Summary of Petition from ICTA, FOE, ETC and others to the FDA

Here is summary of the petition to the FDA

The participants in the petition are -

International Center for Technology Assessment
Friends of the Earth
Greenpeace
ETC Group
Clean Production Action
Center for Environmental Health
Our Bodies Ourselves
Silicon Valley toxics Coalition
The primary six calls are (numbers are p. nos. and f refers to footnote) -

1. Calls for an advisory opinion.
2. Treat nanoparticles as new substances.
3. Label all nanoparticles ingredients.
4. Conduct of Programmatic EIS (justification 37).
5. Reopen the OTC Sunscreen Monograph and amend it to address all engineered nanoparticles as new substances (1999 monograph is inadequate and needs to be revised (51)).
6. Declare all sunscreens products will nanoparticles imminent hazards (photo-reactivity (60)) and request a recall until new drug applications submitted.

The textual arguments in the position highlight -

1. Enforcing appropriate nomenclature (8)
2. 720 products worldwide (13f) with 212 self-identified (WWC 13f).
3. Size reduction enhances intrinsic toxicity (15f, 16, 18).
4. Increased exposure levels and new routes of exposure (22f).
5. Call for predictive toxicity (see Nel 25)
6. FFDCA misbranding and mislabeling (drugs, devices, foods, cosmetics) (26-27).
7. Nanoparticles as a new class of non-biodegradable pollutants (30).
8. Laundry list of pathophysiological outcomes from exposure (59-60).

Major questions -

1. Some misrepresentation of study findings and conclusions.
2. Question of jurisdiction since labeling has shared jurisdictions between the FTC and the FDA.
3. FOE report on their own website covers cosmetics and sunscreens while the FTC petition is specific to sunscreens.