PKSC 3680 Final

17. Regarding extraction studies, what three key phrases are used to describe whether a substance is reasonably expected to become part of the food?

"intended conditions" "detectable migrations" "not reasonable expected to become part of the food"

14. Who can you go to for help regarding TE packaging compliance and designs?

Rely on Suppliers

7. What three categories of products are covered under the tamper evident packaging law?

- OTC drugs and products - Cosmetic products (oral liquids, vaginal) - Contact Lens Solutions and Tablets

8. What type of information is included on the markings of a HazMat package?

- Proper shipping name - UN identification Number - Find in a table in any agency manual - Must be durable - Must be in English - Not obscured by any other markings or labels - MAY NOT OFFER FOR TRANSPORT WITHOUT THESE MARKINGS

2. What are the major provisions of the NLEA Act of 1990?

- Revised Nutrition Labeling - Nutrition Claims - New Diet Guidelines

1. What are the major provisions of the FPLA Act of 1966?

- Statement of Identity - Net quantity Statement - Ingredient Listing - Nutrition Labeling - Deals and Promotions - non-functional slack fill

2. What are the five major provisions of the Food Additive Amendment?

- additives are defined - burden of proof shifted to industry - Delaney clause outlawed carcinogens - Established GRAS (Substances generally recognized as safe) - Established GMP (good manufacturing practices)

4. Legal ethics with respect to gifts means what?

- cannot obligate, or appear to obligate, the receiver for any service, claim, product, or favor - cannot request or solicit personal gifts, services or contributions from vendors, suppliers, or other business partners

4. What are the consequences of violating any labeling regulations?

- complaint issued by regulating agency - hearing will be held, cease and desist order if found in violation - Subject to a fine if manufacturing is not stopped

4. Be able to give some examples of exemptions from NLEA regulations.

- food produced by a small business - food served in restaurants - food served in other establishments such as schools, hospitals and airplanes - food sold by vendors such as sidewalk vendors and vending machines- foods shipped in bulk, not sold to consumers - medical foods such as those for management of diseases as supervised by a physician - foods with insignificant amounts of nutrients (coffee and tea) - dietary supplements - infant formula - food in small packages

11. What parts of the supplemental NDA apply to packaging?

- full description of methods used in the facilities and controls used for, the manufacture, processing, and packaging of the drug and - fully disclosed to the FDA of manufacturing and packaging process - complete description of primary package - package sizes - material (manufacturing) - closures - label - all package copy, labels, inserts, where and how it will be located in the package - sample of finished market package must accompany the application

1. What is the definition of sustainable packaging?

- it is safe and healthy for individuals and communities throughout its life cycle - it meets market criteria for performance and cost -is sourced, manufactured, transported, and recycled using renewable energy - maximizes the use of renewable or recycled source materials - is manufactured using clean production technologies and best practices - is made from material s healthy in all probable end of life scenarios - is physcially designed to optimize materials and energy - is effectively recovered and utilized in biological and/or industrial cradle to cradle cycles.

12. How should the manufacturer address appear on the label in order to comply with the regulations?

- must have name and address of manufacturer - unless name is not actual manuf. then must have a qualifying phrase - manuf. for.. or distributed by.. - address must be current and given as a mailing address

11. What type of information is included on the information panel?

- name and address of manufacturer, packer or distributor - ingredients listing - Nutrition Facts

6. What exemptions are in order for a material to be classified as "Not a food additive"

- prior sanction - GRAS - No migration exemption - Basic Resin Exemption - House ware exemption - Threshold Regulation

8. When are statements based on dual basis required?

- voluntary - "as packaged and "as prepared" (mixes and cereals)

18. What basic food simulates are used for extraction studies? Is there agreement between US and EU simulates used?

-Acid -Alkaline -Neutral -Salty -Sugar -Alcoholic -Oil solutions DISAGREEMENT

If you are interested in protecting and advancing human rights globally, what will you not tolerate?

-Child Labor -Forced Labor -Physical punishment or abuse

20. What government agency was given the task of limiting the number of package sizes? What two specific types of packages were targeted? What happened?

-DOC -Toothpaste and Potato Chips -They did not enforce the policies

1. What government agency first proposed the regulations for the NLEA Act of 1990? What two agencies finalized the regulations?

-Department of Health and Human Services -FDA and USDA

4. What is the difference between a direct and an indirect food additive.

-Direct additives materials directly and intentionally added to foods to perform a functional effect in the food -indirect additives substances not intended to but does become a component of food as a result of use in articles that contact the food

2. What was the basis of disagreement between these two agencies when the final regulations were established? How was this problem resolved?

-FDA listed their nutrient listing based on a 2000 calorie diet and the USDA said 2000 was too low -Issued by President Bush, daily value for both 2000 and 2500 calorie diet on the label

9. Be able to give some examples of nutrition content desciptors.

-Fat free -Free -Low -Lean -Extra lean -High -Good source -Reduced -Less -Light -

19. What six variables must be controlled when performing an extraction study?

-Food Type -Time -Temperature -Surface Area -Conditions of Use -Thickness

2. What regulation was established by OSHA in 1983? What title of CFR is it found under?

-Hazard Communication Standard -Title 29

9. How is data compiled for CR packaging regulation?

-Ingestion pattern collected from 72 poison control centers around the U.S. -families reporting ingestion incidents

5. What are some of the specific features of the Nutrition Facts panel that are required for compliance with NLEA Act?

-Must have nutrition info provided per serving and must be amount customarily consumed

7. What are the three most basic requirements for net quantity statement to comply with the regulations?

-On lower 30 % of PDP -Provides amount of food in package -US and Metric Units

8. Explain why packaging is regulated under the New Drug Act.

-Packaging is considered to be part of the drug itself - packaging must be submitted as part of the New Drug Application (NDA)

5. What is the PDP? What two things are specifically required on the PDP? What are some of the requirements of each?

-Principle Display Panel 1. Statement of Identity 2. Net Quantity Statement Statement of Identity:-prominent print and type - bold type - at least 1/2 the size of the largest print on the label - must use a common or usual name - comply with the standard stated in standard of identity regulations (FD&C 1938) or appropriate descriptive name, something generally understood by the public Net Quantity Statement: Statement on label that provides the amount of food un the package

14. Where are the established regulations published and where are the daily updates published?

-Title 21 Daily Changes: Federal Register

9. Can materials be added or subtracted to the prior sanction list? Can material be added or subtracted from the GRAS list?

-Yes -Yes

12. What were some of the deceptive practices that took place up through the 1800's?

-bread was mixed with aluminum - beer adulterated by various narcotics - tea leaves colored with carbonate of copper

12. What should be included in an application for a patent?

-full description of invention -means of carrying out invention -how it differs from other similar devices/compounds -a drawing

6. Why is Kosher-style considered a confusing term?

-its ussed on meat products as misleading statement for nonkosher products -originated from the first immigrants that created deli shops. The food was considered kosher style.

5. What is the Delaney Clause and how does it affect packaging? What if a carcinogenic compound is used in the manufacturing of the packaging material? How is it regulated under the Delaney Clause?

-limits the use of food additives that have been found to induce cancer when ingested by man or animal -Does NOT apply to monomers used in making the product -

8. What products are conditionally exempt from tamper evident packaging regulation?

-products sold in vending machines -products sold door to door -products sold directly to hospitals, institutions, medical, or first aid units or health professional directly distributing to a patient -products sold through mail order

9. What three organizations approve Kosher products/packages and what symbols are associated with each.

1. "U" The Union of Orthodox Jewish Congregations of America 2. "K" The Joseph Jacobs Organization 3. "Vh" The Rabbinical Council

16. Know the 9 basic changes in the 1995 testing protocol for CR packaging.

1. Added seniors to adult group 2. Four adult panels of 100 each 3. One minute screening test for adults 4. Split adults into 3 age groups >> 50-54 >> 55-59 >> 60-70 5. Two part test for adults >> Familiarization / Actual test 6. Children have min 50, max 200 7. Children divided into three age groups >> 42-44 >> 45-48 >> 49-51 8. Limiting individual testers and test sites to specific amount of children and adults, using specific instructions 9. Implementing a re-closure test

5. What are the five requirements for a food/package to be considered Kashruth?

1. All pork products are inherently unable to be kosher. (Birds of prey and also shell fish) 2. Acceptable animals -- the flesh of all quadrupeds with cloven hoofs-- cattle, goats, sheep are acceptable and also barnyard fowl 3. Fruits & vegetables in natural state are inherently kosher 4. Acceptable animals must be slaughtered and prepared according to regulations, or the food is non-kosher 5. Dairy and meat products cannot be mixed and consumed at the same time. Separate serving dishes.

6. What are the three basic premises of the OSHA standards?

1. Assumes that the wider availability of information relating to workplace hazards required by the regulations 2. Will allow employers to more effectively design appropriate safety measures 3. While providing workers with the information needed to protect themselves

14. What are some hints about using trademarks successfully?

1. Be consistent in use 2. Use distinctive graphic treatment 3. Use T.M. 4. Make sure employees protect the trademark 5. Alert legal dept. when improper use is found 6. Must register any changes

12. What does the FDA recommend with regard to consumer vigilance for TE packaging?

1. Be observant 2. Read package instructions 3. Don't take meds in dark 4. If not sure, don't use

15. What types of nonreclosable packages are covered under the CR regulations? In general, how are they tested? What is the ISO's position on testing/regulating these types of packages?

1. Blister packs 2. Strip packs 3. Unit packaging 4. Pouches FAILS if access more than eight units of the package, or would consume enough to be toxic to a 25 lb child. Similar standards, however they do not think nonreclosable packages need to be tested. If they are opaque, do not look like candy, they are "inherently CR"

12. Designs for CR packages are based on what three basic premises?

1. Children can not read directions 2. Children do not have strength of adults 3. Children can't do two distinct motions at the same time

18. Give some examples of design features that should be taken into consideration for a package to be considered CR compliant.

1. Closures perform better on plastic or metal than on glass 2. Small closures easier to open then large one with children 3 Different size bottles may perform differently using same closure 4. Different closure liners perform differently with same closure

2. What are the four basic elements that determine trade dress for a given package or product. Be able to give an example for each.

1. Competitor's trade dress is similar to your product that there is "likelihood that an appreciable number of ordinarily prudent purchasers are likely to be misled, or indeed simply confused as to the source of the goods in question." 2. Have to prove similarities are attributable to non-functional features 3. Prove that product's trade dress has acquired a "secondary meaning" as a device whose primary significance is identifying the product with your company 4. Prove that you were first: the secondary meaning as acquired prior to competitor's use

10. What types of tests must a package pass to be considered acceptable as a HazMat package, according to the regulations?

1. Drop 2. Leakproofness 3. Internal Pressure (hydro static) 4. Stacking 5. Specifies conditions

3. What are the three regulating agencies and their functions as they relate to package labeling?

1. FDA 2. FTC 3. DOC

10. What are the five steps of OSHA compliance? Be able to describe each.

1. Hazard Evaluation >> Classify chemicals based on hazard they present 2. MSDS Sheets >> Usually packagers will receive them, not create >> Must be in English and contain 12 separate areas of information 3. Label Requirements >> Identity of chemical >> Manufacturer, importer >> Appropriate hazard warnings 4. Employee Training >> Methods & Observations used to detect presence of chemicals in area >> Physical & Health Hazards of the chemicals in work area >> Measures employees can take to protect themselves from such hazards >> The details of the company's hazard communication program, including explanations of the workplace labeling system and MSDS 5. Developing a written hazard communications program >> Companies must develop and maintain a written hazard communication program which describes the manner in which the company has complied with the labeling, MSDS, employee training

10. What are the four basic regulations that determine whether a package is compliant with the tamper evident packaging law? Use one of the 10 FDA suggested compliant packages and explain how it meets with the regulations you just described. (For this question, aerosols are not included as one of suggested compliant packages since it is considered inherently tamper evident).

1. Indicator or barrier must have distinctive design or identifying charcteristic (logo, patern, trademark) 2. Distinctive design: packaging cannot be duplicated by commonly available materials or through commonly available processes 3. Package must bear a statement, prominently displayed, alerting consumer of specific tamper-evident feature 4. Statement must be placed so that it will be unaffected if the tamper-evident feature is breached or missing

9. What products are exempt from tamper evident packaging and explain why they are exempt.

1. Lozenges 2. Ammonia inhalant ampules 3. Aerosol products and compressed medical oxygen Why they are exempt - inherently tamper evident (aerosol) - kept behind counter (inhalant) - Not ingested, so no bodily harm (lozenges)

11. What four elements are necessary for a patent to be granted?

1. Must have not been known or used previously in U.S. or previously patented or described in publication in U.S. or in a foreign country 2. Must require exercise in skill in field which is beyond that of others skilled in the area 3. Must be so different from prior processes or machines or products in the field so that it is not obvious to others with ordinary skill in the field 4. Must not be merely an idea or mathematical formula

10. Explain what a patent covers as it relates to packaging.

1. Package's functional features 2. Manufacturing technique 3. Manner of dispensing a product from a package 4. Package's safety features 5. Package's shape or aesthetic qualities 6. Means for recycling or degrading a package

11. There are two long standing "cases" that are used as a guideline for the no migration exemption. Be able to explain how both are used to establish "no migration".

1. Ramsey Proposal - substance will transfer from package or other food contract articles to food at levels no higher than 50ppb - Components of articles used in contact with dry and/or nonfatty foods - components of articles intended for repeated use with bulk quantities of food 2. Monsanto vs. Kennedy- US Court of Appeals Decision - 1979 - FDA said Contact with food must result in some transfer of package constituent to the contained food - Court Said mere contact is not enough to assume transfer of constituent

5. How is trade dress infringement prevented?

1. Research prior to final design 2. Take photos 3. Keep detailed records showing how design was created 4. Keep records at least 5 years 5. Consider hiring a consultant or legal firm 6. Monitor market for infringements

3. What elements constitute similarity of appearance? Be able to give an example using color or shape.

1. Trademark design 2. Color scheme 3. Graphic design 4. Copy details 5. Shape 6. Function 7. Totality of elements

13. What are the two major incidents that led to the 1906 Pure Food Act? Know and be able to describe the details of these events.

1. Upton Sinclair's book the Jungle 2. Many US soldiers died in Tampa Florida during the Spanish American war. Caused by beef canned in formaldehyde thirty years before, during the civil war.

5. What are ten steps to undergo when making an ethical decision?

1.- think about what you might have an ethical concern about the situation 2.- Identify who is affected by the situation and by your decision 3.- review company's code of ethics 4.- consider decision alternatives and think about consequences 5.- evaluate impact of doing nothing- 6. -find out if a similar situation has been dealt with 7.- seek advice 8.- determine when you must act to produce the best result for everyone involved 9.- think about how your action and decision will affect people, your customers, and the company 10. - think about what is the right thing to do

7. What constitutes a reference amount according to NLEA?

16 oz (454g) pizza CFR reference amount is 140g 1/3 serving size of pizza x 454g = 151g 1/4 serving size of pizza x 454g = 112g Serving size is 1/3 because it is closets to 140g

4. When was the FDA officially established?

1906

3. When did public concern for CR packaging begin? What caused this concern? What product was specifically the biggest issue for CR packaging?

1966

3. When was the DOT established?

1966

1. When was OSHA established?

1970

16. When was the Threshold of Regulation established and who established it? In general, what are the provisions of the threshold of regulation?

1995 by the FDA -FDA has the ability to declare anything exempt that it determines to have migration on a trivial level such that it does not require regulation as a food additive

17. How is CR packaging enforced? If a package is found to be noncompliant, what happens?

1st asked to correct the problem 2nd ask for voluntary recall, halt production until corrected recall can be ordered by regulating agency

3. Why did the NLEA Act have such an impact on the food industry?

257,000 food products and 90 % of meat and poultry were affected

17. How many promotions are allowed in one year?

3

3. How many categories of color "additives" are approved?

4

9. What is a libripen?

A Roman master of public weights

12. What is an ANDA?

Abbreviated New Drug Application

14. Know the general protocol for testing according to the 1995 regulations.

Adults >> Given 5 minutes to familiarize with package >> GIven 1 minute to open and close package If they fail, given a non-cr closure for 5 minutes. If they can open, test fails. If they can't, they are excluded from results. Children >> Testing first done at 5 minutes, then can move onto 10 mins depending on result

13. What age groups are involved in the child testing group, based on the 1995 regulations? What age groups are involved in the adult testing group, based on the 1995 regulations. What percentages of each of these groups must "pass the test" for a package to be considered CR compliant?

Adults/Seniors Ages 50 - 70 90% pass rate Children Ages 42 -51 months 90-80% must fail test, depending on number of participants and which test performed.

15. In what way do copyright laws affect packaging? What symbol is used to signify use of copyrighted material? How long does a copyright last?

Affects photos in packaging -C -28 years (can be extended for 28 more)

2. What agency regulates Alcoholic Beverages? What title of the CFR's are the regulations found under? What three categories are alcoholic beverages divided into? What types of regulations affect the packaging of alcoholic beverages?

Alcohol Tobacco Firearms (ATF) -Title 27 1. Beer 2. Wine 3. Distilled Spirits 1. Brand Name 2. Class and type 3. Name and address of bottler or packer 4. Alcohol content

5. How are state and federal laws different with regard to health vs. air and water control?

Allows for some variation state to state for air and water BUT almost parallel word for word federal requirements for health control

9. In addition to using code marks on the package, what other type of labeling is required on the vehicle used to transport HazMats?

An identifying diamond placard paced on all four sides. Placard has a color, symbol, and number, identifying the group the hazmat falls under.

8. Give examples of how packaging is specifically affected by Kosher laws.

Any chemicals used in manufacturing must be approved. Cleaning materials must be free of ingredients derived from forbidden animals. Aluminum foils must be rolled with synthetic oil. No animal glues allowed.

11. In the area of health and environmental law, states are permitted to have their own regulations as long as they are...what?

At least as stringent as Federal

2. Who regulated HazMat packaging and transportation in the 1960's and 1970's?

Coastguard - Water Federal Aviation Administration - Air Interstate Commerce Commission - Rail and Truck

11. What type of skill was the basis for the new testing protocols...cognitive or strength?

Cognitive

19. How are packages currently being "screened?

Companies voluntarily submit designs for compliant by testing in independent lab or by "self-identify" CPSC and EPA not actively pursuing noncompliant designs

1. What is the definition of a container that is regulated under the PPA Act of 1970?

Container that precludes entry by children under the age of 5, but not adults, to hazardous substances such as drugs, household cleaning agents and pesticides

How are trade secrets protected in a MSDS?

Courts decide if needed. Seek expert help if required to prepare an MSDS that may disclose trade secrets.

3. What role did Wal-Mart have in getting the sustainability movement started most recently?

Created Scorecard that wanted to reduce Packaging by 5 % by 2013. ZERO WASTE

8. Given a rectangular or cylindrical package dimensions, be able to calculate the area of the PDP and use a chart provided to determine the minimum letter size for net quantity statement.

Cylindrical: 40% (height x circumference) Rectangle: Height x Width

10. Be able to name some state agencies that are involved in developing regulations.

Dep of health and environmental control (DEHEC), Clemson University regulates pesticides, fertilizer, and seed certification.

13. What is used to maintain the confidential information of an NDA? Explain how it keeps information confidential.

Drug Master File - suppliers can submit their relevant information directly to the FDA on a confidential basis - FDA can cross reference the data when considering the NDA submitted by the drug manufacturers

9. Be able to name federal agencies that are involved in developing regulations. If you use abbreviations, you must explain what they stand for.

EPA, USDA, FDA

10. What society is attributed with developing standards for container size?

Early Islam

12. How often does a HazMat package need to be retested?

Every 24 months

7. What are some classifications for HazMats? Give an example of how they can be classified by packing group.

Explosives Poisons Radioactive Oxidizing Gases combustible/flammable liquids or solids Miscellaneous

14. What are the major provisions of basic resin doctrine? Know what levels of catalysts and comonomers are regulated and how they are regulated.

FDA clears substances on a generic rather than proprietary basis - must be listed as a basic resin - must be manufactured using GMP's - Must comply with stated extraction requirements

18. Who regulates promotions?

FTC

1. What law affects cigarette packaging? Under this law, packaging is affected in what way?

Federal Cigarette Labeling and Advertising Act of 1965 1. Required print health warning 2. Prohibited misleading advertising in print and media 3. Label requirements for placement of manufacturer info and quantity declaration

11. How are trademarks "registered" and how long does it last?

Fee of $35 and lasts 20 years. Option to extend for 20 more years.

5. What reference is used to find these OSHA standards (regulations)? Who publishes this reference and who wrote it?

Flexible Packaging Association FPA's Hazard Communications Compliance Manual Wahsington Law firm of Keller and Heckman

1. What was the reason for early packaging regulation?

Food Regulations

13. What part of the Food Additives Amendment relates to the General Adulteration Provision?

GMP's and any substance used as component articles that contact food

23. Be prepared to answer questions about the Plastic Bottle Case (Monsanto vs. Kennedy) from the assigned Sacharow reading.

GOT IT

10. What is a GRASP? What advantages does the GRASP have for companies filing information for use of the material?

Generally Regarded as Safe Petition Can be self-determined

7. Explain the term GRASE.

Generally Regarded as Safe and Effective

6. What are the three packing groups used in classifying a HazMat?

Group 1: great danger- for explosive: detonating Group 2: medium danger- rapid combustion rather than detonation Group 3: minor danger- contains group 1 and/or 2 explosives as components but in restricted quantity and certain types of fireworks

1. Who established the "Poison Squad"? What was the purpose of forming this group? What government agency was established by this group?

Harvey Wiley -FDA

5. Know the key words that define a tamper resistant package.

Having an INDICATOR or BARRIER to entry which, if BREACHED or MISSING, can reasonably be expected to provide VISIBLE EVIDENCE to consumers that tampering has occurred.

4. What major law is HazMat packaging covered under today? What title number of the CFR's is it found under?

Hazardous Materials Transportation Act Title 49

7. What types of products does the CPSC regulate with regard to CR packaging?

Household Products and medications

14. Are trace ingredients included on the ingredient listing? Why or why not?

If it has no function then NO

2. What happened in the landmark Tylenol Case? Explain the details of the case and what the result was with regard to proving that the package was tampered with. What happened to the company involved in the case?

In 1982, tylenol capsules laced with cyanide in Chicago. Product placed randomly on shelves at 7 locations, mostly drug and grocery stores. 7 People died. Johnson and Johnson offered $100,000 but case never solved. Stocks of J&J dropped dramatically. They destroyed all 31 million bottles of extra strength tylenol. Resulted in the FDA mandating tamper-evident packaging.

15. Why shouldn't you use a sole source supplier when filing a drug master file?

In order to not reveal trade names to identify layers of a multilaminate

13. Why did Dupont lose the use of their trademark name "Cellophane"?

It became so common of a term through everyday use

6. What beverage is highly regulated with regard to content on the statement of identity? What are some of the details of how this beverage is labeled?

Juice -beverage, drink, cocktail or diluted ______juice -contains _____% juice or _____% juice

1. What law addresses Trade Dress?

Lanham Trademark Act of 1946

4. What types of pigments were eliminated from food packaging?

Lead Pigments

2. What are packaging regulations designed to do in today's society?

Look out for public health and prevent fraud

12. What determines whether a material is classified as an "article"? If a material is considered an article, what exemption is it qualified for?

Manufactured item that is formed to a specific shape or design during manufacture.... Which has end use functions dependent in whole or in part upon its shape or design during end use.... Which does not release, or otherwise result in exposure to, a hazardous chemical under normal conditions of use

14. Who proves whether the material is safe for use with the drug?

Manufacturer must prove it

1. What are ethics? What do they represent?

Moral principles that govern a person's behavior or the conducting of an activity. -Represent values

11. What does "as prepared for transport" mean?

Must include all components of package. Not individual components not assembled.

19. What statements on a package have a specified time limit?

NEW and IMPROVED

2. Are printing inks regulated?

NO

7. Do we have federal laws for solid waste and litter reduction as it specifically relates to packaging?

NO

9. What is an NDA? How does the filing procedure for a NDA differ from a food additive petition?

New Drug Application Filed 30 Days prior to human testing -Large and arrive by Truckload to FDA -100,000 pages

6. What is the definition of an old drug vs. a new drug?

New Drug: not GRASE or is GRASE but not used extensively before 1962 for identical uses with identical labeling Old Drug: GRASE and used extensively for identical uses with identical labeling since 1962

1. By definition, are colors considered food additives? Are they regulated as such? Explain.

No, NO

8. How are solid waste and litter reduction laws addressed?

Not addresses federally Are very packaging specific for state and local

13. What is the industry's position with regard to TE packaging for foods?

Not required but: Voluntarily done and called freshness indicators

7. Who interprets Kosher laws?

Orthodox Rabbi's

5. Compare and contrast PLA, NatureFlex, and Maize based biopolymers

PLA: -field corn, 100% annually renewable natural resource -a wide range of packaging from clear food containers to beverage bottles. PLA USES WATER NATUREFLEX: -wrapping fresh produce, personal care products, confectionary twistwraps -Commonly linked to OPP -Semi-Permeable to Moisture and Provides good Anti-mist properties Maize Based Biopolymers -Commonly linked to PE -Increase water resistance -Comes from pellets

10. What type of information about the packaging is required for an NDA?

Package Sizes Closures Labels

10. Where does the information panel located on a package?

Panel immediately to the right of the PDP

15. What is the housewares exemption?

Paper towels, receptacles, eating utensils are considered outside the scope of the Food Additives Amendment

7. Are the OSHA standards performance oriented or specification oriented?

Performance Oriented

5. The current regulations replaced specification standards with what type of standards?

Performance Standards

6. What types of products does the EPA regulate with regard to CR packaging?

Pesticides used in and around the house

10. According to ingestion statistics, what product prompted need for 1995 revision of the testing protocols for CR packaging?

Prescription Drugs

4. Kosher is a synonym for what word in Hebrew?

Proper

10. Be able to give some examples of health claims that are regulated by the NLEA

Scientific evidence must prove or support it

11. Give an example of features found to most effective for tamper evident packages based on the research study done by MSA and Cornell.

Sealed Tubes Seal on mouth of tube must be punctured to retrieve product Tape Seal Paper or foil with distinctive design is sealed over all carton flaps or bottle cap. Seal must be torn or broken to open container Blister pack Dosage units are individually sealed. The individual compartment must be torn or broken to obtain the product Neck Bands >> Wine bottles, drinks Induction seals Carton Seals >> Use adhesive liberally Individual blister seals >> push in rather than peel >> embossed backing Sound >> Soda bottle releasing carbon

14. Besides packaging, what other issues are covered under the HazMat regulations?

Segregation Table Compatibility Table

1. What was the first HazMat law that was introduced in 1866 in the U.S.?

Sen. Chandler introduced bill to prohibit transportation of nitroglycerine on passenger transport vehicles

4. What is meant by the term "non-functional" as it applies to trade dress? Be able to give an example.

Shape of bottle used to indicate brand identity. Pepsi bottle, axe products

6. What type of regulations vary most from state to state and locality to locality?

Solid Waste and litter

6. What factors should be considered when establishing trade dress in the international market?

Some product/brand names may have different meanings "CANNON" camera = deceitful in chinese Register new name or design for each country.

4. What are the three ways to classify laws?

State Federal Local

12. What symbols are used to label a trademark and what are the conditions associated with the use of these symbols?

T.M. Not required every time, but should be used enough to promote protection.

1. Besides the term tamper resistant, what term is acceptable to use? What term is not acceptable and why isn't it considered acceptable.

Tamper-Evident

6. What are the penalties for violating the tamper evident packaging law?

Tampering - $25,000 and 10 yrs imprisonment Results in Death -$100,000 and life imprisonment

5. Who enforces the regulations regarding use of colorants in food packaging? Is there a problem with this? Explain.

The USDA is deferring to FDA in the matter of packaging materials which doesn't have a formal approval list for colorants. USDA past approval is now insufficient

13. Who is held responsible for a HazMat package?

The packager, unless the package wasn't properly blocked and braced for transport. Then the motor carrier is at fault.

22. Why is it generally inadvisable to ask the FDA for its opinion regarding regulation of a food additive?

Theres no master list of letter or memorandums of additives

2. What title of the CFR lists the regulations for CR packages?

Title 16

4. What title of the CFR's lists the regulations of tamper evident packaging?

Title 21

20. Why is it advisable to use the thickest sample for an extraction test?

To comply with the law that you cannot lose more than 5% weight. if you use a thinner sample you will get higher percents.

11. In contrast to the reason for why today's packaging laws are developed, what was the reason for developing the earliest packaging laws?

To ensure fair trade or to ensure that proper taxes were collected

10. What law covers trademarks?

Trademark Act of 1905

17. What is the USP? How is it used for drug packaging? What material is approved for use for tablets and capsules without prior approval from FDA?

United States Pharmacopoeia -HDPE

6. What constitutes a serving size according to NLEA?

Use table in CFRs that give reference amount for food used to determine the serving size or basis for nutritional claims

18. How are cosmetics regulated?

Usually voluntary, premarket approval not required

9. When calculating net wt., what is included and what is excluded?

Weight of product minus the package -Include propellant -Include liquid unless the food will be drained

13. What constitutes patent infringement?

When what is described in the patent's claim is made, sold or used without the permission of the patent owner. Includes sale of components of a patented machine, composition, material or apparatus

2. Was the 1906 Pure Food Law an effective method of regulating packaging? Why or why not.

YES, created USDA

8. Do similar regulations for CR packaging exist in other countries?

Yes: 1. Germany 2. Canada 3. UK

7. Explain the term "prior sanctioned" food additive. If you worked for a company that claimed it was using prior sanctioned materials, would you feel "safe"? Why or why not

any substance permitted for its intended use by FDA or USDA letter or memorandum written prior to 1958 There is no master list of letters or memorandums if a letter is presented to FDA, it is interpreted narrowly

3. Know the key words used in the definition of a food additive.

any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component...of any food...if such substance is not generally recognized...to be safe under the conditions of its intended use. then submit GRASP

16. Give an example of a drug package vs. a medical device package.

blood bags are considered drug packages, which requires a NDA. Because blood bags contain an anticoagulant which is a drug however bags intended for use in collecting blood products such as plasma and platelets are shipped without anticoagulants are considered a medical device

3. What is antitrust?

cannot fix prices with competitors, manipulate terms of sale, or production output

11. How is bottled water regulated?

definition of artesain, distilled, mineral, purified, spring and well water terms

13. How should the ingredient listing appear on the label in order to comply with the regulations?

descending order of predominance by weight

12. How is slack fill regulated? Explain.

empty space in a package that is filled to substantially less than its capacity for reasons other than: - protection of contents - machinery requirements for enclosing contents in such packages

2. Be able to explain each portion of the definition.

got it.

15. How does the label appear if a manufacturer uses a variety of types of vegetable oils during production?

if the manufacturer cannot predict which oil may be used from one production facility or another (Veg. oil contains: corn oil, soybean oil or safflower oil)

4. What is the Wal-Mart Scorecard?

is a measurement tool that allows suppliers to evaluate themselves relative to other suppliers, based on specific metrics

7. What is the difference between a law and a regulation?

laws outline broad policies, but do not cover details. Regulations usually cover the details

3. Using the Sudafed Case of 1992, explain what components provided evidence of product/package tampering.

man tried to poison wife with sudafed capsules to collect insurance money. bought sudafed, peeled back blister card backing then reapplied backing after contamination Returned contaminated package to store and 2 unrelated people died.

12. What is a doctrine of preemption? Be able to give an example.

many states maintain fulfilling federal law does not exempt from compliance with state law. If federal law was passed to impose 5 cent tax on bottles and state already had a deposit law, State could take Fed Law to court and probably win.

16. What are some examples of how additives may be listed on a food label.

must explain in common language the function of the additive, if an approved food additive is used ("preservative", "to retard spoilage","a mold inhibitor")

3. What are environmental laws designed to do?

protect the purity of air or water, prevent solid waste and litter, and Conserve materials and energy