Bachelor of Science Abstract ID# 1401
Undergraduate Category: Social Sciences, Business and Law Degree Level: Bachelor of Science Abstract ID# 1401
Nano-Problems with No National Solution: State Actors in a Flawed Federal System ABSTRACT The growing and dynamic nanotechnology market builds on the existing issues of the domestic chemicals market. The lack of effective chemical regulation at the federal level in the last 40 years has caused a divergence in regulation within the United States. While the EPA has largely followed a policy of testing chemicals that are already in use, despite the fact they lack a nano-specific testing process, smaller actors within the United States, such as the State of California, have started to govern nanotechnology on their own. In a time wherein nanotechnology is beginning to permeate through the chemicals industry, the shortcomings of federal regulation have become too apparent for smaller actors to allow. These smaller actors are likely motivated by a realistic desire to become more prominent actors within the nanotechnology industry. Using comparative case studies and newly-released data on policies, markets and regulations, this project analyzes the differences between these strategies, e.g. the stricter regulations of California, the codified guidelines of Massachusetts, and the federal chemical regulations that have been repurposed, for nanotechnologies and their effects on markets, public health, and the environment.
BACKGROUND The federal U.S. regulatory regime on nanotechnology is hampered by the shortcomings of American environmental, health and safety laws in general due to a lack of nano-specific regulation. There is an overall trend toward the market, in a dichotomy between regulation and market. In the absence of nano-specific legislation, the EPA has begun to test nanotechnologies as part of its general mission on chemical regulation. The current attempt to test and classify nanomaterials on a large scale is a retooling of an existing high-output chemical testing program. The program, ToxCast, generates data and predictive models on thousands of chemicals, using high-throughput screening methods and computational toxicology approaches to rank chemicals by priority. The use of ToxCast as a test of nanomaterials is problematic. The program relies on a known exposure level for testing, a point that is highly contested and hard to verify. While in the notable cases of carbon nanotubes and silver nanoparticles the exposure levels were later verified in independent research, the lack of any mandate on the verification of exposure levels is concerning from a regulatory viewpoint. The EPA’s regulatory efforts are largely based on the requirement of a Premanufacture Notice (PMN) under Section 8 of the Toxic Substances Control Act (TSCA). The new, proposed nano specific rule would require PMNs for a reportable nano substance or “one that is solid at 25°C under atmospheric pressure and manufactured or processed so that its primary particles, aggregates, or agglomerates are 1-100 nm in size.” Reporting is also required for discrete forms of these substances, changed to alter the substances' size, properties, or both; mean particle size has been altered by 10% or more; the measured change in zeta potential, specific surface area, dispersion stability, or surface reactivity exceeds 7 times the standard deviation of the measured values. Substances excluded from reporting are those with PMNs covering their discrete forms that were submitted in or since 2005, biological materials, substances that completely dissolve in water, nanoclays, zinc oxide, and nano components of film. The problematic approach of federal regulators has opened the door for smaller actors, such as the city of Berkeley, Ca. and the State of California to play a more meaningful role in governance. This project attempts to explain the correlation between the problematic federal system and the rise of smaller, domestic actors within the nanotechnology domain.
CONCLUSIONS
RESULTS Date
Event
Explanation
1947
FIFRA passed
1976 1991
TSCA passed first US federal nanotechnology program NNI founded
Federal Insecticide, Fungicide, and Rodenticide Act Toxic Substances Control Act
2001 2006
2007
Cal. A.B. 289 Berkeley City Ordinance EPA Whitepaper
2008
NGO petition
2008
Cambridge Nano Study
2010
Nanotechnology Safety Act
2010
MA – Considerations for Development
2006
201
Nano-Silver Review
2014
2008 Petition Followup: Lawsuit
2015
EPA Agrees to Regulate NanoPesticides
The NSF initiated and funded the first US federal nanotechnology program on nanoparticle synthesis and processing National Nanotechnology Initiative, created to elicit growth and innovation in the domestic nanotechnology market California Law that gives the Cal. EPA authority to request information from manufacturers, regarding nanomaterials' health and environmental impacts as well as testing methods. Berkeley, Ca. becomes only U.S. city to regulate nanotechnology Outlines the agency’s view of nanotechnology and offers a strategy of how to mitigate risks of the emergent technology Prominent NGOs and the Center for Technology Assessment file petition urging the EPA to strengthen nano regulation Study commissioned by the City of Cambridge recommends against creating municipal level nano regulation First of many failed attempts at increasing the federal level of chemical regulation and updating TSCA. Official compilation of best practices and suggestions for managing the development of nanotechnology within the Commonwealth. The EPA releases a study on the health risks of silver nano-particles The Center for Food Safety leads a lawsuit against the EPA as a follow up to the 2008 petition As a response to the lawsuit, the EPA introduces a review and approval process for new nano-pesticides
REFERENCES http://www2.epa.gov/chemical-research/toxicity-forecasting http://www.ncbi.nlm.nih.gov/pubmed/21788197 http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=241665 http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2010-0572-0001 http://www.centerforfoodsafety.org/press-releases/3823/following-successful-cfs-lawsuit-epa-takes-two-nano-products-off-the-market https://chemicalwatch.com/22450/ngos-sue-us-epa-over-regulation-of-nanosilver https://chemicalwatch.com/biocideshub/22449/ngos-sue-us-epa-over-regulation-of-nanosilver http://innovationsgesellschaft.ch/en/us-ngo-fordert-verkaufs-stop-fur-nano-silber-produkte-bei-der-epa/ http://www.nytimes.com/2006/12/12/technology/12iht-nano.3870331.html?_r=0 http://step.berkeley.edu/White_Paper/Barandiaran.pdf http://www.cambridgepublichealth.org/publications/July_17_08_Nano_Recommendations.pdf http://archive.boston.com/business/globe/articles/2007/01/26/cambridge_considers_nanotech_curbs/ http://www.unitar.org/cwm/portfolio-projects/nanotechnology
The issues with the federal approach to chemical regulation have only been heightened by the emergence of nanotechnology. The complete lack of nano-specific regulation at the federal level, in combination with the proindustry bias of government initiatives such as the NNI has created a regulatory environment problematic enough for smaller actors to take action. The actors with the largest stakes in the nanotechnology market, even down to the municipality level, have taken it upon themselves to try and govern nanotechnology on their own, such are the inadequacies of the federal system. The failure to update the chemical policies of the federal regulatory system have led to an amazing amount of inter-actor tension. This has culminated in municipal level chemical regulation, an incredibly new precedent, and a series of lawsuits against the EPA, which while not a new course of action it has certainly seen an increase in the nanotechnology domain.
ACKNOWLEDGEMENTS A huge thank you to Professor Rodine-Hardy for being a wonderful mentor and teaching me so much.
Nano-Problems with No National Solution: State Actors in a Flawed Federal System ABSTRACT The growing and dynamic nanotechnology market builds on the existing issues of the domestic chemicals market. The lack of effective chemical regulation at the federal level in the last 40 years has caused a divergence in regulation within the United States. While the EPA has largely followed a policy of testing chemicals that are already in use, despite the fact they lack a nano-specific testing process, smaller actors within the United States, such as the State of California, have started to govern nanotechnology on their own. In a time wherein nanotechnology is beginning to permeate through the chemicals industry, the shortcomings of federal regulation have become too apparent for smaller actors to allow. These smaller actors are likely motivated by a realistic desire to become more prominent actors within the nanotechnology industry. Using comparative case studies and newly-released data on policies, markets and regulations, this project analyzes the differences between these strategies, e.g. the stricter regulations of California, the codified guidelines of Massachusetts, and the federal chemical regulations that have been repurposed, for nanotechnologies and their effects on markets, public health, and the environment.
BACKGROUND The federal U.S. regulatory regime on nanotechnology is hampered by the shortcomings of American environmental, health and safety laws in general due to a lack of nano-specific regulation. There is an overall trend toward the market, in a dichotomy between regulation and market. In the absence of nano-specific legislation, the EPA has begun to test nanotechnologies as part of its general mission on chemical regulation. The current attempt to test and classify nanomaterials on a large scale is a retooling of an existing high-output chemical testing program. The program, ToxCast, generates data and predictive models on thousands of chemicals, using high-throughput screening methods and computational toxicology approaches to rank chemicals by priority. The use of ToxCast as a test of nanomaterials is problematic. The program relies on a known exposure level for testing, a point that is highly contested and hard to verify. While in the notable cases of carbon nanotubes and silver nanoparticles the exposure levels were later verified in independent research, the lack of any mandate on the verification of exposure levels is concerning from a regulatory viewpoint. The EPA’s regulatory efforts are largely based on the requirement of a Premanufacture Notice (PMN) under Section 8 of the Toxic Substances Control Act (TSCA). The new, proposed nano specific rule would require PMNs for a reportable nano substance or “one that is solid at 25°C under atmospheric pressure and manufactured or processed so that its primary particles, aggregates, or agglomerates are 1-100 nm in size.” Reporting is also required for discrete forms of these substances, changed to alter the substances' size, properties, or both; mean particle size has been altered by 10% or more; the measured change in zeta potential, specific surface area, dispersion stability, or surface reactivity exceeds 7 times the standard deviation of the measured values. Substances excluded from reporting are those with PMNs covering their discrete forms that were submitted in or since 2005, biological materials, substances that completely dissolve in water, nanoclays, zinc oxide, and nano components of film. The problematic approach of federal regulators has opened the door for smaller actors, such as the city of Berkeley, Ca. and the State of California to play a more meaningful role in governance. This project attempts to explain the correlation between the problematic federal system and the rise of smaller, domestic actors within the nanotechnology domain.
CONCLUSIONS
RESULTS Date
Event
Explanation
1947
FIFRA passed
1976 1991
TSCA passed first US federal nanotechnology program NNI founded
Federal Insecticide, Fungicide, and Rodenticide Act Toxic Substances Control Act
2001 2006
2007
Cal. A.B. 289 Berkeley City Ordinance EPA Whitepaper
2008
NGO petition
2008
Cambridge Nano Study
2010
Nanotechnology Safety Act
2010
MA – Considerations for Development
2006
201
Nano-Silver Review
2014
2008 Petition Followup: Lawsuit
2015
EPA Agrees to Regulate NanoPesticides
The NSF initiated and funded the first US federal nanotechnology program on nanoparticle synthesis and processing National Nanotechnology Initiative, created to elicit growth and innovation in the domestic nanotechnology market California Law that gives the Cal. EPA authority to request information from manufacturers, regarding nanomaterials' health and environmental impacts as well as testing methods. Berkeley, Ca. becomes only U.S. city to regulate nanotechnology Outlines the agency’s view of nanotechnology and offers a strategy of how to mitigate risks of the emergent technology Prominent NGOs and the Center for Technology Assessment file petition urging the EPA to strengthen nano regulation Study commissioned by the City of Cambridge recommends against creating municipal level nano regulation First of many failed attempts at increasing the federal level of chemical regulation and updating TSCA. Official compilation of best practices and suggestions for managing the development of nanotechnology within the Commonwealth. The EPA releases a study on the health risks of silver nano-particles The Center for Food Safety leads a lawsuit against the EPA as a follow up to the 2008 petition As a response to the lawsuit, the EPA introduces a review and approval process for new nano-pesticides
REFERENCES http://www2.epa.gov/chemical-research/toxicity-forecasting http://www.ncbi.nlm.nih.gov/pubmed/21788197 http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=241665 http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2010-0572-0001 http://www.centerforfoodsafety.org/press-releases/3823/following-successful-cfs-lawsuit-epa-takes-two-nano-products-off-the-market https://chemicalwatch.com/22450/ngos-sue-us-epa-over-regulation-of-nanosilver https://chemicalwatch.com/biocideshub/22449/ngos-sue-us-epa-over-regulation-of-nanosilver http://innovationsgesellschaft.ch/en/us-ngo-fordert-verkaufs-stop-fur-nano-silber-produkte-bei-der-epa/ http://www.nytimes.com/2006/12/12/technology/12iht-nano.3870331.html?_r=0 http://step.berkeley.edu/White_Paper/Barandiaran.pdf http://www.cambridgepublichealth.org/publications/July_17_08_Nano_Recommendations.pdf http://archive.boston.com/business/globe/articles/2007/01/26/cambridge_considers_nanotech_curbs/ http://www.unitar.org/cwm/portfolio-projects/nanotechnology
The issues with the federal approach to chemical regulation have only been heightened by the emergence of nanotechnology. The complete lack of nano-specific regulation at the federal level, in combination with the proindustry bias of government initiatives such as the NNI has created a regulatory environment problematic enough for smaller actors to take action. The actors with the largest stakes in the nanotechnology market, even down to the municipality level, have taken it upon themselves to try and govern nanotechnology on their own, such are the inadequacies of the federal system. The failure to update the chemical policies of the federal regulatory system have led to an amazing amount of inter-actor tension. This has culminated in municipal level chemical regulation, an incredibly new precedent, and a series of lawsuits against the EPA, which while not a new course of action it has certainly seen an increase in the nanotechnology domain.
ACKNOWLEDGEMENTS A huge thank you to Professor Rodine-Hardy for being a wonderful mentor and teaching me so much.
