Standards and Compliance in Todays US Optical Market

What Does This Mean for Optical Manufacturing

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

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

CUSTOMS ISSUES AND REGULATORY UPDATE

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 and offered for sale in the U.S., and 3) assisting the FDA in scheduling an inspection of the foreign establishment.

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 the FDA, 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 its FDA 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.

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

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.

Country of Origin Continued

Therefore, imported ophthalmic frames, sunglasses, or ready to wear near vision spectacles must be clearly and permanently marked with the country of origin. The requirements for the procedures to be used in marking imported ready to wear near vision spectacles are set out in 19 U.S.C. 1304 and 19 C.F.R. 134.

Country of Origin Continued

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 constituent components or raw materials undergo a substantial transformation when manufactured into the finished item. By definition, a substantial transformation occurs when an article emerges from a manufacturing process with a name, character, or use that differs from those of the original material subjected to the process.

Country of Origin Continued

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 has resulted 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 raw frame components, may help establish that various raw material, parts or components have undergone a substantial transformation into the finished product.

Country of Origin Continued

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 has more than a trifling amount of foreign content. In this situation, however, a conditional marking may be appropriate.

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.

Lacey Act
2. Compliance issues
The amendment made it unlawful to import plant or plant products without an import declaration containing 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

Lacey Act
2. Compliance issues
Due to this, Customs Animal Plant Health Inspection Service (APHIS), the section within Agriculture responsible 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 Act to determine whether or not the amendment applies to them.

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

FDA Lens Impact Testing Required

Testing and certification required for all lenses
5/8 inch steel ball is dropped 50 inches onto lens Statistically based sampling allowed

Certification letter must accompany every shipment

CONSUMER PRODUCT SAFETY IMPROVEMENT ACT

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

STATE ISSUES

California Proposition 65 - CA Prop 65

1. Duty to warn the consumer
2. Point of sale labeling requirements 3. Over 900 Chemicals

4. The Vision Council Resource Guide

ANSI Z80, Z87 and ASTM Updates

IMPACT OF STANDARDS UPDATES ON MANUFACTURING

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

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

ANSI Z80.5
Revised in 2010 with no major changes
Currently under comprehensive review Considering limited harmonization with the ISO frame standard

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.

ANSI Reader Standard

Reader standard being developed in the Z80 Committee and expected to be published late 2011
Adapting the ISO (International) standard for new ANSI 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

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

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

5. The Vision Council Resource Guide

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

US Optical Market Overview and Outlook

The Vision Council

Trends in Vision Correction:

Is America Seeing Clearly?

Percentage of American Adults Using Any Form of Vision Correction within Gender and Age Groups
Total wearing

75.7% 75.2%

Male

73.2% 71.9% 78.1% 78.3%

Female

12ME Dec 09
18 to 34 35 to 44
45 to 54 55+ 61.9% 58.0% 63.4% 61.8%

12ME Dec 10

84.3% 85.3% 91.6% 93.8%

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

Overall Market Performance

Vision Care Products & Services Total U.S. Market BreakoutIn Millions
-2.1% -3.1%
$8,139 $9,526

In Millions

All Retail*
Inflation not taken into consideration

12ME Dec 08 12ME Dec 09 12ME Dec 10

+7.7% +1.5%
$3,501

-11.1%
$3,217

$5,018

-24.0%
+7.9%
$671 $1,750

Frames

Lenses

Contact Lenses

Sunglasses*

OTC Readers

Examinations**

Refractive Surgery

*All retail includes dollars spent at all retail types 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.

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

Plano Sunglasses & OTC Readers

Plano Sunglass Retail Sales Dollars & Units

Retail Dollars (In Millions)
$3,617.7
$3,424.1

12ME Dec08 12ME Dec09 12ME Dec10

$3,217.5

Units (In Millions)

12ME Dec08 12ME Dec09 12ME Dec10

105.2 98.3
92.5

-6.0% 2010 against 2009 -11.1% 2010 against 2008

Nominal $s Not revised for Inflation

-5.9% 2010 against 2009 -12.1% 2010 against 2008

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

US Plano Sunglass Retail Sales 12ME Dec. 2010 By Channel (Millions)

Sunglass Specialty Drug/Grocery/Mass/Ware house Club Better Department & Specialty Stores Optical Chains
Optical Independent

9.9
32.5 3.5 1.1 1.0 2.4 $182.9 $331.7 $602.3

$1,194.8

$133.6
$113.9

Retail Units

Retail Dollars

Sport
Flea Market

3.0 $33.0

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

OTC Readers Wearers & Purchases

Ages 18+

In millions
Number of People Wearing

43.2

Number of Pairs Sold 44.2

41.4

43.8

25.1

25.6

26.3

26.5

12ME Dec 07

12ME Dec 08

12ME Dec09

12ME Dec10

Repurchase Cycle 0.58 years

0.62 years

0.60 years

0.61 years

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

Prescription Eyeglasses Ophthalmic Frames

Retail Structure of Frame Market (Dollars)

09/10

% change $8,400.7M
Independents 46.2% 47.0%

$8,278.7M

$8,139.4M

-1.7%

Chains

48.3%

+1.0%

Mass Merchandisers
30.2% Department Stores Other

29.5%

28.7%

-4.2%

16.1%
4.8% 2.7%

13.8%
5.1% 4.6%

11.7%
5.3% 6.1%

-16.7% +1.5% +28.5%

12ME Dec08

12ME Dec09

12ME Dec10

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

Eyeglass Frames Retail Price Point Profile In Units Trended

28.7% 24.8% 22.7% 20.3%

Retail Over $150

44.8%

56.8%

56.3%

58.9%

Retail $100$149

Retail Under $100

26.5% 22.4%
12ME Dec 2008

21.0%
12ME Dec 2009

20.8%
12ME Dec 2010

12ME Dec 2007

Base: Respondents purchasing frames

VisionWatch: The Vision Council Annual Sample Size: 100,000+ Adults

2011 / 2012 Outlook

Key Points: Future Outlook

A Weak Recovery Beginning to Take Effect
> Economic Conditions Improving by Still Weak
Lowering Unemployment, Strengthening Employment Outlook; Changing Employment Landscape Productivity Rising; Leading Economic Indicators are Up Consumer Spending and Consumer Confidence Rising

> Recovery is VERY Fragile

Rising Energy and Food Prices Political and Global Turmoil Housing Market Still Flat

Optical Specific
> Purchase Intent Up for Eyeglasses, Exams, Contact Lenses and Plano SG > ECPs Are Optimistic (But Still Cautious) About the Future > The Optical Industry is a Lagging Industry

THE VISION COUNCIL RELATED PROGRAMS/RESOURCES

Lens Description Standard - LDS

1. Standard for format for electronic data
2. Allows interface with
1. Laboratory Management Systems 2. Warehouse systems 3. Practice management systems

3. Flexible for new or existing lens products 4. Standard available on-line

Data Communication Standard - DCS

1. Standard for format for machine communication
2. Allows interface with
1. 2. 3. 4. Laboratory Management Systems, Warehouse systems Practice management systems Business Enterprise software

3. DCS Simulator

4. Standard available on-line

Job Tray Standard

1. Standard for format for job trays physical dimensions
2. Useful for development of automation 3. Standard available on-line

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.

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.

Contacts
Greg Chavez, Vice President of Member Services, gchavez@thevisioncouncil.org
Jeff Endres, Technical Director, jendres@thevisioncouncil.org Kenneth Frederick, Sunglass & Reader Division Liaison, kfred@gvtc.com Kenneth Wood, ASC Z80 Secretariat, ken@woodcolorado.com Amber Robinson, Manager, Member & Technical Programs, arobinson@thevisioncouncil.org

Websites
www.thevisioncouncil.org
www.z80asc.com ANSI eStandards Store