All Published Articles

Lynn L. Bergeson, Carla N. Hutton, "FDA’s Final and Draft Nanotechnology Guidance Documents: No Big Surprises," Nanotechnology Law & Business, Spring 2015.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.
Lynn L. Bergeson, "Comments Due July 6 On Proposed Reporting And Recordkeeping Requirements For Nanoscale Materials," Nanotechnology Now, April 6, 2015.

The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. 

Lynn L. Bergeson, "New Technologies and an Old Law: Renewable Chemicals Invite Challenges under TSCA," Natural Resources & Environment Volume 29, Number 4, Spring 2015.

The resurgence of chemical production derived from renewable feedstocks reflects the new business imperatives of which chemical product manufacturers are all keenly aware: produce greener chemicals and reduce carbon footprints. Careful review of the Toxic Substances Control Act (TSCA), a law enacted almost forty years ago during the heyday of petroleum-derived chemical production, suggests that more can be done now to promote the commercialization of renewable chemicals to achieve these imperatives. This article describes renewable chemicals, provides a brief overview of TSCA, discusses key TSCA challenges as applied to them, and suggests actions to ensure TSCA’s implementation now and potential future TSCA revisions to facilitate the commercialization of renewable chemicals. 

Lynn L. Bergeson, "USDA NOP Releases New Policy Memo on Nanotechnology," Nanotechnology Now, March 30, 2015.
The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations.
Lynn L. Bergeson, "EPA Issues Response to ICTA Petition Regarding Nanosilver," Nanotechnology Now, March 25, 2015.
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition.
Lynn L. Bergeson, "French Agency Publishes Opinion on Silver Nano Particles," Nanotechnology Now, March 24, 2015.
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on March 10, 2015, an Opinion concerning exposure to silver nanoparticles that "stresses the research that has been carried out to examine the potential health and environmental effects of silver nanoparticles but notes that this is still insufficient to allow the health risks to be assessed."
Lynn L. Bergeson, "OSHA Publishes HCS Compliance Guide," Chemical Processing, March 17, 2015.
On Feb. 9, 2015, the U.S. Occupational Safety and Health Administration (OSHA) published the Enforcement Guidance for the Hazard Communication Standard (HCS) effective June 1, 2015. The Guidance offers important insights into OSHA’s HCS enforcement strategy with regard to mixtures, and is therefore a must-read for stakeholders if they wish to be in the best possible position to avoid enforcement consequences for non-compliance with the HCS.
Lynn L. Bergeson, "EPA Eyes Perfluorinated Chemicals," Chemical Processing, February 11, 2015.

Between the late 1990s and early 2000s, the EPA identified potential issues presented by PFOS, a perfluorinated acid. Data showed PFOS to be present in low levels in humans and wildlife worldwide, and that PFOS appeared to be highly persistent. At the time, PFOS was used in industrial and consumer applications, including soil and stain repellant sprays, fire-fighting foams and semiconductor manufacture. Between 2000 and 2002, 3M Company, the principal domestic manufacturer of PFOS, voluntarily phased the chemical out of production. Working with industry, the EPA followed this action with a series of SNURs that were effectively intended to limit uses for which alternatives were not available. Several years later, similar concerns were raised with regard to PFOA, other LCPFACs, and other chemicals known as fluorinated telomers that potentially could degrade to PFOA in the environment. The EPA worked with the manufacturers and users of these chemicals to understand the risks and encourage development of alternatives. These efforts yielded the 2010/2015 PFOA Stewardship Program through which industry made and delivered on a series of commitments that, over time, made the current proposed SNUR possible. 

Lynn L. Bergeson, "EPA Promulgates SNUR for Polymer of Terephthalic Acid and Ethyl Benzene with Multi-Walled Carbon Nanotube (Generic)," Nanotechnology Now, February 3, 2015.

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs). The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  

Lynn L. Bergeson, "Canada Begins Review of SNAc Orders and Notices for Nanomaterials," Nanotechnology Now, February 2, 2015.

On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA). See http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2 According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify "significant new activities." 

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