On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the
Administration
Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials
The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account…
U.S. Delegation May Present Nanotechnology Guidance at UN GHS Subcommittee Meeting
The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of…
Amended Federal Regulation Will Require Contractors to Report Purchase of Biobased Products
On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service…
FDA Releases Draft Guidance Documents on Nanomaterials
On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients…
B&C and Acta Will Hold an OSHA GHS Webinar
Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration’s (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations’ Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.…
Coalition Sues FDA Over Alleged Risks from Nanotechnology and Nanomaterials
A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011. The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center…
ICON Announces Availability of Presentation Slides from Training Course
On November 8, 2011, the International Council on Nanotechnology (ICON) announced the availability of the presentation slides from the modules for the training course entitled “Introduction to Nanomaterials and Occupational Health.” The course was developed under a grant from the Occupational Safety and Health Administration (OSHA), and is intended to prepare safety professionals…
NNI Will Hold Webinar to Announce 2011 EHS Research Strategy
The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group…
Nanotechnology Regulatory Science Act of 2011 Introduced in Senate
On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications…