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Phototoxicology:
Standards and Regulations in Photobiology
Forbes, Paul Donald1
Charles River Laboratories (Argus Division)1
Abstract-
Few of this Society s
members would list themselves as having a primary interest in the quality
and safety issues associated with light-related products and services.
However, a large percentage of the members have already contributed
to the science behind the regulations and standards governing applied
photobiology.
Regulatory and standards-setting bodies, both public and private, operate
with varying mandates related to the quality and safety of products
and services, or at least the standardization of defined activities.
A substantial number of standards and regulations now specify how certain
photobiological terms are defined, or activities are to be performed,
or devices are to function, or measurements are to be made. Course material
will include an annotated list of such standards and regulations. The
evolution of phototoxicology is one example of the impact of regulations
on applied photobiology. National regulatory bodies (drug administrations,
ministries of health, etc.) in attempting to protect the citizens, require
proof of safety (and in certain cases, efficacy) for products and services
in the marketplace. Some products are intentionally light-activated;
some are designed to be photoprotective; some have unintended light
interactions. The effects of the unintended interactions can range from
inconsequential to chemical instability to photobiological disaster.
In addition to several broad sets of regulations governing clinical
and contract laboratory activities (e.g., Good Clinical Practices, Good
Laboratory Practices), selected regulations and guidance documents address
specific categories of products and services (e.g., sunscreens, cosmetic
tanning businesses, drugs with potential photosafety issues, testing
for chemical photostability, light-emitting devices with unintended
effects, etc.). In this field, as in most, a body of standards and regulations
represents both limitations and opportunities. As it turns out, there
are probably few photobiologists who are not affected at all.
Keywords: phototoxicology,
regulations, standards, safety/efficacy
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