Proposed Changes To The FDA Eyewear Standard

Don Smith · 05-21-2002, 04:58 AM

FYI:

I do not have the "language" of the changes to the eyewear "standard" that FDA will "propose" to TEPRSSC on Wednesday, May 22, 2002. And I doubt if anyone (except FDA) will see them before they are presented.

However, Ask Don has "found out" the sum and substance of these changes and he has some concerns about them.

Here"s what will be required in the future:

1. In order to be compliant, eyewear will be required to "allow" AT LEAST one percent transmission of the "weighted" (by the Luminous Action Spectrum) wavelengths between 400 nm and 550 nm (1% T).

2. In order to be compliant, eyewear MUST NOT allow more that five percent transmission of the "unweighted" (irradiance source) wavelengths between 400 and 550 nm.

Requirement 1 isn't a problem. Requirement 2, IMHO, IS a problem (and so I will make some comments about this requirement at the meeting).

I'll have more information for you after the TEPRSSC meeting.

Don[ This Message was edited by: Don Smith on 2002-05-21 09:49 ]

tangirl · 05-21-2002, 07:16 AM

Don - Have you done any testing on the current eyewear on the market? What are they allowing to be transmitted now?

Don Smith · 05-21-2002, 09:05 AM

FYI:

My thanks to Dr. Cyr for e-mailing me the "language" he will propose to TEPRSSC regarding eyewear. It is listed below.

Eyewear (goggles)Current FDA:
“The spectral transmittance shall not exceed a value of 0.001 over the wavelength region 200 to 320 nm, and a value of 0.01 for 320 to 400 nm, and shall be sufficient over the wavelength region > 400 nm to enable user to see clearly enough to reset the timer.”

Eyewear (goggles)Proposed:
"For visible region, a more quantitative definition: “the luminous transmittance shall not be less than 1% over the 400 to 550 nm wavelength region and the unweighted transmittance (2 nm intervals) shall not exceed 5%."

Don

PS To Tangirl: Yes, we have tested all of the most common eyewear at the UVR Research Institute and our tests have used tanning lamps as the irradiance source (and this is, we believe, VERY important). Unfortunately, I won't have time to post results before I have to leave for the airport. The "bottom line" is that some of the "new" eyewear (Sun Sets, Eye Candy, etc) that allow more "light transmission" won't "pass" the new requirements. More later.

BooBop · 05-21-2002, 09:25 AM

Thanks Don,. Oh my, I new the Eyecandy was questionable, but I thought the Sunsets were good to go. I have been selling quite a few of the Sunsets this year.

Don Smith · 05-21-2002, 09:47 AM

Mitzi:

Existing products will probably be "grandfathered" and so it will only be new products that will have to meet the new standards. Your Sun Sets are safe!

Don

Frankie · 05-22-2002, 11:46 PM

Don I have thought all along the eyecandy did not protect you like some of the others. The 2 times I used eye candy my eyelids got red. Is this the reason? I liked the way they fit my eyes but not the way they protected them. I am a stong believer in eye wear. My customers MUST show them each visit.

Makes a person wonder how they got by the FDA? I don`t think they should be
grandfathered if not up to Federal regulations.

Just my opinion... But What Do I Know??

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05-21-2002, 04:58 AM	#1 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,597 Rep Power: 10	FYI: I do not have the "language" of the changes to the eyewear "standard" that FDA will "propose" to TEPRSSC on Wednesday, May 22, 2002. And I doubt if anyone (except FDA) will see them before they are presented. However, Ask Don has "found out" the sum and substance of these changes and he has some concerns about them. Here"s what will be required in the future: 1. In order to be compliant, eyewear will be required to "allow" AT LEAST one percent transmission of the "weighted" (by the Luminous Action Spectrum) wavelengths between 400 nm and 550 nm (1% T). 2. In order to be compliant, eyewear MUST NOT allow more that five percent transmission of the "unweighted" (irradiance source) wavelengths between 400 and 550 nm. Requirement 1 isn't a problem. Requirement 2, IMHO, IS a problem (and so I will make some comments about this requirement at the meeting). I'll have more information for you after the TEPRSSC meeting. Don[ This Message was edited by: Don Smith on 2002-05-21 09:49 ]

05-21-2002, 07:16 AM	#2 (permalink)
tangirl Join Date: Jul 6 2001 Posts: 2,184 Rep Power: 8	Don - Have you done any testing on the current eyewear on the market? What are they allowing to be transmitted now?

05-21-2002, 09:05 AM	#3 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,597 Rep Power: 10	FYI: My thanks to Dr. Cyr for e-mailing me the "language" he will propose to TEPRSSC regarding eyewear. It is listed below. Eyewear (goggles)Current FDA: “The spectral transmittance shall not exceed a value of 0.001 over the wavelength region 200 to 320 nm, and a value of 0.01 for 320 to 400 nm, and shall be sufficient over the wavelength region > 400 nm to enable user to see clearly enough to reset the timer.” Eyewear (goggles)Proposed: "For visible region, a more quantitative definition: “the luminous transmittance shall not be less than 1% over the 400 to 550 nm wavelength region and the unweighted transmittance (2 nm intervals) shall not exceed 5%." Don PS To Tangirl: Yes, we have tested all of the most common eyewear at the UVR Research Institute and our tests have used tanning lamps as the irradiance source (and this is, we believe, VERY important). Unfortunately, I won't have time to post results before I have to leave for the airport. The "bottom line" is that some of the "new" eyewear (Sun Sets, Eye Candy, etc) that allow more "light transmission" won't "pass" the new requirements. More later.

05-21-2002, 09:25 AM	#4 (permalink)
BooBop I love Derf!! Join Date: Apr 5 2001 Posts: 9,496 Rep Power: 13	Thanks Don,. Oh my, I new the Eyecandy was questionable, but I thought the Sunsets were good to go. I have been selling quite a few of the Sunsets this year.

05-21-2002, 09:47 AM	#5 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,597 Rep Power: 10	Mitzi: Existing products will probably be "grandfathered" and so it will only be new products that will have to meet the new standards. Your Sun Sets are safe! Don

05-22-2002, 11:46 PM	#6 (permalink)
Frankie Join Date: Jul 24 2001 Location: BULLDAWG COUNTRY Posts: 242 Rep Power: 8	Don I have thought all along the eyecandy did not protect you like some of the others. The 2 times I used eye candy my eyelids got red. Is this the reason? I liked the way they fit my eyes but not the way they protected them. I am a stong believer in eye wear. My customers MUST show them each visit. Makes a person wonder how they got by the FDA? I don`t think they should be grandfathered if not up to Federal regulations. Just my opinion... But What Do I Know??

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