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MICHIGAN STATE UNIVERSITY
EAST LANSING, MICH. 48824 31293 10416 2429

This is to certify that the

thesis entitled

TESTING OF TAMPERpRES [STANT PACKAGING

presented by

JOHN SNEDEN

has been accepted towards. fulfllhnent
of the requirements for . w" I

d

MASTER'S of SCIENElEegree in PACKAGING

 

 

 

lMEfM

Major professor

Date ”2 ”‘72 5" 8 3

 

0-7 639 MS U is an Affirmative Action/Equal Opportunity Institution

 

 

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TESTING OF

TAMPER-RESISTANT PACKAGING

by
John Sneden

A THESIS

Submitted to
Michigan State University
in partial fulfillment of the requirements
for the degree of

MASTER OF SCIENCE

SCHOOL OF PACKAGING
1983

ABSTRACT

 

A new regulation for tamper-resistant packaging, found in volume 41,
number 215, page 50442 cf the Federal Register, requires, by definition only,
fiatcertainprod:ct3behtamperreflstantcontainers.Todetermineifflfis
definition would adequately protect the consumer, eleven sets of package forms
were tested for their tamper-resistance.

Sample sets for the tat consisted & tampered and non-tampered control
packages shown to consumers who were fired, ”Having cbserved this package,
doyouthinkithasbeentampered with?" When the tampered (and repaired)
packagee were examined, 75 percent of the ooneamers tested could not
correctly determine whether or not the package had been tampered with. Thirty
percentof theconsumers didmtcorrecflydetermine thata control package
had not been tamed with.

These results reflectadefim’teneedforfurthertesdngarfi developmentof
tamper-resistant packaging when protecting against malicious individials.

This thesis is dedicated to my wife, Bethany Rae, Without
her continual support and positive encouragement this

thesis would not have been possible; ‘
A special 'Thanks' to Dr, Hugh Lockhart for all his

insights and assistance, especially in allowing me to

graduate before the year 1990!!!

ii

ACKNOWLEDGEMENTS

The author would like to express his appreciation and

gratitude to the following individuals:

Dr.

Dr.

Ms.

Dr.

Ms.

Dr,

Mr.

John Gill, Animal Science, Michigan State University,
for his guidance in statistical analysis and methods.

Michael Richmond, Packaging, Michigan State University,
for serving as a committee member.

Mary Zehner, Agricultural Economics, Michigan State
university, for serving as a committe member and for
special guidance in developing the attitude survey
and final test forms.

Julian Lee, Packaging, Michigan State University,
for his assistance in programing the computer to
collate our data and results.

Denise Scodellaro, Packaging Student, Michigan State
University, for her ability to organize and lead the
student test proctors, especially during a time of need-

Hugh Lockhart, Packaging, Michigan State University,
for his advice and guidance as major professor.

Lee Albrecht, International Closures Division, Alcoa,
Richmond, Indiana, for his willingness to share
information and insights.

. Donald Kouns, Eli Lilly, Indianapolis, Indiana, for his

willingness to share information and insights.

. Darcy Willis, Abbott Labs, North Chicago, Illinois,

for his willingness to share information and insights.

iii

TABLE OF CONTENTS

IntrOdUCtion 0000.0000.00000000000000000000000000000000000 1

Definitions o.oeooooooooooooooeooo00000000000.000000000000 5

Historical Background .................................... 6

Tamper-Resistant Packaging Regulations ...................12
Milk Products ..................................... 12
Alcoholic Products ................................ 13
Sterile Opthalmics ................................ 14
OTC Drugs and Oral Cosmetics ...................... 15

21 CFR 211.132 ............................ 16
21 CFR 31h.8 .............................. 17
21 CFR 700.25 ............................. 17
21 CFR 200.50 and 800.12 .................. 17

Review* of New Tamper-Resistant Packaging Regulations .. 19

PrOdUCt Liability......o...............a......o.... 20
Classification of Tamper-Resistant Packaging ............ 21
FDA Classification of Tamper-Resistant Packaging .. 22

Gen. Classification of Tamper-Resistant Packaging . 2N

Prij-le OfaTamperer 00.0.00...0.0.0....0.00.00.00.00... 28

iv

Test Development ........................................
Initial Test .......................................
Results ............................................
Conclusion .........................................
The Test ...........................................
Consumer Perception Survey .........................
Tamper Identification Study ........................
Populations Tested .................................
Results ............................................

Consumer Perception Survey .................

Tamper Identification Study ................

Statistical Evaluation of Tamper-Resistant Identification

conCIUSionS cocoon-nooncanoe-00.0cocoa-ooooooooonIeooeoo

Consumer Perception Survey .ooooooooooooooooooooooo

Tamper Identification Study .......................

Experimental Error OIOCOIOOOOOO00.000.000.00...00.0.00...

Good Tamper-Resistant Packaging .........................

Attitude Survey: Tamper-Resistant Packaging .............

Results 0......OOOOOIIOO0.0000ICOOIOOOOOOOOOOOOOOI

COnCIUSionS OI.0......IOOIOOOOOOOOOO0.00.00.00.00.

Summary OOOOOOOOOOOOIOOOOOOOOI.00.......0...0.0.0.0000...

34
35
40
42
4h
#6
48

55
58

58
6O

58
58
65

67

69
73
78

82

83

Appendix A:

Sequence of events ................................. , ........ 87
Appendix B:
Senate Subcommittee Hearing ............................... 92
Appendix C:
Raw Data — Tamper Identification Test and Consumer
Perception Survey ..................... ....uu. 95
Appendix D:
Histograms - Tamper Identification Test ............ ....101
Appendix E:

Statistical Computations - Tamper Identification Test.112

Appendix F:

Histograms - Consumer Perception Survey ................. 123
Appendix G:

Raw Data - Attitude Survey ................................ 127
Appendix H:

Proctor Instructions for Completion of Testing ,,,,,,,, 132
Backnotes ................................................ 135
Bibliography ........ - ................................ -....137

Table
Table
Table
Table
Table
Table
Table

\JO‘IUlJ-‘wNH

LIST OF TABLES

Tamper-resistant package users .............. 9
Results of initial test ..................... 40
Population Data for Final Test .............. 56
Population Data for Final Test .............. 57
Consumer Perception Package Ranking ......... 59

Statistical set-up of Tamper Identification..6l

Statistical and percentage results of Tamper
Identification Test ......................... 63

INTRODUCTION

On September 30, 1982, three people were reported to have died from
ingesting potassium cyanide laced Eadie-Strength Tylenol crapsflm (an over-the
counter drug product).1 When the report, issued by the Coroner's OfiEice of
Cook Comty, Illinois, where the deaths took place, was redeved by McNeil
Consumer Products, a division of Johreon and Johnson, Imorporated and
manufacturer of Tylenol Products, an immediate recall was med for the two
qaeciac lot numbers involved. This recalltotalled an estimated 93,000 bottles
of Extra-Strength mend m?

Withinaperiod cfthree daysatotalof sevenpeopleinthe Chicagoarea
died as a result of ingesting potasium cyanide laced Extra-Strength Tylenol
capsules. Several other lot numbers became involved and more recalls were
issued totalling approximately 171,000 botth of product.3 The Food and Drug
Administration (FDA) was called in to conduct tests on all recalled bottles in
an effort to determine the extent of contamination. During the tests, two
ctherbou‘leswerefomdtocontain oontanfinatedcapaflesbfingingamtal
number of potamlum cyanide laced Extra-Strength Tylenol capsule battles to
eight.

On October 5, 1982, California authofities found strychnine poison in three
bottles of Ema-Strength Tylenol capsiles. This incident led McNeil Consumer
Products to Me an immediate recall of all Tylenol capsuled products not
packagedin unitdoseblisterpacks. Allrecallscf Tylenolbrand poducts
involved approximately 31,000,000 bottles}

Facts, details, and events alrmunding the fatal Chicago poisonings were
reviewed extensivelyby audioritiesinan efforttodeterminethe sourceof

l

contamination. Based upon FDA plant inspections of Tylenol manufactndng
sitesand the sequence cfeventsleadingtothepoisorfingsdtwasconclnded
that the contamination was the result of package/product tampering by a
muddle medians). 11: is believed that the tamperings took place after the
product had beenshippedto dismimmrsand mostlikelysometime afterthe
oapsfles had reached the retail shelves. This conclmion led to an immediate
nationwide investigation. However, as of February 25, 1983, no conclIBive
evidence has been found to prove that someone tampered with the Tylenol
podict and the investigation is continuing.

Over the two months following the Tylenol poisonings several cther
package/product tampering incidents (web as the California Tylenol tampering)
also took place involving food products and other over-the-oounter (OTC) drug
troducts. Many of these incidents were labelled ”copy-cat" poisonings because
of the similarities to the Tylenol poisonings. No one died from these tamperings
but several people were injrred.

State and local governments reacted quickly to the Tylenol and ”copy-cat"
incidents by proposing regulations requiring OTC drugs to be packaged in
tamper-resistant containers. The Proprietary Asociation, a national trade
acciation representing manufacturer's d OTC drugs, agreed with date and
local governments that regulations were necesary and requested the FDA to
mine the task of establishing quecific requirements. The FDA was
sabsequently directed bythe Secretary of Health and Human Services, Richard
Schweiker, to draft a nationwide regulation for tamper-resistant packaging. In
crdertoassisttheFDAintheeeéforts,aJdntComndtteeonProduct

SecudtyaswellasanExpertTechrfioalCommiuee wereestablishedbythe

3
Proprietary Asociatn'on. These two committee's were setup to develop and
report on @ecific recommendations for tamper-resistant packaging.

The outcome of these efforts was a new tamperhresistant packaging
regulation announced on November 5, 1982, in the Federal Register, volume 47,
no. 215, page 50442. The regulation effects Title 21 of the Code of Federal
Regulations (CFR) for the following Part and Section numbers: 1) 211.132,

2) 314, 3) 700.25, 4) 800.12, and 5) 200.50. The regulation will initially take
effect February 7, 1983, for some cosmetic and OTC drug products. These
productsarecondderedtfighfiskardbelievedtobemmesiscepfibleto
tampering. Products in this category include all capsules, oralliquid cosmetics,
contact lens solutions, and opthalmic preparations. Other products affected by
the regulation are required to be packaged in tamper-redstant containers
effective May 5, 1983. These products are tablet and vaginal products.
(“Tamper-resistant packaging has been availabh for years and there are
several previous regulatory requirements involving tamper-resistant or: tamper
indicative packaging. None d these previous regulations dealt with malicious
adulteration of a packaged product. Historically tamper-resistant packages
have not been intended to deter a: halt intentionally malicious individuals but
were mainhr used to deter common in-szore opening of the package by normal
consumers. Therefore, in light of the recent malicious tamperings, the
following questions have become a concern: 1) Can the package adequately
protect the consumer from malicious adulteration of a product through
tamper-resistant packaging?; 2) Can the package protect against both
"copy-cat" and ”Tylenol Killer”?; 3) Ard if not, then why has the FDA
established regulatory requirements)”; 4) With the new regulation not containing
an evalua'ion a: test standard how will the package engineer objectively

evaluateanddetermineifapackagedaign adequately meetsthe regulatory

4

requirements?; 5) How will the new regulation affect the consumer and who '
will benefit the most?; 6) What legal ramifications will ream: if the Tylenol
and/o: "copy-eat" poisonings are repeated with products that are packaged in
tamper-resistant containers?

These quesfiorsardsibjectsarelodcedatardaddremedinttfisthesis.
Various conclusions and recommendations are made concerning tamper-resistant
packaging, the new regulation, consimer attitudes and perceptions, as well as
development of a possible test for tamper-resistant packaging agaimt malicious

The tampering incident involving Tfienol was a nationwide news event that
introduced some new vocabulary and meanings for qaeciflc terms. Tylenol
tamperings, Tylenol Killer, and any other such reference to Tylenol within this
thesisisonly meanttodescribean eventin abroadand generalsense.Itis
not the author'sintent to single out any brand name (1' manufiacuirerin
referencing these vocabulary words and identifications.

DEFINITIO NS

The events surrounding the September, October, and November 1982 Tylenol
and aibsequent "copy-cat" tamperings established a need for some careful
definitions of vocabulary. The following are several definitiors that become
esentialtothelogicalanalys'sanddiscusionofourmbfect.

Webster's American Hedtage English Dictionary definm the word 'tamper'
as‘bbinterfereinaharmfulmanner.” Mcre specifically,theGlossaryof
Packaging Terms defines 'tamperproof' a “a term often loosely and incorrectly
used for tamperhresistant or tamper-alerting." The Glosary also defines
'tamper-resistant band', tamper-resistant seal', and ”camper-resistant container'.
Forthepurposeofthisthesis, we willdefinecontainer,band,seal,andother
arch idiom as 'packaging'. Tamperproof will be used in its loose definifion when
qud:ing sources only. The term tamperproof is otherwise viewed as imposible to
achieve.

"A tamper-resistant package is one having anindicator or barrier to entry
wtfichifbreactedornfisingcanreasombhrbeexpectedmprofidevisible
aridencehotheuserthatthepackagehasbeentamperedwithoropened. This
definition primarily covers the immediate container and/or closure system, as
wellasthesecondarycontainer arrd/arcloairesystem.TtfistypeoEpackaging
will provide visualindication of package integrity when handledin areasonable
manner during manufacture, dism'bufion, a: retail display."5

TteseiermsvfillbemedtluougrDuttifisfliesistoexplainthelfistofical
developmentoftamper-resistantpackaging and file functionitis being asked to
perform in today's moiety.

HISTORICAL BAC KGROUND

 

Tamper-resistant packaging has been used in many different industries for a
variety of reasons. The medical products (devices) industry has teed
tamper-resistant packaging for years to indicate sterility and protect controlled
drugproductsfromposibletheft. The military,aswellasmanyindustrial
packagers, have also read tamper-resistant packaging in preventing and
indicating pilferage of supplies and products. In this thesis, however, we will.
focusmainlyupontheconsrmer marketplace whererroductsaresold
over-the-counter and the package becomes the point of purchase container.

Protecting product integrity has been a bait: package function for many
years. Protection against product/package tampen'ng has been a part of securing
this integrity for many different products in the past. This integrity, however,
wasonly meanttobesecuredfrommn—malicioustypssoftampering.1t was
used toprotectthe productfrominadvertentnormalopeningofapackage/
productsystemandisintendedminsureconfidenceamisafetyforthe
contained product.

During the early yearsof Prohibition Rqaeal, whenthe salecfalcohol was
again legalized, many whiskey groducts came in tamper-resistant packages
Ibecausethe ”whiskey customerstillwantedasairancathatit wasthe 'real
thing'.“6
down whiskeywithaninfedoranddieaperproductnistillersadapbed

Consumers thought that bartenders and store owners were watering

tamperiea'stantpackagingmmeirrxoductsmcrdertoreassureconmmers.

Tl'edistillers wereusing marketingstrategybyguaranteeingthe 'realthing'

through tamper-resistant packaging and posibhr protecting the consumer from

the not-m-l'nnest retailer. Drug and Pharmaceutical companies also read
6

tamper-resistant packaging "as a closure seal for the assurance it conveys that

the product is genuine and pure"?

This was also a marketing strategy as well
aaprotection device from inadvertent normalopening. The foodindustry was
probably the majoruserof tamper-resistantpackaging. Thisisprobably a
result of changes in the United States marketing structure.

As the U.S. marketing structure grew and developed, so did packaging
requirements. The growth and spread of self selection retail stores meant there
wasnolongerastore clerk around tokeep merchandise outofthe customer's
reach. Many retailers and manufacturers were experiencing "varying degrees of

annoyance from people unknown tampering and adulterah’ng packages and
products".8 This adulteration usually comes in the form of spoilage due to
rancidity, oxidation, staling, and other forms of product breakdown that occurs
over time when a product is exposed to the environment. Makers of shortenings
and oilsfound that a product'srancidity couldbe “traced tothe habitofsome

9This wasthereason

women shoppers opening a bottle to smell the contents.“
for using tamper-resistant packaging in the mid 1960's when the problem
became moreapparentasto "howtokeep themriousshopperfrom opening,
tasting,testing and otherwisespoilingthepackage protectionthathasbeenso
carefully built around the product.“10 Again, a problem of in-store tampering
prior to the product's purchase and removal from the store.
Odierrroblemssirfacedwiththeintroductioncfaerosolcansand
standardizafioncidifferenta‘zebouzlefinishes. People couldnotresist
dischargihgtheaerosolrroductwhileitsatonthememelf. Tamper-
resistant seals were also being used to protect ”against 'cap-switchers', who
have been known to switch large and small. caps of the same product."]’1

Manufacturesandretailerswerefindingitverynecsmaryto protect

8

themselves and future sales. Without tamper-redstant packaging, consumers
were finding quiled products whentheyopened theirpurchases at home. Once
tome, the consumer had no way of knowing that someone had previously (pened
thepackageinthe store. Ttfisresiltedinlostfumre salesfromooraimers not
repurchaa'ng the same product. Retailers and manufacturers were seeing "thin
(profit) margins evaporating due to pilferage and qnilage" from abduct/package
tampering.12

Uptothispoint, wehavediscussedpackagetampefing onlyinthe senseof
manoeaxflprotectionforthemstomerawellastheretaflerand
manufacturer from inadvertent product spoilage due to normal package opening.
These are the circumstances out of which tampertesistant packaging was
developed. TIisconcepthasalsobeenclose‘lywociated withresistingtheft
and pilferage. Many types of tamper-resistant packaging were developed out of
aneedtodeteranddisuadeconaimersfromstealingaproductfromits
package. This thesis is not concerned with product pilferage, however, we must
leepinmindthattheftrsflstanceiswallyoonsideredapartof
tamper-resistant packaging.

’7 Today, tamperhresimnt packaging performs the same function that it has in
the pad; Our present day marketplace inclrdes giant self-serve sipermarkets
and drug stores. Clerks place productsonthe shelvesin the billions eachyear
fiorcustomerstoselect themselves. These products may have as manyasfouror
fivedirectoompetitors creafingvastselectiondecisionsforscorescf
consumers. Tamper-resistant packaging attempts to keep the consumer from
easing ttn'sdecisionrrooesthrough deteringtaste testingarin store mmpling.
In today's world, tamper-resistant packaging generally offers the advantages of
product protec’don,indicationoftampering at a glance andusually easyaccsm
to a product for the purchasing consumer. Disadvantages usually include

increased unit costs and machinery costs, as well as slower production speeds
and higher tooling costs. As the number of tamper-resistant packages used
each year grows into the billiors, it is becoming obvious that the advantages
are outweigtfing the disadvantages.

Tamper-resistant packaging fists in properly protecting the product from
environmental elements priorto opening as wellasindicatingtheOpeningoE a
package evenaftertheclosurea'sealhasbeen replaced. Thesefunctions must
beaccomplished,whileatthesametime asauingeasy packageOpeningforthe
purchasing consumer. In today's society, many types of products use
tamper-resistantpackaging.Alistof manyoftheseproductsbyindustxyis
down below.

 

TABLE 1
FOOD AND BEVERAGES
MILK BEER WINE SAUCES
PUNCH DRINKS LIQUOR BABY FOOD SYRUP
PEANUTS SODA POP DRESSINGS TEA BAGS

VEGTABLES

OTC DRUGS AND MEDICINES
COUGH SYRUPS COUGH DROPS OINTMENTS VITAMINS

DEC ONGESTANTS LAXATIVES ANTACIDS EYE DROPS

Acuriouspattern emerges amongthe manydifferenttypesofproducts
listed. Many of the products, incluiing over-the-oounter drugs, are products

10

that utilizethe sense oftaste when aoonsumerusesthem. Withthe many
different flavors available within each of the above products the consumer is
motivatedtoopenandtaste theproductpsiortopurchasing.Foodsnaturally
fallintotlfispattembitsodocoughdropsaxrisymps,fiq\fidantadds,cold
medicines, as well as laxatives. Most of the food and beverages listed (Table 1)
have sensitive product stabilities when the package has been opened. Some
products that are extre mely sensitive to environ mental factors are covered by
regulations requiring tamper-resistant packaging. These products include milk
and qathalmic preparations (drops, solutions, etc. for the human eye). Alcoholic
beverages are also regulated with tamper-resistant packaging requirements but
for reasons of tax revénue collection. These regulations are medfically
discused in a separate section ofithis thesis.

Sofar, we havediscused foods quite heavily and withgoodreason. Many
cf the tamper-resistant packages available today were developed specifically
for the food industry. However, tamper-resistant packaging has also been used
inthe OTC drugindustryformanyofthesame reasons. Additionally,ithas
beenused asa marketing strategyintlfisindustrytoasireconsimersthatthe
productis authentic andpure. Buttamper-resistance hasquiteoftenbeen more
diasecondarytoolthanarroblem solver. The primarytoolbeingthatof
appealing tothecustomers needs and attitudes. The secondarytoolbeingone
of protection for the coramer from normal in-store package opening.

The function of protection being a secondary concern is heavily reflected
inurfitdoseblisterproducts became tamper-resistance wasinitiallyanadded
advantage for this suedfic packaging system. The bulk or multiple count
packagecanbefomflinmn-tamper-resistant containers whiletheunitdose
blisterof the same productusesa tamperhresistantpackage. Butthe unitdose
was not primarily chveloped for tamper-resistant reasons. It was a marketing

11
tooltsedtogivethe consumrtheconviencecfcarryingmedicines withthem

without concern for contaminating the product when placed in a dirty shirt or
pants pocket. So the historical pattern of using tamperresistant packaging for
marketing strategies a wellas protectingthe productfrom being removed by
curious customers also holds true in the OTC drug industry. However,
tamperhresistantpackaging hasnever before been used inthisindustry crthe
foodindustrytoprotectandassurethecoraimerthatapoisonhas nctbeen
added to the products they purchase.

Tamper-resistant packaging has grown extensively over the years. With the
tampering events sirrounding Tylenol and other poducts, tamper-resistant
packaging willcontinuetogrow and changeinadertoadaptto theincreasing
demand.

TAMPER-RESISTANT PACKAGING REGULATIONS

"Nunerousaspectsofafetyandsociallyresponsible packaginghavebeen
exacted into federal laws and regulatiom with administration and enforcement
13 Tamper-rss'stant packaging is
included in these many different laws and regulations. Four distinct regulations
exist that qiecifically call out tamper-resistant packaging according to it's
definition. These four regulations cover milk, alcoholic beverages, sterile

asigned to major branches of the government."

mthalmies preparations, oral ccsmeties and many over-the-counter drugs.

MILK PRODUCTS

The Urfited States Dq>artment (f Health, Education, and Welfare in
cooperation with the Food and Drug Administration established recomendatiom
for an ordinance in 1978 covering Grade A Pastuerized Milk. The Ordinance
comrsmanydifferentaspectscfprccefing,produdng,distdmfingarfi
packaging of fluid milk products. The Recommendation qaecifically discusses
cappingcrclodngofamilkcontainerforpiblicretailsale. Thisrequirement,
Item l9p., titled "Capping", states that milk containers shall be capped a

closed I'in a sanitary manner" by approved equipment.“

"Thecapcrclosure
dmllbedesignedarfiappliedinelchamannerfliatfliepouflnghpisprotected
matleastitshrgestdiameterard,withrespecttoflifidprcductcontainers,

removal cannot be made without detection.”l5

This makes these types of
containers tamper-resistant by definition. However, all evidence reviewed to
date hasnotmentioned anythingabmtprotecting against malicioustampering

but rather keeping contamination by microbials, bacteria and filth to a minimum.

12

13

ALCOHOLIC PRODUCTS
Tlepackagingcfthesepoductsaremainlyregulatedbythe Bureauof
Alcohol, Tobacco and Firearms (BATF). This federal agency establishes
regulations under title 27, part 19 cf the Code of Federal Regulations.
Tamper-resistant packaging regulations of alcoholic beverage is required under
thistifle and part rumber according to the etablishmentcf Public Law 85-859,
72 Statute 1358. The regulation deals with revenue tax stamps and states that
containers cfalcoholic beverageinamcuntsof 5 winegallonsorlee aretobe
sealed byaszamp that'eallbebroken whenthecontaineriscpened, unlee

thecontainerisonethatcannotagainbeusedaiftercpening."16

This stamp is
expectedtoprovidevisibleevidencethatthepackage hasbeencpened and
guaranteethateachdmeabcttleisfllledataxrevenuewillbeassessed.
Therefore, the stamp become a tamper-resistant packaging feature by
definition. It was, however, etablished for the purpose of insuring control of
tax revenue and no evidence dnws any intention towards protecting the
cone mer from malicious tampering.

Recently some change have been made to the BATF strip stamp
requirements in 27 CFR 19. The change are found under 27 CFR 19.663, ”Strip
Stamps and Alternative Device". This section allows for the use of "alternative
devicein lieu of red (I green strip stamps" thereby allowing the packager cf

alcoholic beverage some flexibility}.7

Upmnilthischange,sm'pstamps were
jJst sealed over the package's closure so when removed, the stamp was
denoyed.Thepad<agercanmwuseanaltemafi.vede\dcethatissecurely
atfixedtothecontainersothatitwfllleaveaporh’onofthedevicecnflie
containeraftercperdng.ThedeviceusedmustfirstbeapprovedbytheBATF

Director arri meet various labelling and coding requirements. These alternative

14

device can also be defined e tamper-resistant package features. Defining
thee device as tamper-resistant may not be completely correct because there
isroom fortheBATF Directortoaccepta designthat meets thestated
requirements but will. not provide reasonably visible indication of opening to

the average consumer.

STERILE 0PTHALMICS

Opthalmies are preparations used in the human eye. These products are
generally drops, washes, contact lens solutiors, etc. They are sold as an OTC
drug product and regulated by the FDA. Tamper-resistant packaging regulations
for these products stem from the FDA's requirement for product sterility cf
cpthalmic preparations. The FDA state that an cpthalmic product met be
sterile toensiresafeusebytheccnsaningpublic.1nordertoprctectthe
integrityof ancpthalmicpreparadon,theFDA requiretheseprcductstobe
packagedin containersthat ”mallbesten'leatthetime offlllingandclosing,
andthecontainerormdividdalcartonshanbesosealedfliatfliecontene

cannot be used without destroying the seal.”18

This regulation, 21 CFR 200.50,
continue on m'th requirements for multiple dose package and preper labelling.
Requirements for multiple dose containers include microorganism inhibitors so
thatthe product willnotbe rendered harmfulafterinitialuse.
Integritydasten’leprcductisdepexflentmprotecfionfrom
contamination. Contamination in this regulation is related to microbials,
particulate, and bacteria and not malicious introduction of a harmful substance.
Opthalmicsareinclifled,with referencetotlfisreglflafion,inthenew

tamper-resistant packaging requirements.

15

OTC DRUGS AND ORAL COSMETICS

The Food and Drug Administration etablished final regulations for
tamperhresistant packaging requirements of certain over-the-counter human
drugs and cosmetic products incliriing contact lens solutions on November 5,
1982. This regulation was etablished as a response to seven deaths due to
malicious product/package tampen'ng and was intended to improve OTC drug
packaging security. The FDA also stated that this regulation would "obviate the
need for State and local laws aimed at accomplishing the same cbfective for
smaller numbers of people."19 This statement was in respome to numerous state
andlocalreactionsfliatwereproposedacroeflienadonvdflfinweeksithe
seven deaths.

The FDA define tamper-resistant packaging as "one having an indicator or
barriertoentrywhich,ifbreachedor mieingcanreasonablybeexpectedto
provide visible evidence to consmers that tampering has occured."20 They do,
l'nwever, require that a tamper—resistant package be labelled in $1011 a manner
that consumers will know what the tamper-resistant feature of the package is.

The regulation is broken down into several different sections. All sections
areinclnded in Title 21 (ithe CcdeoEFederal Regulations. These sectionsare
as follows: 1) 21 CFR 211.132 - Tamper-resistant requirements for
overdone-comer human drug products; 2) 21 CFR 314.8 - New Drug
Applicatiors; 3) 21 CFR 700.25 - Tamper-resistant packaging for cosmetic
pcducts; 4) 21 CFR 200.50 - Opthalmic preparations and dispensers; and 5) 21
CFR 800.12 - Tamper-resistant packaging requirements for contact lens
solutions and tablets.

16

21 CFR 211.132

This section requires tamper-resistant packaging for all OTC drugs except
dermatological, dentifrice, or insulin products The reguhtion require the
tamper-redstantfeaflnembeofdisfixwdvedesignaidendfyingdmractedsdc
to prevent sibstitutions of commonly available materials. The regulation states
that "a tamper-resistant package may involve an immediate container or: closure
system a secondary container or carton systems or any combination of systems
intended to provide a visual indication of package integrity."21 The
tamper-resistant feature is required to remain intact when handbd in a
reasonable manner during manufacture, distribution, and retail display.

Labellingrequiremenestatefl'iatconsimers mustbe alertedtothe
tamper-resistant features of the package by a prominently placed statement on
the container. This statement must be unaffected if the tamper-resistant
feature is breached or missing.

Tlereguhfiongoemmdiscuerequedsfcrexempfionsfromflie
packagingandlabelingrequirementsas wellaseffecdvedates,effectstothe
Poison Prevention Packaging Act, and new drug applications.

The inin'aleffectivedate forpackaging requiremenein thissectionis
February '7, 1983. On this date, the regulation state that affected OTC drug
productsexeptcxalardvaginaltabletsarflvaginalarflrectalsippcsitode
wfllberequiredtobepackagedacccrdingtothereguhfion.0mla'vaginal
tabletatvaginala‘rectalslppcsitofiemetbepadragedacccrdingtotrfis
regulation effective May 5, 1983. All affected OTC drug products on the retail
shelf must be in tamper-resistant packages on February 6, 1984. However, any
affected product packaged after May 5, 1983, must comply with the stated
regulation.

17

21 CFR 314.8

 

Part 314 d the regulations deals with new drug applications. The
tamper-resistant packaging regulations amends 21 CFR 314 by adding section
314.8. This admendment revise the packaging and labelling requirements of new
drugs whenfilingfcr FDA qaproval.Itcoversq)ecificchangecradditionsin
vocabulary and requirenew drugstobe packagedandlabelledaccording toZl
CFR 211.132 before application is albmitted.

21 CFR 700.25

This part of the regulations covers tamper-resistant requirements for
cosmetic products. Cosmetic goductsare definedasliquidcralhygiene

 

products and vaginal poducts for retail ele. The requirements for
tamper-resistant packaging features are the same as 21 CFR 211.132 inclirling
material sabstitution nevention, immediate/econdary package definition,
labelling, and exemption requets. The effective date for packaging affected
cosmetic products except vaginal tablets is February 7, 1983. Vaginal tablets
met be packaged in tamper-redstant packages on May 5, 1983. Reail shelf
package cf affected products must comply with this regulation February 6,
1984. Labelling and distinctive design date requirements are the eme as OTC

drugs; May 5, 1983.

21 CFR 200.50 and 800.12
Tleseregflafiorsdealwithcpttalmicgeparationsandcontactlens
products.Sincethese;rcductsarealreadyrequiredtobecontainedin

18
tamper-resistant package, the new regulation adds requirements for distinctive

design of tamper-resistant feature and revised labelling.

Thispartofthenewregulationnow etablisheaclassificadonofcprthalmic
[reparations and contact lee products. This section of the tamper-resistant
regulations etablishe 21 CFR 800.10 to cover contact lens products as medical
device. 21 CFR 800.12 goes further in requiring the tamper-resistant packaging
featurefcrcontactlensetobe thesameasdefinedforaffected OTC drug
and Cemetic Products. Contact lee products were previoer regulated under
21CFR200.50 as cpthalmic drug products.

Tie effective date for cpthalmic and contact lee productsis February 6,
1983, for solutions in liquid form because they are more susceptible to
tampering. Tabbts become afiected May 5, 1983, and all products in these
categories mustbeontheretailshelfinpackageaccordingtotheregulation
on February 7, 1984.

REVIEW OF NEW TAMPER-RESISTANT PACKAGING REGULATIONS

The new tamper-resistant packaging regulations have etablished the
fcreeeability of intentional tampering by malicious individials. The packaging
engineer met realize that the contained product must now be packaged so as
to guarantee the protection of coeumers from intentional and potentially
larmfuladulterafion.Thisismtasimpletask. A maingrcbhmishowto
interpretfliedefixfifdoncftamper-resistantpackagingasfourdinthe
regulation. The definitionazatethatiftampednghascccun‘edflienthe
tamper—resistant feature eould "reasonably" be expected to provide visible
evidence. How doe the word 'reasonabhf' become interpreted? No where in
theregulationdceit statecr tell howtocbjectively evaludzeif thepackage
complie with the regulation. What happens if the Tylenol incident occurs
again with a package previoer determined to be tamper-resistant? What
might the consequence be? If the package is tested for tamperHresistance,
what engineeu’ng and/o: statistical basis should be used. The regulation also
does not provide guideline for complying with the labelling requirements
dated. What size should the copy or eatementbe and what kind d type face
eould be mad?

The preentregulationdcenotincludetheabove subjectsandleaveroom
for a variety of interpretations. The packaging engineer met determine the
interpretationhecrhiscompanyisgdngtoadcptandrrcceed from thatpoint
to objectively evaluate the functionality of their tamperresistant package.

19

20.

PRODUCT LIABILITY

 

Because there is no established standard for evaluating whether or not
package meet tamper-resistant regulatioe, there become the pceibility of
increased problems for the manufacturerin defending himself in court.

Moststate and federalprcductliabilitycase,tcday, aresettledeitherout
of court or by a jury trial. In a jury trialinvolving tamper-resistant packaging,
average consumers, who may or may not be technically trained, will be asked
to determine whether or not a company packaged their product in compliance
with the regulations. The problem for the manufacturer is one of defending a
package that has no availabb tet standards by which a jury can cb'ficfively
judgetamperhnsistance. Each memberofthejurywillmakeuptfisnfind
according to expert testimony from both a'de. The manufacturer's position
become even more difficult because the regulation has etablished reasonable
fioreeeability of the problem. The manufacturer will also have a difficult time
winning a suit if they could have made their package more tamper-resistant
regardlesscfthe cost.Evidence showsthatfuriedonctthirflcaboutthe
economics involved and believe that a company should do whatever is
neceeary to make its product safe.

Ifstardardtetguidelinewere setupandusedasanindustrystarxiard,
manufacwrerswillhavebetteravenueofdefenseformaldng
tamper-resistant packaging decisions. But mere compliance with the regulations
will notprotectthe packagerfrom liabilityin the eventthat someoneis
injured by malicious tampering.

CLASSIFICATION OF TAMPER-RESISTANT PACKAGING

The definition of tamper-resistant packaging lends iiself to many different
containerand materialdesigns. Tlefunctionoftamperresistancealsovarie
with each combination of material and container dea'gn.

The new regulation for tamperresistant packaging doe not provide a
complete classification of package that meet the stated definition. However,
thepreambletotheregulafionfouniinthe FederalRegisterofNovemberS,
1982, doe highlight some alternative tamper-resistant packaging systems. The
eleven categorie shown in the preamble are the same eleven etegorie
recommended to the FDA by the Proprietary Aecciation in a U.S. Senate
Slbcommittee Hearing regarding tamper-resistant packaging and die Tylenol
incident on October 15, 1982. This list has been used in the meamble by the
FDA to sugget options for tamper-resistant packaging designs. The list doe
not preclude any technical innovation or other package form that meets the
regulation definition.

21

FDA CLASSIFICATION OF TAMPER-RESISTANT PACKAGING
(taken from the Federal Register)

1) Film.Wrappers - transparent films that are securely
wrapped around a product or product container. The film
must be of distinctive design in order to comply.

 

2) Blister or Strip Packs - dosage units are individually
sealedfiin élear plastic or foil.

3) Bubble Packs - the product and container are sealed in
plastic and mounted in or on a display card.

 

4) Shrink Seals and Bands - bands or wrappers are shrunk by
heat or drying to seal the union of the cap and container.
The requirement for a distinctive design is stated here.

5) Foil, nger, or Plastic Pouches - the product is enclosed
in an individuaI pouch.

6) Bottle Seals - paper or foil sealed to the mouth of a
container under the cap. The requirement for distinctive
design is stated here.

 

7) Tape Seals - paper or foil sealed over all carton flaps
or a bottIe cap. The requirement for a distinctive design
is stated here.

 

8) Breakable Caps - the container is seales by a plastic or
metal cap that either breaks away completely when removed
from the container or leaves part of the cap attached to
the container.

 

9) Sealed Tubes - the mouth of a cube is sealed.

 

10) Sealed Carton - the flaps of a carton are securely sealedi

 

11) Aerosol Containers - these containers are inherently
tamper-resistant.

 

Each of the package forms with the exception of aerosols
require the tamper-resistant feature to be torn, cut,
punctured, broken, or damaged when removing the package

contents .

22

23

The eleven classifications by the FDA and Proprietary
Association represents the major types of tamper-resistant
packaging. However, the definition of tamper-resistant
packaging as found in this thesis is better classified into

an improved general format on th following pages.

GENERAL CLASSIFICATION OF TAMPER-RESISTANT PACKAGING

1) BANDS - these are a narrow continuous material used

II)

III)

primarily as a secondary closure to secure without the
use of adhesives.

A. Plastic

1. Heat Shrink — material shrinks when heating,
thereby providing a tight, contour fit about
the package's primary closure system.

2. Stretch - material provides a tight, contour fit
about the package's primary closure system through
tension of the film's elastic memory.

B. Cellulosics

1. Shrink - material is applied wet and shrinks
upon drying to provide a tight, contour fit of
the package's primary closure system.

WRAPS - materials used to cover, encircle, enfold, or
wind around a packaging system, a package's primary
closure system, or a product. Materials conform to the
shape around which they are wrapped and are further
defined by their end use.

A. Partial Wraps - materials that only cover, encircle,
enfold, or wind around a specific part or section of
a packaging system or a package's primary closure
system.

B. Overwraps - materials that cover, encircle, enfold,
or wind around an entire packaging system or the
product itself.

POUCHES OR BAGS - packages made of flexible materials

in which a product and/or primary package is placed and
sealed resulting in a non-rigid container that covers or‘
encircles. These package types usually do not conform
to the shape of what they contain.

A. Heat Sealed
B. Adhesive Sealed

24

25

IV) TAPES - non-continuous materials that are coated with all
adhesive for sealing a package's primary closure system.

V) THERMOFORMS - plastic films that are heated and forced
into or over a mold or product by air, vacuum, or
mechanical pressure. The thermoformed film holds,

contains, or becomes an integral part of the packaging
system.

A. Blister Packs - the product or primary package is
sealed between a molded thermoformed plastic and a
backing material.

1. Peel Off - the adhered backing material is
designed to peel off from the thermoformed
plastic in order to obtain the package contents.

2. Push Out — the blister pack is designed so that
the product or primary package can be obtained by
pushing it through the backing material.

3. Tear Out - the blister pack is designed so that
the product or primary package can be obtained by
tearing the backing material and/or thermoformed
plastic.

B. Skin Packs - the product or primary package is sealed
between a close fitting plastic film and a backing
material. The product or primary package system
serves as a mold for the heated plastic which is
draped over and vacuum drawn to the backing material.

VI) CLOSURES - a sealing or covering device affixed to or
on a container for the purpose of retaining the contents
and preventing contamination. Usually an integral part
of the primary closure system.

A. Caps - a cover which fits over a container neck or
opening rather than into it.

1. Continuous Thread (C/T) - caps that are held by

engaging internal threads to external threads of
the container.

a. Breakaway
b. Strip Away

c. Vacuum Caps

D.

26

2. Snap Ons - caps that are held by air pressure or
friction of the internal parts against the external
parts of the container opening.

a. Breakaway
b. Strip Away
0. Vacuum Caps

Seals - materials which cover a container opening
or primary closure system.

1. Membrane seals - seals that cover the mouth of a
bottle by adhering to the finish.

2. Roll-en over—cap

Integrally Designed - closures that are a direct part
of a package system after product filling and package
closing. Destruction of the container or package
form must result in order to remove the closure.

1. Cans - metal and composite closures that in-
corporate closures that require a can opener or
manipulation of an opening system to obtain the
product. Usually results in destruction of the
container lid.

Sealed-End Cartons - rigid or semi-rigid containers
closed by securely adhered end flaps or tucks.

VII) OTHERS

A.

Ampoules - a relatively small container made from
glass, the end of which is drawn into a stem and
closed by fusion after product filling. Opening is
achieved by breaking the stem.

Capsules - small cylindrical container made of two
parts that mate to form the closed package after
filling.

1. Snap Lock - multiple snap looks around the cir-
cumference of the capsule mating parts.

2. Ring Lock - continuous ring or groove around the
circumference of the capsule mating parts. The
convex ring snaps into the concave groove.

27

3. Gel Band - continuous band of gelatin applied to
the filled and closed capsule in such a manner
that the mated capsule parts are bonded together.

A. Gelatin - one piece capsules made up of a gel-
atinous substance. Enclosed product must be in
liquid form.

C. Aerosols - considered inherently tampered-resistant.

Ikch of Ureaflxwe dbaificafioms‘mIMMy namfinathe tampermeésfium
ibahne<mmgm$agetnlxadamagalupmunmnmflxxmmfineremuy.

EmmacflxsfiflxmkmlcommmmsvafiousIxm$age fixmm.tmm:ame nd:1£namy
employed by the OTC drug industry bat do require listing for complete
afiegadzadon.fmfis dhsmficadon can be usilin the funne fbr pnxxm
12mmer13dshuqumkafingaségnmam;{firzdhsfificadonshouklbermxfifiedin
aaxxdamxavfiflaanyfuuuetECNMcaLadwmxxs.

PROFILE OF A TAMPERER

Attempting to determine the level. of tamper-resistant packaging first
requiresidentifyingthe characteristimafanindivimal who mighttamper with
package/{rocket systems. We previously diseased individuals who open shelf
packagesin thestoretotaste, sample,orgenerallyinspectproduct contents.
Ttmepeopleumallyhaveno maliciousintentandgener'anymlyqam'lapmduct
and its dielf-life. These individuals concern the manufacturer and packager but
nottothesamedegzeeasthe malidorstamperer. Therefore, wewill
concentrate exclusively onthecharacterisdcsofthoseiniifimals whopoisonar
adflter package/product systems in a purposely harmful manner. Since the
individuals responsible for the seven Tylenol deaths and acted "copy-cat"
poisonings have mtyetbeenapprehended, we can only speculate withhelpfrom
mychologistsandpsyclfiatristsasto whatcharacberistimandpersonalitiestlme
peonle posses-

The ”Tylenol Killer" who allegedy laced capsules of Burs-Strength Tylenol
with potasmm cyanide has been charactenized a "meticulom, well organized

and azientifically acute".22

Dr. Shervert Frazier, chief psychiatrist at McLean
Hospital in Belmont, Masachusetts, aye the killer "knows how to carry out
actions in a goal oriented, purposeful way."23

wividual'sabflitymplacecyanideintosmancapmbsardremmflietainted

Psychiatrists believe this

packagesmttestoredielfrevealsagreatdealafmretakeninaccomplistfing
the desired task. Psychologists believethat thisindividualfumtions normallyin
societyand agee withpsychiatristthatthe ”Tylenol. Killer"isp:obably a
'loner,isolatedand unnoticed,with fewifany friends. Heisprobablylowin

self-esteem, paranoid and hypersensitive, taking offense at real or: imagined

28

29

slights from those around him“ Detailed characben'zations of the "Tylenol
Killer" apersonshavingthesametraitsarevague. Mostexpertshave
concentrated on "copy-cat" individuals. This may indicate that those who
“copy-cat" have the same traits a the ”Tylenol Killer”, but most evidence
gatheredtodatedoasmtrevealthisstatementtobemie.

Dr. Gary Kaufmann, psychologist for the Michigan State Police, believes
there are probably three different clas’fications of people involved. He draws
lishypothesisfromcbsendnguieldxxiandcordifionscimeoccurencesunt
havetakenplaceto date. Heclasifiesthesepeopleintc threecategories which
we small call lethal tamperers, "copy-cat" tamperers, and self tamperers.

La'hal tamperers are those individials involved in poisoning a: maliciously
adulterating a prodict in a fatal manner. Dr. Kaufmann characterized this
person as an individual who desires power, strength, control, and recognition.
Tteseindividialsmallyfeelthey havelittlea: nocontrolovertheirown
lives. They believe they are unrecognized and have been given a ”dirty deal” by
society. Tampering with aproductin alethal mannerserves as an attempt to
strike-out at their environment and acquire the control, power, strength and
recognition they feel they deserve. Society becomes a hostage. From this
captivity plus the media embellishment of the event this individlal can rectify
lispsychologicalfrmtrations. Thisindividial. mayevengoasfaras
rationalizing thedeathsthat occurby believingthey are of a divine under. He
feelsthat his victim's time had come and that they probably deserved what
happened to them. By indiscriminantly poisoning individaals, he is abh to burden
allofsodetyvfithflmefearsanifiushadonshelfimselfisfeeling.Dr.
Kaufmambelievesttmeindifidialsmaypossesslfighlevelsofdcfllarfl
intelligence. They even demonstrate cleverness and cunning in arcing out their

30

desired actions. They may even be challenged by attempting to siccessfully
poison a drug without consumer detection. The chance that this indivichal will
repeatifisacfionsishardbopredictItis,however, averystrongpossibflity
became the only predictor is past preformance. Under similar conditiors this
individual may repeat his previous actions.

The second classification is ”copy-cat” tamperers. This clasification
involves many speculativetheorimfiiatseemtobeinaccordancewithme
another. Dr Kaufmann believes individuals that copy this type cf crime are
highly suggestible and probably not as motivated as the lethal poisoner. They
experience manyof thesamefrustrafionsthelethalpoisonerfaces withdesires
for recognition, power, and solving their problems through example. Their
potentialforcommittfingthistypeofcrimeliesinaneedtobetoldwhattodo.
'l‘heyfindakeytotheirprobbmsbycopyingthecrimeofanother. These
diaracteristics are sipported by those who describe the "copy-cat" poisoner as
an ”emotionally immature human being that is desperate for a leader and an

excuse to carry out their frustrations."25

Dr. Arnold Rdabins, forersic
psychiaudst at W Medical Schoolin Boston, describesthe "copy-cat" as
somebody who certainly has a great amount. of arggrea‘on."26
wally have diffiwltyrunning their ownlives and rely heavily upon othersand

The ”copy-cats"

alggestive stimuli to pattern their lives. These ”copy-cat” individuals have seen
trepiblidtysinomdingflieWylelemer'andtaveobservedfliedifficulty
auflndtieshaveexpedencedmappreterfiingarfiprustungflfisperson.mms
hasservedtomotivmthe'mpy-cat'tcsimilarviolence.

One majcr difference between the "Tylenol. Killer” and the "copy-cat"
poisonermmtbepointedoutThe'copy-cat'ismtmotivatedtolo'JLhehasno
reedtolnldsodetymstage.fieprobablyprefersmttoldlladogreatbodfly
tarm.Tre 'copy-cat”cansatisfyhisneedswithapublicdiscoveryoftfis

31

tampered packages. This results in product recalls and massive society reaction,
thereby, giving the ”copy-cat” his desired atisfaction. The ”Tylenol Killer”, on
the other hand, ldllsindiscriminantly. Heis meticulous and carefulin his actions
making public detectiondifficultun’dlsomeonehasdiedandthedeathis apart
&hissuccessin maldngsodetypayaswellassufferinthesame wayhedoes.

The third group described by Dr. Kaufmann is the self-tamperer. This type
cf individial poisons cr tampers with a package/predict system and then callsit
totheattenfionofaudmon’ties.Theytake advantagedavolatiles’tuationin
ader to gain recognition. They may also feel that they might experience some
sortof materialgain through alaw siitiftheirfraudulent claimissuccemful.
Tinsehflividialsaremtconsideredaseverelydistmbedasfleprevicustwo
grape and accomplish their desired goals without physically harming anyone.

Reviewing the various theoretical classifications of individ1als who might
tamper withaconsumer productin amalicious mannerbringsaboutsome
suedfic conclmions. Tamper-resiaant packaging has a renewed importance in
protecting the public from malicious individials. The poisoner who tampers with
agoductinapotentiallylethalmannerhasbeendescfibed assldlledand
clever. Heappearstobe motivatedenoughto mendthenecesarytimerequired
tocarryoutadesiredgoal.This motivation myleadthisindividialtorepeat
his actions and become further challenged by tamper-resistant packages. High
still, intelligence, and motivation levels drive this individaal to accomplish and
atisfyhisdssires. Tamper-resistantpackaging maycnlyservetofiorcethis
personto workharderandenjnygreaterrewardsifhe canadequately defeat
the packages safety features.

Therefcre, mmperresistantpackaging maymtdeterthisindividialfrom
accomplishing his task. The regulatiors, however, may lead the American public

32

to concllrie thattheyare safe fiom thelethalpoisoner. This willonlyserve to
create afalsesemeofsecufityintheconsumer.

The ”copy-cat", on the other hand, mainly desires recognition and will
probablynctgotothesamelengthsasttelethaltamperer.Ttesepeo;fle have
no desire to kill. Tamper-resistant packaging does not concern the "copy-cat"
individialaslongasthe mediaandpresscontinuetokeeptampered packagesas
headline news. This is became consimers will find adulterated packages through
observation of broken tamper-resistant packaging features and this may cause
enough news coverage to satisfy their needs. Because tamper-resistant
packaging is supposed to indicate a“ reveal tampering, package designs and
forms maybetterserveto afisfythe "copy-eatM'hanit didbefcre. Hecannow
tamper with a package and know that somebody will most likely find and report
it.

Because the "copy-cat" tamperer may also posses high still and motivation
levels, successfully defeating tamper-resistant packaging features may not prove
tobedifficult. Dr. Kaufmannbelieves thatoncethe mediaandprescoverage
ceases to make tampered packages a major headline, a "copy-cat" individual's
reedforrecognifionardattenfion mayleadtotheharmingofcthersincxder
to satisfy his desires. Tamperhresistant packaging may protect the consumer
better from ”copy-cat" individuals than it does from lethal. poisoners, but again
themblicmaymlybeacquiringafalsesemeofsecurityregarding
mcvpadcage integrity-

Self-tamperersdo notseemto proposeaphysicallyharmfulthreattothe
public but do become quite damaging to a product and its manufacturer. Lea of
agoodnameanitrustinaproduct, as wellasrecallsandtmting willallaffect
a manufacturers costs, profits, and future 91%. Tamper-resistant packaging will

33

probablyriayasmllrolewithself-tamperersduetofletypeofinddents
involved.
Itsmtfldberememberedthatflieexperlswhohavediscusedttnsefliree
goupsagreethatallofthesepeople arevery muchintouchwithreality. They
canusiallyfunction normallyinsodetyandcsnnctbes’ngledmtas'crazies"
bytheirappearancecrbehavior.Peopleinthesecategofies maybevery
intelligentanidefeating tamper-resistantpackages maynotprovetobevery
difficultfortheeepeopletoaccomplish.

TEST DEVELOPMENT

While studying the new tamper-resistant packaging regulations and the
packages that meetits requirements, the following concerns became apparent:
DTleregulationdidnotqiecificallydefinetheldndofpackagingthatwould
adequately deterorpreventa malicious tampering;and 2) The regulation could
implyto the consumer that he isguarded against malicious tampering when in
realitytheprotection mightnotexist.

Ttepackaging,asdefinedinthereguhfion,isthetypeofpadcagingthat
was designed to deter and prevent casual in-store opening by normal
corsmers.Tleindivid1a1thatfleregmfladonisattempdngmprctectagainst
iasnotbeendescribedsanormalcorsumer,andallevidencegameredto
dateindicatesthattheTylenolandothertamperedpackages werefirst
removed fromthestore,contaminatedatalocationoutsideofthestore,arxi
fizenmhmedtottestoredielfamahterdate.Tlfisaflowedflieindividialan
cpportmitytoworkcarefunyarflurxietectedwithwhatevertodsoraideshe
couldcommonlyobtain.

Ttenewreguhtionmayalsoinsdnafalsesenseofsemrityinthepublic
andflmeymayfieelgxotectedfromquemalidoustamperhgsBeing
technically uninformed, consumers may puttheirtrustinthe manufacturer,the
tamper-resistant package, and the fiederalgovernment when believing that they
are now safe. They may become lea cautious and feel that they can easily
identify that a package has been tampered with because the new regulation
requires the package to perform this function.

Inadertoeffectixelyevaluateanddeterndneifthemnrentreguladon
willprovide adequategotectionforthe consuming public,atestwas

34

35

developed. This test should eventually lead to the development, as proposed in
fiaeregulatiorssectionoftlfisthesis,ofanevamadonteststandard that will
allow packaging engineers and manufacturers an opportunity to objectively
evaluate their medfic package design for tamper-resistance.

The developed test involved the fiollowing concepts: 1) How well does
tamper-resistant packaging perform as a barrierto entry with visible evidence
cf breaching; 2) Can consumers identify a tampered package; and 3) The
repairabflityofatampered package. Thesethree conceptsarethebasison
which our test was developed.

The test development is broken down into the following three different
parts; 1) The initialteet; 2) A consumer perception survey; and 3) A tamper
identification test. The consumer percqation my and the tamper
identificationtestmakeup whatisdiscussedfurtheronasthefinaltest. All
threeofthesetestsaredeecribedonthefoflowingpagesintermsof
development, change, and procedures used.

INITIAL TEST
Theinitialtestusedrepresentativepackagesfrommostciflie
tamper-resistant package clasifications presented on pages 224-27 . Certain
classifications such as ampoules, aerosols, capsules, and cans were notinclnded
because theyare eithercondderedinherentlytamperhresistantbydesign (rare
seldomusedasapackageforminthecver‘the-counterdrugindustry.

36

Samplesusedinthetestinclnde:

l) Wirz tamper indicating cpthalmic tube

2) Glassjarwithplasticbreakawayringcap

3) Glassbottle with metal breakawayfingcap

4) Gluedendpaperboardbox
5)Glassbottlewithvert:icallyperforatedshrinkbandaroundthecap
6) Foilandplasticunitdoseblister
7)Paperbagwithsea1edclosure

8) Glassboufle withpaperandcorrugatedcverwrap

9) Stretched wrappedpaperboardcardcfindividualmitdoses
10) Membranesealedplasticbottle

11) Clearplasticoverwrapwithateartape

12) Plasticbottle withshfinkbandedchildresistantclosure
B)Fdl/plasticoverwrap

14) Plastic shrink wrapped paperboard carton
15)Plasticbottlewithtapesealoverclos.1re

16) Glassbottlewithmetal/plasticcentersealedbreakofflid
l7) Metalsealedendtube

18)Foilpouches

19) Fdlmembranesealcvertte mouthofaplasticboflle

Atotalofthirty-fioursamples wereused withvariationsinmaterialsand
desigrsoffleaboverfineteencategafies.Prod1ctnamesandmanufacmrersare
notidentifiedinthistext. Noneofthesamgesinthisinitialtestwere
tampered with. Samples were purchased from local stores.

37

These tamper-resistant packaging samples were shown to a small group of
consumers to determine whether or not they could identify tampered packages.
Fa: this initial testthe consumers were all Michigan State University, School
cf Packaging staff and students. The consumers were asked to answer 'yes' a:
'no' to the following question, "Having daserved this package, do you think it
has been tampered with?" Any 'yes' arswers recieved were considered false
positives because none of the packages had been tampered with.

Each consumer was allowed to handle and daserve the ample packages as
ifthey wereinastoreandabouttopirchasetheproducts. They were
notallowedto open anypackages andthey wereaskedtorefrainfrom poking,
ficking,peelingorotherwisedamaginganyoftheamplesinmldngtheir
decisions. Eachsample hada 4"x6"cardaignedtoitthatidentifiedthe
package and its tamper-resistant feature in an attempt to bring the packages
into compliance with the new tamper-resistant packaging regulations. Samples
were displayed on a table under floureecent lighting with consumers moving
around the table from package to package in making their responses.

The consumers were giveninstructionand testresponsesheeisasshownon
thefollowingtwopages. Each amplehadaseperatetestresponsesheetfor
diecorsimertomarkresporses.AtotaloEoneirstrucfionsheetand
thirty-four response sheets made up a consumer's test packet.

SAMPLE TEST FORM ONE

TEST FOR TAMPER-RESISTANT PACKAGES
SCHOOL OF PACKAGING

MIC HIG AN STATE UNIVERSITY

Instructions

Please read all material carefully before you make an cbservation. Please
circle mly one answer and print comments legiby. You may handle the
package/product system but please do not open or damage the package in any
manner. If the package becomes accidentally damaged, then immediately call it
to the attention of the test proctor.

Ttank you for yourparticipation.Itwillresiltinsomeveryhelpful
research data.

Name:

Afiress:

City/ State/ Zip:
Telwhoned )
Age: Sex:
Edication:

Oazupation:

38

SAMPLE TEST FORM TWO

II'EM NAME AND NUMBER:

 

THE PACKAGE/PRODUCT SYSTEM THAT YOU WILL OBSERVE MAY OR
MAY NOT HAVE BEEN TAMPERED WITH. PLEASE IMAGINE THAT YOU ARE
IN A STORE AND ABOUT TO PURCHASE THIS PRODUCT. THE FOLLOWING
QUESTION NEEDS TO BE ANSWERED - ”HAS THIS PACKAGE BEEN TAMPERED
WITH?"

(Please circle and arswer the appropriate answer below)

YES -INDICATES THE PACKAGE HAS BEEN TAMPERED WITH.

NO - INDICATES THE PACKAGE HAS NOT BEEN TAMPERED WITH.

Ifyes,pleaseexplainwhyyoubelieveso-

 

 

 

Ifno,pleaseexplainwhyyoubelieveso-

 

 

 

Additional Comments -

 

 

 

39

40

RESULTS of INITIAL TEST

Table 2

Total Samples Tested - 34

Total Tat Participants - 43
Average time required to complete the test. - 45 minutes

Total question responses recieved - 1,367
Total yes answers - 296
Total no answers - 1,071

Total scipped ample answers - 138

Average percentage of yes answers over all amples — 21.7%
Range of yes amwers for individual amples - 0.0% - 74.0%
Median of yes amwers for individial amples - 21.25%

Two amples were destroyed airing the testing and removed from the

expedmentafter23and261espomeswererecieved.

41

A graph of yes responses as a function of the number of
participating in the test is shown below. Each consumer was

numbered in ascending order according to when they completed

the test.

NUMBER ‘6
OF YES ‘5
RESPONSE3:4

dMQ§UfiO~Vm0

     

4 6 81012141618 20 22 24 262830323436384042

 

2

PARTICIPANTS IN ASCENDING ORDER

FIGURE 1

42

CONCLUSIONS FROM INITIAL TEST
Tledatafromthisinitialtestrevealedsome interesting observationsand
pointedoutaneedtomakesomedaangesinprocedureforthefinaltestThe
packagingsafientsardszaffmembersoftzeSdnolofPackagingappeartobe
highly sensitized to the issue cf tamper-resistant packaging. The average
amountoftime taken (45 minutes) tocomplete the testshows theirconcern and
sensitivitytothesibjectltcanbeafely assumedthatmostconsumers would
notaendtteameamountoftimeperamplethatthetestpartdpantsdid.
Furthermoreitisnotlikely that conamerswillaendthisamountoftme
evaluatingpackageswhiledwpping.
Tlestaffandszudentsalaproducedanaveragerespoaeofovertwenty
percent false positives withyesanswers to the question, "Having observed this
package, do you think it has been tampered with?” These twenty percent yes
answers were probabhr die to a number of reasons such as: 1) Stxients were
very conscientious of any package imperfection; 2) Rough handling of amples
created damage that the next participant interpreted as tampering: 3)
Partdpantsansweredttequesionvdtha'yes'a'"m't1tqui:eoftennegated
theirarewerswithcomments. One exampleisastudent who answered “yes"for
aquecificample,butfolloweditup withthecomment,"Idon'tthinkthe
packagehasbeentamperedwithbutitboksawfulslspidoustouldmtmy
it." Thispercentagecffalsepositivesisprobably muchhigher thanwhat would
beobtainedinatestofalargermcrerepresentatvepopulationample.
Tledatashowsarangecfo.0to74.0percentyesanswers fortheamples.
Tte74.0percentreflectsaveryhighrateofyesreeponsestothequeston
asked.Ttistfighrate<fyesresponsesrefleclswhatthecons1merpemeived
whentoldthattheamples maycrmaynothavebeentampered with.After

43

investigating amples that received a high percentage of yes responses, we
found a variety of ample imperfections from [roduction variation and
distn'but'on handling. These imperfections were probably construed as
product/package tamperings and test participant comments reflected this
conclusion. Thisopensupanew area of problems forthe manufacturer. Willit
be necessarytoproduce a perfectpackage sothat consumers willnotthinkit
hasbeentampered with; and if notwillitbecome necessaryto tighten quality
control of outgoing goods?

Became of the above results and problems, the following changes were
made before conductingthe finaltest: 1) Tat partdpants willbeindividuals
with notechnical education ortraininginthefieldof packaging; 2) Samples
will be periodically checked for handling damage and replaced immediately if
any problem is detected; 3) Iretead of "yes" cr “no" answers, test participants
willbeallowedtoplacetheirarsweronascale orrange thus allowinga
greaterlatitudeofreqaonses; 4) Totalrumbercr amples willbekepttolea
than twelve to reducethe amountof time necessaryto completethe test; and
5) A general percqation survey will be conducted along with the tampering
anidytopmvirhgreateropportunitesfaextendeddatarelationslups.

STATISTICAL DATA EVALUATION

No statistical computations were performed on the data collected in the
initialtest. However,astatistca1evalnation wasused forthe finaltest. The
mefliodfirstdiosenforamlyzingthedotaineddatainfliefinaltestcentered
aroundaCti-square testThistestanalyzesthedataaccordingtothe
increase in population muses from control (non-tampered) amples to
tampered amples. Based on the tall hypothesis (H ) that conamers cannot

44

detect tampering, the answers to control amples and tampered amples should
have smallincreasesordecreasesbetween each otherifthehypothes’sis true.
The test statistic analyzes and differentiates the number of "no" responses
received.

This form of Chi-square test wasbased on the assumption that answers
wouldbeeither"yes"a"m"asintheinitialtest. However, withthechangeof
possibb answers from 'yes‘cr"no"to ascale, we must change thestatistic
used. The Cti-squaretestwillstillbeusedmtimteadofcheckingfora
differenceinresporeestwinhesttepropordonalitiesoffleresporses.1f
consumers cannot detect tampering,thentheanswers fromthescalefor both
tamperedand control amples willbeproportionallytheame. We willtestthe
resulisusinganalphaof.05andfourdegreesoffreedom. Specificequations
andhestdeterminatonsanbefomdintheresfltssectoncfthefinaltest

FINAL TEST

 

The following pagesoutlinethefinalproceduresforcorducting aconsumer
perception arveyand atamperidentification test. This finaltesttakesinto
account thethree main concepts discuaedpreviomly. These are the following:
1.) How welldoesatamper-resistantpackage pedormthebarn’ertoentrywith
visibb evidence d breaching; 2) Can consimers adequately identify packages
thathavebeentampered with;and 3) The repairabilityofatampered package.

Tie consumerperception arvey wasused tohelp determine how consumers

feel about certain tamper-resistant packaging classifications. These perceptions
abuldtelpmformtepackagingengineerarfimarketngaedalistofwhatfle
consimerfeelsthe mostconfidentabout. Thisdatamightalsoprovide a
relationship betweenaconsimer'sbeliefthatapackagehasbeentamperedwith

45

and how he feels about a tamper-resistant packaging claaification. While this
thesis is not concerned with consumer perceptions, the sibj'ect must be taken
into consideration when asking a consumer to determine if a package has been
tampered with. Strong answers of “No, the package has not been tampered
with", may relate to how confident a consumer is of the tamper-resistant
packaging claaification being tested. The concept of consumer percqations and
identficatonoftamperedpadcagesisafurflrerareaofpoa’blereeearchinto
what a consumer actually observes and perceives.

Tl'e tamperidentification testof the finaltest will aovideinsightsinto
whether a not consumers can determine if a package has been tampered with.
Tteproceduresandtestformsforbothparaofthisfinaltestbonamer
perceptions and tamper identification) can be found on the following pages.
Each partistreated asaseparate entity with appropriate conclusions reported.
Proctor instructions for completing the tamper identification stxly can be found
in Amendix H.

46

FINAL TEST - PART I

 

CONSU MER PERCEPTION SURVEY

Methods

Place amples sothattestparticipantscomplete this section of the test
first. Enough amples for adequate representation shall be obtained for each
classification allowed by the Food and Drug Adninistrat'on. Participants shall
be individuals having no technical training in packaging. Each person will be
fired to rate each classification for tamper-resistance by circling a number on
ascalethatbestdescribestheirpercept’onoffeeling.

Question: "How do you rate this group of tamper-resistant packages?"

BAD GOOD

Materials
Fc' our perception arvey the following seven groups tr classifications were
surveyed:

1) Shrinkbandscfplasdcardcellubsicin white,clear,and
aecfrclogodeslgns.

2) Wraps of cellulose and plastic with distinctive and common

desigrs.Partialandcompleteoverwrapswerepresentedin
avarietyofcolorsawellastxansparentStndnkandglned

wraps were equally inclirled.

47

Materials continued -
3) Breakaway caps of plastic and metal that either become
completely destroyed cleave aportionofthe capbehind
when removed.

4) Tapesealsinavarietycfcolorsanddesignsinclnding
delaminatesandtearaways.

5)BlisterpacksofonlyunitdcsesinplasticandfoiL

6) Membrane seals of common and distinctive dec'gns with
greaure sensitive and induction seals.

7) Glued Erri Boxes.

This survey was carded outin unison withthe tamperidentification
test.Therefore, population data for both tests (consumer perception and
tamper identification) is the ame. Survey sheets can be found on page
with population data, results, and simmary following the tamper
identification test design and procedures.

FINAL TEST - PART II

TA MPER IDEN'IIFIC A'I'ION TEST
SCOPE

Tlepmposecfthisexperimentistodeterminetheperformancei
tamper-resistant packaging systems as they relate to protecting the consumer
fiom malicious adulteration of the contained product.

TESTING PROCEDURE
1) Sample Packages
Two amples of the ame package will be detained from each major
tamper-resistant claaification allowed by the Food and Drug Administration.
Samples willbe inconanerpurchasedorstoredisplayform. Ore ample will.
arveasacontrolandremaininoriginalstorepirchasedform. A second ample
(itheamepackagewillbesib'pctedtovariousnethodsoftampering.
Tampednginthisexperimentwillbedefinedas malicious entrance intoa
packageinslch amanner thatproduct contentscanbe adultered and the
package reeealed. Tampered and contol amples (cf the ame package) will be
evaluated separately. No participant will be allowed to compare tampered versus
controlamplesdftheame package. Tie concernis whethercrnotthe
consumer can adequately identify tampering without any outside aaistance.
2) Tampering Techniques
a. Hard Tampering - This inclules carefulopening of ample packages
teing human hands only.
b. Tool Tampering - This includes carefuIOpening of ample packages
\einganycommonly availabletool. Atoolisdefinedinttfistestasany

48

49
com mon mechanical or non-mechanical device or equipment incluiing
leating or freezing apparatis.
c. Solvent Tampering - This incluies careful waning of ample packages
\eing any commonly available chemical or solvent such as water,
alcohol, non-polar solvents and others.

Tte tampering technique chosen for each package will be determined using
tieeasiesttaperformandtiehardesttodetectmethod.A combinationof
nethods may be used if wprwn'ate. After acceafully entering a ample
package andremoving some productcontents,it willbe repaired toits original
form. Repairs will be made by any commonly available mean sich as adiesixes,
tapes, glues, leat and others.

Tampering and repairing will be performed by a knowledgeable panel of two
a: three individuals. Trey will. tamper with any part of the ample package
system in attempting to acceesfully defeat the package protection of the
contained product.

SAMPLE PRESENTATION

Testpackageswillbedividedintotwodifferentgrwps.Nogroup will
coreist cf controlled and tampered amples cf the ame package. This is so
part'cpants cannot compare tampered and controlamples of the ame package.
Eachgroupwillhaveatleastoneamplefromeachofthemajor'claaificatons.
Notestparticipant willevaluate morethancne ample group. Be/she willbe
wcedtoevaluate eachampleinttegrowbyansweringaspecficquestion.
Tleiestpardcpantswillnothaveanytechrficalt'airfingintiefieldcf
packaging-

50

Each ample will. be identified by an information card. The card will
describe the tamper-resistant feature of each ample. Each card and package
willbeident‘fiedbynumbers. Numbers willbeasc'gnedinamannerthatwill
retintroducebiases.

Sample packages that require removal of a secondary container or closure in
adertodisplaythetamperbresistantpackagingfeatire willbepreeented
apprwriately to allow participants prwer observation. An example would be
removalcfabot'lecaptodiwlayamembranesalortaldngablisterpackout
itemmarycarton.8amplesusedinwrtestingasidentfiedby
tamper-resistant packaging classification are as follows: 1) A coated thin paper
nembraneaalwithadistncdvededgn;2)Awmteplasficvertcallyperforated
anjnkband;3)Apaperandcorrugatedghedoverwrap;4)Ametalbreakaway
fingcap;5)Adistinct:ive1ydesignedplastcshrinkband;6)Aclearplasticglued
overwrap; 7) A white styrene membrane seal; 8) A glued end box; 9) A foil and
fiastcdisdmtvelydedgneddelaminafingtapeseaklmAdearplasdcshdnk
overwrap;].1)AplastictapeseaL

None w the amples obtained totally met the new tamper-resistant
packaging regulationsduetothereedforlabelling,distinctivedesignora
combinationofboth.

Egg:
Testparticpantsvdllbeaskedtocrcleanumberonadefinedscalethat
bestdeecibestheirresponsetothefollowing question:"Havingobservedthis
package, do you think thatit has been tampered with?"
Testparticipams willbetoldthatthepackagesthey deserve maycrmay
nothavebeentampered with. Tl'ey willbeinstructedtoanswerthequestionas

51

ifthey were abouttopurchasethisproductintlestore. They willbe allowed
tohandlethepackageinageneralmannerlmtwillbetoldmttopeeLplnck,
or otherwise damage the package.

gpssnou RANKINGS
Tie questonasked willbeasignedascale whichrepresemsarangeof
possible answers.

Qusdmlfifib:
1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

Thisrange willallowtestparticipantstoplacetteirresponsewttescale
inawaythatbestreflectstteirbelieforjtfigement.

SUMMARY

Uponcompletonoftleexpefimentrestflts willbetabulatedandreported
using stadsticaltests.Fcrourpurposeswe willtestthedifferencesin response
ptwcrtionalities using Chi-square. Details concerning tampering, however, will
beavailabletoqualifiedindividialsonly.Packageschosen willonlybe
deecfibedingenericdetail.

SAMPLE TEST FORM THREE

TAMPER-RESISTANT PACKAGING STUDY

Michigan State University

This study is broken into two separate parts; one part on each table.
Your participation in completing both parts is greatly appreciated.

PART i

Please rate separately, the seven tamper-resistant package groups diSpiayed.
Each group is identified by a letter and group name. You _mgy_ not pick the packages
up in this port of the study. Rate the groups for their tamper-resistant ability.

)Group K - SHRINK BANDS
"How do you rate this group of tamper-resistant packages?" Circle 3 number.
I 2 3 A 5
BAD GOOD
DGroup V - HRAPS
"How do you rate this group of tamper-resistant packages?" Circle a number.

i 2 3 A 5
BAD GOOD

 

Daroup i - GLUED END BOXES
"How do you rate this group of tamper-resistant packages?" Circle a number.

i 2 3 4 5
BAD GOOD

 

Daroup n - BREAkAwAv CAPS
"How do you rate this group of tamper-resistant packages?" Circle a number.
i 2 3 A 5
BAD 0000
)Group R - TAPE SEALS ,
"How do you rate this group of tamper-resistant packages?" Circle 1: number.

i 2 3 is 5
BAD GOOD

 

’Group F - DUSTER PACKS
"How do you rate this group of tamper-resistant packages?" Circle a number.

i 2 3 '0 5
BAD GOOD

Daroup T - MEMBRANE SEALS
"How do you rate this group of tamper-resistant packages?" Circle 3 number.

i 2 3 h 5
BAD soon
you SHOULD HAVE SEVEN RESPONSES, WITH ONE NUMBER CIRCLED FOR EACH caoup. PLEASE CONTINUE.

 

 

552

PART II

(Continue to next table.)

Please look at each sample container separately.

of the study may or may not have been tampered with.

SAMPLE TEST FORM FOUR

The samples In this part
You may pick up the

samples in this part of the study. but please do not alter the package In
any manner (That is do not pick. peel. or pluck at the displayed packages.)

-Sample Container -

"Having observed this package.
Please Check One.

CI

ND

C]

NOT LIKELY
- Sample Container -

"Having observed this package.
Please Check One.

[3

NO

NOT LIKELY
’Sample Container -
"Having observed this package,
Please Check One.

CI

NO NOT LIKELY

-Sample Container -
"Having observed this package,
Please Check One.

CI

NO NOT LIKELY

- Sample Container -
"Having observed this package.
Please Check One.

E]

NO

-Sample Container -
"Having observed this package,

NOT LIKELY

Please Check One.

CI

NO

EJ

NOT LIKELY

do you think it

CI

DON'T KNOW

do you think it

DON'T KNOW

do you think It

DON'T KNOW

do you think it

DON'T KNOW

do you think it

DON'T KNOW

do you think it

DON'T KNOW

53

has

has

has

has

has

has

been tampered with?"

HOSTDLI KELY YES
been tampered with?"
HOST LIKELY 521
been tampered with?"
HOST LIKELY EEZ

been tampered with?"

HOST LIKELY YES
been tampered with?"
HOST LIKELY YES
been tampered with?"
HOST LIKELY YES

SAMPLE TEST FORM FIVE

-Sample Container - _
"Having observed this package, do you think it has been tampered with?"
Please Check One.
NO NOT LIKELY DON'T KNOW HOST LIKELY YES
’Sample Container -
"Having observed this package, do you think it has been tampered with?"
Please Check One.

E] D U E] [3

NO NOT LIKELY DON'T KNOW MOST LIKELY YES

-Sample Container -
"Having observed this package, do you think it has been tampered with?”
Please Check One.

. D I: [:1 u a

NO NOT LIKELY DON'T KNOW HOST LIKELY YES
-Sample Container -

"Having observed this package. do you think it has been tampered with?"
Please Check One.

Cl C] E] E] El

NO NOT LIKELY DON'T KNOW HOST LIKELY YES

-Sample Container .- _
"Having observed this package. do you think It has been tampered with?"

Please Check One.
D E] D E] [21

NO VNOT LIKELY DON'T KNOW HOST LIKELY YES

YOU SHOULD HAVE ELEVEN RESPONSES WITH ONE RESPONSE FOR EACH SAMPLE PACKAGE.

SomeJuestions aboutlourself. ’ SEX Hale Female (Please Circle One)

was CI

Under 25 26-35 35-hh h5-5h 5h-6S Over 65

'00 you buy over-the counter drug products such as aspirin. cough syrup, eye drops,
etc.? Please Check One. ‘

DNever UOnce every six months DOnce every two weeks
UOnce a year . Dance a month EIAt least once a week
COMMENTS:

 

 

51+

55

POPULATIONS TESTED - FINAL TEST, PARTS I and II

AtotalonOOpeopleweretesbedarfissrveyedforthefinaltest. Time
people weretestedin Lapeer, Miclfiganduringanadulteducadonseminaram
in Holt, Michigan at a Travelog Kiwanis Club meeting. At each location people
chose which one of two grows of packages they were going to observe. The
growsofpackages werethosedeecfibedinthetamperidenfificationtest
procedure. Choosing a group of packages put consuners into a total population
for that grow. Package grows were the same at each location. Therefore, two
populations, according to the package grow observed, were developed. Time
twopopulafiomareassumedtobeimflarforstafisficalrrocedtmandare
distributed by age and sex as shown on the following pages. Population one is
made w of 110 people that observed one grow of packages and PopuJation two
consistsof 90peoplethatobservedanothergrowcfthesame packagesonly
wposite in control or tampered status.

quhfimnOmm
AG}.

CATEGORY

ummrzs
zs-34
E5-44
44-54
35-64

OVER 65

CATEGORY
Male
Femfle

MDRewnma

56

Table 3

NU MBER OF PEOPLE
9
18
32
12
24
13

NU MBER OF PEOPLE
42
60
8

PERC ENTAG ES
8.2
16.4
29.1
10.9
21.8
11.8

PERCENTAGES
38.2
54.5

Population Two
592
CATEGORY
Order 25
26 - 34
35 - 44
45 - S4
55 - 64

(Over'GS

§1_~3_)g
CATEGORY
ldahes
Ftnnahes

lkalkssxxxrae

.57

Table 4

NU MBER OF PEOPLE
9
21
24

18

NU MBER OF PEOPLE
33
45
12

PERC ENTAGES
36.7
18.0
26.7
8.9
20.0

6.7

PERCENTAGES
36.7
50.0

FINAL TEST RESULTS AND CONCLUSIONS

 

The following pages consist of data summaries, summary tables, and reams
of computations for the consumer perception eirvey and tamper identificadon

best.

CONSUMER PERCEPTION SURVEY

The cormmer perception survey (pages 46-47lthataskedmtpartidpants
matecertaintamperhresistantpackaginggrowsresultedinabroadmngeof
answers and distributiors. The average values reported for each grow in Tabh
Sonthefollowing page shows generalitiesofresponsesin themmerical
extremes ofthe"good"to"bad" scale. One exampleistheshfinkbandgrow
whichaveragedaboutafouronthescaleaffiveshowing thatthetotalofboth
consumer pwxflatiorstestedperceivetlfisformaftamper—rea’stant packaging as
being good. However, this average is further enhanced with forty percent of the
answers at the "good" extreme and only twelve percentatthe "bad" extreme of
timescale. Trfissl'fiftstheresponsestowardsthebestendafthescaleand
mflectsflzatcorsumemperceiveshfinkbandsmbegoodtamperirfiicators. One
d:hergrowthatreceivedagoodrafi.ngaverageisblisterpacks.Anofthe
bfisterpackemmplessmwntocorsumersweremfitdosepadtsofrflasficarfi
foil. The oonsumersinthe finaltestratedblistersasthehighestgrow.
Breakaway caps, wraps, and tape seals received middle of the scale average
responses,h1tlooldngatthedistdhifions,wecanobeervethatwrapsami
breakaway caps are shifted in their distributions towards the "good” extreme.
Tapeardmembranesealsappeartobeanevenlydistdmtedwcertaintyforme
consumer with neither a ”good” a: "bad” rating. Glued end boxes, however,

58

59

received a 2.47 rating and its distribution of answers shows them drifted
inwards the ”bad" end of the scale. Over fifty-five percent of the respondents
thought glued end boxes were "bad”.

Withtlmeresultsinnfind,thefiollcwing diowsarankingi
tamper-resistant packaging grows from highest to lowest average of consumer
perception response:

Table 5
Grow Average Response
1. Blister Packs 4.00
2. Shrink Bands 3.905
3. Wraps 3.52
4. Breakaway Caps 3.53
5. Tape Seals 3.08
6. Membrane Seals 3.02
7. Glued Erri Boxes 2.47

These average responses were the amber answers given by consumers to

the question, "How do you rate this grow of packages?"

Bad Good

RawdataardcompletedisuimfiomcfrespomescanbefoundinArpendixc
andfirespectively.

6O

TA MPER IDENTIFICATION TEST

 

Tlepementageofresponses,beststafisdc,andacceptancea'rejecdonof
themllhypothesisisreported foreach samplesetonthefollowingpages.
Complete distributiomof responses and statistical computationscanbe fioundin
Appendix E. Rawdataisin Appendix D.

Tlestatisticalevalnationofourtestisbasedwonthe Chi-squaretast.
'I'histesthelpsdetermine whetherornotthe proporfionsofamwersforthe
controland tampered samples ofthe ame package are the ame ordifferent.
Because we believe that the average consamer cannot detect careful and
malicious tampering of tamper-resistant packages, we shall adopt the following
mlhypothesis:

H:"The proportionsof arswersforbothtamperedandcontrolsamples

are the same.”

Tlfisstatesflntfliedistdbudonofanswersfortletamperedpackageisthe
ameasfortheconflolpackage.1ftheproportionsarethesame,then weare
abJetostate thatconsumersdonotperceiveadifferenceintamperedversus
control packages. To make this statement, we met first choose a confidence
leveloralpha value. ThislevelisatypeIerror whichtellswtheprobability
wehaveibeing wrong whenaccepfingorrejectingthenunhypothesis. We
lavechosenanalphavalueof.05fortifisst1fly.

Thenextpageshowsthe statistical equationsand mathematical set-up of
ourChi-squaretest.

61

The following are the mathematical computations used to

obtain statistical data. For this example we used the coated

paper membrane seal packages, numbered 5021 and 2572. These

are the same packages but package 5021 was tampered with. The

other ten sets of sample results are on the following pages.

The responses recieved were for the question, "Having observed

this package, do you think it has been tampered with?"

Answers were given on the following scale:

1
NO

Observed Results

 

Control
Tampered

Totals

Expected Numbers

 

2 3 . 4 5
NOT LIKELY DON'T KNOW' MOST LIKELY YES
Table 6
ROW
NO NOT LIKELY DON'T KNOW MOST LIKELY YES TOTALS
39‘ 33 13 15 9 109
35 30 6 l4 5 90
74 63 19 29 14 199

 

 

 

 

 

 

 

 

Control

Tampered

 

 

(Row Tota1)(Column Total)/(Grand Total)

 

NO NOT LIKELY DON'T KNOW OST L KE YES
40.53 34.51 10.41 15.88 7.67
33.47 28.49 8.59 13.11 6.33

 

 

 

 

 

A 5
. _ _ 2 =
Chi-square Test Statistic - g E (oij . Eij) /Eij 2.318

Degrees of Freedom

4

. 2 _
Critical Value )(005,4 - 9.488

(Number of Rows-l)(Number of Columns-l)

62
For each set of samples in our test the Critical Value is
equal to 9.488. For this specific example the Chi-square
test statistic is less than the Critical Value so we Accept

Ho'

2.318 < 9.488 therefore accept Ho

The following pages report response percentages and
general statistics for each sample set tested. Actual comp-
utations and disribution histograms can be found in

Appendix E and D ,respectively.

RESPONSE PERCENTAGES AND STATISTICAL RESULT

 

Table 7

COATED PAPER MEMBRANE SEAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Test
Responses: 1 2 3 4 5 StatisticJ Ho
Control 27.3 28.2 24.5 12.7 6.7 . _ '
Tampered 25.0 29.5 19.3 18.2 8.0 1°87J ACCE'H
VERTICALLY PERFORATED SHRINK BAND Test
Responses: 1 2 3 4 5 Statistic Ho
Control 25.5 24.5 18.2 20.0 11.8[ A ’
Tampered 25.0 29.5 15.5 18.2 7.95 1'30 ACCEPT
PAPER and CORRUGATED OVERWRAP .Test
Responses: 1 2 3 4 5 Statistic l Hb
Control 40.7 38.4 13.95 4.7 2.3 7.34 ACCEPT]
Tampered 42.6 24.1 16.7 13.0 3.7
METAL BREAKAWAY RING CAP Test
Responses: 1 2 3 4 5 Statistic Ho
Control 43.8 25.8 13.5 10.11 6.7 40.61 I REJECT]
Tampered 13.76 17.4 13.8 14.7 40.4 7
DISTINCTIVE DESIGN SHRINK BAND Test
Responses: 1 2 3 4 5 Statistic HO
Control 46.7 35.6 7.8 6.7 3.3 8.57 ACCEPT
Tampered 58.3 25.0 12.0 .93 3.7
CLEAR PLASTIC OVERWRAP Test
Responses: 1 2 3 4 5 Statistic Ho
Control 49.1 35.5 9.1 2.7 3.6 21.31 I REJECTI
Tampered 28.1 34.8 9.0 20.2 7.9 _

 

 

63

STYRENE MEMBRANE SEAL

Responses: 1
Control 29.
Tampered 23.

GLUED END BOX

Responses: 1
Control 10.
Tampered 27.
DELAMINATING TAPE
Responses: 1
Control 39.
Tampered 30.

2

9
O

SEAL

3
0

Table 7 continued

30.3
23.6

2
21.8
28.1

2
33.7
28.2

27.0
31.0

23.6
22.5

3
12.4
22.7

CLEAR PLASTIC SHRINK OVERWRAP

2
29.2
25.5

2

3
7.9
10.0

3

Responses: 1
Control 60.7
Tampered 49.0
TAPE SEAL
Responses: 1
Control 35.8
Tampered 38.9

30.3 12.0

33.3

6.7

64

10.10
16.4

30.9
16.9

12.4
16.4

1.1
10.0

13.8
15.6

6.7
5.5

12.7
6.7

Test
Statisticl Ho

 

 

3.58 ACCEPT]

 

 

 

Test
Statistic

 

Ho _

10. 37 l REJECTI

 

 

 

 

 

Test

Statistic Ho
5.95 ACCEPT]

Test

Statistic] Ho

 

 

 

 

 

 

 

10.78 REJEC

Test

Statistic Ho
2.32 ACCEPT

 

 

 

65

Reviewingtheresullscfthisslmdy,we observevaryingdistrimtionsof
arswers received overallpairsof tampered and controlsamples of the ame
package(SeeAppendix ).Sevenoutoftheelevensetsofcontrolversus
tampered packages show that consumers answer the question, “Has this package
been tampered with?",inthe same proportions. When testingtoan alpha equal
to .05,tlmesevensetsshow thattheconsumertested wouldhaveansweredthe
same way whetherthe package hadbeentampered withornct. Theydidnotsee
any difference between control and tampered samples of the ame package.
Four sets of amples showed statistically different response proportions between
tampered and control ample. Three of the four still contained over fifty
percent wrong responses for the tampered samples by answering 'No" a "Not
Likely" that the package had been tampered. Two of the three were Clear
Plastic Overwrap and Clear Plastic Shrink Wrap. ch both of time, the
consumers showed some ability to detect tampering, but both showed over sixty
percent failure to detect tampering. One of the three, Glued End Boxes,
received cverfcrtypercent'Yes" arswers wheninrealityithadnotbeen
tampered withat all. The tamperedample received five percentresponses
towardsflme”No"endofthescalecrjstoppcsiteoffl1econtrolsample. This
wmonstrates the consumers inability to detect (1' identify tampering with
respect to this tamper-resistant package form.

The onesetof samplesthatdidshow anysignificantresullsfavofingtl'ie
ability of the consumer to detect tampen’ng was the metal breakaway ring cap.
This wasthefourthsetofamplesthatshowedstafisficany differentresponse
rroportions. The ream-s showedcver fiftypercent (i therespondentscorrectly
identified the package as being tampered. The control ample demonstrated the
ame results with over fifty percentalso giving rightanswers. We stillobserve

66

a twenty percent response rate that is wrong for the tampered sample but this
is the lowest percentage of all the tampered packages.

Overall, there were 1099 and 1081 responses to the tampered and control
amples, respectively. The tampered amples, overall, aow a thirty-fliree
percent wrong response rate at the far extreme of I'No". When we include "Nd:
Likely", the percentage becomes a'xty percent. Time two wrong answers that
thepackagehasnotbeentampered with,whenin realityithasbeen,showa
definite inability, in the consumers tested, to detect tampering for the amples
and tampering methods used. If we include the answer of "Dm't Know", we find
that over seventy-five percent cf the consumes did not know or could not
correctly identify a tampered package.

Thecontrolamples,overal1,showonlyasixpercent wrong responserate
at the far extreme of "Yes”. When we incluie "Most Likely“, the percentage
rate becomes eighteen percent. This percentage is not a large increase in wrong
responses when compared tofleresporeesfor the tampered amples.If we add
the ”Don't Know" results, the percentage becomes thirty-three percent. Again,
not as great an increase in the tampered ample responses. However, the wrong
answer percentages for the ample sets apport some interesting conclmions.

The consumer's inability to detect and correctly identify a tampered
packagehasalreadybeen mentionedandbringsto lightthe questionofjtsthow
safe will the consumer be with new tamper-resistant packages. With over
seventy-five percent iourconsumer population rotabletodetectandiden’dfy
atampered package, we become concerned thatlittle ornoprotection willbe
affordedintheeventofquJre malicioustamperings.

Withtheconorolgroup receivingcvertifirtypercentwrong answers, we
onlygeneratethethoughtofwhatit willmeantoalesandproduction.1fthe
consumerthinksapackage hasdefinitelybeentampered with arevenifthey

67

question whetherit hasbeen,then willtheybuy it? We donotthinkso,but
thisarea needs tobe furtherinvestigated. Are consumers observing production
variations a impedections normally present in the package as tampering? If
fixatisthe reason for such high percentages,thendoesthis mean manufacturers
willhave totightentolerances and makeaperfectpackage? Again,thisarea
reedstobefurtherinvestigated.

Overall, we have shown that consumers cannctdetectthe way we tampered
withmanyofourchcsenamples.Tiereisroomforerrorin ouranalysisand
resultsaslistedbelow, however, the dataisfaifly suongand initiallypresents
ame future problems for the tamper-resistant function of many packages. The
nextstepseems clearin attempting toidentify exactly whatthe conamercan
andcannotdetect. Further studiesinthis areacouldgivewalevelfrom which
to work from in developing truly tamper-resistant packages.

EXPERIMENTAL ERROR
Thefollowingisalistofpoaibleerrorsthat mayhaveoccurredand
derebybiasorchangetheresfltswereceived:
1. The aaumptionthatourtwo populationsaresimilarisnottrue.
2.Ccnsumers weremtgiventhechancetocompare tamperedpackages
withconfiolpackagesastheymightbeabletointhestore.
3. Consumers were notallowedtoopen anycfthepackagesand
flierebyinspecttheintegfitycfthepackagecomponemsforrepairs.
4.5amp1edisplaylighting mayncthavebeenthesameawhatis
availableinastore.
5. Testproctorsmay haveinadvertentlybiasedtestparticipanisin
regardstoampleidenfification.

68

6. None of the packages tested totally met the new tamper-resistant
packaging regulation requirements.

7. Testpartidpantswereirfitiallysensitizedtothefact thatthe

amples they would look at "May a may not have been tampered with.” This

statement may have increased their awarenea more than what it would be in a

normal product purchasing s’tuation.

GO OD TA MPER-R ESISTANT PAC KAGING

During the development and completion of the test certain tamper-redstant
packagingfeaturesrxomdtobebetterthancthersTiisismtsnpfisingas
thereeadstsfiourmajorpackaging materialsallcoreistingcfdifferent
marfies.Witifineachofflmefommatefials(glaa,paper,plasfic,mdmetaD
derearehmldredscfdifferentmatefialmakempseachwithdifferent
properties. Tiese material properties combined with numerous package design
p:operties can produce any number cf package forms. Tamper-resistant
packagingismexception.Withamulfitudeofpoaibbdesdgnsandmatefial
combinations, there exists a range of performance and functionality levels.

Some of the major tamperhresistant packaging classifications are listed
below. Fa each claaification there are observations that disma certain
featuresanddesigns which performthefuncfionoftamper-resistancebewer
thancthers.

teams;

-Verfi.calperforationsintheshrinkband madeitdifficulttoremove
without breaking. The greaterthenumberofperforations,the harderitbecame
toremovetheband withoutdamage. Verticalperforatiorealso madeit more
difficulttorepairbecaaeofmaterialbreakage.

-Clear<xtrarspanentbandsarehardtorepairaftertampefingbecause
flecormnerandetectflierepairbyseeingbeidndwrwderltheband.
However, thepresence of clear bands that contained no distinctive markings
wasdifficultfortheconsumertosee.

-Heatshdnkbandsarema:etamper1esistanttiancellubsicshdnkbands.

69

7O

-Bd:tlmorjarsthathadtheshrinkbandsealedcverthecapamialarge
transferbeadorctier non-uniformity were more difficultto remove and replace
thanpackages with smocthanduninterrupted finishes. The band wasshrunkcver
thetransferbeadinacha waythatdamage usually hadtooccurinorderto
QBtthematerialpastthebead.

-Tie longerorfurtherdownthepackagetieshfinkband extended,the
harderitbecametoremovethebandandrepair.

-Alloftheseobservafionsforbandsasa1methatthe matefialhasbeen
appliedinatightandcontourfitting manner.

-SIn:inkbandsandchild-resistantclos.1resdonotuaallymakegood
tamper-resistantpackages.

Ir-w_ra.e
-Theclearerthe wraptheeasieritwasforaconsumertodetect
repairs.
-Perforatiorecrtearstripsmadeitdifficulttoremoveandreplacethe
wrapinonepiece.
-'I‘ightonepieceshrinkoverwrapsfromaheatsealedpoucharemore
difficulttotamperwiththanadiesivesealedcverwraps.

lILTfi Seals

-Thethinnerthetapematerialtheharderitbecametopeelcffinone

-Adhesivesthatwerestrongerthanthetape matedalsresultedintorn
paperfibersordestrucdonofthetapewonremcval.

71

-Delaminafingtapescfplasticandfoilweredifficulttodefeatwithout
detection.

-Tapesealedcartonsshou1dalsohaveatapesealappliedtotheglned
cartonfpintarsideseam.

-Gloayhighlycalenderedmaterialsusedtomanufacmrecartonswere
easiertoremovetapesealsfrombecauseoflittleornofiber

pill.

IV.Thermoforms

-Unitdoseblistersofmcstidndsproveddifficulttodefeat.v

-Unit dose blistrs with push orpunch through foil backings performed
muchbetterthanpeeloffs.

-Unitdose blisterswiththinfoilbackings weredifficulttoremovein
cnepiece. '

- Embossed unitdoseblisters made entry to the package without damage
hardtoaccomplish.

V.Closures

- Metal break away ring caps performed much better with horizontal
aoresonly.Verticalscoresallowedtheringtocomecffthebcu-lein virtually
cnepiece.

-Membranesealsofthinfoilsealedbyinductionprovedtobedifficult
to tamper with without visible damage.

-Thi.n membranesealsthatmatchedthediameterofthebcu'lemouth
withoutanyoverhang were difficulttoremcve withoutatleastsomeinitial

72

damage. Membrane seals with overhang allowed for some hiding of repairs to
tampered packages.

- Membrane seals with distinctive logos sometimes hid the damage or
tampen'ng thattook place. Adngleordoublepn’ntlogointhecenter tithe
aal wouldallow the consimertolook atthe edges withoutany added
interference.

-G1uedcrsealed endcartore were hardertodefeatwhenthe adhesive
was wread over a large surface area. The author, however, does not believe
that this type of packaging should be considered tamper-resistant by defintion.

Timeareobservafiorsmatweremteddufingthecoursecfthetesting
azudy. Some tamper-resistanttypes ofpackaging arenotdiscuaed because they
usuallyarenctusedinthe OTC drugindusizyorbecauseamplesinthose
categories were nctreviewed and tested.

ATTITUDE SURVEY: TAMPER-RESISTANT PACKAGING

Dufingtheinirialstagesofthisthesis, webegantofocusonconsumer
awareness and attitudes. Since September 30, 1982, consumers have been forced
into an awareness of tamper-resistant packaging because the Tylenol and
”copy-cat" incidents were thrust won them through national news, headline
a'ories, magazine articles, and advertisements. With the introduction of a
relatively new packaging concept to most consumers, many marketing and
research people developed attitude arveys to gain data and information on how
the corsumer was feeling towards tampering, product afety and security, and

Our anvey focused on how consrmers feel about the new regulation and
whetheror notitwillprotectthem. Webuildwoneach question akedby
leading the consumer through the survey in an orderly manner. Many of the
questions use a scale for answers, thereby, allowing greater latitude in
respmdingtothequestion.Thearveyalsoaddresseswecificabjects
pertaining to tamper-resistant packaging of cosmetics, hygiene products, and
foodproductsaswellas OTC drugsand medicines.

Population data, survey fcrms and questions, as well as results can be found
cnthefollowingpages. Rawdatacanbefoundin Appendix G.

73

SAMPLE TEST FORM SIX

NUMBER

 

Tamper-Resistant Packaging Survey
School of Packaging
Michigan State University

The purpose of this survey is to obtain an overall
view of the consumer's attitude toward tamper-resistant
packaging. Please read each question carefully and
answer it by circling or marking the response that
best describes your personal thoughts or actions.
Please conplete this survey without any outside

assistance or further information than presented here.

For the purpose of this study the words taper-evident
and tamper-resistant mean the sanething. Both words

may be used interchangeably.

THANK YOU FOR YOUR ANSWERS AND PARI‘ICIPATICN .

74

I.

SAMPLE TEST FORM SEVEN

PLEASE READ CAREFULLY AND MARK YOUR ANSWERS CLEARLY

Do you buy over-the counter drug products such as aspirin, cough syrup, eye drops, etc.?
PLEASE CHECK ONE.

 

D NEVER ' DONCE EVERY SIX MONTHS DONCE EVERY TWO WEEKS
ONCE A YEAR ONCE A MONTH DAT LEAST ONCE A WEEK

How often do you buy food products? PLEASE CHECK ONE.
DNEVER DONCE EVERY SIX MONTHS DONCE EVERY TWO WEEKS
DONCE A YEAR DONCE A MONTH DAT LEAST ONCE A WEEK

Think about how you select and buy a food produci from the store. Do you look at the
condition of the package? PLEASE CIRCLE A NUMBER ON THE SCALE.

l 2 3 4 5 6 7
VERY SELDOM ALWAYS

. Think about how you select and buy an over-rhe-counier drug product. Do you look at the

condition of the package? PLEASE CIRCLE A NUMBER ON THE SCALE.

l 2 3 4 5 6 7
VERY SELDOM ALWAYS

. Do you know what tamper-resistant packaging is? CIRCLE A NUMBER ON THE SCALE.

 

i 2 3 4 5 6 7
NOT AT ALL DEFINITELY

. Are you aware of the product/package tamperings involving Exira-Sirengfh Tylenol? PLEASE

CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Did you know that similar incidents iermed "copy—car" iamperings also occurred? PLEASE
CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

. Do you believe ihai what happened with Tylenol could also happen +o food producis?

PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Do you believe that what happened with Extra-Strength Tylenol could also happen with

cosmetics such as makeup, perfume, colonge, etc.? PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Do you believe that what happened with Exira-Sirength Tylenol could also happen with
hygiene products Such as Toothpaste and mouthwash? PLEASE CIRCLE A NUMBER ON THE SCALE.

 

l 2 3 4 5 6 7
NOT AT ALL DEFINITELY

75

SAMPLE TEST FORM EIGHT

PLEASE READ CAREFULLY AND MARK YOUR ANSWERS CLEAR

11. Did you become more cautious in buying over-the-counter drug products after the Tylenol
incident? PLEASE CIRCLE A NUMBER ON THE SCALE.

. i 2 3 4 5 6 7
NOT AT ALL DEFINITELY

i2. Did the Tylenol and "copy-cat" tamperings stop you from buying over-the-counter drug
products such as aspirin, cough syrup, etc.? PLEASE CHECK ONE.

 

 

EYES [.3 NO
12a If yes, have you or will you go back to buying over-the-counter drug products in the
future? PLEASE CHECK ONE.
LJYES i: No

13. Did you think it was necessary to become more cautious in buying food and beverage products?
CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

14. Did you know that a new U.S. Food and Drug regulation requiring tamper-resistant packaging
on all over-the-counter drugs has been established? PLEASE CHECK ONE.

 

[2:]
NO HEARD SOMETHING HAVE READ ABOUT mow REQUIREMENTS

15. If all over-the-counter drug products were In tamper-resistant packages, would people have
to look closely at each package to see tampering? PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

16. Do you believe that the new tamper-resistant packaging regulations will prevent future
deaths from tampering? PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

17. Do you believe that the new tamper-resistant packaging regulations will prevent future
"copy-cat" tamperings? PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

18. The new tamper-resistant packaging regulation only applies to over-the-counter drug
products and oral cosmetics such as mouthwash. Do you believe it should also apply
to food and beverage products? PLEASE CHECK ONE. YES NO

19. If a package (product) had been tampered with, do you believe that you could detect
the tampering upon looking at the package closely? PLEASE CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

PLEASE TURN THE PAGE.

763

SAMPLE TEST FORM NINE

PLEASE READ CAREFULLY AND MARK YOUR ANSWERS CLEARLY

20. Would you be willing to pay extra for tamper-resistant packages? PLEASE CHECK ONE.

[3 YES [3 NO

IF YES, then how much extra would you pay? PLEASE CHECK ONE.

[:1 [:1

1-5 cents 6-10 cents 11-15 cents 16-20 cents 21-25 cents over 25 cents

 

A FEW QUESTIONS ABOUT YOURSELF.
Sex - Please circle one. Male Female

Age - Please check one.

 

UNDER ;5 YEARS 25-34 YEARS 35-44 YEARS 45-54 YEARS 55-65 YEARS 66-OVER

Education - (Last Year Attended) Please Check One.

SOME HIE; SCHOOL COMPLEQGH SCHOOL SOME EOLJEGE OR COMPL:IEO COLLEGE

TECHNICAL SCHOOL OR MORE

 

 

City and State in which you live

 

COMMENTS:

 

 

 

 

 

 

THANK YOU VERY MUCH FOR YOUR PARTICIPATION!

77

78

ATTITUDE SURVEY RESULTS

 

The following results are reported by averages for each

question. Population results are as follows:

POPULATION

 

SEX: 130 MALES
135 FEMALES
5 NO RESPONSE

 

270 TOTAL RESPONDENTS

AGE RANGE MOST FREQUENTLY CHECKED: 25 - 34 years

EDUCATIONAL LEVEL MOST FREQUENTLY CHECKED: Some College

QUESTIONS

 

I. Do you buy over-the counter drug products such as aspirin, cough syrup, eye drops, etc.?
PLEASE CHECK ONE .

D NEVER IDONCE EVERY SIX MONTHS DONCE EVERY TWO WEEKS
ONCE A YEAR ONCE A WNTH DAT LEAST ONCE A WEEK

 

Average Response: Once every six months

2. How often do you buy food products? PLEASE CHECK ONE.

DNEVER DOME EVERY SIX WNTHS [:lONCE EVERY TWO WEEKS
DONCE A YEAR DONCE A WNTH DAT LEAST OWE A WEEK

Average Response: Once every two weeks

79

3. Think about how you select and buy a food product from the store.

Do you look at the
condition of the package? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
VERY SELDOM ALWAYS

Average Response for Question 3: 6.095

4. Think about how you select and buy an over-the-counter drug product. Do you look at the
condition of the package? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
VERY SELDOM ALWAYS

Average Response for Question 4: 5.67

5. Do you know what tamper-resistant packaging ls? CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 5: 6.34

6. Are you aware of the product/package tamperings Involving Extra-Strength Tylenol? PLEASE
CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Re8ponse for Question 6: 6.6

7. Did you know that similar incidents termed "copy-cat" tamperings also occurred? PLEASE
CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 7: 6.21

8. Do you believe that what happened with Tylenol could also happen to food products?
PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 8: 6.7

8O

9. Do you believe that what happened with Extra-Strength Tylenol could also happen with
cosmetics such as makeup, perfume, colonge, etc.? PLEASE CIRCLE A NUMBER ON THE SCALE.
1 2 .3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 9: 6.04

10. Do you believe that what happened with Extra-Strength Tylenol could also happen with
hygiene products such as toothpaste and mouthwash? PLEASE CIRCLE A NUMBER ON THE SCALE.

2 3 4 5 6 7

1
NOT AT ALL DEFINITELY

Average Response for Question 10: 6.44

11. Did you become more cautious In buying over-the-

counter drug products after the Tylenol
incident? PLEASE CIRCLE A NUMBER ON THE SCALE.

NOT AT ALL DEFINITELY

Average Response for Question 11: 5.33

12. Did the Tylenol and "copy-cat” tamperings stop you from buying over-the—counter drug
products such as aspirin, cough syrup, etc.? PLEASE CHECK ONE.

[Eyes [:1 No

Average Response for Question 12: NO

12a If yes, have you or will you go back to buying over-the-counter drug products in the
future? PLEASE CHECK ONE.

[:3fl5 [:3NO

Average Response for Question 12A: YES

I}. Did you think It was necessary to become more cautious In buying food and beverage products?
CIRCLE A NUMBER ON THE SCALE.

1 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 13: 5.33

14. Did you know that a new U.S. Food and Drug regulation requiring tamper-resistant packaging
on all over-the-counter drugs has been established? PLEASE CHECK ONE.

N0 HEARD SOMETHING HAVE READ ABOUT KNOW REQUIREMENTS

Average Response for Question 144 ‘Heard Something

81

15. If all over-the-counter drug products were In tamper-resistant packages, would people have
to look closely at each package to see tampering? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 15: 4.81

16. Do you believe that the new tamper-resistant packaging regulations will prevent future
deaths from tampering? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 16: 4.79

17. Do you believe that the new tamper-resistant packaging regulations will prevent future
”copy-cat" tamperings? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 17: 4.65

18. The new tamper-resistant packaging regulation only applies to over-the-counter drug
products and oral cosmetics such as mouthwash. Do you believe It should also apply
to food and beverage products? PLEASE CHECK ONE. YES NO

Average Response for Question 18: YES

19. It a package (product) had been tampered with, do you believe that you could detect
the tampering upon looking at the package closely? PLEASE CIRCLE A NUMBER ON THE SCALE.

I 2 3 4 5 6 7
NOT AT ALL DEFINITELY

Average Response for Question 19: 4.45

20. Would you be willing to pay extra for tamper-resistant packages? PLEASE CHECK ONE.
Elves Elm

IF YES, then how much extra would you pay? PLEASE CHECK ONE.

CI [3

1-5 cents 6-10 cents 11-15 cents 16-20 cents 21-25 cents over 25 cents

 

Average Response for Question 20, part 1; YES
Average Response for Question 20, part 2: 6-10 cents

82

ATTITUDE SURVEY CONCLUSIONS

While reviewing the results of the attitude survey, certain observations
become obvious. Consumers appear to be very aware & both the Tylenol. and
”copy-cat" incidents. They also believe that they know what tamper-resistant
packaging is.

Some less obvious relationships also appear. Consumers feel strongly that
what hashappenedto OTC drugscanalsohappentofood,cosmeficandhygiene
[rockets They even fieel that foods @0qu be required to have tamper-resistant
packages. They state that they usaally look at the condition of the package
before making a purchase and that they became relatively more cautious in
theirpurchasing habitsafterthe Tylenolinddent. Withallthisstated
oaub'omnemani belief that tamper—resistant packagesshouldbe used far foods
and a willingness to pay extra for it, commers still do not demonstrate much
confidence in their ability to detect tampering. They are not really sue that
line new regulations will prevent future tampering problems but from the
average mean values one can conclude that the consumer probaby places the
Tylenol. deaths in the same category as "copy-cat" poisonings.

Anothercbservationcomesfrom the qimliononhow closely andcauliousa
person looks at a packaged product before pinchasing. Consumers say they look
closely at packages but also show a reduction in cautiousness with the new
regulation. Tleyarenotsure if they willhave tolookcloeely atpackages with
new tamper-resistant features in order to detect tampering. However, their
indecision daoutanyabilitytodetecttampering may continuetoleadthe
cormmer to closely inspect packaged products.

Thissurvey mainlyreflectstheattittflesand awarenesseeofconsumers
livinginthestateaf Miclfigathmayalsoreflectahighersensifivitytothe

SUMMARY

 

On September 30, 1982, three people died from ingesting a product that was
malim’ously tampered with. What followed in terms of four more deaths and
mmerous "copy-cat" tamperings, sent the American public into a scare and
rocked the veryprinciples upon which the OTC drugcompanis hadbuilttheir
industry. Weobservedammbercfpolidcalreaclionsthroughproposed
regulationsatthestateardbcallevelswithallcfthemdifferentardall
requiring tamper-resistant packaging. The OTC companies saw their cutomers
very lives threatened by maliciom individials that they could not control and
agreed with state and local governments that regulations were necesary.
However, with different regulations calling for different packaging, they saw a
flireattotheir economiescfscaleJossof profitabflity,andprodictdistfibution
nightmares. They, therefore, asked for and received a federal tamper-resistant
packaging regulation established by the FD A; a regulation which only requires
thatapackagemeetadefirfiin'onthathasmszandardbywhichtomeasire
compliance. This regulation and the function which tamper-resistant packaging
isbeingaskedtoprovidehasbeenthe mainsubjectofthisthesis.

Historically, we have seen the development of tamper-resistant packaging
forthe deterencecfmrmalin—storepackage waning byoonsumers who sample
atestrrcdmtsTmstypeofdeterencelasbeuersewredmeprodJct's
Self-life from inadvertent environmental deterioration. Some other regulatiors
requiringtamperuesistant packaging alsoexistfor variomreasors. No evidence
inreseamlfingtleseestabfisledregulafiomsmwsareedcxdedretodeter
malicious and intentional tamperings. The new tamperHres'stant packaging
regulation for some OTC drugs and liquid oral cosmetics specifically pertains to
deterence cf malicious tampering and package/product adulteration. It even

83

84

statesoneoffliereasonsforthereguhfionistorestorecorsimerconfidence
intheproductstheybuyanduse.
Lmazdertobetterurderstarfiflietotalhnpactofthetampefinginddents,
weidenfifiedflechamctedsfimofmalidomtampemmmfidevelopedteslsarfl
alnzittflesirveystodeterminehowtheconsimerwillreacttonew
tamperresistant packaging. We found thatthe'Tylenol Killer'isquitedifferent
from the “copy-oat" tamperer because he is characterized as being quite
determined, cunning, and uncaring for human life. The ”copy-cat", onthe other
hand, maynotwanttoinjureorharm someone because they oangainpowerand
recognitionwithoutit.

Test developments and eirveys show that consumers are aware of
p‘oduct/package tamperings, overalL but demorstrate an inability to detect a
tampered package. Their perceptions and attitudes reflect a concern for
requiring tamper-resistant on many products including food, yet they show
hfiedsivenessinitsabflitympmtectflemardotlerconsimers.01rteslshave
reinforced what most people have been aying, that no package is tamperproof.

Asthissibjectbecomes moreimportantandresearchiscompleted,then
certain conclusions and concepts will come to be better understood. The
manufacunerstodayareworldngandperformingintlfisareatothebestd
theirabflities. Theyhave putforthaconsczientious efforttopmtecttheir
customers and themselves. However, the packaging we have in our society,
today, wlietleritbetamper-resistantamwillpmbabynotaffordthe
recessaryrrotectionmdedtostcpamaliciomindivimaLTtetypeof
packagingthatisdefinedinthenew regulation wasnotdevelopedtostopthis
malicious tamperer but rather to deter normal in-store Opening by average
mm.Tlerresentreguhfionis<pen-endedandreedstobedeveloped
Emmerifitisexpectedtobetotallyeffeclive.korfically,flietampedng

85

incidents tookplacediringan election monthand manypolicitiansjimpedon
the bandwagon all acrcm this country. They over-reacted to the situation by
immediately looking toward legislative actions and a a‘mple solution in a
prodict's packaging. This over-reaction forced the OTC drug industry and FDA
to enact regulatory requirements in the best posible manner. Evidence of
pomiblecver-reactionisreflectedbydzherfreecarfitalisdccountfies. Our
closestneighbor, Canada,hasnotenactedorrroposedanysuch legislationto
date, th they have drawn it to manufacturer's attention.

RECOMMENDATIONS
Emedupon the research and studioscompleted forthis thesis,I have some
recommetriafionsforthoseconcerned.FirstcfaD,are-evaluationcfflie
message being conveyed to corsumers needs to be examined. The FDA, in its
regulation,andmanycthers arestadngthattamper—resistantpackaging will
re-stablish consumer confi<bnce in the product's integrity and that the
tamperings $0qu not deter the public from safely using OTC drugs and (the:
ptoducts. These statements may be erroneous and misleading to the consumer,
waedsafalsesensecfsecufitybybelievingflnttamper-redstantpackaging
wiIldetera maliciomindifidialandidenfifytothem whethercrnctapackage
hasbeentampered with. Weneedboimurethatthecorsimerhasan
understanding cf who mightbedoing thetamperingsandthatthe characteristic
profilescE'Tylenol Killers"arxi"copy-cart" tamperersarequitedifferent.
~lfwearemexpecttamper-resstantpackagingtoperfa'mitsrewfuncdons
andduties, we mustfirstestablishan identification levelat whichthe consimer

is capable (f detecting a tampered package:)The regulation should reflect this

86

(htection level by establishing a test standard that will enable the packager to
adequately perform his duties.

Most tamper-resistant packages on the market today, which meet the
general FDA regulation definition present very little deterence to malicious
individials. As long as our society continues to be terrorized by intentionally
malicious people the problems experienced by OTC drug manufacturers and
dzher product companies will continue to be prevalent.

APPENDIX A:
SEQUENCE OF EVENTS

SEQUENCE OF EVENTS LEADING UP TO TAMPER-RESISTANT
REGULATIONS BY THE FDA ON OTC DRUGS AND MEDICINES

September 30, 1982

An early morning report of three deaths due to cyanide laced
Extra-Strength Tylenol in capsules was received by McNeil
Consumer Products, Division of Johnson and Johnson. The
report came from the Cook County, Illinois, Coroner's Office
Chief Toxicologist, Michael Schafer.

McNeil Consumer Products immediately issued a recall of the
lot number involved -- some 93,000 bottles of Extra-Strength
Tylenol in capsules.

October 1, 1282

A fourth person who had been in serious condition since
having been poisoned September 30, 1982, also dies from
cyanide laced Tylenol. Two additional deaths from cyanide
laced Tylenol (Extra-Strength capsules) are also reported in
the Chicago area. Two additional bottles of Extra-Strength
Tylenol capsules are found on the shelves containing cyanide
laced capsules. A second lot number is identified as being
involved and a second recall is issued -- some 171,000 bottles.
A precautionary withdrawal is ordered of all Extra-Strength
Tylenol capsule bottles in an eight county Chicago area.
McNeil Consumer Products, in cooperation with the Illinois
State Attorney General's Office, issues a 100,000 dollar
reward for information leading to the arrest and conviction
of any person or persons responsible for the deaths.

Production Of all Regular and.Extra-Strength Tylenol capsules
is halted by McNeil Consumer Products until further notice.

October 2, 1282

A seventh death is reported in the Chicago area as a result
of cyanide laced Extra-Strength Tylenol capsules. McNeil
Consumer Products issues a withdrawal of all Regular-Strength
Tylenol capsules. Chicago authorities issue an order for
suspension of sales of all Tylenol products.

 

87

88

0ctober_3,41982

The OTC Proprietary Association establishes a committee to
seek ways of dealing with malicious tampering and adultering
of OTC drug and medicine products. The committee will deal
with product security.

October A. 1982

United States Department of Health and Human Services
Secretary, Richard Schweiker, directs the FDA to draft a
national regulation for tamper-resistant packaging.

Cook County, Illinois, passes an ordinance without public
hearings making it unlawful to sell OTC medicines that are
:hgested, inhaled, or inserted into the human body in con-
tainers that do not possess a separate seal which secures
the lid or cag to the container. The ordinance takes effect
January 2, 19 3, ninety days after passing.

0ctober.5.1982

Reports from California are confirmed that strichnine has
been found in three bottles of Extra-Strength Tylenol cap-
sules. One person becomes ill but not seriously. McNeil
Consumer Products issues a nationwide recall of all Extra-
Strength and Regular-Strength Tylenol capsules.

The Proprietary Association's committee meets with top
leaders of OTC drug and medicine companies, pharmacy experts.
and the FDA to explore ways of reducing the risk of future
problems due to malicious adulteration of OTC medicines.

FDA Commissioner, Dr. Arthur Hayes, announces that the FDA
is working on regulations for tamper-resistant packaging as
well as identifying additional tamper-resistant packaging
that may not have been thought of in regards to the Tylenol
problem.

Joint Committee for Product Security is established to devel-
op and recommend a workable framework for a national regula-
tion on tamper-resistant packaging and to identify various
kinds of packaging that are tamper-resistant.

89

October 7.31982

McNeil Consumer Products recalls all Tylenol and CoTylenol
products in capsules and not in individual blister packs.
This was done so the Tylenol name would not become an abused
target for tampering. All recalls totalled an estimated
31,000,000 bottles of product removed from the consumer
shelves by McNeil Consumer Products.

Between October A and October 15. 1982

Bills calling for regulations on tamper-resistant packaging
have been introduced in the city of Chicago, the state of
Massachusetts, the state of Ohio, Cook County, Illinois, and
Los Angeles County, California. Hearings for possible action
have been scheduled in the states of California, Connecticut,
Pennsylvania, Maryland, and New Jersey. The Pennsylvania
Department of Health and the New York City Health Department
are considering issuing regulations on tamper-resistant
packaging.

Octobe£:12L1982

A man in Grand Junction, Colorado, is reported in good con-
dition after his eye was burned by hydrochloric acid in a
Visine A.C. eye drop bottle. Authorities found several
bottles of the Visine A.C. on the store shelf with the acid
inside the bottles. It is believed a "copy-cat" individual
tampered with the product. Visine A.C. is packaged with a
shrink band around its closure. All tampered with bottles
hagthebands removed.

October 15, 1982

A series of Health and Environment Senate Subcommittee hearings
are held on tamper-resistant packaging. Present at the meeting
are Dr. Hayes and other representatives from the FDA,
representatives from the Pro rietary Association and
representatives from.McNeil onsumer Products and its parent
company, Johnson and Johnson, Inc.

October 12, 1982

Authorities in Florida report that four bottles of Lavoris
mouthwash were found on a store shelf to contain acid laced
product. A man received minor burns from using the product,
found to be laced with muriatic acid.

90

A teenager is arrested in Kentucky after reportedly trying
to extort money from a grocery store. He allegedly wrote a
Jletter stating that some food products in the store had been
tainted with neurotoxic poison and demanded 5,000 dollars in
return for identifying the contaminated foods.

A rural couple in Cedar Rapids, Iowa, were arrested for
allegedly threatening to inject insecticide into grocery
items 0

October 2h,11982

A tranquilizer pill is found in a frozen pie in Grand
Junction, Colorado.

October 25 to 27L11982

Anacin capsules are found to be tainted with rat poison in
Grand Junction, Colorado. A man becomes poisoned with
mercuric chloride after consuming Extra-Strength Anacin
capsules.

As many as sixty containers of laxative are found to be
tampered with on Florida's west coast.

A woman suffers minor mouth burns from drinking an acetone
laced Tropicana fruit punch.

October 29 to131I 1982

Pins, nails, razorblades, and poisons are reported found in
Halloween candies across the nation. Only minor injuries are
reported.

A petroleum compound was found to have been injected into a
carton of Tropicana Orange juice consumed by a Florida police
officer; Minor stomach and throat burns are reported.

Nails and razorblades are reported found in Hygrade Ball
Park hot dogs. Five separate reports are made resulting in

a Michigan, Ohio, and Indiana recall of the frankfurters from
the store shelves. All five incidents are later found to

be hoaxes.

91

November 5. 1982

The FDA anounces new tamper—resistant regulations for OTC
drugs and medicines. Some oral cosmetics, such as mouthwash,
are also regulated. The regulation requires all high risk
items such as capsules and liquids to be contained in tamper-
resistant packages within ninety days. All other products
are given a six to fifteen month effective date. The re-
gulation also imposes new labelling requirements informing
the consumer of the tamper—resistant features of the package.

*Numerous other accounts of tamperings and poisonings are
reported in the following months. Some of the incidents
resulted in minor injuries to the consumers involved. With-
in this time span, authorities have checked out some 270
reported cases of possible product contaminations and an
estimated 8,000 phone calls were answered from individuals
that thought they had ingested or taken a tampered medicine.

APPENDIX B:

SENATE SUBCOMMITTEE HEARING

COMMENTS AND RECOMMENDATIONS FROM THE OTC
PROPRIETARY ASSOCIATION TO A HEALTH AND ENVIRONMENT
SENATE SUBCOMMITTEE HEARING ON TAMPER—RESISTANT
CLOSURES: OCTOBER 15, 1982

Definition of tamper-resistant packaging according to the
Proprietary Association as stated in a Health and Environ-
ment Senate Subcommittee hearing on tamper-resistant
closures -- October 15, 1982.

"A tamper-resistant package is one having an indicator
or barrier to entry which if breached or missing can
reasonably be expected to provide visible evidence to
consumers that the package has been tampered with or
opened."

An eXplanation followed with this definition:

"Tamper-resistant packaging involves the immediate
container or closure systems or secondary container
carton systems or any combination thereof intended to
provide a visual indication of package integrity when
handled in a reasonable manner during manufacture,
distribution, or retail display. The visual indication
will be enhanced by appropriate illustrations or state-
ments on the product calling to the buyer's attention
the safeguarding mechanism. An illustrative list of
tamper-resistant packaging which we believe meets the
definition should be attached to this statement."

Further recommendations by the Proprietary Association:

Products to be covered should be all OTC drugs for
human use including the following:

1. All drugs that are ingested such as capsules, tablets,
liquids and others inclusive.

2. All products (OTC) that are inhaled such as throat
and nasal Sprays, nose drops, and inhalants.

3. OTC drugs intended for insertion into the human
body including suppositories, vaginal foams, creams,
and gels, douches, and ear drops.

4. Interocular products such as and including eye drOps,
eye washes, and contact lens solutions.

92

93

The Association suggested the following list of allowable
tamper-resistant packaging:

1. Film wrappers which cover or wra completely around
the entire product or secondary primary package.

2. Blister or strip packs - unit doses in punch through
or peel backings.

3. Bubble packs - blister trays permanently or securely
affixed to a display card.

4. Shrink seals or shrink bands arOund closure and
bo'ttleo ‘ '

5. Foil, paper, plastic pouches - more unit doses.

6. Bottle seals - induction seals and others under the
closure over the mouth of the container.

7. Tape seals - including tax stamps, tapes over or
around closure and container, flaps taped on shelf-
carton.

8. Sealed tubes - such as blow molded contact wetting
solution bottle. Container and closure are one, the
closure must be snapped off, single usage containers.

9. Sealed cartons - glue ends or taped.
10. Aerosol containers

11. Breakable caps - plastic and metal: roll ons and strip
caps (milk bottles, etc.).
These were the eleven categories with only a few examples from
each for explanation.

The Association stressed to the subcommittee and to the
FDA that pre-emptive federal government regulation is essential

in order to achieve regulatory uniformity throughout this
nation.

The Association also emphasized "that tamperproof
packaging is impossible to achieve, hence the term tamper-
resistant." They went further to say that this case was
"probably one of criminal tampering" and that it is ”impos-
sible to completely protect society from malicious criminal
acts."

94

In the Senate Subcommittee meeting the Chairman of the
meeting, Mr. Henry Waxman, Senator from California, stated
that "tamper-resistance will give the public the assurance
that the product has, as best they can tell, not been
tampered with and they should feel comfortable to purchase
the product again. That's clearly what we must now do to
re-establish the confidence that we've had in the;past. It's
a goal I think all of us should be working toward.”

This statement was somewhat of an echoing of the two

important points Dr. Arthur Hayes, FDA Commissioner, made in
his statements:

1. We must now do something to prevent or deter will-
full tampering and at the same time make this
tampering evident to the consumer.

2. Our goal is to reassure the consumer of the

protection so that they can once again trust the
product.

APPENDIX C:

RAW DATA - TAMPER IDENTIFICATION TEST
AND CONSUMER PERCEPTION SURVEY

 

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C
fl’H—O'NMH—dNMInfiHMN’H'mNNH“IMHO-4nM‘NNMMHNMMNNMfiH'MN—OHN

u-ovmmvnmncv«ONNvvacvmnnnu—qmdwmnnmvunnunnnvvnvvacuum—cu:

nmmmnmvvnvnmvmvnvnmmvvvnmmmmnmvmv—tvnvnvvvamnvnNn

1200
1201
1202
1203
1204
1205
1206
1207
1209
1210
1211
1212
1213
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235
1236
1237
1238
1239
1240
1241
1243
1244
1245
1246
1247
1248
1249
1250

 

RAH DATA: Twat-RESISTANT PACKAGI” PILOT me

88! $80

88 89 810 811

87

S2 83 84 85

81

GN

GI

GK

1.0.“).

99

n I
l . 1 3 . c

9 ' ‘
u

, 7
HCHNNHNHGM'MNMMMMIDHCMCMMNMP‘MNHHCNHNNNNMNH

«No-4N.I‘flflflflflfl—OMNHNMNGO’I...’flnflflfiflv'fl.“fl.nfifl

I

NdNON—ONNNNANNdNNNNdNN—ONdH—OflfldOddMNNNNdNN—d

I

o

1
HM'fiMdMN“H.MNN.dHNMC—4.NH'°MQCN".HP‘INdNHHH

dHMHH—OMMMnCOO—4M.0-4QNHNHHMMHfi'MMN'N’HNNNNNmH
dddlflflcdflndvdflfldddfiflflfiCNHNMMHMHNN‘HHHHHNdH
HHNAHHMN—OInmHHNCHHHNHI-IOnHNNHMdNHdflwfldflddvnm
dHNHHa-ONNHU“CHMNHdeN.NNNHMNMHNNNHN—IHNflHI-Oflfl

III—O'HfldnfldIfl'fiNMHHHHHIflNV'NNN'N'dCNNHHflHNNNU‘D

dd—llflfldfiflfl'HMHNMHHNNI‘N'HHNMHGNNMHflHHNNm—IHH

HMdfl'fl—OMMNNMNMMHNNN'MNCCNNHNHN'M'HHV'm'mm

MdddfidflQMAHHHNCHHNNONddmNOMNNHNdenHHNHHH
HHHHddNHMdMHNANHHANNNOQNANMNNAMHNAMHNmflNH
CH"ddfin.’HHNAH'NHNNHNHAAHNNGMN'HNHNfiNNNAd
vmnndvnnnNanvvwnnnvnunannnvnnnflnuménnnnmm
vnvnvgvvnvnnmnfidvvvnmvnvmvvvmnvnvmnnnnnnm

. . .
«vnvmmnnauvdmnnmnuvdnvnnnmnnvvnnuvnnnnnvn
mvvvvmvnmanavmavnnvnmomflmununvvmvmmmnmnmm
mdflflvdmdddddNCNmMNNAHVMOfiNHHM'NmNMHMNdCO.'
nnnnnnnvflvnavnnmvnnnnonnnndnunvnwnmmnnnvm

mvnmnnvnvnmflmmnnvmnmmnmdnflnvvuvmnmnmnmmmv

dNH'WOU‘O’O-ONM'tflwhO3~NflVlflOFOG°ANfi'WFOOO-‘Ffl|fl
mmmmmmmmmowcoooooowhhfihhhhhhcoocoomomaaom
NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN
H—Odd—tdHAHHHHHHHHHHH—‘HHHHHdHHHHHdHHHHH—IH‘H

 

RAH DATA: TAIPEI-RESISTANT PACKAGIN P1110!I 1'88?

88! ”KC

82 83 84 85 86 87 88 89 810 811

GP 81

GN

GI

GK

1.0.30.

99

l 1 2 ' '

. ' :
MCGNNMNMGH’MNMMMMIIM.M'MMNMMMNHM'NMNNNNMNH

a

«Ndnvnnnnnnm—cnununflnnouovmnnmnuvvnomnomno
: A _
NHNfiN—ONNNNHNNANNNNdNNHNdHHNN—OOdHHNNNNHNN—II
l
1

0-4".flMdHNflH'MNN'flHNM.H’NHCOMCQN.‘QHMNHNHHH

dflddddMMMOCN—OM'H'NMNHMHMHI‘O'HMN'N'dNNNN“Inc-4
”HHmNOHNMH'HNHHHHo-tflnfl.NHNMHHMHNN‘HHHHHNO‘H
ddflddflnfldmlfldo—ON.dHHNHflONHNNHM—‘NMHH-HdddflCHI!
ddNHflHNN-dm'HHNNHHHN'NNNMMNMMNNNHNd—CNdH—QNH

HAdIflH-flMNN'HHMNHHFflNNON.HMNMMMNNMHMHHNNU‘I‘HH
Hddm'fldMMNNMNdeNNN'MN'QNNHNHN'H'flH'Cfl'iflIfl
"—4—4'40-40-4HC”0-40-40-40-4NCO-404NN'NddI‘N'MNNHéHNHHHHNHHH
“HHHHHNH99HMHNHNHdHNNNOCNdNndNa-‘MdfldMHNU‘HNH
'deHdfifi'dHN—OH.NdNNMNHd—OdNNMHN'HNHNnNNNHfl

'fiMMHCMMMNdM'CN“MM'MAMNHHH'MmmNMHm—Onfifllfliflm

“C'V'mCHlflHHN'mN'HGCNU‘OIflNnNMNN"Ifl'NlfllflMlflfimlfl

IfldNH'dfldHfldHN'NfiflNNo-OH’MQ“Na-4'4”.NIBNMHMNI-l"G

nnnnnnnvwon—avnn':Invnnmnonnmn—cnnnvnflnmmnunvm

:nvnmunvnvnnflnmnnvmnmnnm—cnunvvuvhnmnmnmnmv

dNM'GOFOOO—ONH'U‘OFCOHNHCU‘VBFQOOHNMCOFQOO-‘nlfl
mmmmmmmmmwwocoouomwhhhhhhhhhcoocmoacomo~c~o
NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN
Hd—O—OH—ld—(Hd—OHHH—OAHHHH—OHHHHHHHHHHHHHHHHAda-4H

1

 

KAI DATA: TAIPIK KKSISTAI? PACKAGIIG 808VIY

010 011 012 012A 013 014 015 016 017 018 019

05¢” W 0"”

01 02 03 04

1.0.
.-..

- u u '
88:88:522326858
aaagagiggzgaaza
mum mmmoomzmmmm

- 1 q

3

4 Ifll8lm8

dHNNN—OHHHHHNNdo-IMH

'NANAANANNNNNHAAHN

nuconuoocnnnudopo

dHNNdHNNNd—Odddflflc

.F'nFUUNFfl'UFflnfl.

ananuuuanuaéuunau

FMCH’IflflMUGFNUUi'I-io

FH'nCOHHU’NFNUFnH'

.h'l‘CBnNmCflNFMmFfl

dNNMM—‘HNMMN—INNNMM

FF'FnFFFFV‘MmOmFF

OOOOOQOOO-‘OOOCOOO

I

NNNNNNNNNHNNNNNNN

bhdhmhdhhnohhvosh

FFMFFFFUFFOFFFFBF

UFNFFOFUFVOFFUIUFF

thhhthhnhhhhhhh

o

hhnhohhohnhhhhbhh

hhhhhhhohehhbhonh

uhhbuhbbovhhhhhhh

Fhfin'hhtflhiflflhhwwflw

hhhhvhhmhnvhoomhh

UGFCUOU‘WOONOC‘UIIDUO

NN'C'HNNMNMMNMMMN

OHNn'flOFOOO—ONM'
vnmmmmmmmmwooow
”MMMMMMMMMMMMMM
HHHFOHHHHHHHHHHH

1365
1366

100

APPENDIX D:
HISTOGRAMS - TAMPER IDENTIFICATION TEST

101
Item Identification: Control Sample 2572-Membrane Seal

Question: "Having observed this package, do you think
it has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40
33
31
30 27
2O
14
IO 7
Average Numerical " 2 3 4' 5
Response: 2.03 NUMERICAL RESPONSE

'Item Identification: Tampered Sample 5021-Membrane Seal

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 9
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER 0F 40
RESPONSES
30 26
22
IO 7

 

. I 2 3 4 5
Average Numerical
Response: 2.52 NUMERICAL RESPONSE

102
Item Identification: Control Sample 3190-Perf.Shrink Band

Question: "Having observed this_package, do you think
it has been tampered with?"

1 2 3 u 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40
30 28 27
20 22
2O
13
10
Average Numerical I 2 3 4 5
Response: 2.68 NUMERICAL RESPONSE

.Item Identification: Tampered Sample2494--Perf.Shrink Band

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER 0F 40
RESPONSES
3O 26
22
20 17 16

IO

 

   

A . I 2 13 4 5
Average Numerical
Response: 2.52 NUMERICAL RESPONSE

103

Item Identification: Control Sample 9034-Paper Overwrap

 

Question: "Having observed this package, do you think
it has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40
3O
20
‘ 12
IO .
4 2
Average Numerical I 2 3 4 5
Response: 1,83 NUMERICAL RESPONSE

'Item Identification: Tampered Sample 9069—Paper Overwrap

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

5° 46
NUMBER OF 40
RESPONSES
3O 26
20 I 8
14
IO

 

. I 2 3 4 5
Average Numerical
Response: 2.07 NUMERICAL RESPONSE

104

Item Identification: Control Sample 67lS-Breakaway Ring

Question: "Having observed this package, do you think
it has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF 39
RESPONSES 40
3O
23
20
12
IO 9 6
Average Numerical 1 2 3 4 5
Response: 2.10 NUMERICAL RESPONSE

Item Identification: Tampered Samp192826.-Breakaway Ring

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

so 44
NUMBER OF 40
RESPONSES
30
19
2° 15 15 16
IO

 

. I 2 3 4 5
Average Numer1cal
ReSponse: 3,47 NUMERICAL RESPONSE

105

Item Ident1fication: Control Sample 286l— Shrink Band

Question: "Having observed this_package, do you think
it has been tampered

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF 42
RESPONSES 40
32
3O
20
IO '7 6
3
Average Numerical ‘ 2 3 4 5
Response: 1.87 NUMERICAL RESPONSE

Item Identification: Tampered Sample1980-Shrink Band

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
No NOT LIKELY DON'T KNOW MOST LIKELY YES
63
so
NUMBER OF 40
RESPONSES
30 27
20
13
IO

I 4

. I 2 3 4 5
Average Numerical
Response: 1.67 NUMERICAL RESPONSE

 

106
Item Identification: Control Sample 3492-Plastic Overwrap

Question: "Having observed this PaCRage' do you think
it has been tampered w1th?"
1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

54
50
NUMBER OF 39
RESPONSES 40
3O
20
IO 1°
3 4
Average Numerical 1 2 3 4 5
Response: 1.76 NUMERICAL RESPONSE

Item Identification: Tampered Sample 9265 —Plastic Overwrap

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50

NUMBER OF 40
RESPONSES 3]
25

20 18

30

IO 8 7

 

. I 2 3 4 5
Average Numerical
Response: 2 , L: 5 NUMERICAL RESPONSE

 

107
Item Identification: Control Sample 5634-Membrane Seal
QBEEIEQQ‘ "Having Observed this package, do you think
it has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40
3° 27
26 24
20
IO 9
3
Average Numerical 1 2 3 4 5
Response: 2.28 NUMERICAL RESPONSE

'Item Ident1fication: Tampered Sample3710-—Membrane Seal

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER OF 40
RESPONSES 34
3° 26 26
2o 13
IO 6

 

. I 2 3 4 5
Average Numer1cal
ReSponse: 2.56 NUMERICAL RESPONSE

108
Item Identificat1gg: Control Sample 8723- Glued End Box
Question: "Having observed this package, do you think
it has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40
34
30 24 26
2O 14
I2
IO
Average Numerical I 2 3 4 5
Response: 3.16 NUMERICAL RESPONSE

'Item Identification: Tampered Sample 4036- Glued End Box

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
No NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER OF 40
RESPONSES

30

24 25
20 2O
15
IO 6

 

I 2 3 4 5
Average Numerical
Response: 2.52 NUMERICAL RESPONSE

109
Item Iden§1fication: Control Sample5042 — Delamin.Tape
Question: "Having observed this package, do you think

it has been tampered with?"

1 2 3 t: 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40 35
3o 30
20
II
2
Average Numerical ' 2 3 4 5
Response: 2.44 NUMERICAL RESPONSE

.Item Igent1fication: Tampered Sample6251 - Delamin.Tape

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER OF 40
RESPONSES 33
30 3'
25
20 13
IO

3

 

. I 2 3 4 5
Average Numerical
Response: 2.34 NUMERICAL RESPONSE

TAMPER IDENTIFICATION STUDY
Item Identification: Control Sample 4765- PlaS- Overwrap

 

Question: "Having observed this package, do you think
it has been tampered with?"

 

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES
54

50
NUMBER OF
RESPONSES 40
30
26
20
IO 7
I I
Average Numerical ' 2 3 4 5
Response: 1.42 NUMERICAL RESPONSE

Item Identification: TaMpered Sample1AZ9-— p133, Overwrap

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

54
50
NUMBER OF 40
RESPONSES
30 28
20
II II
IO 6
. I 2 13 4 5
Average Numerical
Response: 1,97 NUMERICAL RESPONSE

110

111

Item Identification: Control Sample'8278-Tape Seal

Question: "Having observed this_package, do you think
it has been tampered with?"

1 2 3 a
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

 

50
NUMBER OF
RESPONSES 40 39
33
3O
2O
13 15
IO ‘ 9
Average Numerical ' 2 3 4 5
Response: 2.26 NUMERICAL RESPONSE

Item Identification: Tampered Sample 4082 - Tape Seal

Question: "Having observed this package, do you think it
has been tampered with?"

1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

50
NUMBER OF 40
RESPONSES 35
20
:4
IO 6

5

 

. I 2 3 4 5
Average Numerical
Response: 2.12 NUMERICAL RESPONSE

APPENDIX E :
STATISTICAL COMPUTATIONS - TAMPER IDENTIFICATION TEST

112
Control Sample NuMber: #2572
Tampered Samp1e Numberw:#5021

Tamper-Resistant Package Type: Membrane Seal

OBSERVED RESPONSES:

 

 

 

 

 

1 _ 2 3 g 4 _ 5 Row Total
Control 33 J 31 I 27 l 14 7 110
Tampered 22 I 26 I 17 “1 16 I 7 I 88
Column Total 12 I 573 44 1 30 J_ 14 1 198

EXPECTED RESPONSES:

 

 

11L - 2 , _31 _ 4 - 5
Control 2 31 67 24.44 16.67 7.78
Tampered 23111 W 25.33_ 19.56 _13-33 6.

TEST STATISTIC = 1.870

CRITICAL VALUE ($1.34) = 9.488

 

[ACCEPT HO]

 

RESPONSE PERCENTAGES:

\o-I-‘M
2:1:

Confiol 2 2.3
Tampered 25.0

F__J
mun
—r—-I
huv

:1—4.

113

Control Sample Number: #3190
Tamered Sample Number: #2494

Tamper-Resistant Package Tme: Vert. Perf- Shrink Band

OBSERVED RESPONSES:

 

 

 

 

 

 

 

 

 

 

 

 

 

1 _ 2 3 f 14' _ 5 Row Total
Control 28 I 27 I 20 I_22 I 13 I 110
Tamgered 722 [—25 I IT I 16 I 7 I ~83
Column Total 50 I 53 j 37 1‘32? L20 I 198
EXPECTED RESPONSES:

1, _ 2 _ 3 _ 4 _ .
Control 27.73 I 29.44I 20.56I 21.11I11.11I
Tampered 72.22 [23.56flo.44]“16.89I878©]

TEST STATISTIC = 1.300
CRITICAL VALUE (fljn4) = 9.488

lACCEPT Hg]
RESPONSE PERCENTAGES:

1 2 , .3 4 5
Control 25.5 I 24.5 I18.2 I 20.0 I 11.8
Tampered 25.0_L2_9.5 I 15.5 ]_ 13.7] 7.9:

 

114

Control Sample Number: #9034
Tampered Sample Number: #9069

Tamper-Resistant Packagg Type: Paper Overwrap

OBSERVED RESPONSES:

 

 

 

1 _ 2 3 , 4 _ 5 Row Total
Control 35 I 33 I 12 r 4 I 2 86
Tampered 2:6 | 26 I 18— I 14 I 4 I 108 _
Column Total 11 I 39 f 30 ]_ 187 j_ 6 T 19?

 

EXPECTED RESPONSES:

 

Control 35. 91 1I262. lSj 13. J3oI 7. #9772. 5661
{Lampered 45.091371351711170 no. 0213. 341

TEST STATISTIC = 7.337
CRITICAL VALUE (7.2.34) = 9.488

BCCEPTiO-I

RESPONSE PERCENTAGES:

 

 

 

1 7 2 .3 4 5
Control 40.7 I 38.4 L13.95T 4.7 I 2.3
Tampered 42.64 24.1—I 16.7 ]_ E0 I 3.7

 

115

Control Sample Number: #6715

Tampered SamLIe Number: #2826

Tam er-Resistant Package M‘ Metal Breakaway Ring Cap

 

OBSERVED RESPONSES :

 

 

 

 

 

 

 

 

 

 

 

 

 

1 _ 2 3 4 _ 5 Row Total
Control 39 I 23 TI 12 [19 I12] 1:373
Tampered 15 19 l.) 6
Column Total 54‘ 1 742 “1 27‘ J ‘25—'1 *50 I‘ 198 _::
EXPECTED RESPONSES:

1 p 2 - 3 _ -
Control 24.27 I 18.88I 12.14I 11.24I22.47I
Tampered 29.73 I 23.12] 14.86] 13.76127.53I

TEST STATISTIC = 40.61
CRITICAL VALUE (7664) = 9.488
[REJECT Ho]
RESPONSE PERCENTAGES:
___l_ 2 3 4 - 5

Control 43.8 I 25.8 L135 IlO.11I 6.7
Tampered 13.76_I_17.4'I 13.8’] I§}7‘| 40.4__

 

116
Control Sample Number: #2861
Tampered Sample Number: #1930

Tamper-Resistant Package Type: Dist. Design Shrink Band

OBSERVED RESPONSES:

 

 

 

 

1 _ 2 7 3 4 _ J5 ROW'Total
antrol 42 I 32 I 7 L 6 I 3 90
Tampered 63 I 27 I 13— I 1 I 4 I 108
Column Total 105 I 59 j 2(T I 7fi I 7 T 19?

EXPECTED RESPONSES:

 

 

 

Control 47. 73 1I26. 82I 9. 3O9I 3. “MI-3. 518I
Tampered 57.27 J32 18_I_ 10.91] 3. STI3 82I
TEST STATISTIC = 8.574

CRITICAL VALUE (735.4) = 9.488

LACCEPT H OI

RESPONSE PERCENTAGES:

 

 

 

1 2 - 5
Control 46.7 I 35.6_I 7.8 I 6.7 I 3.3
Tamed 58.34 25.0] 12.0 1 #93] 3.;

 

117

Control Sample Number: #3492
Tampered Sample Number: :#9265

Tamper-Resistant Package Type: Clear Plastic Overwrap

OBSERVED RESPONSES:

 

 

 

1 _ 2 3 _ 4 Row Total
Control 54 _J 39 I 10 I3 _I 54I*110
Tampered 25 J 31 I 8 I 13 I 7:] 789D

 

Column Total 29 7] 70 .J 18 I 21 1__111 199

EXPECTED RESPONSES:

 

 

1 ___2 - _3 _ 4 - ,
Control 43.67 I 38.69] 9.95I 11.61I6.08I
Tampered 35133 I31.31J 8.05] 9.39]_4.92I

 

TEST STATISTIC = 21.31

CRITICAL VALUE (11,4) = 9.488

 

IREJECT H oI

 

RESPONSE PERCENTAGES:

2
Control iI 35
Tampered1_L_334%

118

Control Sample Number: #5634
Tampered Samgle Number: #3710

Tamper-Resistant Package Type: Styrene Membrane Seal

OBSERVED RESPONSES:

 

 

 

1 _ 2 3 1 4 _ 5 Row Total
Control 26 _J 27 I 24_¥ 9 I 3 89 Ifi_
hampered 26 l 26 J 34— l 18 I 6 l 110
Column Total 52 l 153 '1 58 I__27 I. 9 I‘ 199

 

EXPECTED RESPONSES:

 

 

 

1 _ 2 A J _ _ _

Control 23.26 I23.70I 25.94I12.08I4.03I

Tampered 28.74 I 29.30 [—32.06] 14.92I4.97I
TEST STATISTIC = 3.575

CRITICAL VALUE (13.34) = 9.488

IACCEPT H o I

RESPONSE PERCENTAGES:

 

1 I 2 3

Control 29.20 I 30.30I 27.0 I10.10I 6.70
Tampered 23.604136“ 31.0] 16.4 I5.50_

119

Control Sample Ngmbeg: #8723
Tampered SampTe Number: #4036

Tamper-Resistant Package Type: Glued End Box

OBSERVED RESPONSES :

 

 

 

1 _ 2 3 , 4 _ 5 Row Total
Control 12 I 24 I 26 I 34 I114 110
Lampered 24 I 25 L20 I 15 I 6 I 89
Column Total 36 I 49 —I 36 J 49 I 20 I 199

 

EXPECTED RESPONSES:

 

 

 

1 2 3 _ 4
Control 19. 9 I27. 09] 25. 43 I 27.09—111.II
Tampered 151 J ”91! 20.57 I21. 91 I8. 94I_
TEST STATISTIC = 10 . 366

CRITICAL VALUE ( :54) = 9. 488

 

IREJECT H OI

 

RESPONSE PERCENTAGES :

1

Control 10. 9 I 21. 278i23 6 I3“ 3.0 9
Tampered 27. 0 478.1] 22. 5 _ ]1E9

 

I127
I6.f

120

Control Sample Nmeegfl ‘#5042

Tampered Sample Numberw‘#6251

Tamper-Resistant Package Type: IDelaminating Tape Seal

OBSERVED RESPONSES:

 

 

 

 

1 _ 2 3 4 45 Row Total
Qpntrol g; I 30 I 11kIfi11 I 2 89
Egmpered I 31 I 23— I 18 I 3 I 110 E__
Column Total 68 I 61 ‘I 36 J 29 I 5 I 199 l.

EXPECTED RESPONSES:

 

 

 

1 - 2 - _3 _ 4 - 5 .

Control 30.41 I27.28 I 16.10I 12.97—I2.24I

Tampered 3739 I33.7TJ 19.90fl6.0TIZ.7E]
TEST STATISTIC = 5.950

CRITICAL VALUE (2’25” = 9.488

ECCEPT H o I

RESPONSE PERCENTAGES:

 

 

 

 

___1 f 2 .3 - .5
Control 39.3 I 33.7_I_12.4 I12.4 I 2.2
Tampered 30.0_I 28.2—I 22.7—I lgpé I 2.1

121

Control Sample Ngmgeg: -#4765

Tampered Sample Number: #1429

TamperaResistant Package Type: Clear Plastic Shrink Overwrap

OBSERVED RESPONSES:

 

 

 

1 _ 2 3 - 1: Row Total
Control 54 I 26 I 7__I 1 l 5I 89
Tampered 54 I 28 I 11 I 11 6 I 110'fi_
Column Total 108 I 54 DI 18 I 12 I 74] 199

 

EXPECTED RESPONSES:

 

 

 

 

 

 

 

 

 

. - _3 _ 4 _5
Control $1; IT4.15 I 8. 05I 5. 37 3.13
Tampered I29. 85 _ 9. 95I 6. 63I_3.87I

TEST STATISTIC = 10.778
CRITICAL VALUE (13.4) = 9.488
IREJECT HOI
RESPONSE PERCENTAGES:
1 f 2 .3 4 _ 5
antrol 60.7 I29.2 I 7.9 I 1.1 I 1.1
Tampered 49.0_?125.5 _I 10.07] I§}O l 5.5

 

'122
Qontrol Sample Numggg: #8278

Tempered Sample Number: #4082

Tamper-Resistant Package Type: Tape Seal

OBSERVED RESPONSES:

 

 

 

1 _ 2 3 7 4 _ 5 Row Total
Control 39 J 33 T 13 I 15 I 9 109
Tampered 35 I 30 I F I 14 I 5 I 90
Column Total 24 l _83 ‘1 19 _l 29 _I 14 1‘ 199

 

EXPECTED RESPONSES :

1

 

 

 

_ _3 _ 4 - 5 _

Control 40.33 I842. 51I 10.41.I15 88I7. 67I

Tampered 33 47 I28 49I 8. 59T13. 11l6. 33I
TEST STATISTIC = 2.318

CRITICAL VALUE (1’1“) = 9.488

I ACCEPT g

RESPONSE PERCENTAGES:

 

 

Control 3
Tampered 3

APPENDIX F
HISTOGRAMS - CONSUMER PERCEPTION SURVEY

123
CONSUMER PERCEPTION SURVEY
Group Identification: K 4 SHRINK BANDS

Question: "How do you rate this group of tamper-resistant

 

 

packages?"
81
Responses: 1 2 3 5
BAD GOOD
53
SO
42
NUMBER OF 40
RESPONSES
30
20
14
IO ‘0
Average Numerical I 2 3 4 5

Response: 3.905
NUMERICAL RESPONSE

Group Identification: V - WRAPS
Question: "How do you rate this group of tamper-resistant

 

 

packages?"
1 2 3 4 5
Responses: BAD 56 56 GOOD
50 50
NUMBER OF 40
RESPONSES
30
22
2O
15
10
Average Numerical I I 2 3 4 5

Response: 3.52 NUMERICAL RESPONSE

124

Group Identification: I - GLUED END BOXES

Question: "How do you rate this group of tamper-resistant

 

 

 

packages?"
1 2 3 4 5
Responses: BAD 5357 GOOD
50 46
NUMBER OF 40
RESPONSES
30 23
2O 15
10
Average Numerical 1 2 3 4 5
ReSponse= 2~47 NUMERICAL RESPONSES

Group Identification: N - Breakaway Caps

Question: "How do you rate this group Of tamper-resistant

 

packages?"
1 2 3 4 5
Responses: BAD 5] 57 GOOD
50 ‘
41

NUMBER OF 40 38

RESPONSES
30
20

11
10
Average Numerical I 2 3 4 5

Response: 3.53 NUMERICAL RESPONSES

125

Group Identification: R - TAPE SEALS

Question: "How do you rate this group of tamper-resistant
packages?"

1 2 3 4 5
Responses: BAD 6‘ GOOD

50
44 46

NUMBER OF 40
RESPONSES

3O 27

IO

 

Average Numerical

Response: 3.08 I 2 3 4 5

NUMERICAL RESPONSES

Groupgldentification: F - Blister Packs

Question: "How do you rate this group of tamper-resistant

 

 

packages?" 92
1 2 3 4 5
Responses: BAD 58 GOOD
50
NUMBER OF 40
RESPONSES
3O
23
20 I
5 12
10
Average Numerical I 1 2 3 4 5

Response8 “-0 NUMERICAL RESPONSES

126

Gropp Identification: T - MEMBRANE SEALS

Question: "How do you rate this group Of tamper—resistant

 

 

packages?"
1 2 3 4 5
Responses: BAD 57 GOOD
50
NUMBER OF 40 4° 36 38
RESPONSES
3o 29
2O
10
Average Numerical I 1 2 3 4 5

Response: 3-02 NUMERICAL RESPONSES

APPENDIX G:
RAW DATA - ATTITUDE SURVEY

CHMNflWB

IAN DATA! TAIPII RESISTANT PACKAGING SURVIY

0‘ 05 0‘ 07 0. 09 010 011 012 012A 013 01‘ 015 016 011 01. 019 020 020A 8! AG ID

01 02 03

 

1.0.

127

I II‘ ‘ I
~82IIIO IISU I IIIII 8' SI I 8 I II I0 I
=¥§§§98¥§*‘38§ fififififisaaa§SE¥SE§EEE§§E¥§§§i§§gsass8 8
E§§§§§EKEE§E§§n§§82§§22§§§922§§§§§o§E§§g§§=2m$§33§sg
asESEE23353223133239252.:8§32835:2:Pasgssagsggagagéé

‘ - g u .

I
I

NNNNNNNNNNNNNNN‘NNNNNNNNNNNNNNNNNNNNNNHHHNHHI-CNH-ONNNNFO

- O

NHdNO—(NOMOMINNONdUHOOMOHNOMHMMNOCfIQNNOMM.“HF‘HCNOOCOOO

Hid—OHNHHNHflHNH—INHHH—INNHNHHHIGH—OddNHNHHNHHHHHNdeNNN—Idfl

FOO-0NddHflHHHHfl—QHN-F‘H—O—iNNNdHHHHHHHNHH—OHHHNHNHHNOF‘HHH—INNN

mfiNflFFOU‘U'I—‘nh—C'“FOMHFI‘IM..IMFIom'hn’hflndn“NMI'UIIFHH

IONU‘FF'MIBF.OBCFHMU‘DF“'HFIFICIHFHIIVFICFFFF.fiNMUHfiflOFd—l

F'N'FFFFUFCB“FF‘“FINUFFII'IMFm—IFIHIFHOFFF.FMHINIDU‘HFF
MNNNMNMMVein—0C'NMMMMMNNMMNMNNMMHMMu-‘MMNMCI-OMNMHH'NNMM—tfl

FCmNhFMhhfihEFF5NmhhhmflfihhfihUhhmFOdhfidhfihCNGOMOdhOMd'

&.

I

NNNNNNN—QNHNHNNNNNNHNNNNNNNNNNHNNNN'INNNNNNNNNNNNHNNNN

I
.
' I

. g . ' .

hunmhhyhhhhhbhhvhhhhuhhhhhhnhhhhhdhhuhhhh«unhhdhhudu

FFthhhfiFFFhhhh'hFFFFBFFBFUFFFmFFFFfiFFhfiflhhflfihhOFmFB
I .

t O .
.

I

Pb"'1thFFFFFFFFUFF.FFFFFFFFNFINPFFFFFIFHMOBCIFFUFIFF

hfihnhhhhfishhhhhonfiohhhphhhhhhhhhhhhhhhhhhnhoohhuhhhh

shhhhuhhnhhhhhhvmhkhhhhhhhuunhhdhdhhurrahhhuohhohhhh

o

hphhhHhhhhhhhproshhhhhhobhhhhhhhhdhhhhsasshuohhshhhp
_ I
FFFFFBFFFFFFFFF.Fhn’FFFOFOOFFFFFFFFFFFFFFFOUIFFBBFFO

F0“OFh.BFPFFOFFUFFOFBDFDFNFFFFFFONFQFMBFCOUNBmCDOdGO
buoohhhhhhhhabhorhuhhhhhhhhhbhhhohhhhnhhnnouhhuhhnnh
oovnoooovmnvoovvwouooonoooonooowooonoonvvovmwaoomvvo

.NNNHHU‘INHMM'MNHCQNMIHMMIICNNHHMMNNNMMMMNMNF‘F‘NNNMNMHM

OHMCGIFIOO—‘NMCIIFIOOdflfifilflUFIOO-ONH'IOFIOOHNH'IDOFIQO—‘N
OOOOOOOOOddHH—O—I—OHHHNNNNNNNNNNMMMMMMMHMM'QCCCCOfi'vmmu‘
OOOOOOOOOOOOOOOIOOOOOOOOOOOOOOOOOOOOGOOOOOOOOOOOOOOO
Fido-CHHHHHHHHHHHHHHPia-1HHH—OHHHHHHHHHHHHHHHHHHMHHdHHdH—tH—fi

"IAG UDCHMNNWI
-_

020A

0”

RA" DASAx TAMPER RESISTANT PACKAGING SURVEY
mum-nun.-.-

01 02 03 04 05 06 07 0. 09 010 011 012 012A 013 010 015 01‘ 011 '01. 019

 

1.0.

128

-I

...3.

8% 3 8388848 .833885 8. 38 83828888 88 8 =§8
E 8’28882822232 gaizsagssgamszaasgss22222;: E 3‘:
I3 iguagi’mgmmm I. ”20:01:08 g: game: MOWIOMMfia I 60:
I O; 2\ 2 >IZIu-IZ\ IO Emma-1‘46: 22 253 2:1: I I
5\zm\ mum—1 Sqaoqziammgzg 32H 555%4434 Sazmzazgrs
isaassaasaésascsssaga.ssséfissssssssassssssss2:288;
' _; I I . .3 ‘

HAHN—0H.MMN”0404deHHHHflHdHHHflHHHHHM—‘Hdrill-OddHNHMHMHNHH

‘
‘

ONdNU—OHHMMM—lMONNU—IMNMHOdIfiO—i.d~.d¢dd’.‘F‘OM'OOMONMO

“Flu-4HHHHHHH'HHHNHHHHHHHHNF‘NHF‘HHNdHr‘No-O—OHHHHNflHNNfiNada-ON

nvvnnmvnmmmonououvnvununnnmnvmvvuvnnnvehflnvvnonono

"I'd—C‘F..NFFIIMFNIMCIHU.UHCI'VNI'MIOOIIIIUN'.Im‘u‘.‘
'HNMMMNNNNNMNMF‘NNNNMMNMdeNNMNNfl—OMHMMNMHMN—iMNNNHNNN

“FFI’VFFIOFFFIIFFUNVCUOIIIFHIICI‘FOCCUIBICNIH'NNfim'

\

o

060°CDOC-4°OHHOO—OOOOOOOOOOOOdHOOdOONOO—IOOGOOOOOO00—00

-
:

NNNNNNNNNNHHdNo—ONNNNNNNNNNNdNNNN—ON—ONNHNNNNNNNNNNNNN

thhfwhhhflhhhhVIDOFOFFfiFIUFOFFF“FGFIFVFFFIFFFDODFI
unhhpnhhhchhhhnmhooonbhpnnhopuhthhosvhhpnhhhonoun
upshpmphpQhBBBBBFOFOFFShhhhhhhhh90hhhvhhhohhhuophn
ourbahhphhhhhdhhthhdhvhdhéhovvhhouhhnbhhhhhhhhuhh
UHFFFhhBFFFFFCF6FFFFHOFFUOUQOCFFFOFFNFFFthhhhhfihh
whhhhhhhhhfihhhhhhobhnovhnnhn§hhmaupowwhhhhhhhhohhh
nanodhhvhnonhunhanhhhvuvnhbomdnopnnnnnmhhvvnommmon
ashwho»mhvmhhvnhbmoshocmnhhnebnhhonhophhhmmmo~anon
minoonnévvooonmvmmownmémounvvvoovmvwomovmvoooonmao

M'IflOFQOOdNM‘IflWFIOO-‘NM‘U‘WFIOO—IN'U‘WI‘IOOdNM‘IflOFIC‘O—INM
mmmmmOIOIUOOOOOOWFFFFFFFFFFIOIIQQIIIOOOOOOU‘OOOOOOO
GOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOGOOOOO—‘d—d—o
HHHHHHHHHHHHHHHHHHI—fio-CHPOI-OHMHF.HHH—IHHHHHHHHH—IH—‘HHHHHHH

 

”mama:flmnmnuuflmnpmmmmsmnwn

01 02 03 04 05 06 07 OI 09 010 011 012 012A 013 01‘ 015 016 017 01. 019 020 020A 8! AB ID

CITY/STA?!

1.0.
I...

I
088588680868088335§ =5 8 88 . 8:3 . 38
.zzaasaazzazszzasasagig‘ggs E a: g US$95 g 863:
”Ooggxuxaxzpraxxuxxxgggs a a aw in 22 93::
:1"?*=~~~~ttsgst~=~~t\\815g3 g ~0 3 =35=22515512
.89888003333220082323322338982p 3: SSSESSSSSSSS

1JZ9

‘3

a4.

HOHNH—ONMMNOOOQ—OOMNNOIOMNH’NOOCF‘MNOCON'NIOONN—OHO046-0

MNHHF‘HHHAHNNNNI‘NHHHNNNddHHHNNNHHNNNNd—Odd"NH—ONIONadv-O

«woman's:m—camnnannvnvm—cnhwonnnvnmvananonvnunnononnn

.NdNHH—dddHNNNHHF‘HHHHHHHNHHHNHNF‘HHHHHNF‘HHF‘HNHHHal-flNH

HNFOU’M—O“UFFF'ICNIFFI'FIHIFH'I‘F.“HIIFU’FI'QOH'HOMFU‘
III-OFH.FUNDfi'dflFMnIFNIFFII‘IFIo-OIQF“FNUNIFOUF'NIOOMHN

N'F‘QFFFFFMANF‘IU‘IFFFFNAFFIUFIHONIFBNI‘FIFFFFFMM'I"FF

NNNNNNNNNOAANNNNANNHNdNNNNNNNdNHNHNdNNNNNANNNNNAN
«nuhuhonhbhn909~kbhonvhnhhnhhnhhhohvnhhhhhvhhovso

hushhhhmhhhhhhmonphhhdhfithhhhnhhhhunhhhpdnmpnvpn
dohnhhhabhhhhbnvvnhondhhhhhhChavnomdhhhhhnnnhvvhd
hwhhhhhmhhhfihhhhhhhhhhhhfihhhOFFFFFFFFFFFFCMmFFFFN

hhhhhhwmhhho~hnuhhhh§pnhhhpdhophhhuflbhvnhdhhphhpa
hhhhhhhuhhdwhb§mvhhhhhhthBFFOhvhhhhhhhohwhhhhhhh
hhhhovunfhsunbumhnhhhhhhhhunvhuhhhhhhhbhhhhhnhhha
unuvnpnoushnnnnnhhhhhduvhhnnhnhbhhhuvhomhdhnmhhhv
onhhnwhnnhonvobhhhhhhhvohhnvhnhhhhhhohonhdhnnhhhv

UIOOUOIW.DUOOOIIIUUIUNIUUI‘UUUUIIUIINUfimnOGIIDOU‘UO

0
MMMMCMM'NIMN'CMNNMMMMNNMM'MIINHNHMHNM'CN'HCMMMNMM

1104
1110
1119.
1121
1122
1123
1141
1142
1143
1144
1145
1146
1141
1140
1149
1150
1151
1152
1153
1154
1155.
1156
1151
1150
1159
1160
1161
1162
1163
1164
1165
1166
1161
1160
1169
1110
1111
1112
1113
1114
1115
1116
1111
1110
1119
1100
1101
1102

:n
O
v-O
H

 

”mama:unnamuummrmmnmmzwmmr

01 02 03 04 05 06 07 08 09 010 011 012 012A 013 014 015 016 017 018 019 020 0208 8! IQ ID CITY/STAR!

a

1.0.
m-

130

; i
a u I 0' u a

:20 3 g g u a i" an a as as: gas 3 23:? a!

$1302 6030122202.§202§5’323 2§§§3figgsaaaaggat§agia§

2§5356230333asizigaiggg§gzzugsagaigqi3EEEEBE§535§§E

§0§§§§§53230EE£E§2§§§§§E§§§§§280235233§§§EEEEESEES:

1

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NfiUC‘Co-ON."H“I!'04“0'4""..HNHHHHHHNMQNGMN.MMMNNNNCNMN."
. . 1

,5

mnddaoGHOH—OHONdOdOMNd'NNMONHOdHCMOHNNHMNa-dHNC'HHOOON

94—44-40-4NN—OHHH0'40'4“3'4dNHNHde‘HO-OHHHHNNHHHNdHHHH-flflH.4-4N0-44-4N0-4r-4—4

“FI‘MF—INNU.CvOFfilflNO“an"..ndnflnflfl'hhahd'oU'UflvaUFONN

“F.OdHfiUOCfl'UnnflF—O'mnNUn.FDn¢IUN—4“FCF'I-‘UI‘C004'. “I‘FN—O
“FOUddeU‘CGF'FH F.“MO'B'FU\.00NCOF'F‘F¢U§U§VIflhUOdfl'F'1‘
MMNNNMNNNVNHMHMNdMMHMMMN—OdfiflflflnnM'MNMNNNHM'MMNMNMMN

hhhhdh'mOFQONUFthmthonhHhhflhhhhhflhhhDBCBFm'mhhhfih

NOOOOOOOdHOOOOOOOO—lOOOOMHHI‘OHHOOOOOOHOOOGHOOONHOOOO

u

dNNNNNNNNdNNNNNNNNNNNNNNdNNNNNNNNNNAANNNNHHNNNANNdN
FBBBOhflmhhfiflhhhBFPFFFFFOFHMBOFFFFDFFDBOCmFFOGQHFFhN

hhhhdhhhhhnhhthNthbrushhhhhhfihhhhhhhhhohhhnhhohhh
fibhhdhfihhhhth.flfimfihhhmhhhhfihFFBODthhFhflhhflhhh'hhh
hhhhdhhhhhhohhhuhhbhhhnhhdhhhhhhhhhhhhhhohhhohvhhhh
UFFFHFDFFVFFFOHUdFOFFFFGFFBMUFFFFFUOFnMBOFFFFFCMFFh
OFFFOFFFFFDFFFFFFFFFFFFBNHBnhhh'whwfihhMFOthhthhwh
UFVN'FFFFBhnhfihhdhhEFFOFOFFOhhhhhh'OhFfiFflOhfiflhhnhdh
hhnnhhvnhhhohhhnFAQNFOFOFhvohhhoshbhhwhhvhhfmhhposh
hankhfiflopshahhoohvvhuohonhhnhhhhhhbhhhhhvbhvmhhuvvh
mmvwoommwomoooouoonvnoovvvvoooooowownooonwmomwwMove

MMMMHOMMNMNCMMGFIMNNNMMCNMMNC..MMHN'NMNMMMCMMMMMMMMM

1183
1185
1186
1187
1188
1189
1191
1192
1193

C
9
iii
0'4

1194
1195
1196
1197
1198
1199
1200
1201
1202
1222
1223
1224
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1236
1237
1239
1240
1241
1242
1243
1244
1245
1246
1247
1248
1249
1250
1251
1252
1253
1254
1255

 

0

RAH DATA: TAMPER RESISTANT PACKAGING SURVEY

01 02 03 04 05 06 07 08 09 010 011 012 012A 013 014 015 016 017 018 019 020 020A 8! AG ID

CHMNflWB

1.0.
..-

131

00 ' ' . I! U

a: 00 a a a 0" °0 0=~
3§§3m38855535583555833355§§<8§§833 §2§2§§3af§0§§2¥§
. :53;3333*?i‘2‘3‘3???39’gagigg’3066gzg§§§igéimgg§a
H U! U: 51 m m 2 0-4
03EE2%33353§§§§§3§33333§§a§§5=355§§Eaéséééssigésazi

Una-49".I-4I'I“-4“N'N—II‘U’U’NN.H'HF‘HH'NCNNMHHNHH-‘HddHH—ONNM—OH

CHONNNHflflddd—Odddfld“Nd—ONNNNNNNNdNNdHHdNNNNNNNNN—ON“Na-4

"MNANHHNHdNOOMCOflNNOOOOHHHOHCOdHN°.HMONCNMflHa-4HCFOdado-4

0-4'49-40-40-4'4dado-404d"HAHN-4'4ANNNNHdHNHNNddHNOdHNHHo-fldHaida-40104FOO-4'4

dFCMHMdfiOCQnC“GGNGO‘CNNFUOGflfl'OIflnOU..fiFNfiOOflflMMN03"

.HHNOH"Haiti—4HCHNHflHHflNNNHNHHMHNOflo-lflflNdHHfiHHHflH—IHHdHo—O

“$0.45”.fiUIflUO'fi'FM'Uflfl'n.N.FfindCFMMH'flM'MM.630M75000F
“F.NNMv.flO.H.FONU\NOFFF4HFN.HCN'I\FFUIIIMOOanmFNNCMNFFN

CFUmNF"FFUNFFFNOMFFFFd—ihnfiFFNV'CFM..h'a-IUCIII’MM'MN[~56

hada—4FOFFOO—4040404NOOdOHOOOOOdOHOH—OHOOd—dGOdOOOONOOOOOO—QO

o

I
CdNNONC—ONNNNNNNNNNNNNNNNNN—OONNGNNNNNNNNNNNdNNNNN(Va-4N

NFU‘NHNOFUHFFFNN'FF’CHAFHUFFHfiNFNNFHh'dfiflUFUO'nnhfilfl

UnhnhhhfifihhhhFhfihhfihhhhfivmhhflVFFFOMFFFBFFOFBBOOFFUB

DUF.FFFFFFFFFBFBFFFFFFFFO.FBF.FHFNMFFOFDF'.IflMMFOFUI‘
O

conchhhhhhhhhhhhhh69hhhhhhhhhhhmhhnhhhhbhhnhbnhhbps
thdhhdhhflhhhfiFthfihhhhhdhhhvwnhhfihFFFFUFFFFUUFFFFB
shahvhhhhuhhphhhhhhhhhhhuhhhfihnhnhhhhuhhhhhhhhhhssh
hnhnhhhhhascouponnhhhhhhhoohhhvanohobnhmhosnnhhohhh

BF.FFFU\OOI~F'CFOHFF'OUFFFNU‘FFFOfiMFUnFFFBmFInM'VMNIflFFIh

vhuhhhoohhhhhwonhhhhhhhhnhhhnhonhonhhhhnhhhvnoumhho

0000vuoowoooooounmmmnoooonoovooooooovvvmvonnnuooomm

NNNMMQNMHM'.'NM—4MHM"MMCHMMNNHCNN'NMHMNMMHHHNMMMIflNN

UFOOO—INM.130FOOO—INM'U‘OBOOO—ONH'U‘U‘OFOOOANMCIBOFQQOHNVDF.
mmmWOOWOOOOOOOFFFFFFFFFFDODDQOQOQOQOOG¢$OO$QGQ°O¢V¢
NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNMHMMMM
deHHHHHHHHHHHAdv-OHFIHHHHHHHHHHHHHHHHHHHdHHHHHHo—IHHPIA—4

 

RAH DATA: TARPER RESISTANT PACKAGING SURVEY

01 02 03 04 05 06 07 08 09 010 011 012 012A 013 014 015 016 017 018 019 020 020A 81 AG ID CITY/STATS

1.0.
I...

131

'..—
up...

FLORIDA
4 B/LNS RICH '“

3 PRTNHLS RIC
4 PRTNHLS RIC
2 SAG RICH

3 BSTN RASS

2 BRRNHR RICH
2 ANARBR RICH
3 "RN RICH

3 HSLTT RICH

‘ .

4 HLND RICH
4 R/LHS RICH
2 LRS RICH
4 3300 RICH

' 4 B/LNS RICH"’
4 LRS RICH
4 DET RICH
4 HSLTT RICH
4 NONS
4 OKRS RICH
3 CRSHL RICH

‘3 GLDHN RICH
3 GLDHN RICH
2 HNLULU HA"
3 LNS RICH
4 OKRS RICH
0 OKRS RICH
4 B/LNS RICH
4 FLINT.RICH
4 LANSING.RIC

4 CHI ILL
4 I100 RICH
2 SAG RICH
4 SAG RICH
3 SAG RICH
2 SAG RICH
4 SAG RICH
3 SAG RICH
2 SAG RICH
2 SAG RICH
3 SAG RICH
1 SAG RICH
4 SAG RICH
2 SAG RICH
1 SAG RICH'
2 SAG RICH
3 SAG RICH
3 SAG RICH
2 SAG RICH
4 SAG RICH
1 SAG RICH

Una-4H.'dnRic-4U!“’NHI‘OI‘INN'M'Hdd—O'"CNNMflANHHHdeH—OdflflFlo-4H

CHONNNHNNdHHI-lHHHNI‘NNddNNNNNNNNHNNHHH—ONNNNNNNNNHN“Na-4

NMNHNMHNHHNOOMOOflNNOOOOflo-IHOFOOCHHNO'FIHGN'NMI‘AHHCIH04—4—4

deHdflH—OdddNNdNNflHHNNNNfldHNHNNHd—ONOHHNFIHHNHHAHHHOdo-4'4

.dHNUdNHHHHH'HNdHfldHNNNHNHHHHNO-fldfldNfldflfifldfldo-OHHH0-40-4—4

noovnnvnomooonvhnvuonvnuuthndvhnnnvnnvnno10090190006
“FUNNHV’“U'H'FONU‘FOFFflHFNCHCN’mFFmflflmUFflmflhNN'HNPEN

'FOU‘INFMRI"OdhhFNOMFFFFHHBMFFFN'Q'FMO'FV—IO.U‘I\MM'MNI‘Dh

FHOHFOhHOHAHHNOOHOHOOOOOHOHOHHHOOd-flGOdOOOONOOOOO04-00

I
OdNNONOHNNNNNNNNNNNNNNNNNNHONNHNNNNNNNNNNNMNNNNN(Va-ON

NFO'NdNOFOHI‘FFNN'FF'Vii—48".UFFHU’NI‘NNFHF'HWINOFUU'MMhl‘m

omhmhhhhhhhhfiFFBFFFFFFFFCmFFHVFFFVMhhhhhhflhhhmwhhwh

uufivhhhhhhhhhhhhhhhhbhhhnvhhhwhdhunhhnhhhvvnnnhohuh
I

owhenhhhhhbhhhphthhhhhhhhhhhhhnhhnhhhhhhhmhhnnhhhh
hmhdhhdfihflhhhhFOFFFFFFBFAFFB’OflFFFBFFDPUBFFFDOFFDFB
huh»cashhuhhhhhhhbhhhhhhahhhhhnhnhhhhflhhfihhhhhhhhhh
Fmhnhhhhhwh'QBFDF“FBFFBFBOCFFFCNnGFOFnF“FOFMMFFOFFF

FF'BFFH‘IOOFF'CF\OHFPVOUFFFNMFI‘meMFUH‘FFI‘F“901M"HNMFFOD

'FHFFFOOFFbfihfi'flhhfihhfihFMhFhMFUMFOmFthmhFF’mwflmhhw

cooovoooooooouo—cmmmmnouoommovooouuoovvvmvunnnoooomm

NNNHM'HMMM'.CNMdnHM'QMM'HMMNNM'NN'NMMMNHMMMNNMMMMNN

1256
1258
1259
1260
1261
1262
1263
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284
1285
1285
1286
1287
1288
1289
1290
1291
1292
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1346
1347
1348

p
m
N
F4

APPENDIX H:
PROCTOR INSTRUCTIONS FOR COMPLETION OF TESTING

 

PROCTOR INSTRUCTIONS - TAMPER IDENTIFICATION EXPERIMENT

Sample Presentation

 

Samples will be placed on a flat surface in an organized
manner. Be sure samples have been placed far enough apart
to allow participants access to the samples one at a time.
Each sample will be assigned a random number and a
corresponding information card will be displayed in front
of the sample. Make sure these cards are displayed with the
appropriate samples. The samples should be displayed in
good lighting. All sample settings should be maintained

in a similar manner to eliminate any bias.

NOTE: Be sure to remove and replace any sample that
becomes damaged through test participant handling. Do not

allow participants to pull, pluck, or damage samples.

Samples that require removal of a primary package or
closure system to display the systems "tamper-resistant
feature" must be presented adequately. Blisters will be
removed from their carton and displayed next to each
other. Caps over membrane seals will be removed and
placed next to the bottle. Other samples in this category

will be displayed similarly.

TEST PARTICIPANTS

 

Feel free to use any individual (test participant)

for this test that is not a member of your immediate

132

133

family, has had no technical training in the field of
packaging and is generally above the age of 18.

Please do not administer the test to persons you have
discussed the topic of tamper-resistant packaging with.
You should apply the test to as many different age and sex

groups as possible.

Sample Evaluation

 

Test participants will recieve a sheet of paper
consisting of scales that contain a range of answers.
These scales correspond to the question asked about each
sample:

"Having observed this package, do you think it has
been tampered with?"

Scale: 1 2 3 4 5
NO NOT LIKELY DON'T KNOW MOST LIKELY YES

Participants will be asked to respond to the answer that
best describes their thoughts. Sample identification
numbers will already be entered on each form. Be sure

the numbers match up with the samples.

TEST INSTRUCTIONS TO PARTICIPANTS

 

When preparing a test participant to take the test
'make sure you give instructions carefully. Each participant
should be informed of the nature of the test. This is done
in a very general manner only. Let the individual know

that it is a test regarding tamper-resistant packaging and

134

that they will be shown some samples and asked some related
questions. Inform test participants that it is for a
graduate research project at Michigan State University.
Their answers are totally anonymous and will be greatly
appreciated.

If they agree to participate, give them a test sheet
and further instructions. After showing them all the
samples together, tell them that the individual packages
they look at may or may not have been tampered with.
Based on that statement, have them answer the question
asked as if they were in a store and about to purchase
the products displayed. They are also to be told that
they can pick the packages up and handle them if they
feel it is necessary. Again, please ask them.not to
mishandle the samples. (Ask them not to peel, pluck, or
pull at the sample packages.)

Let them know that secondary closures and packages
have been removed on some samples for display purposes
only and it should not influence their answers.

Please ask them.not to speak to anyone while taking
the test and that you cannot provide answers to any
questions until after they have completed the test. Be

sure to thank each participant for their contribution.

Good organization makes for good results!!!

Thank you for your participation. GOOD LUCK!!!

BACKNOTES

Senate Subcommittee Hearing, Health and Environment
Committee. Tamper-Resistant Packaging, Washington,
D.C., 15 October 1982.

 

Ibid.
Ibid.
Ibid.

Food and Drug Administration. ”Tamper-Resistant Packaging

 

Requirements; Certain Oversthe-Counter Human Drugs

 

and Cosmetic Products; ContaCt Lens SolUtions and
Tablets; Final Rules", Office of the Federal Register,
volume 47, No. 215, p.50444.

 

 

 

Modern Packaging, November 1950. "Four Roses", p.84.

 

Modern Packaging, August 1973, p.78.

 

Modern Packaging, December 1949, p.138.

 

Mbdern Packaging, October 1961, "Background for Packaging",
p.44.

 

10 MOdern Packaging, November 1965, "New ways to tamper-

proof”, p.107.

 

11 Modern Packaging, October 1961, "Background for Packaging",

p.44.

 

12 Package Engineering, April 1979, "Show and Tell

Closures", p.37.

 

13 The 1981 Packaging‘Encyclopedia, "Safe and Legal

 

Packaging", p.40.

135

14

15

16

l7

l8

19

20

21

22

23

24

25

26

136

U.S. Department of Health, Education, and Welfare, Public
Health Service/Food and Drug Administration. "Grade A

Pasteurized Milk Ordinance (1978 Recommendations)",
p.31.

Ibid.

U.S., Statutes at Large, Public Law 85-859, 72 Statute
1358.

 

Bureau of Alcohol, Tobacco, and Firearms, 27 Code of
Federal Regulations 19.663.

 

 

Food and Drug Administration, 21 Code of Federal
Regulations 200.50.

 

 

Food and Drug Administration,"Tamper-Resistant Packaging

 

Requirements; Certain Over-the-Counter Human Drugs
and Cosmetic Products; Contact Lens Solutions and
Tablets; Final Rules", Office of the Federal Register,
volume 47, No. 215, p.50443.

 

 

 

Ibid.,p.50444.
Ibid., p.50450.

Church, George J., "Murder by Remote Control", Time,
October 18, 1982, p.18.

 

Ibid 0

Ibid.

"COPYcat criminals weak-ego type”, Staté Journal,
October 28, 1982.

"Tainted goods may be result of a grudge", State News,
October 28, 1982, p.10.

BIBLIOGRAPHY

Periodicals

Church, George J. "Murder by Remote Control." Time, October
18, 1982, pp.l6-19.

Food and Drungackaging, January 1974, p.13. "Milk containers
closure regulation."

Food and Drug Packaging, September 17, 1970, p.1, 21.
"Alcoa Introduces Roll—On Closure for Deposit on NR
Bottles."

 

Harris, William. "Extra-strength Scherer." Forbes, November
8, 1982, p.8.

Martin, William L., Jr. "Use of tamper-evident packaging to
increase with wide range of options." Packaging
Technology, August 1981, pp.l9-21.

 

 

Modern Packaging, May 1970, p.70. "Wyeth labs has tamper-
visible narcotics tray to deter stealing of barbituates

 

from hospital inventories."

Modern Packaging, November 1967, p.46. "Rifled packages."

 

Modern Packaging, November 1965, p.107. "New ways to tamper-
proof."

 

Mbdern Packaging, October 1961, p.44. "Background for
packaging."

 

Modern Packaging, February 1961, p.48. "Tamperproof, self

 

opening closure."

Mbdern Packaging, January 1960, p.46. "Tamperproof aerosol
cap."

 

137

138

Modern Packaging, April 1957. "How to get rid of the
'handle'."

Modern Packaging, November 1949, pp.83-84. "Bowman milk
containers - seal for easy detection of tampering."

Mbdern Packaging, November 1949, pp.94-98. "Smith Brothers
Cough Drops - overwraps for protection from water."

Modern Packaging, June 1951. "Foolproof closure for
parenterals."

Modern Packaging, November 1950, p.84. "Four Roses."

Package Engineering, January 1983, pp.35-38. "Seal, Carton,
Film, Blister expand tamper options."

Package Engineering, April 1979, pp.37-40. "Show and Tell
Closures."

Package Engineering, December 1982, pp.10,18. "News/Trends/

 

Regulations."

Package Engineering, November 1982, pp.52-55. "A look at
11 solutions to O-T-C tamper packages."

The 1981 PackaginngnCyclopedia, pp.40-48. "Safe and Legal
Packaging."

Newspapers

 

"TampereEvident Comparison Chart". The Bottle Blurb, Issue
10, December 1982.

 

"Fool-proof packages to increase costs." State NeWs,
November 28, 1982.

 

"Copycay poisonings signal decaying morals." MSU NeWs -
Bulletin, November 18, 1982.

 

"Outspoken Head of Denver Poison Center Draws Criticism
but Programs Win Praise." wall Street Journal,
November 5, 1982.

 

139

"U.S. Sets Up Rules On Drug Packages To Bar Tampering."
New York Times, November 5, 1982.

 

"This year, Halloween fear was real." Detroit Free

 

Press, November 1982.

"Hygrade Ball Park Franks Recalled; Production Stops."
Detroit Free Press, October 30, 1982.

 

"Hot Dogs 'Tampering' Investigated." Grand Rapids Press,
October 30, 1982.

 

"Tainted goods may be result of a grudge." State News,
October 28, 1982.

 

"Drug Packaging will cost." Detroit Free Press, October
28, 1982.

 

"Copycat criminals weak-ego type." State Journal, October
28, 1982.

 

"Product sabotage reports spread across the country."
Detroit Free Press, October 27, 1982.

 

"Protective Drug Packaging May Appear Next Week, Spurred
by Mere Tamperings." wall Street Journal, October 27,
1982.

 

"Tylenol TV talk to assure public." State JoUrnal,
October 23, 1982.

 

"Tampering scares town." State NeWs, October 27, 1982.

 

"Mere cyanide found in Chicago Tylenol." State NeWs,
October 22, 1982.

 

"Tylenol Aftermath: Cities and states try to halt those
who would poison." Detroit Free Press, October 20,
1982.

 

140

"New FDA Rules May Be Problems For Packagers." The
Journal of Commerce, October 21, 1982.

 

"Tamperproof packages industry's aim." State Journal,
October 14, 1982.

 

"Tylenol deaths make customers cautious." Detroit Free
Press, October 8, 1982.

 

Documents

Food and Drug Administration. "Tamper-Resistant Packaging
Requirements; Certain Over-The-Counter Human Drugs
and Cosmetic Products; Contact Lens Solutions and
Tablets; Final Rules", Federal Register, 47FR50442,
November 5, 1982.

 

Bureau of Alcohol, Tobacco, and Firearms. "Subpart S -
Strip Stamps and Alternative Devices", Code of
Federal Regulations, 27CFR19.661 - 19.663.

 

Food and Drug Administration. "Subpart C - Requirements
for Specific Classes of Drugs", Code of Federal
Regulations, 21CFR200.50.

 

 

U.S., Statutes at Largg, Public Law 85-859, 72 Statute 1359.

 

Papers

Litsky, Warren. ”Insuring Food Quality by TampervProof
Packaging." American Health AssOciatiOn Annual

 

Meeting, November 6, 1979.

141

Books

Glass, Gene V. and Stanley, Julian C. Statistical Methods

in Education and Psychology, Prentice-Hall, New Jersey,
1970.

 

 

 

 

Bhattacharyya, Gouri K. and Johnson, Richard. Wiley Series
in Probability and Mathematical Statistics, John
Wiley and Sons, New York, 1977.

 

 

 

142

REFERENCES

Interviews

Kaufmann, Gary, Psy.D. Behavioral Science Section,
Michigan Department of State Police, East Lansing,
Michigan. 20 December 1982.

Boyden, Joel, Attorney at Law. Baxter and Hammond Law
Offices, Grand Rapids, Michigan. 15 January 1983.

Gill, John, Professor. Animal Science Department,
Michigan State University, East Lansing, Michigan.

Hearings _

Tamper-Resistant Closures, Senate Subcommittee on Health
and Environment. 15 October 1982.

"010010!“