposition:
Whoever violates any provision of this regulation may be penalized by the non-criminal •
method of disposition as provided in General Laws, Chapter 40, Section 21 D or by filing
a criminal complaint at the appropriate venue.
7
r
The use of e-cigarettes is prohibited wherever smoking is prohibited per M.G.L. Ch.270,
• §22 and the Salem Environmental Tobacco Smoke(ETS)regulation. -
P. Violations:
1. It shall be the responsibility of the establishment,permit holder and/or his or her
business agent to ensure compliance with all sections of this regulation pertaining to his
or her distribution of tobacco and/or nicotine delivery products. The violator shall
receive:
a. In the case of a first violation, a fine of one hundred dollars ($100.00).
b. In the case of a second violation within 36 months of the date of the current
violation, a fine of two hundred dollars ($200.00) and the Tobacco and Nicotine
Delivery Product Sales Permit shall be suspended for seven.(7)consecutive
business days.
c. In the case of three or more violations within a 36 month period,a fine of three
hundred dollars ($300.00)and the Tobacco and Nicotine Delivery Product Sales
Permit shall be suspended for thirty(30)consecutive business days.
2. Refusal to cooperate with inspections;pursuant to this regulation shall result.in the
sus`ension of the Tobacco and Nicotim Delivery Product Sales Permit for thirty(30)
• consecutive business days.
3. In addition to the monetary fines set above, aiiy permit holder who engages in the sale
or distribution of tobacco or nicotine delivery:products directly to a consumer while his
or her permit is suspended shall be subject to the suspension of all board of health issued
permits for thirty(30)consecutive business days:
4. The City of Salem Board of Health shallprovide notice of the intent to suspend a
Tobacco:and Nicotine Delivery Product Sales Permit,which notice shall contain the
reasons therefor and establish a tir e.:and date for a hearing which date shall be no earlier
than seven(7)days after the date of-said notice. The permit holder or its business agent
shall have an opportunity to be heard at such hearing and shall be notified of the Board of
Health's decision and the reasons therefore in writing. After a hearing,the City of Salem
Board of Health shall suspend the Tobacco and Nicotine Delivery Product Sales Permit if
the Board finds that a:sale to a minor occurred. For purposes of such suspensions,the
Board shall make the determination notwithstanding any separate criminal or non-
criminal proceedings brought in court hereunder or under the Massachusetts General
Laws for the same offense. All tobacco products and nicotine delivery products shall be
removed from the retail establishment upon suspension of the Tobacco and Nicotine
Delivery Product Sales Permit. Failure to remove all tobacco and nicotine delivery
products shall constitute a separate violation of this regulation.
Q.Non-Criminal Disposition:
• Whoever violates any provision of this regulation may be penalized by the non-criminal -\
method of disposition as provided in General Laws, Chapter 40, Section 21 D or by filing
a criminal complaint at the appropriate venue.
7
• Each day any violation exists shall be deemed to be a separate offense.
R. Enforcement:
Enforcement of this regulation shall be by the City of Salem Board of Health of or its
designated agent(s).
Any citizen who desires to register a complaint pursuant to the regulation may do so by
contacting the City of Salem Board of Health or its designated agent(s) and the Board
shall investigate.
S. Severability:
If any provision of these regulations is declared invalid oz`cuienfoeeable,the other
provisions shall not be affected thereby but shall continue in full force-and effect.
T. Effective Date:
This regulation shall take effect on
with the exception of Section F(Cigar Sales Regulated which shall take effect on
February 4, 2013.
•
8
• Regulation of the City of Salem Board of Health
Restricting the Sale and Use of Tobacco Products & Nicotine Delivery
Products
FINAL DRAFT
A. Statement of Purpose:
Whereas there exists conclusive evidence that tobacco smoke causes cancer,respiratory
and cardiac diseases, negative birth outcomes, irritations to the eyes,nose and throat
(Centers for Disease Control and Prevention(hereinafter "CDC'), Health Effects of Cigarette Smoking
Fact Sheet, (January 2012)); whereas among the 15.7%of students nationwide who currently
smoked cigarettes and were aged less than eighteen(18) years4 j4.1%usually obtained
their own cigarettes by buying them in a store (i.e., convenience:store, supermarket, or
discount store)or gas station during the thirty(30)days before t6.a ey(CDC, Youth Risk
Behavior, Surveillance Summaries. 2009, MMWR 2010:59(No"SS�55)`at 11); whereas nationally in
2000, sixty-nine(69%)percent of middle school,age children who smoke`at least once a
month were not asked to show proof of age whentpurchasing cigarettes (CDC,-;Youth
Tobacco,Surveillance Summaries. 2000, MMWR 2001 50YYo SS-04)),whereas the U.S
Department of Health and Human Services has concludedthat nicotine is as addictive as
cocaine Or heroin(U.S.Department of Health and Human Seivices.How Tobacco Smoke Causes
Disease: The Biology and Behavioral Basis for Smoking-Attributable-Disease:A Report of the Surgeon
General, Atlanta, GA: U.S.Department of Health and Human Services Centers for Disease Control and
Prevention,National Center for Chronic Disease',Preventii*and Health Promotion, Office on Smoking
and Health, 2010.); whereas despite state lawk rohibi'tm the sale of tobacco products to
minors, access by minors jo tobacco products is a major�.pro blem; whereas according to
the CDC, cigarette price incrcas'as reduce the'Vemand for'cigarettes and thereby reduce
smoking prevalence, cigarette consumption, and youth initiation of smoking (U.S.
Department of Health and Haiman Services. Reducing Tobacco Use:A Report of the Surgeon General.
Atlanta, GA. U.S.Department of Health and Human Services, Centers for Disease Control and Prevention,
National Center for Chronic Disease Prevention an'd=Health Promotion, Office on Smoking and Health,
171,
2000 at 35,8) '..�
Whereasthe 2012 U.S. Suigeon General's Report on Preventing Tobacco Use Among
Youth and`:Young Adults,reports that in 2005 Ringel, Wasserman, &Andreyeva(U.S.
Department of Health and Humd»:'Services,Nicotine Addiction,Atlanta, GA: U.S.Department of Health
and Human Services;;CDC,National Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health,;1988)conducted logistic regression analyses to examine whether
increased cigar prices aid state tobacco control policies affected the rate of cigar use.
(U.S.Department of Health and Human Services.Preventing Tobacco Use Among Youth and Young
Adults,Atlanta, GA: U.S.Department of Health and Human Services, Centers for Disease Control and
Prevention,National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking
and Health, 2012 at 706). Using the 1999 and 2000 iterations of the National Youth Tobacco
Survey, Ringel and colleagues analyzed data from 33,632 adolescent participants aged
nine to seventeen. They found that increased cigar prices significantly decreased the
probability of male adolescent cigar use and found that a 10% increase in cigar prices
would reduce the sample's cigar use by 3.4%(Ringel JS, Wasserman J,Andreyeva T,Effects of
Public Policy on Adolescents'Cigar Use:Evidence From the National Youth Tobacco Survey, 95 Am.J.
Pub.Health 995-8(June 1, 2005); whereas according to the CDC's youth risk behavior
• surveillance system, the percentage of high school students in Massachusetts who
reported the use of cigars within the past 30 days went from 11.8% in 2003 to 14.9% in
2009 (CDC, Youth Risk Behavior. Surveillance Summaries,2009. MMWR 2010;59(No. SS-55)at 72;
• CDC, Youth Risk Behavior. Surveillance Summaries, 2003. MMWR 2004;53(No. SS-02)at 54); whereas
nicotine levels in cigars are generally much higher than nicotine levels in cigarettes. (Nat'l
Cancer Institute at the Nat'l Inst. of Health, Questions and Answers About Cigar Smoking and Cancer
(Oct. 27, 2010));
Whereas commercial Roll Your Own(RYO)machines enable loose, unpackaged tobacco
to be poured into a machine and placed into empty,unpackaged cigarette tubes to be
inhaled by individuals who smoke them. This procedure provides risk of contamination
of the tobacco and unsanitary conditions in the machine and is injurious to public health;
whereas commercial Roll Your Own (RYO)machines located in retail stores enable
retailers to sell cigarettes without paying the federal and state excise taxes that are
imposed on conventionally manufactured cigarettes(RYO FILLING'STATION,
www.ryorllinzstation.com (Feb. 27,2012). High excise taxes encourage adult smokers to quit
and deter youth from starting (Kenneth E. Warner, Smoking and.-ke lth.itnplications of a Change in
the Federal Cigarettte Excise Tax, 255 J.AM. MED.Ass'N 1028,(1986),FranO Chaloupka&Rosalie
Liccardo Pacula, The Impact of Price on Youth Tobacco Use, 11i4.SMOKING AND;TOBACCO
CONTROL MONOGRAPHS: CHANGING ADOLESCENTySMOKING PRE VALENCE]93(U.S.Dep't
Health and Human Services et al. eds., 2001)). Therefore, inexpensive cigarettes„like those
produced from RYO machines,promote the use oftobacco resulting in a negative impact
on public health and increased health care costs, andseverelyindercut the evidence-
based public health benefit of imposing high excise taxes-on tobacco;
Whereas the sale of tobacco products and ncotine delivery products are incompatible
with the mission of health care institutions because-.they are detrimental to the public
health and undermine efforts to educate patients on the,safe and effective use of
medication; r=
Whereas educational institution sell tobacco products to a younger population, which is
particularly at risk for becoming smokers and such sale of tobacco products and nicotine
delivery products are incompatible with the w-mission of educational institutions that
educate ayouunger population=about social,'`environmental and health risks and harms;
T. .#.....p #
Now,therefore it is the intention ofthe City of Salem Board of Health to regulate the
access of tobacco product's.and nicotine delivery products.
B. Authority: =`'
iJ=
This regulation is promulgated pursuant to the authority granted to the City of Salem
Board of Health by Massachusetts General Laws Chapter 111, Section 31 that 'Boards of
Health may make reasonable health regulations".
C. Definitions:
For the purpose of this regulation, the following words shall have the following
meanings:
•
1
Blunt Wrap: Any tobacco product manufactured or packaged as a wrap or as a hollow
• tube made wholly or in part from tobacco that is designed or intended to be filled by the
consumer with loose tobacco or other fillers.
Business Agent: An individual who has been designated by the owner or operator of any
establishment to be the manager or otherwise in charge of said establishment.
Cigar: Any roll of tobacco that is wrapped in leaf tobacco or in any substance containing
tobacco with or without a tip or mouthpiece not otherwise defined as a cigarette under
Massachusetts General Law, Chapter 64C, Section 1, Paragraph 1.
Commercial Roll-Your-Own(RYO)machine: A mechanical device, by whatever
manufacturer made and by whatever name known, that is designed to roll and wrap
tobacco into products. RYO machines located in a private home, used for personal
consumption, are not Commercial Roll-Your-Own machines.
E-Cigarette: Any electronic Nicotine Delivery Product'composed of a mouthpiece,
heating element, battery and/or electronic circuits that provides a vapor of liquid nicotine
to the user, or relies on vaporization of solid nicotine or any liquid. This term shall
include such devices whether they are manufactured as e-cigarettes, e-cigars, e-pipes or
under any other product name.
Educational Institution: Any public or'private.college, school,professional school,
scientific or technical institution, university or other institution furnishing a program of
• higher education.
Employee: Any individual who performs services for air employer.
Employer: Any individual, partnership, association, corporation, trust or other organized
group of individuals that uses the services of one(1)or more employees.
Health Care Institution: An individual, partnership, association, corporation or trust or
any person or group of persons that provides health care services and employs health care
providers licensed, or subject to licensing,by the Massachusetts Department of Public
Health under M.G.L. c. 112 or a retail establishment that provides pharmaceutical goods
and services and subject to the provisions of 247 CMR 6.00. Health care institution
includes,but is not limited to, hospitals, clinics, health centers,pharmacies, drug stores,
doctor offices and dentist offices.
Minor: Any individual who is under the age of eighteen(18).
Nicotine Delivery Product: Any manufactured article or product made wholly or in part
of a tobacco substitute or containing nicotine that is expected or intended for human
consumption,but not including a tobacco substitute prescribed by a licensed physician or
a product that has been approved by the United States Food and Drug Administration for
sale as a tobacco use cessation or harm reduction product or for other medical purposes
and which is being marketed and sold solely for that approved purpose. Nicotine delivery
• product includes,but is not limited to, e-cigarettes.
2
Permit Holder: Any person engaged in the sale or distribution of tobacco or nicotine
• delivery products directly to consumers who applies for and receives a tobacco and
nicotine delivery product sales permit or any person who is required to apply for a
tobacco and nicotine delivery product sales permit pursuant to these regulations, or his or
her business agent.
Tobacco Product: Cigarettes, cigars, chewing tobacco, pipe tobacco,bidis, snuff or
tobacco in any of its forms.
Vending Machine: Any automated or mechanical self-service device,which upon
insertion of money, tokens or any other form of payment, dispenses or makes cigarettes,
any other tobacco product or Nicotine Delivery Product.
D. Tobacco and Nicotine Delivery Product Sales to Minors.Prohibited:
1. No person shall sell tobacco or nicotine delivery products or permit tobacco or nicotine
delivery products to be sold to a minor; or not being the minor's parent or.legal guardian,
give tobacco or nicotine delivery products to a minor.
2. Required Signage
a. In conformance with and in addition to Massachusetts General Law, Chapter 270,
Section 7, a copy of Massachusetts General Laws, Chapter 270, Section 6, shall
be posted conspicuously by the owner or other person in.charge thereof in the
• shop or other place used to sell tobacco products at retail. The notice shall be
provided by the Massachusetts Department of Public Health and made available
from the City of Salem Board of Health. The notice shall be at least 48 square
inches and shall be posted_conspicuously by the permit holder in the retail
establishment or-other place in such a manner so that it may be readily seen by a
person standing at or approaching the cash register. The notice shall directly face
the_purchaser and shall'not be obstructed from view or placed at a height of less
than four(4)-feet or greater than nine (9) feet from the floor. The owner or other
person in charge'of a shop or other place used to sell tobacco products at retail
shall conspicuously post any additional signs required by the Massachusetts
Department of Public Health.
b. The owner or other person in charge of a shop or other place used to sell tobacco
products at retail shall conspicuously post signage provided by the City of Salem
board of health that discloses current referral information about smoking
cessation.
c. The owner or other person in charge of a shop or other place used to sell nicotine
delivery products at retail shall conspicuously post a sign stating that"The sale of
nicotine delivery products to minors under 18 years of age is prohibited." The
owner or other person in charge of a shop or other place used to sell e-cigarettes at
retail shall conspicuously post a sign stating that"The use of e-cigarettes at indoor
establishments may be prohibited by local law."The notices shall be no smaller
• than 8.5"by I I"and shall be posted conspicuously in the retail establishment or
other place in such a manner so that they may be readily seen by a person
standing at or approaching the cash register. These notices shall directly face the
3
purchaser and shall not be obstructed from view or placed at a height of less than
• four(4) feet or greater than nine (9) feet from the floor.
3. Identification: Each person selling or distributing tobacco or nicotine delivery products
shall verify the age of the purchaser by means of valid government-issued photographic
identification containing the bearer's date of birth that the purchaser is 18 years old or
older. Verification is required for any person under the age of 27.
4. All retail sales of tobacco or nicotine delivery products must be face-to-face between
the seller and the buyer.
E. Tobacco and Nicotine Delivery Product Sales Permit:
1. No person shall sell or otherwise distribute tobacco or nicotine delivery products at
retail within the City of Salem without first obtaining a Tobacco and Nicotine Delivery
Product Sales Permit issued annually by the City of Salem Board of Health. Only owners
of establishments with a permanent,non-mobile location in Salem are eligible to apply
for a permit and sell tobacco products or nicotine delivery products at the specified
location in Salem.
2. As part of the Tobacco and Nicotine Delivery Product:Sales Permit application
process, the applicant will be provided with the City of Salem Board of Health regulation.
Each applicant is required to sign a statement.declaring that the applicant has read said
regulation and that the applicant is responsible for-instructing any and all employees who
• will be responsible for tobacco and nicotine delivery product.sales regarding both state
laws regarding the sale of.tobacco and this regulation.
3. Each applicant who'sells tobacco is required to provide proof of a current tobacco sales
license issued by the Massachusetts Department of Revenue before a Tobacco and
Nicotine Delivery Product Sales-Permit can be issued.
4. The fee for a Tobacco and Nicotine Delivery Product Sales Permit shall be determined
by the City of Salem Board of Health-annually. All such permits shall be renewed
annually.
5. A separate permit is required for each retail establishment selling tobacco or nicotine
delivery products.
6. Each Tobacco andNicotine Delivery Product Sales Permit shall be displayed at the
retail establishment in a conspicuous place.
7. No Tobacco and Nicotine Delivery Product Sales Permit holder shall allow any
employee to sell tobacco products or nicotine delivery products until such employee
reads this regulation and state laws regarding the sale of tobacco and signs a statement, a
copy of which will be placed on file in the office of the employer, that he/she has read the
regulation and applicable state laws.
• 8.A Tobacco and Nicotine Delivery Product Sales Permit is non-transferable. A new
owner of an establishment that sells tobacco or nicotine delivery products must apply for
4
a new permit. No new permit will be issued unless and until all outstanding penalties
• incurred by the previous permit holder are satisfied in full.
9. Issuance of a Tobacco and Nicotine Delivery Product Sales Permit shall be conditioned
on an applicant's consent to unannounced, periodic inspections of his/her retail
establishment to ensure compliance with this regulation.
10. Issuance and holding of a Tobacco and Nicotine Delivery Product Sales Permit shall
be conditioned on an applicant's on-going compliance with current Massachusetts
Department of Revenue requirements and policies including, but not limited to,minimum
retail prices of tobacco products.
11. A Tobacco and Nicotine Delivery Product Sales Permit will not be renewed if the
permit holder has failed to pay all fines issued and the time.period to appeal the fines has
expired and/or has not satisfied any outstanding permit suspensions.
12. Maximum Number of Tobacco and Nicotine Delivery Product Sales;Permits.
At any given time, there shall be no more.than 60 Tobacco and Nicotine Delivery
Product Sales Permits issued in City of Salem >No;permit renewal will be denied
based on the requirements of this subsection except any permittee who has failed
to renew their current permit within(30)days of expiration will be treated as a
first-time permit applicant. Applicants who purchase a business that holds a
current Tobacco and Nicotine Delivery Product Sales Permit at the time of the
• sale of said business may apply, within sixty(60)_days"of such sale, for the permit
held by the Seller if-the Buyer intends,to sell tobacco products and/or Nicotine
Delivery Products'. New applicants for permits who are applying at a time when
the maximum number of permits have been issued will be placed on a waiting list
and will be eligible to apply for a permit'on'a"first-come, first-serve"basis as
issued permits are.either not renewed or are returned to the Board.
F. Cigar Sales Regulated-.
1.No retailer, retail establishment,,or other individual or entity shall sell or distribute or
cause to be sold or distributed a cigar unless the cigar is contained in an original package
of at least four(4).cigars.
2. This Section shall not apply to:
a. The sale or distribution of any cigar having a retail price of more than two dollars
and fifty cents ($2.50).
b. A person or entity engaged in the business of selling or distributing cigars for
commercial purposes to another person or entity engaged in the business of
selling or distributing cigars for commercial purposes with the intent to sell or
distribute outside the boundaries of City of Salem.
• 3. The Board of Health may adjust from time to time the amounts specified in this
Section to reflect changes in the applicable Consumer Price Index by amendment of this
regulation.
5
G. Prohibition of the Sale of Blunt Wraps
•
No person or entity shall sell or distribute blunt wraps within the City of Salem.
H. Free Distribution and Coupon Redemption:
No person shall distribute, or cause to be distributed, any free samples of tobacco
products or nicotine delivery products. No means, instruments or devices that allow for
the redemption of tobacco products for free or at a reduced price below the minimum
retail price determined by the Massachusetts Department of Revenue shall be accepted by
any permittee.
I. Out-of-Package :
No person may sell or cause to be sold or distribute or cause to be distributed, any
cigarette package that contains fewer than twenty(20)'6garettes, including single
cigarettes.
J. Self-Service Displays:
All self-service displays of tobacco products and/or nicotine delivery products are
prohibited. All humidors including, but not limited to, walk-in humidors must be locked.
• K. Vending Machines:
All tobacco and/or nicotine delivery product vending machines are prohibited.
L. Commercial Roll-Your-Own-Machines
All commercial R611-Your=Own machines are prohibited.
M. Prohibition of the Sale of Tobacco and Nicotine Delivery Products by Health Care
Institutions:
No health care institution located in City of Salem shall sell or cause to be sold tobacco
or nicotine delivery products. No retail establishment that operates or has a health care
institution within it such as a pharmacy or drug store, shall sell or cause to be sold
tobacco products or nicotine delivery products.
N. Prohibition of the Sale of Tobacco and Nicotine Delivery Products by Educational
Institutions:
No educational institution located in City of Salem shall sell or cause to be sold tobacco
or nicotine delivery products. This includes all educational institutions as well as any
retail establishments that operate on the property of an educational institution.
• O. E-Cigarette Use:
6
The use of e-cigarettes is prohibited wherever smoking is prohibited per M.G.L. Ch.270,
• §22 and the Salem Environmental Tobacco Smoke(ETS)regulation.
P. Violations:
1. It shall be the responsibility of the establishment, permit holder and/or his or her
business agent to ensure compliance with all sections of this regulation pertaining to his
or her distribution of tobacco and/or nicotine delivery products. The violator shall
receive:
a. In the case of a first violation, a fine of one hundred dollars ($100.00).
b. In the case of a second violation within 36 months of the date of the current
violation, a fine of two hundred dollars ($200.00) and the Tobacco and Nicotine
Delivery Product Sales Permit shall be suspended for seven,(7)consecutive
business days.
c. In the case of three or more violations within a 36 month period,a fine of three
hundred dollars ($300.00) and the Tobacco and Nicotine Delivery Product Sales
Permit shall be suspended for thirty(30)consecutive business days.
2. Refusal to cooperate with inspections pursuant to this regulation shall result in the
suspension of the Tobacco and Nicotine Delivery Product Sales Permit for thirty(30)
consecutive business days.
• 3. In addition to the monetary.fines set above, any permit holder who engages in the sale
or distribution of tobacco or nicotine delivery;products directly to a consumer while his
or her permit is suspended shall be subject to the suspension of all board of health issued
permits for thirty(30)consecutive business days.
4. The City,of Salem Board of Health shall provide notice of the intent to suspend a
Tobacco and Nicotine Delivery Product Sales Permit,which notice shall contain the
reasons therefor and establish a time and date for a hearing which date shall be no earlier
than seven(7)days after the date of said notice. The permit holder or its business agent
shall have an opportunity to be heard at such hearing and shall be notified of the Board of
Health's decision and the reasons therefore in writing. After a hearing, the City of Salem
Board of Health shall suspend the Tobacco and Nicotine Delivery Product Sales Permit if
the Board finds that a'sale to a minor occurred. For purposes of such suspensions, the
Board shall make the determination notwithstanding any separate criminal or non-
criminal proceedings brought in court hereunder or under the Massachusetts General
Laws for the same offense. All tobacco products and nicotine delivery products shall be
removed from the retail establishment upon suspension of the Tobacco and Nicotine
Delivery Product Sales Permit. Failure to remove all tobacco and nicotine delivery
products shall constitute a separate violation of this regulation.
Q. Non-Criminal Disposition:
• Whoever violates any provision of this regulation may be penalized by the non-criminal
method of disposition as provided in General Laws, Chapter 40, Section 21 D or by filing
a criminal complaint at the appropriate venue.
7
• Each day any violation exists shall be deemed to be a separate offense.
R. Enforcement:
Enforcement of this regulation shall be by the City of Salem Board of Health of or its
designated agent(s).
Any citizen who desires to register a complaint pursuant to the regulation may do so by
contacting the City of Salem Board of Health or its designated agent(s)and the Board
shall investigate.
-r
S. Severability: Y
.4b
If any provision of these regulations is declared invalid or"_'t nenf&beable, the other
provisions shall not be affected thereby but shall continue-in full feed-and effect.
fF ''
T. Effective Date:
i} ry7k
This regulation shall take effect on �, 2012,
with the exception of Section F (Cigar Sales Regulated)which shall take effect on
February 4, 2013. .
�w.
P:
ti .oi
.S:
I •
8
4k
Municipal Tobacco Control
Technical Assistance Program
Donald J. Wilson, Director
c/o Massachusetts Municipal Association (617) 426-7272
One Winthrop Square FAX (617) 695-1314
Boston, Massachusetts 02110 djwilson@mma.org
----------------------------------------------------------------
----------------------------------------------------------------
MEMORANDUM
TO: Salem Board of Health
FROM: D. J. Wilson
RE: Concerns Raised at July 10 Public Hearing
DATE: July 11, 2012
At the above-captioned public hearing a number of local business owners testified regarding
concerns about three sections of the regulation: Section E.12—Permit Number Cap, Section F—
• Cigar Sales Regulated and Section G—Prohibition of the Sale of Blunt Wraps.
I'd like to answer concerns raised on each after first noting that the draft before the Board
contains over a dozen components all in the effort to keep youth from smoking and to encourage
current smokers to quit. There is no one"silver bullet"to do this and it is important to note that
only these sections of the draft were raised at the hearing.
Section E.12—Permit Number Cap
The proposed language makes the permit more valuable in that there would be a finite number of
permittees allowed to sell tobacco products and places those businesses in a privileged class.
That privileged class means that not only do they hold a valuable commodity but that they need
to be diligent in preventing this privilege taken away from them as a result of being repeat
offenders to the regulation. The proposal mimics long-held theory by the Commonwealth and
their liquor license local allotment formula that containing the number of outlets has reasonable
public health and public welfare goals. The proposed language is intended to ensure that a
current permit holder is not disadvantaged when selling their business to a buyer who is not a
permit holder. Upon concerns from one trade association, that language was clarified to indicate
that a bona fide buyer will get a permit and not be "shut out"by the permit cap.
Section F—Cigar Sales Regulated
In February of 2011,the City of Boston instituted a ban on the sale of cheap single cigars. The
impetus for doing so was that evidence existed that youth were buying these cheap cigars. This
effort mimics the ban on single cigarettes ("loosies") and"kiddie packs" (packs of 5 or 10
cigarettes)by controlling the price or size of cigar packs sold. No evidence exists in
Massachusetts that the ban on"loosies"led to increased smoking because smokers were now
compelled to buy a whole pack of cigarettes. Rather, impulse buys of single cigarettes,priced as
low as 25 cents at the time of the state law ban,were reduced. To date, compliance has been
high in the city of Boston and no lawsuits have been brought against the City. The delayed start
date for this section of the proposed regulation is intended to allow for a year's worth of
enforcement experience in Boston before other cities in towns in Massachusetts institute their
own effort on cigar sales.
Section G—Prohibition of the Sale of Blunt Wraps
One retailer opposed the ban on blunt wraps. Boston has had this ban in place for three years.
Lynn, Worcester and New Bedford also ban blunt wraps. Boston's ban survived a legal
challenge when the Massachusetts Supreme Judicial Court siding with the city. After that
decision, a federal lawsuit against Worcester's ban was dropped.
Section H—Free Distribution and Coupon Redem tp ion
Lastly, while no one testified on this subject at the hearing, the Board did receive written
communications concerning the redemption of coupons.
The language in this draft accomplishes two goals: (1) for all tobacco products, no coupon can be
• redeemed that results in the product being free, which confirms the first sentence of this section
that bans "any free samples of tobacco products" and(2) if it is a coupon for cigarettes,the
amount of the coupon cannot drive the price below that listed in the Massachusetts Department
of Revenue's minimum pricing list. The section is thusly worded in case the Mass. DoR decides
in the'future to expand its minimum price list beyond cigarettes to other tobacco products.
This provision will actually help retailers from violating the state law by permitting the
acceptance of only those coupons that keep the then discounted price above the Commonwealth's
legal minimum.
There is in fact a federal court case involving a coupon redemption ban imposed by Providence,
Rhode Island. Differentiating this lawsuit from the language in the draft is the important
distinction that the Massachusetts Department of Revenue maintains a minimum price list for
each and every brand of cigarette sold in the Commonwealth. No such list exists in Rhode
Island. It is also important to note that nowhere in the draft regulation is there any regulation of
flavored tobacco products.
• ! •
Sign in Sheet for Public Hearing for Tobacco Sales Regulation
"Please print information' 7/10/2012
NAME (PRINT) STREET ADDRESS ESTABLISHMENT
TT
'01770 Uf,-
O (� 1.► � � ITC,-4 �
P C . 6, ,�
2W14AE� l
7 3, S
0
Sign in Sheet for Public Hearing for Tobacco Sales Regulation
**Please print information*'k 7/10/2012
NE
�a r�vc� rS 1
ca^aA ZZ,
L-AA..-3 m nc 11 A
` A) �' /`� 6 L AN (� Co n v Cv1 i e n�.
/\/�)k A r V2 -3Lck 4 4c, I
-
M JfJryjr F
New England Convenience Store Association
Dr. Barbara Poremba, Chairperson
Salem Board of Health
120 Washington Street(4th floor)
Salem, MA 01970
VIA electronic mail and regular mail
July 9, 2012
Comments of the New England Convenience Store Association Regarding Proposed Regulation
of the Salem Board of Health Restricting the Sale of Tobacco Products and Nicotine Delivery
Products
Dear Chairperson Poremba and Members of the Salem Board of Health:
I am submitting this letter on behalf of the New England Convenience Store Association (NECSA).
NECSA's membership consists of independent, family owned convenience stores,
independently owned franchise stores as well as chain-operated convenience stores.
According to the National Association of Convenience Stores [NACS] latest industry report,
as of December 2010, there are approximately 2,800 convenience stores operating in
Massachusetts.
Passage of several of the proposed regulations-particularly 1) the cigar mandates that could
ironically require consumers to buy more tobacco products than they choose to consume
and 2) the provisions regarding limitations and potential elimination of retail sales permits
for store owners - will directly and negatively affect the ability of small businesses in Salem
to remain in business, grow, and create and maintain jobs in the community. We
respectfully ask that you not adopt these provisions.
1) Requiring consumers to buy more tobacco products than they want seems
inconsistent with a health regulation
The proposed regulation stipulates that no cigar may be sold in packs of less than four-
except cigars over a certain price point. With all due respect to the drafters of this
proposal, how can a regulation requiring people to buy as much as four times more of a
tobacco product than they want possibly be construed as a productive health ordinance?
This question does not seem to have a clear answer to those who would be regulated under
this proposal and will ultimately cause economic harm to store owners in the City of Salem.
Unlike cigarettes, there are many adults who may want only one cigar of their particular brand and
compelling them to purchase more than they want seem illogical. In fact, data shows that
less than 1% of cigar smokers do soon a daily basis (see below).
For Salem's convenience stores, a ban on single cigar sales with a retail price of$2.50 or less would
have a significant financial impact on retail sales and a store's ability to maintain their bottom line.
Regardless of an individual's feeling about tobacco, cigars are legal adult products and are important to
your local convenience store's business. According to the National Association of Convenience
Stores'(NACS)State of the Industry Report for 2010,`other tobacco Products including cigars' on
average constitute 4%of sales at convenience stores which is the 5t highest in store sales
product.
Single cigar sales for the`under$2.50 retail class' represent a significant sales category and would
severely impact their overall sales and a store's profit which impacts their ability to employ staff. This is
1044 Central Street Suite 203-Stoughton, MA 02072-Phone:781-297-9600- Fax: 781-297-9601
New England Convenience Store Association
an industry in which every dollar counts and convenience stores should not be deprived of an opportunity
to generate revenue from their fifth largest selling category in this competitive market.
Here is relevant data that may be of interest to you about single cigar sales.
• 60%of machine-made large cigars are sold in convenience stores(Volume By Trade Class)
Source: STARS Geo Agg Database updated 9/3/11, data through week ending 7/2/11
• 70 %of machine-made large cigars are sold as single cigars(Transactions by Cigar Count)
Source: Symphony IRI Group Info Scan Database updated to 9/4/11, data through week
ending 7/3/11
• Less than 1%of adults who smoke cigars do so on a daily basis. See National Cancer
Institute, Monograph 9: Cigars: Health Effects and Trends, Trends in Cigar Smoking and Smoking
Prevalence,40-49(1998); CDC, Cigarette Smoking Among Adults—United States, 2004, 295
JAMA 749, 749-50(2006). This relates to our members'view that most adult consumers
legitimately prefer to purchase cigars in smaller quantities-perhaps only a single cigar or a few
cigars at a time.
Also, our members'customers may travel to a neighboring town or order products over the Internet to the
financial disadvantage of the local convenience store's business and the city's economy.
2) Arbitrary Limits on Sales Permits are Detrimental to Small Business Growth
The proposed regulations seem to limit the number of retail sales permits to no more than
sixty and then allow the Board of Health to, presumably at their sole discretion, to
potentially lower that number even further. Sales of businesses would not ensure the
transfer of the permit to subsequent owners. In fact, the proposal expressly states that the
permit is non-transferrable. This could significantly impact the value of every existing retail
store that currently sells tobacco in Salem since there is no guarantee that a subsequent
owner would be able to continue the business. In addition, anyone seeking to start a new
business in Salem could-and it seems would-be denied a permit if the limit set by the city is
reached. Regardless of the intentions, this proposal seems to have no clear, legitimate
basis as a health regulation but rather as a means of stopping the creation of job-
generating businesses that sell legal products in a responsible manner. We respectfully
urge you not to adopt it.
For the foregoing reasons we ask that you not adopt these regulations referenced above.
Thank you very much for your time and consideration of our request.
2teDphe
yaA, Esq.
Executive Director
New England Convenience Store Association
1044 Central Street Suite 203^ Stoughton, MA 02072-Phone: 781-297-9600- Fax: 781-297-9601
- Lan Ramdin -- ------
From: Duffill, Raymond A <Raymond.Duffill@fda.hhs.gov>
Sent: Tuesday,July 10, 2012 9:45 AM
To: Larry Ramdin
Cc: O'Malley, Elizabeth
Subject: FW: Salem 2102 grant application.doc
Attachments: Salem 2102 grant application.doc
Good Morning Larry,
Congratulations! Your Program Standards Funding proposal for the 2012-2013 year has been qpproved. A purchase
order will be processed to award $2500.00 for the deliverables as described below:
'(:''The City if Salem Board of Health will enroll in the FDA Voluntary Retail Food Regulatory Program Standards
('Program Standards)and submit the required National Registry and Permission to Publish forms to the FDA Regional
Office Retail Food Specialist.
2.::-::The City of Salem Board of Health will complete a Food Protection Program self-assessment against the current
ygo§ion of the Program Standards within 12 months of enrollment and submit the required National Registry and
Eei mission to Publish forms to the FDA Regional Retail Food Specialist to report that accomplishment.
3. The City of Salem Board of Health will develop an action plan and submit a report and/or National Registry and
Permission to Publish forms as applicable to the FDA Regional Retail Food Specialist on or before July 1, 2013.
Please review and if acceptable to you, amend your proposal to reflect the deliverables as detailed above in items 1-3. If
there are questions or there is a need to change anything, please do not hesitate to conteact me.
Thank you and best regards. Ray
From: Larry Ramdin [mailto:Iramdin(56alem.coml
Sent: Tuesday, July 03, 2012 11:42 AM
To:: Duffill, Raymond A
Cc:,O'Malley, Elizabeth
Subject: RE: Salem 2102 grant application.doc
Ray,
The application is attached,thanks for your assistance in completing it.
Sincerely
Larry Ramdin
Health Agent
Salem Board of Health
120 Washington Street, 4th floor
Salem MA 01970
978-741-1800 (phone)
0 978-745-0343(fax)
1
1999 Food Code
6-501.115 Prohibiting Animals.*
(A) Except as specified in 1111(B)and (C)of this section,live animals may not be allowed on the
premises of a food establishment.
(B) Live animals may be allowed in the following situations if the contamination of food; clean
equipment, utensils,and linens;and unwrapped single-service and single-use articles can not result:
(1) Edible fish or decorative fish in aquariums,shellfish or crustacea on ice or under refrigeration,and
shellfish and crustacea in display tank systems;
(2) Patrol dogs accompanying police or security officers in offices and dining,sales,and storage areas,
and sentry dogs running loose in outside fenced areas;
3 In areas that are not used for food preparation and that• (. ) p pare usually open for customers,such as
dining and sales areas,service animals that are controlled by the disabled employee or person if a
health or safety hazard will not result from the presence or activities of the service animal;
(4) Pets in the common dining areas of group residences at times other than during meals if:
(a) Effective partitioning and self-closing doors separate the common dining areas from food storage or
food preparation areas,
(b) Condiments,equipment,and utensils are stored in enclosed cabinets or removed from the common
dining areas when pets are present,and
(c) Dining areas including tables,countertops,and similar surfaces are effectively cleaned before the
next meal service;and
(S) In areas that are not used for food preparation,storage,sales,display, or dining, in which there are
caged animals or animals that are similarly restricted,such as in a variety store that sells pets or a tourist
park that displays animals.
(C) live or dead fish bait may be stored if contamination of food; clean equipment, utensils,and linens;
and unwrapped single-service and single-use articles can not result.
FDA Food Code Public Health rationale
-6-501.115 Prohibiting Animals.*
Animals carry disease-causing organisms and can transmit pathogens to humans through direct and/or
indirect contamination of food and food-contact surfaces.The restrictions apply to live animals with
limited access allowed only in specific situations and under controlled conditions and to the storage of
live and dead fish bait. Employees with support animals are required under§ 2-301.14 to wash their
hands after each contact with animals to remove bacteria and soil.
Animals shed hair continuously and may deposit liquid or fecal waste, creating the need for vigilance
and more frequent and rigorous cleaning efforts.
The definition for"service animal" is adapted from 28 CFR 36.104 adopted pursuant to the Americans
with Disabilities Act(ADA)of 1990(42 U.S.C. 12101 et seq.). A service animal performs some of the
functions that persons with a disability cannot perform for themselves,such as those provided by
"seeing eye dogs"; alerting persons with hearing impairments to sounds; pulling wheelchairs or carrying
and picking up things for persons with mobility impairments; and assisting persons with mobility
impairments with balance. A service animal is not considered to be a pet.
Under Title III of the ADA, privately owned businesses that serve the public are prohibited from
discriminating against individuals with diabilities.The ADA requires these businesses to allow people
with disabilities to bring their service animals onto business premises in whatever areas customers are
generally allowed.Some,but not all,service animals wear special collars or harnesses.Some, but not all,
are licensed or certified and have identification papers.
Decisions regarding a food employee or applicant with a disability who needs to use a service animal
should be made on a case-by-case basis.An employer must comply with health and safety
requirements,but is obligated to consider whether there is a reasonable accommodation that can be
made. Guidance is available from the U.S. Department of Justice,Civil Rights Division, Disability Rights
Section or the U.S. Equal Employment Opportunity Commission,the federal agency which has the lead
in these matters, in documents such as, "Commonly Asked Questions About Service Animals in Places of
Business"; "The Americans with Disabilities Act Questions and Answers"; "A Guide to Disability Rights
Laws"; and "Americans with Disabilities Act Title III Technical Assistance Manual, 1994 Supplement."The
ADA Information Line is 800-514-0301(voice)or 800-514-0383 (TDD) and the Internet Home Page
address is http://www.usdoj.gov/crt/ada/adahoml.htm3.
Larry Ramdin
Frorn: dildar hussain <barkeleywater@hotmail.com>
Sent: Monday,July 09, 2012 12:14 PM
To: Larry Ramdin
Subject: Tobacco Ordinance
My Name is Dildar Hussain.i own 2 small businesses in the city of salem,Canal st gloabl ,200 canal st,and pump n
pantry,10 paradise road.
i am a resposible retailer,been selling the tobacco prodcuts to adult consumers of legal age never have issues of any kind.
with the new purposal of cigar tobacco regulation it will certainly hurt the small retail business as is we are struggling to
meet our.end needs.
The,reason being our sales of tobacco product will go down drastically and it will hurt us financially.
Consumer point of view struggling with econmy they prefer buying single units due to the price structure and
convienence packing.
Fair trade market,also if the can buy the same product crossing the town,salem retailers will loose the sales and the
revenue also the taxes
state and city collects on the merchandising.
My humble request to the board is please review carefully with retailer point of view and then make decision on it
Best Regards.
Dildar Hussain.
08-327-8815.
i
1
N
A 11
T�w
July 10,2012
officers Larry Ramdin,RS/REHS,CHO, CP-FS
Chairman Health Agent
Me Salem Board of Health
;-
120 Washington Street,40 Floor
Salem,MA.01970
Vice Chairman
Re: Proposed Tobacco Regulation Amendments
Secretary Dear Agent Ramdin,
The Retailers Association of Massachusetts (RAM), established in 1918, is a
Treasurer statewide trade association of over 3,400 member companies. Our membership
�
�411"71'1'" ranges from independent, "mom and pop" owned stores to larger, national chains
Executive Staff operating in the general retail, restaurant and service sectors of the retail industry.
The industry's contributions to the Commonwealth include over $112 billion in
President annual sales; over $5.7 billion in annual sales and use taxes collected; 17% of all
.K!n 1`. ilul;,r Massachusetts jobs; and operations in over 38,000 locations across the state.
Vice President
V1`i1 i.;:1-;;-*. RAM wishes to be recorded in opposition to the proposal to be considered by the
General Counsei Salem Board of Health during a public hearing on Tuesday, July 10, 2012, which,
aims to ban on the sale of tobacco products in retail pharmacies and drug stores
Membership Director located in your town.
Finance Manager We find this proposal to be discriminatory in that it seeks to ban the sale of tobacco,
a legal product, in certain types of stores. In taking this proposed course of action,
your municipality is essentially picking winners and losers in a very competitive
retail marketplace. Retail pharmacies will be placed at a competitive disadvantage
with the loss of tobacco products from their shelves. Retailers should be allowed to
decide for themselves whether or not to offer tobacco products to adult consumers.
It is simply unfair to deprive a legitimate and licensed retail business the opportunity
to sell a legal product.
The proposed sales ban will not result in a decrease in tobacco usage. Yet, it will
result in the loss of revenue for those retail locations that currently sell tobacco and
seek to operate a pharmacy in the future. The elimination of products from their
shelves will result in a decrease in customer traffic and will impact the sale of any
number of other product lines. Depending on the current economic viability of a
. particular retail location,the resulting revenue loss to a competitor across the street that does not
have a pharmacy may translate into job loss and possibly store closings.
Furthermore, any proposal that directly or indirectly hinders the sale of legal products is illogical
in today's economic climate where the Commonwealth is hard pressed for revenue needed to
fund local aid. Every sale that goes unrealized by a retailer translates into a loss of badly needed
state revenue.
It is also important for any Iocal government to be aware of the real possibility of costly legal
action resulting from the adoption of such a law. Although no lawsuit has yet to be brought
against any of the growing number of Massachusetts cities and towns which currently have a
ban, we caution you that it is only a matter of time. Just last spring, a large grocery chain in San
Francisco brought suit against that city challenging a similar ordinance adopted there. This most
recent action follows a string of previous suits dating back to 2008 when the original ordinance
was adopted. As more local tobacco bans are imposed and more retailers become aware of
efforts, like those taken in San Francisco to protect retailers' Constitutional rights, the more
likely it becomes that local businesses will follow suit.
For the reasons detailed above, RAM is also opposed to those provisions of the proposal which.
aim to prohibit the sale of cigars in packages of less than four and which restrict the sale of e-
cigarettes. Again these prohibitions apply to legal products intended for consumption by adult
consumers. To prohibit the sale of these products is competitively unfair, has a negative impact
on state tax revenue and exposes the government to costly legal disputes.
Today's consumer has a wide variety of choices available to them when deciding where to shop.
Many consumers look for that one stop shopping experience and appreciate the availability of a
wide variety of product offerings. We ask that consumers be allowed to continue to enjoy that
current flexibility of choice in the marketplace.
RAM respectfully requests that you oppose this proposal and we thank you for your
consideration.
Sincerely,
Ryari'C. Kearney
General Counsel
cc: Salem Board of Health Members
. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1140
[Docket No. FDA-1995-N-0259] (formerly Docket No. 1995N-0253)
RIN 0910-AG33
Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco To Protect Children and Adolescents
SUBCHAPTER K--TOBACCO PRODUCTS
PART 1140--CIGARETTES AND SMOKELESS TOBACCO
Subpart A--General Provisions
Sec.
1140.1 Scope.
1140.2 Purpose.
1140.3 Definitions.
Subpart B--Prohibition of Sale and Distribution to Persons Younger Than
18 Years of Age
1140.10 General responsibilities of manufacturers, distributors, and
retailers.
1140.12 Additional responsibilities of manufacturers.
1140.14 Additional responsibilities of retailers.
1140.16 Conditions of manufacture, sale, and distribution.
Subpart C--[Reserved]
Subpart D--Labeling and Advertising
1140.30 Scope of permissible forms of labeling and advertising.
1140.32 Format and content requirements for labeling and
advertising.
1140.34 Sale and distribution of nontobacco items and services,
gifts, and sponsorship of events.
Authority: 21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123
Stat. 1776.
Subpart A--General Provisions
Sec. 1140.1 Scope.
(a) This part sets out the restrictions under the Federal Food,
Drug, and Cosmetic Act (the act) on the sale, distribution, and use of
cigarettes and smokeless tobacco that contain nicotine.
(b) The failure to comply with any applicable provision in this
part in the sale, distribution, and use of cigarettes and smokeless
tobacco renders the product misbranded under the act.
• (c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
Sec. 1140.2 Purpose.
The purpose of this part is to establish restrictions on the sale,
distribution, and use of cigarettes and smokeless tobacco in order to
reduce the number of children and adolescents who use these products,
and to reduce the life-threatening consequences associated with tobacco
use.
Sec. 1140.3 Definitions.
(a) Cigarette. (1) Means a product that:
(i) Is a tobacco product; and
(ii) Meets the definition of the term ' 'cigarette' ' in section 3 (1)
of the Federal Cigarette Labeling and Advertising Act; and
(2) Includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of tobacco used in
the filler, or its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
(b) Cigarette tobacco means any product that consists of loose
tobacco that is intended for use by consumers in a cigarette. unless
otherwise stated, the requirements applicable to cigarettes under this
chapter shall also apply to cigarette tobacco.
(c) Distributor means any person who furthers the distribution of
cigarettes or smokeless tobacco, whether domestic or imported, at any
point from the original place of manufacture to the person who sells or
distributes the product to individuals for personal consumption. Common
carriers are not considered distributors for the purposes of this part.
(d) Manufacturer means any person, including any repacker and/or
relabeler, who manufactures, fabricates, assembles, processes, or
labels a finished cigarette or smokeless tobacco product.
(e) Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2] , including any salt or complex
of nicotine.
(f) Package means a pack, box, carton, or container of any kind in
which cigarettes or smokeless tobacco are offered for sale, sold, or
otherwise distributed to consumers.
(g) Point of sale means any location at which a consumer can
purchase or otherwise obtain cigarettes or smokeless tobacco for
personal consumption.
(h) Retailer means any person who sells cigarettes or smokeless
tobacco to individuals for personal consumption, or who operates a
facility where vending machines or self-service displays are permitted
under this part.
(i) Smokeless tobacco means any tobacco product that consists of
cut, ground, powdered, or leaf tobacco and that is intended to be
placed in the oral or nasal cavity.
Subpart B--Prohibition of Sale and Distribution to Persons Younger
Than 18 Years of Age
• Sec. 1140.10 General responsibilities of manufacturers,
• distributors, and retailers.
Each manufacturer, distributor, and retailer is responsible for
ensuring that the cigarettes or smokeless tobacco it manufactures,
labels, advertises, packages, distributes, sells, or otherwise holds
for sale comply with all applicable requirements under this part.
Sec. 1140 .12 Additional responsibilities of manufacturers.
In addition to the other responsibilities under this part, each
manufacturer shall remove from each point of sale all self-service
displays, advertising, labeling, and other items that the manufacturer
owns that do not comply with the requirements under this part.
Sec. 1140.14 Additional responsibilities of retailers.
In addition to the other requirements under this part, each
retailer is responsible for ensuring that all sales of cigarettes or
smokeless tobacco to any person comply with the following requirements:
(a) No retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age;
(b) (1) Except as otherwise provided in Sec. 1140.16(c) (2) (i) and
in paragraph (b) (2) of this section, each retailer shall verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
(2) No such verification is required for any person over the age of
26;
(c) Except as otherwise provided in Sec. 1140.16(c) (2) (ii) , a
retailer may sell cigarettes or smokeless tobacco only in a direct,
face-to-face exchange without
[ [Page 13231] ]
the assistance of any electronic or mechanical device (such as a
vending machine) ;
(d) No retailer may break or otherwise open any cigarette or
smokeless tobacco package to sell or distribute individual cigarettes
or a number of unpackaged cigarettes that is smaller than the quantity
in the minimum cigarette package size defined in Sec. 1140.16 (b) , or
any quantity of cigarette tobacco or smokeless tobacco that is smaller
than the smallest package distributed by the manufacturer for
individual consumer use; and
(e) Each retailer shall ensure that all self-service displays,
advertising, labeling, and other items, that are located in the
retailer's establishment and that do not comply with the requirements
of this part, are removed or are brought into compliance with the
requirements under this part.
Sec. 1140.16 Conditions of manufacture, sale, and distribution.
(a) Restriction on product names. A manufacturer shall not use a
trade or brand name of a nontobacco product as the trade or brand name
for a cigarette or smokeless tobacco product, except for a tobacco
product whose trade or brand name was on both a tobacco product and a
nontobacco product that were sold in the United States on January 1,
1995.
(b) Minimum cigarette package size. Except as otherwise provided
under this section, no manufacturer, distributor, or retailer may sell
or cause to be sold, or distribute or cause to be distributed, any
cigarette package that contains fewer than 20 cigarettes.
(c) Vending machines, self-service displays, mail-order sales, and
other ' 'impersonal' ' modes of sale. (1) Except as otherwise provided
under this section, a retailer may sell cigarettes and smokeless
tobacco only in a direct, face-to-face exchange between the retailer
and the consumer. Examples of methods of sale that are not permitted
include vending machines and self-service displays.
(2) Exceptions. The following methods of sale are permitted:
(i) Mail-order sales, excluding mail-order redemption of coupons
and distribution of free samples through the mail; and
(ii) Vending machines (including vending machines that sell
packaged, single cigarettes) and self-service displays that are located
in facilities where the retailer ensures that no person younger than 18
years of age is present, or permitted to enter, at any time.
(d) (1) Except as provided in paragraph (d) (2) of this section, no
manufacturer, distributor, or retailer may distribute or cause to be
distributed any free samples of cigarettes, smokeless tobacco, or other
tobacco products (as such term is defined in section 201 of the Federal
Food, Drug, and Cosmetic Act) .
(2) (i) Paragraph (d) (1) of this section does not prohibit a
manufacturer, distributor, or retailer from distributing or causing to
be distributed free samples of smokeless tobacco in a qualified adult-
only facility.
(ii) Paragraph (d) (2) of this section does not affect the authority
of a State or local government to prohibit or otherwise restrict the
distribution of free samples of smokeless tobacco.
(iii) For purposes of paragraph (d) of this section, the term
qualified adult-only facility' ' means a facility or restricted area
that:
(A) Requires each person present to provide to a law enforcement
officer (whether on or off duty) or to a security guard licensed by a
governmental entity government-issued identification showing a
photograph and at least the minimum age established by applicable law
for the purchase of smokeless tobacco;
(B) Does not sell, serve, or distribute alcohol;
(C) Is not located adjacent to or immediately across from (in any
direction) a space that is used primarily for youth-oriented marketing,
promotional, or other activities;
(D) Is a temporary structure constructed, designated, and operated
as a distinct enclosed area for the purpose of distributing free
samples of smokeless tobacco in accordance with this paragraph (d) (2)
of this section;
(E) Is enclosed by a barrier that:
(1) Is constructed of, or covered with, an opaque material (except
for entrances and exits) ;
(2) Extends from no more than 12 inches above the ground or floor
(which area at the bottom of the barrier must be covered with material
that restricts visibility but may allow airflow) to at least 8 feet
above the ground or floor (or to the ceiling) ; and
(3) Prevents persons outside the qualified adult-only facility from
seeing into the qualified adult-only facility, unless they make
unreasonable efforts to do so; and
(F) Does not display on its exterior:
(1) Any tobacco product advertising;
(2) A brand name other than in conjunction with words for an area
or enclosure to identify an adult-only facility; or
(3) Any combination of words that would imply to a reasonable
observer that the manufacturer, distributor, or retailer has a
sponsorship that would violate Sec. 1140.34 (c) .
(iv) Distribution of samples of smokeless tobacco under paragraph
(d) (2) of this section permitted to be taken out of the qualified
adult-only facility shall be limited to one package per adult consumer
containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If
such package of smokeless tobacco contains individual portions of
smokeless tobacco, the individual portions of smokeless tobacco shall
not exceed eight individual portions, and the collective weight of such
individual portions shall not exceed 0.53 ounces (15 grams) . Any
manufacturer, distributor, or retailer who distributes or causes to be
distributed free samples also shall take reasonable steps to ensure
that the amounts in this paragraph (d) .(2) (iv) are limited to one such
package per adult consumer per day.
(3) Notwithstanding paragraph (d) (2) of this section, no
manufacturer, distributor, or retailer may distribute or cause to be
distributed any free samples of smokeless tobacco:
(i) To a sports team or entertainment group; or
(ii) At any football, basketball, baseball, soccer, or hockey event
or any other sporting or entertainment event determined by the
Secretary to be covered by paragraph (d) (3) of this section.
(4) The Secretary shall implement a program to ensure compliance
with paragraph (d) of this section and submit a report to the Congress
on such compliance not later than 18 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act.
(5) Nothing in paragraph (d) of this section shall be construed to
authorize any person to distribute or cause to be distributed any
sample of a tobacco product to any individual who has not attained the
minimum age established by applicable law for the purchase of such
product.
(e) Restrictions on labels, labeling, and advertising. No
manufacturer, distributor, or retailer may sell or distribute, or cause
to be sold or distributed, cigarettes or smokeless tobacco with labels,
labeling, or advertising not in compliance with subpart D of this part,
and other applicable requirements.
[ [Page 13232] ]
Subpart C--[Reserved]
Subpart D--Labeling and Advertising
Sec. 1140.30 Scope of permissible forms of labeling and advertising.
(a) (1) A manufacturer; distributor, or retailer may, in accordance
with this subpart D, disseminate or cause to be disseminated
advertising or labeling which bears a cigarette or smokeless tobacco
brand name (alone or in conjunction with any other word) or any other
indicia of tobacco product identification, in newspapers; in magazines;
in periodicals or other publications (whether periodic or limited
C
distribution) ; on billboards, posters, and placards; in nonpoint-of-
sale promotional material (including direct mail) ; in point-of-sale
promotional material; and in audio or video formats delivered at a
point-of-sale.
(2) A manufacturer, distributor, or retailer intending to
disseminate, or to cause to be disseminated, advertising or labeling
for cigarettes or smokeless tobacco in a medium that is not listed in
paragraph (a) (1) of this section, shall notify the agency 30 days prior
to the use of such medium. The notice shall describe the medium and
discuss the extent to which the advertising or labeling may be seen by
persons younger than 18 years of age. The manufacturer, distributor, or
retailer shall send this notice to the Office of Compliance, Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850-3229.
(b) [Reserved]
(c) This subpart D does not apply to cigarette or smokeless tobacco
package labels.
Sec. 1140.32 Format and content requirements for labeling and
advertising.
(a) Except as provided in paragraph (b) of this section, each
manufacturer, distributor, and retailer advertising or causing to be
advertised, disseminating or causing to be disseminated, any labeling
or advertising for cigarettes or smokeless tobacco shall use only black
text on a white background. This section does not apply to advertising:
(1) In any facility where vending machines and self- service
displays are permitted under this part, provided that the advertising
is not visible from outside the facility and that it is affixed to a
wall or fixture in the facility; or
(2) Appearing in any publication (whether periodic or limited
distribution) that the manufacturer, distributor, or retailer
demonstrates is an adult publication. For the purposes of this section,
an adult publication is a newspaper, magazine, periodical, or other
publication:
(i) Whose readers younger than 18 years of age constitute 15
percent or less of the total readership as measured by competent and
reliable survey evidence; and
(ii) That is read by fewer than 2 million persons younger than 18
years of age as measured by competent and reliable survey evidence.
(b) Labeling and advertising in an audio or video format shall be
limited as follows:
(1) Audio format shall be limited to words only with no music or
sound effects.
(2) Video formats shall be limited to static black text only on a
white background. Any audio with the video shall be limited to words
only with no music or sound effects.
Sec. 1140 .34 Sale and distribution of nontobacco items and services,
gifts, and sponsorship of events.
(a) No manufacturer and no distributor of imported cigarettes or
smokeless tobacco may market, license, distribute, sell, or cause to be
marketed, licensed, distributed, or sold any item (other than
cigarettes or smokeless tobacco or roll-your-own paper) or service,
f
which bears the brand name (alone or in conjunction with any other
word) , logo, symbol, motto, selling message, recognizable color or
pattern of colors, or any other indicia of product identification
identical or similar to, or identifiable with, those used for any brand
of cigarettes or smokeless tobacco.
(b) No manufacturer, distributor, or retailer may offer or cause to
be offered any gift or item (other than cigarettes or smokeless
tobacco) to any person purchasing cigarettes or smokeless tobacco in
consideration of the purchase thereof, or to any person in
consideration of furnishing evidence, such as credits, proofs-of-
purchase, or coupons, of such a purchase.
(c) No manufacturer, distributor, or retailer may sponsor or cause
to be sponsored any athletic, musical, artistic, or other social or
cultural event, or any entry or team in any event, in the brand name
(alone or in conjunction with any other word) , logo, symbol, motto,
selling message, recognizable color or pattern of colors, or any other
indicia of product identification identical or similar to, or
identifiable with, those used for any brand of cigarettes or smokeless
tobacco. Nothing in this paragraph prevents a manufacturer,
distributor, or retailer from sponsoring or causing to be sponsored any
athletic, musical, artistic, or other social or cultural event, or team
or entry, in the name of the corporation which manufactures the tobacco
product, provided that both the corporate name and the corporation were
registered and in use in the United States prior to January 1, 1995,
and that the corporate name does not include any brand name (alone or
in conjunction with any other word) , logo, symbol, motto, selling
message, recognizable color or pattern of colors, or any other indicia
of product identification identical or similar to, or identifiable
• with, those used for any brand of cigarettes or smokeless tobacco.
Dated: March 11, 2010.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
Dated: March 11, 2010.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2010-6087 Filed 3-18-10; 8:45 am]
BILLING CODE 4160-01-5
:..,
gn A
NEW ENGLAND SERVICE STATION&
AUTO REPAIR ASSOCIATION.INC.
July 9th,2012
Board of Health
Salem City Hall
120 Washington St.
Salem, MA 01970
Re:Comments on Proposed Minimum Cigar Pack Size Restriction
Dear Board of Health members:
The New England Service Station and Automotive Repair Association strongly opposes the Salem Board
of Health's proposed amendment to the Tobacco Regulation that would ban the sale of loose cigars in
Salem.The proposed regulation,which would ban the sale of cigars with a wholesale price of two dollars
or less,except in packages of four or more,would adversely impact our adult customers who legally
purchase tobacco products.
Many of our retailers sell single cigars,and in fact 70% of machine-made large cigars are sold as single
sticks.There is an adult market for this legal product.The proposed regulation would not only have a.
negative economic impact on our members who responsibly sell tobacco, but would force adult
consumers to purchase more tobacco than they choose to consume.
NESSARA members adhere to strict policies for tobacco sales in Salem to deter and prevent sales to
minors. For years our members have voluntarily trained their clerks to help them properly check IDs,
spot fake ones and prevent the sale of tobacco to minors. And to mark our industry's progress,the most
recent national Synar survey showed the lowest level of tobacco sales to minors in history.
We are also concerned that people will circumvent a single cigar sale regulation, placing sales of
individual cigars outside of the retailer environment and onto the streets where sellers will not check ID,
refuse a sale to a minor, have the proper license or collect the appropriate tax revenue.
We share the goals of the Salem Board of Health—keeping tobacco products out of minor's hands.The
goals you seek to accomplish can be achieved through continued retailer enforcement and
accountability and continued anti-tobacco youth education.
The proposed amendment therefore is unnecessary, and redundant. Banning us from selling single
cigars will do nothing more than cut off revenue from our loyal adult customers,and further burden us
during these tough economic times.
Please do not hesitate to contact me at 978-667-7706 or mattl@nessara.org if you need additional
information.
Sincerely,
461- _
Matthew LeLacheur
Executive Director, NESSARA
I ,
(city of ale ,
- (office of the Cetp Council
• ��9� � Citp Jball
COUNCILLORS-AT-LARGE JOAN B. LOVELY WARD COUNCILLORS
PRESIDENT
2012 CHERYL A. LAPOINTE 2012
KEVIN R.CARR,JR. CITY CLERK ROBERT K.MCCARTHY
THOMAS H.FUREY MICHAEL SOSNOWSKI
JOAN B.LOVELY TODD A.SIEGEL
ARTHUR C.SARGENT III p ('Z JERRY L.RYAN
`) `rl�( ` JOSH H.TURIEL
PAULC.PREVEY
JOSEPH A.O'KEEFE,SR.
La v- r Yj -5 U
c:V%.. w v- c v. 5
LC G ra U
� U J t h e d✓�. J ✓ t \C/"� a h Ct fn
cL lUrn c � C e� w� a\c��no�c GR�. �� ��.N ! ea'a� £�5��ta�U
�r o�5 wQtTQ ail G Qa � ��� uJe `a v\ y\GW 15
C_c ve- s -�� e`r c Q Irt t C a`� c�2 _I'
�G� 6 4j'&C K )U N G S - � } ( l i
`o rn )��'J1J� �� G � jcL ` C �G $ems es
Y 4 0 U l � l " `M Sc—t�. V. G V i �/1/\�.l Vi
o�e�� Sy Ckr 1 `� Q GAS v+ee� ( GA S G-
kec-
1ov, �GsC
,�, �o � ,� aAj, -FtG�, rug- Y
Gip � Lg �
�YG�' e N l \�tJ t e af
�%Gi b Pe W
0- C-CO >� U �/ (`
r+1`ec� P `� pn ..(�. -{1,� e v w Se `t'" py
Gl �. (f � v�
e it t1 iC� liv -�Q 1 la�v � �!p y-L) �(-� -3 cry
U "TT � 1 v
VA c�v e C� c,
_•o,�--�(�n rt 2 �e f''v r �� t-4 e 4. �
b M Cw 1 r 0.Yt
e ( e.C'N ( r� L ��, d rp re v`e
�h e S , -Q �T� cCIL
c�
o
�d�` � 5` �40 s -�1,�-�-�- s '.2ay� � 3p 6 �Y ���.. s 5 v�' �•E'�t�.t �,n `-�-o -sec�cr\ �.
Yco( b PC r � +1"z tC per. F
v o c'p—
6,"- /nvk�
y o vv` qq J
�I' ���. y�p V e
�",� y
SALEM CITY HALL o 93 WASHINGTON STREET SALEM, MA 01970-3592 a WWW.SALEM.COM
•
•
i'I •