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Standards and

Compliance in

Todays US Optical

MarketWhat Does This Mean for Optical

Manufacturing


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Your Presenters

Ken Frederick> Sunglass & Reader Division Liaison

Ken Wood> Lens Processing & Technology Liason, ASC Z80

Secretariat

Jeff Endres> Technical Director

Amber Robinson> Manager, Member & Technical Programs


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Overview of Topics

1. U.S. Customs and Regulations

2. Consumer Product Safety Improvement Act (CPSIA)

3. California State Proposition 65

4. U.S. National Standards

5. The Vision Council Programs and Resources


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CUSTOMS ISSUES ANDREGULATORY UPDATE


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Best Practices for US Importing: US FDA Agent

a) Definition of a US Agent

All foreign establishments required to register with

the FDA must designate a U.S. Agent. The U.S.Agent is responsible only for 1) assisting the FDA in

communicating with the foreign establishment; 2)

responding to FDA questions concerning the foreign

establishments products that are imported andoffered for sale in the U.S., and 3) assisting the FDA

in scheduling an inspection of the foreign

establishment.


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Best Practices for US Importing: US FDA Agent,

Cont.

b) Whats the difference between US agent and

Official Correspondent?

If the foreign establishment needs to inquire of theFDA, then this communication must originate from

the companys official correspondent, not its U.S.

agent. As discussed above, the official correspondent

is the individual designated by the company in itsFDA registration as the spokesperson for the

company. The FDA will not address any inquiry put to

it by anyone who is not the official correspondent of

the registrant.


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Country of Origin For Lenses and Frames

Lenses

1. U.S. Customs Regulation for Importation

2. Human Readable Made in China

3. Machine Readable Barcode

4. The Vision Council Resource Guides


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Country of Origin Continued

Unless subject to an exception, United States

Customs laws require that all goods that are

produced outside of the U.S. must be physically,

conspicuously and legibly marked with information

concerning the country where the item was produced.

This marking must be permanent enough to convey

this information to the ultimate purchaser of the good.


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Marking becomes more complicated when the

manufacturing process occurs in more than one

country. In those circumstances, the country of origin

will be the country in which the constituentcomponents or raw materials undergo a substantial

transformation when manufactured into the finished

item. By definition, a substantial transformation

occurs when an article emerges from amanufacturing process with a name, character, or

use that differs from those of the original material

subjected to the process.


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This is a subjective test, with Customs considering

the amount and type of work performed in each

country, as well as the value added, to determine

whether a change in name, character or use hasresulted in a substantial transformation of those

components into a finished frame. Multi-step

processing in manufacturing of a frame, such as

soldering, drilling, bending, mitering, polishing of rawframe components, may help establish that various

raw material, parts or components have undergone a

substantial transformation into the finished product.


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Merely stamping a ready to wear near vision

spectacle with the name of a country DOES NOT

constitute substantial transformation.

Merchandise can be marked made in the USA or

the equivalent thereof only if the product is all or

virtually all US origin. Such a marking cannot be

used in the event that the product to be marked hasmore than a trifling amount of foreign content. In this

situation, however, a conditional marking may be

appropriate.


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Lacey Act

Covers the importation into the United States of any

product containing wood or cellulosic products.

1. What is covered by the Lacey Amendment? A recent amendment to a long standing Department

of Agriculture law, known as the Lacey Act, could

create compliance issues for sunglass and reading

glass companies that incorporate any wood or other

plant material in their products.


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Lacey Act

2. Compliance issues

The amendment made it unlawful to import plant or

plant products without an import declarationcontaining the scientific name of the plant, its value,

quantity and country of origin. As amended, the

revised law could be broadly applied to capture any

number of products

Continued


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Lacey Act

2. Compliance issues

Due to this, Customs Animal Plant Health Inspection

Service (APHIS), the section withinAgricultureresponsible for overseeing this law, have moved to

limit the products actually covered by the law.

Companies knowing that their products incorporate

any type of plant matter should review the Lacey Actto determine whether or not the amendment applies

to them.


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Lacey Act

Amendment of law covering import, export, transport,

sell, receive, acquire or purchase of plants or plant

products without:> Import declaration w/scientific name of plant; value of plant;

quantity of plant; country of origin of plant

> Covers any product with any plant atoms lemonade

(lemon essence), pharmaceuticals (cellulose), and shirts

(cotton).> Hangtags and warranty cards now excluded

> Packaging excluded, except if as a commercial item


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CONSUMER PRODUCTSAFETY IMPROVEMENT ACT


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Consumer Product Safety Improvement Act

- CPSIA

1. Covers Frames, cases, lenses, accessories

2. Federal Requirement

3. No Marking requirement

4. Products in violation subject to public recall

5. The Vision Council Resource Guide


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STATE ISSUES


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California Proposition 65

- CA Prop 65

1. Duty to warn the consumer

2. Point of sale labeling requirements

3. Over 900 Chemicals



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IMPACT OF STANDARDSUPDATES ONMANUFACTURING

ANSI Z80, Z87 and ASTM Updates


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U.S. National Standards

The Vision Council is active in all standards groups

ANSI coordinates standards development for

sunglasses, readers, lenses and frames Z80 develops standards for dress eyeglasses

> Vision Council is Z80 Secretariat

> U.S. TAG to ISO TC172/SC7 meets with Z80

Z87 develops safety eyeglasses standards

ASTM develops eye protector standards for sports


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ANSI Z80.1-2010

Sets minimum performance of prescription lenses

Power measurement now sphere and cylinder

Compensated power for near and distance

Abrasion resistant lenses must meet ISO 8980-5

A-R coating durability added from ISO 8980-4


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ANSI Z80.5

Revised in 2010 with no major changes

Currently under comprehensive review

Considering limited harmonization with the ISO framestandard


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Z80.3-2010 : the US Sunglass Standard

Revised in June 2010 to bring it up to date with

addition of Country of origin, Resistance to radiation

clause, and several corrections to tables.


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ANSI Reader Standard Reader standard being developed in the Z80

Committeeand expected to be published late 2011

Adapting the ISO (International) standard for newANSI standard not feasible for the following reasons:

> Limits to diopter range for OTC readers in ISO-not

necessary in the US

> Clarifying definition of bifocals, specifically for sun readers

> Modifying label requirements-making them simpler

> Including FDA Impact standards

> Including country of origin marking


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Z87.1 2010 Standards

Most recent revision April of 2010

Major reorganization

New Requirements for dust, splash and mist

New Requirements for testing complete device

New Frame marking regimen


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ANSI Z87.1-2010 Impact Requirements

1. Related to Z80.1 Impact requirements

2. U.S. Customs regulations for importation

3. Recently Updated

4. Covers a wide range of devices



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ASTM International:Society for Testing and

Materials Association for testing standards covers sport

eyewear

Motorsport Goggle Standard near completion Ski Goggle standard revision published in 2010

New committee forming this year to review antifog

claims for lenses.

Current US leadership for the ISO sunglass

committee


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US Optical Market Overviewand Outlook

The Vision Council


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Percentage of American Adults Using Any Form ofVisionCorrection within Gender and Age Groups

VisionWatch:The Vision CouncilAnnual Sample Size: 100,000+ Adults

93.8%

85.3%

61.8%

58.0%

78.3%

71.9%

75.2%

91.6%

84.3%

63.4%

61.9%

78.1%

73.2%

75.7%

55+

45 to 54

35 to 44

18 to 34

Female

Male

Total wearing

12ME Dec 09

12ME Dec 10


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Overall Market Performance


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$8,139

$9,526

$3,501$3,217

$671

$5,018

$1,750

Frames Lenses Contact Lenses Sunglasses* OTC Readers Examinations** RefractiveSurgery

12ME Dec 08

12ME Dec 09

12ME Dec 10

Inflation not taken into consideration

Vision Care Products & Services Total U.S. MarketBreakoutIn Millions

*All retailincludes dollars spent at all retailtypes at any retail location on the sale of either spectacle lenses (including Rx

sun), frames, contact lenses, sunglasses (plano), OTC readers, or revenue earned from refractive surgery (LASIK only) or

eye examinations. This number does not include sunglass clips and reflects the dollars spent only by those U.S. residents

18 and older.Does not include retail dollars spent by/for contact lenses and exams for those 17 years of age and younger.

All Retail*-3.1%

+1.5%

-2.1%

+7.9%

+7.7%

-24.0%

In Millions

-11.1%



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Plano Sunglasses&

OTC Readers


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Plano Sunglass Retail Sales Dollars & Units

Nominal $s Not revised for Inflation

$3,617.7 $3,424.1

$3,217.5

Retail Dollars(In Millions)

12ME Dec08

12ME Dec09

12ME Dec10

105.2

98.3

92.5

Units(In Millions)

12ME Dec08

12ME Dec09

12ME Dec10

-5.9% 2010 against 2009

-12.1% 2010 against 2008

-6.0% 2010 against 2009

-11.1% 2010 against 2008



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US Plano Sunglass Retail Sales 12ME Dec.

2010 By Channel (Millions)

$33.0

$113.9

$133.6

$182.9

$331.7

$602.3

$1,194.8

3.0

2.4

1.0

1.1

3.5

32.5

9.9

Flea Market

Sport

Optical Independent

Optical Chains

Better Department &Specialty Stores

Drug/Grocery/Mass/Warehouse Club

Sunglass Specialty

Retail Units Retail Dollars



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In millions

OTC Readers Wearers & PurchasesAges 18+

Repurchase Cycle0.58 years 0.62 years 0.60 years 0.61 years

25.1 25.6 26.3 26.5

43.241.4

44.2 43.8

12ME Dec 07 12ME Dec 08 12ME Dec09 12ME Dec10

Number of People Wearing Number of Pairs Sold



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Prescription Eyeglasses

Ophthalmic Frames


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2.7% 4.6% 6.1%4.8% 5.1%

5.3%

16.1% 13.8% 11.7%

30.2% 29.5% 28.7%

46.2% 47.0% 48.3%

12ME Dec08 12ME Dec09 12ME Dec10

Independents

Chains

MassMerchandisers

Department

Stores

Other

$8,139.4M$8,278.7M-1.7%

+1.0%

-4.2%

-16.7%

+1.5%

$8,400.7M

*

+28.5%

% change

09/10

Retail Structure of Frame Market (Dollars)



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Eyeglass Frames Retail Price Point ProfileIn Units

Trended

Base: Respondents purchasing frames

26.5%21.0% 20.8%

44.8% 56.8% 56.3% 58.9%

22.4%

20.3%28.7%

22.7%24.8%

12ME Dec 2007 12ME Dec 2008 12ME Dec 2009 12ME Dec 2010

Retail Over$150

Retail $100-$149

Retail Under$100



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2011 / 2012 Outlook


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Key Points: Future Outlook

A Weak Recovery Beginning to Take Effect> Economic Conditions Improving by Still Weak Low er ing Unemploym ent, Strengthening Employment Out look;Changing Emp loyment Landscape

Product iv i ty Rising; Leading Econom ic Ind icators are Up Consum er Spending and Consumer Conf idence Ris ing

> Recovery is VERY Fragile Rising Energy and Food Prices Pol i t ical and Global Turmoi l Hous ing Market Sti l l Flat

Optical Specific> Purchase Intent Up for Eyeglasses, Exams, Contact Lensesand Plano SG

> ECPs Are Optimistic (But Still Cautious) About the Future> The Optical Industry is a Lagging Industry


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THE VISION COUNCILRELATEDPROGRAMS/RESOURCES

.


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Lens Description Standard - LDS1. Standard for format for electronic data

2. Allows interface with1. Laboratory Management Systems

2. Warehouse systems

3. Practice management systems

3. Flexible for new or existing lens products

4. Standard available on-line


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Data Communication Standard - DCS1. Standard for format for machine communication

2. Allows interface with1. Laboratory Management Systems,

2. Warehouse systems

3. Practice management systems

4. Business Enterprise software

3. DCS Simulator



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Job Tray Standard1. Standard for format for job trays physical dimensions

2. Useful for development of automation



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Optical Product Code for Lenses OPC codes needed for all lenses sold in the U.S.

OPC codes are used by lens suppliers to provide

unique identification of every prescription lens blank. The code is a 10-digit number and barcode that

identifies the manufacturer and the specific product.

The Vision Council manages manufacturer code

assignments and is the only source for OPC codes.


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Sunglass & OTC Regulatory Guide Available for anyone interested are copies of a

Regulatory guidance manual that covers sunglasses

and reading glasses sold in the US. The manual is

comprehensive and covers standards for these

products, FDA and US Customs regulatory

requirements (as well as some state specific

regulations). The manual is a great reference guide

and should answer most questions. If you do have an

issue in the future that isnt clearly addressed, please

do not hesitate to contact Amber Robinson and we

will attempt to answer.


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Contacts Greg Chavez, Vice President of Member Services,

[email protected]

Jeff Endres, Technical Director,[email protected]

Kenneth Frederick, Sunglass & Reader Division

Liaison, [email protected]

Kenneth Wood, ASC Z80 Secretariat,

[email protected]

Amber Robinson, Manager, Member & Technical

Programs, [email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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Websites www.thevisioncouncil.org

www.z80asc.com

ANSI eStandards Store
http://www.thevisioncouncil.org/http://www.z80asc.com/http://webstore.ansi.org/?source=linkshare&src=ls&siteID=XObeKAG_7T4-vGSZtgT2saXy1faatRE3GQhttp://webstore.ansi.org/?source=linkshare&src=ls&siteID=XObeKAG_7T4-vGSZtgT2saXy1faatRE3GQhttp://www.z80asc.com/http://www.thevisioncouncil.org/

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