Nanotech Policy Environment at FDA and NGO responses Ian S. Illuminato Friends of the Earth Collaborative on Health and the Environment (CHE) Partnership Call Health and Medicine: the Impacts of Nanotechnology October 11, 2007

Friends of the Earth is the U.S. voice of an influential, international network of grassroots groups in 70 countries. Founded in San Francisco in 1969 by David Brower, Friends of the Earth has for decades been at the forefront of high-profile efforts to create a more healthy, just world. Our members were the founders of what is now the world's largest federation of democratically elected environmental groups, Friends of the Earth International.

Nanotechnology and the U.S. Government NSET NTSC's CT NNI Nanoscale Science, Engineering and Technology Subcommittee National Nanotechnology Initiative National Science and Technology Council’s Committee on Technology

23 Federal agencies participate in the National Nanotechnology Initiative (NNI) Consumer Product Safety Commission USDA/FS Department of Commerce Bureau of Industry and Security, Technology Administration Department of Commerce, National Institute of Standards and Technology Department of Defense Department of Education Department of Energy Office of Science, Office of Basic Energy Sciences, Office of Fossil Energy, Office of Industrial Technologies Department of Health and Human Services, National Institutes of Health FDA NIOSH Department of Homeland Security Department of Justice Department of Labor Department of State Department of Transportation Department of Treasury EPA Intelligence Community International Trade Commission NASA National Science Foundation Nuclear Regulatory Commission Patent and Trade Mark Office NNI website:

NNI Agencies with R&D Budgets for Nanotechnology Department of Commerce, National Institute of Standards and Technology Department of Justice Department of Defense Environmental Protection Agency Department of Energy National Aeronautics and Space Administration National Institutes of Health National Science Foundation National Institute for Occupational Safety and Health Department of Agriculture (USDA), Cooperative State Research, Education, and Extension Service Department of Homeland Security Department of Transportation NNI website:

Agency 2001 Actual2002 Actual2003 Actual2004 Actual2005 Actual NSF DOD DOE DHHS (NIH) DOC(NIST) NASA EPA56557 USDA123 DHHS (NIOSH)3 DOJ11122 DHS2111 TOTAL Adapted from NNI website chart: NNI Budget History by Agency (dollars in millions)

Agency2006 Actual2007 Estimate2008 Proposed NSF DOD DOE DHHS (NIH) DOC(NIST) NASA EPA USDA (CSREES) DHHS (NIOSH) USDA/FS DHS DOJ DOT (FHWA)0.9 TOTAL Adapted from NNI website chart:

Budget for Environmental, Health, and Safety R&D, (dollars in millions) Agency2006 Actual2007 Estimate2008 request NSF DOD1.0 DOE DHHS (NIH) DOC(NIST) NASA0.0 EPA USDA (CSREES)0.1 DHHS (NIOSH) USDA/FS0.0 DHS0.0 DOJ0.0 DOT (FHWA)0.0 TOTAL Adapted from NNI’s Supplement to the President’s 2008 Budget.

Nanotech EHS Spending Must Increase Substantially EHS currently only 4% of NNI’s annual $1 billion budget Biggest chunk of NNI’s annual budget goes to Department of Defense [2006: $423.9 million] EPA received only $4.5 million budget from NNI in 2006 $8.3 billion spent on nano since NNI request for EHS budget is $58.6 million, an increase of 55% from 2006 spending: NOT ENOUGH!

FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. Ch. 9 et seq.) –Many currently available nano-products fall under FDA’s broad regulatory scheme –Cosmetics (21 U.S.C. § 361 et seq) –Sunscreens (21 U.S.C. § 321(g)) (classified as human drugs)

Nanotech’s History at FDA Early 2005: Under the National Cancer Institute’s (NCI’s) Alliance for Nanotechnology in Cancer, FDA works to accelerate nano cancer applications. FDA and NCI join forces under the nano-subcommittee of the Interagency Oncology Task Force (IOTF). May 16th 2006: International Center for Technology Assessment (ICTA) and Friends of the Earth (FoE) file citizen petition with FDA. August 2006: FDA launches its own FDA Nanotechnology Task Force “to identify and recommend ways to address knowledge or policy gaps to facilitate the safe and effective use of nanoengineered materials in FDA-regulated products.”

October 10 th 2006: FDA’s Task Force “first success,” FDA holds public meeting on nanotechnology, widely attended by NGO community and many presentations and comments submitted. July 25 th 2007: As promised at the Oct public meeting, FDA releases report Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force. August 2007: FDA proposes new sunscreens regulations that focus on sunscreen protection from UVA light. –As part of the proposal FDA has also solicited public comment on the safety and effectiveness of nano-sunscreens “because of the potential risk of nanoparticle ingredients penetrating consumers’ skin.” FDA also helps lead efforts on nano with a number of other organizations and working groups: NNI, NSET, NEHI, NPEG, GIN.

Citizen Petition to the US FDA First-ever Legal Action On Risks Of Nanotechnology May 2006: ICTA, FoE and coalition of consumer, health, and environmental groups file legal petition challenging FDA’s failure to regulate human health and environmental threats from nanomaterials. (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

The petition calls for: Comprehensive nanomaterial-specific regulations New paradigms of nano-specific toxicity testing Classification of nanomaterials as new substances Mandatory nanomaterial product and ingredient labeling Compliance with the National Environmental Policy Act (NEPA)

Petition Focus: Nano-sunscreens Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-market regulation. Red flags regarding free radical creation and DNA damage; unanswered questions about skin penetration. Despite their unique dangers and patented differences, FDA currently considers nano-sunscreens equivalent to bulk material sunscreens. Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre-marketing testing data proving the drugs’ safety and efficacy.

Friends of the Earth Nanomaterials, Sunscreens and Cosmetics Report –At least 116 cosmetics, sunscreens, and personal care products containing nanomaterials commercially available. Friends of the Earth Nanotechnology and Sunscreens Report –Surveyed more than 150 sunscreen manufactures on use of nanoparticles –After release, FDA opens comment period on nanotechnology in sunscreens, “because of the potential risk of nanoparticle ingredients penetrating consumers’ skin.” Recent Friends of the Earth Reports on Nanotechnology in Personal Care Products

The Nanotechnology Task Force Report: is this all we get? The report and the Oct public meeting are FDA’s biggest contributions to nano regulation and oversight thus far. The Task Force Report highlights comments received during the public meeting and comment period, yet excludes nearly all of them in its recommendations. FDA’s interpretation of “safety” is far from NGO position and could compromise human and environmental health. FDA relies to heavily on industry to assure nano product safety. FDA refuses to label nano products, compromising a consumers’ freedom to choose by his or her own judgment what is safe and healthy.

Task Force Report Statements Vs. Recommendations/Claims FDA states: FDA admits nano health risks: “Because of some of their special properties, nanoscale materials may pose different safety issues than their larger or smaller (i.e., molecular) counterparts.” FDA recommends/claims: No labeling: “because the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials.”

FDA states: “Developing a comprehensive description of products that are currently produced with nanotechnology…would be difficult at best, and likely infeasible.” Wilson Center’s Project on Emerging Nanotechnologies did it (2007): 500+ self-identified nano-products currently on the market. FDA recommends/claims: “The Task Force has considered a broad array of available information on a wide range of products, materials, techniques, and technologies.” What products? From what information? (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

Conclusion FDA must employ the precautionary principle for nano-products regulation: FDA highlights the fact that some “available information does not suggest that all materials with nanoscale dimensions will be hazardous,” which does not mean that many nano materials will not be hazardous. Adequate Regulation: A regulatory framework is needed that protects workers, the general public and the environment from the impacts of nanomaterials throughout their lifecycle. – FDA is not regulating nanotechnology. Why do they claim they are?

Learn from the past: FDA must act quickly if it hopes to avoid repeating the mistakes of past federal agency regulatory failures of “wonder” materials or technologies (e.g., asbestos, CFCs, DDT, PCBs, GMOs) Much more robust EHS Study: Adequate, publicly available, independent, peer-reviewed safety studies on the environmental and health impacts of nanomaterials FDA must not rely on voluntary programs: human and environmental health should not be left in the hands of industry.

For More Information: Ian Illuminato Health and Environment Campaigner Friends of the Earth US 1717 Massachusetts Avenue NW, Suite 600 P: F: E:

Resources Friends of the Earth US and Australia: and Woodrow Wilson International Center for Scholar’s Project on Emerging Nanotechnologies: Natural Resources Defense Council (NRDC): National Nanotechnology Initiative (NNI):