Future Tanning Rules Could Be Influenced By World Standards
FDA Pressured By International Committee
by Rick Mattoon
THE GLOBAL HARMONIZATION OF GOVERNMENTAL POLICIES is not a new issue—its advantages and disadvantages have been debated for decades. In the past, harmonization was an attempt at facilitating a standard of health and safety across the globe. Currently, the primary focus seems to be on promoting trade rather than safety- and health-enhancing concepts. Today, the indoor tanning industry has moved closer to the effects of global harmonization through pressures administered by the International Electrotechnical Commission (IEC).
At an April meeting of the Maintenance Team (MT16), a working group of the IEC, the team asked the Food and Drug Administration (FDA) to change the U.S. system of irradiance limits to harmonize “the markets.” The main difference between the IEC and FDA standards is that the approach to limit regulations is only based on dose limits, according to MT16 documents.
Additionally, at the Oct. 1, 2003 meeting of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), committee members heard proposals from Sharon Miller of the FDA, admittedly influenced by the IEC. Miller disclosed at the meeting that three of the government’s suggested rule amendments had been “fine-tuned or slightly modified since the last meeting partly in order to better harmonize with IEC.”
Specifically, the proposed amendments changed to satisfy world approval included warning labels, the definition of a manufacturer, and protective eyewear.
The proposed revised warning label would be required to include the text:
“WARNING”-Ultraviolet radiation may cause:
Injury to the eyes and skin
Skin aging
Skin cancer
Additionally,
the newly suggested label would include:
Read instructions carefully
Wear protective eyewear provided
Certain medicines and cosmetics may increase sensitivity to ultraviolet
radiation
Significant modification of a sunlamp would mean recertification as a manufacturer.
Regarding protective eyewear, UV limits would remain the same, but standards for the visible region (> 400 nm) would include a more quantitative definition: The luminous transmittance would not be less than 1 percent over the 380 nm to 780 nm wavelength region and, based on standards from the IEC, the 400 nm to 550 nm region would not be allowed to exceed 5 percent.
Just Who Is The IEC?
The IEC is reported to be the leading global organization that prepares and publishes international standards for all electrical, electronic and related technologies. These standards are designed to serve as a basis for international standardization and as references when drafting international tenders and contracts.
According to the IEC, its standards are vital since they also represent the core of the World Trade Organization’s Agreement on Technical Barriers to Trade, whose 100-plus central government members explicitly recognize that international standards play a critical role in improving industrial efficiency and developing world trade.
IEC standards claim to provide industry and users with the framework for economies of design, greater product and service quality, more interoperability, and better production and delivery efficiency while at the same time encouraging and improving quality of life by contributing to safety, human health and protection of the environment.
Many in the indoor tanning industry do not agree that the FDA should take direction from the IEC. “The ITA is against any change in the name of global harmonization,” says Dan Humiston, president of the Indoor Tanning Association (ITA). “We support the Bush administration’s position that … U.S. companies shouldn’t be mandated to harmonize for the sake of harmonizing.”
What’s In Store?
Global harmonization of products and technology could lead to lower levels of consumer protection through a “lowest common denominator” effect. For reasons of national independence, technological standards differ from country to country based on each nation’s circumstances and best interests.
Furthermore, eliminating or diminishing normal regulatory process will move the decision-making away from accessible and accountable state and national standard-making bodies to international groups that are largely inaccessible to indoor tanning representatives and typically operate without accountability to those who must live with their decisions.
Global-harmonization disputes could become more complicated as more FDA standards are manipulated to correspond with world preference. New dispute-settlement procedures will be necessary in resolving international disagreements. This will complicate even further the regulatory process, which has, for the most part, successfully maintained industry in this country for more than 200 years.
Although no TEPRSSC meetings are scheduled this calendar year, tanning advocacy groups will continue their vigil to ensure that future regulatory amendments expected to be addressed early next year are based on sound reasoning and not pressure from the international community.
