As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.
J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.
Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.
TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.
FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information. He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic." Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.
DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."
Other recommendations by Mr. Davies beyond long-term regulatory action are:
Research: dramatically increase federal nano-related EHS research funding (FY 2009 – $100 million; FY 2010 – $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.
Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.
Resource Requirements: increase regulatory agency budgets and staffing.
EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.
FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.
OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.
CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.
Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.
Public Involvement: give the public more information about nanotechnology; obtain the public’s views about nanotechnology; convene a stakeholder dialogue.
Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora’s box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora’s box."