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FDA URGED TO GET OTHER AGENCIES’ INPUT ON NANOTECH
PETITION
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Date: July 28, 2006
A regulatory reform advocacy group
says a petition calling for nanoparticle-containing sunscreens to be regulated
as new drugs puts FDA "in the vanguard" of an international debate over how to
regulate nanotechnology, and urges the agency to seek advice from other federal
agencies, states, international regulators and stakeholders.
The Center
for Regulatory Effectiveness warns FDA that its decision on the petition could
set a major regulatory precedent, not only domestically but internationally as
well.
"The FDA’s action on the petition will have far-reaching and
precedent-setting impact in both the United States and foreign countries. The
FDA’s action will affect stakeholders all over the world on all sides of the
issue," CRE says in a June 6 letter to FDA.
CRE, without saying how it
thinks the petition should be decided, asks FDA to hold a public meeting and
actively solicit input on the petition.
The group agrees with the petitioners that FDA should not continue regulating
products that include nanotechnology on a case-by-case basis, but the group
believes a new FDA policy should be debated publicly, and should comply with the
Data Quality Act.
CRE spearheaded the DQA, which requires that federal
agencies justify regulatory decisions with scientific data. Some groups such as
environmentalists have argued that the law is aimed at slowing
regulatory
development, though some of the organizations associated with the pro-regulation
camp have tried to use the law to thwart policies they oppose.
The
environmental groups’ petition proposes a detailed regulatory regime for
sunscreens containing nanoparticles. The petition calls on FDA to mandate
labeling of nanomaterials in cosmetics, create toxicology testing specific to
nanotechnology, define nanomaterials and conduct
environmental studies that
comply with the National Environmental Policy Act.
The CRE letter states
that FDA is one of many regulatory agencies here and abroad struggling with
nanotechnology policy, and several standard-setting organizations also are
working on the matter. FDA nanotechnology policy is important and must be
deliberated in public, the group says.
FDA should seek comment on the
petition from any federal agency dealing with nanotechnology. FDA also should
solicit input from the states and international standard-setting organizations,
CRE says.
Proponents of stricter nanotechnology regulation worry that FDA
is regulating products that use nanotechnology under current existing schemes on
a case-by-case-basis instead of creating a distinct
regulatory scheme for
nanotechnology that it applies to all FDA-regulated products. They say the
current approach is especially problematic for cosmetics, which are lightly
regulated compared to other products such as drugs.
The environmentalists’ petition focuses on sunscreens because they are
regulated as nonprescription drugs, which FDA has the authority to regulate more
strictly than cosmetics. |