Standards and Compliance in Today's US Optical Market

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Oct 19, 2013 (4 years and 23 days ago)

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Standards and
Compliance in
Today’s 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
establishment’s 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) What’s 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 company’s “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


IMPACT OF STANDARDS
UPDATES ON
MANUFACTURING

ANSI Z80, Z87 and ASTM Updates

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

VisionWatch:

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

Overall Market Performance

Inflation not taken into consideration

Vision Care Products & Services


Total U.S. Market
Breakout

In Millions


*
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.

All Retail
*

-
3.1%

+1.5%

-
2.1%

+7.9%

+7.7%

-
24.0%

In Millions

-
11.1%

VisionWatch:

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

Plano Sunglasses

&

OTC Readers




Plano Sunglass Retail Sales


Dollars & Units


Nominal $s


Not revised for Inflation

-
5.9% 2010 against 2009

-
12.1% 2010 against 2008

-
6.0% 2010 against 2009

-
11.1% 2010 against 2008

VisionWatch:

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

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

VisionWatch:

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

In millions

OTC Readers Wearers & Purchases

Ages 18+

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

$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)

VisionWatch:

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

Eyeglass Frames


Retail Price Point Profile

In Units
Trended

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.
Laboratory Management Systems,

2.
Warehouse systems

3.
Practice management systems

4.
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 isn’t 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