Page 40 - enLIGHTenment - November 2017

| legislationUpdatE

Continued from page 36

THe PerFormance STanDarDS
The performance standards for lighting

products are found in 21 CFR Subchapter
J Part 1040 of FDA documentation. Part

1040 is titled “Performance Standards for

Light-Emi ing Products,” but there are no
speci c requirements for LED.
California Prop65

1040.10 – Applies to laser products

1040.11 – Applies to speci c purpose

laser products
1040.20 – Applies to sunlamp products

and ultraviolet lamps intended for use in

sunlamp products
1040.30 – Applies to high-intensity

mercury vapor discharge lamps
Prop65: Labeling Deters Lawsuits

According to information provided by

Bloom eld, typical factors within the per-
formance standards are: source wavelength,
David Ga o, Manager/Product Compliance & Quality
radiant energy, irradiance, and radiance.

As per the FDA’s reporting guidelines, Control for Westinghouse Lighting, explained how
manufacturers are required to maintain
lighting manufacturers place themselves at risk for
records and submit reports to the Center for
Devices and Radiological Health (CDRH) for
lawsuits if they do not label their products correctly.
their electronic products that emit radiation.

Reports must be submi ed before a C
manufacturer can sell its product. If the alifornia Prop65 details a consumer warning that is required if there

product is imported, it is recommended to is a reasonable likelihood of exposure to any Prop65 listed chemical.
submit the corresponding report at least one As Ga o noted, “There are more than 900 chemicals listed to date,

month before those products arrive at the and new chemicals are added regularly.” Any product manufacturer whose

border/U.S. Customs. The CDRH needs at products are sold in California (or whose business is located in California) must
least one month to acknowledge receipt of supply this label. In areas where foreign languages are used, warnings must also

the report and provide an accession number.
be in those languages.
Bloom eld shared with the Engineering “To warn or not to warn, for lighting manufacturers that truly is the question,”

Commi ee that “currently the regulation Ga o said, adding, failure to warn (i.e. label) is virtually guaranteed to result in

appears only applicable to lamps (bulbs), how- legal expenses associated with frivolous lawsuits from “bounty hunter” rms.
ever discussions are on-going to determine if While warning labels add cost, take up valuable space on packaging, and may

LED luminaires will be within that scope.”
discourage some consumers from purchasing products they fear are “unsafe,”
some manufacturers may nd it less costly to label products based on a reason-

able likelihood that a speci c chemical may be present in order to reduce

testing costs and avoid potential litigation.
According to Ga o, most Prop65 cases are brought under the law’s “bounty

hunter” provision, which allows private plainti s to bring an action seeking
penalties for alleged violations. Apparently every month, scores of new cases

are led – mostly by a dozen or so highly active private plainti groups – alleg-

ing failure to warn due to the presence of listed substances. When it comes to
lighting, lead is the most commonly cited “chemical” in Prop65 lawsuits.

Continued on page 40

38 enLIGHTenment magazine | november 2017
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