Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Tag Archives: Administration

FDA Bill Signed by President Includes Nanotechnology Provision

Posted in Federal, Legal/Regulatory Issues, United States
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… Continue Reading

Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
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… Continue Reading

U.S. Delegation May Present Nanotechnology Guidance at UN GHS Subcommittee Meeting

Posted in Federal, International, Legal/Regulatory Issues, United States
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 Standards… Continue Reading

Amended Federal Regulation Will Require Contractors to Report Purchase of Biobased Products

Posted in Federal, Legal/Regulatory Issues, United States
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… Continue Reading

FDA Releases Draft Guidance Documents on Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
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 that… Continue Reading

B&C and Acta Will Hold an OSHA GHS Webinar

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
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… Continue Reading

Coalition Sues FDA Over Alleged Risks from Nanotechnology and Nanomaterials

Posted in Federal, International, Legal/Regulatory Issues, United States
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… Continue Reading

ICON Announces Availability of Presentation Slides from Training Course

Posted in International, Occupational Health and Safety Issues
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 to address… Continue Reading

NNI Will Hold Webinar to Announce 2011 EHS Research Strategy

Posted in Federal, Legal/Regulatory Issues, Research, United States
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, will… Continue Reading

Nanotechnology Regulatory Science Act of 2011 Introduced in Senate

Posted in Federal, Legal/Regulatory Issues, Research
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… Continue Reading

FDA Regulatory Science Plan Addresses Nanomaterials and Nanotechnology

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to discover,… Continue Reading

IATP Criticizes Development of Nanotechnology Products Without Regulatory Oversight

Posted in Federal, Legal/Regulatory Issues, United States
The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps… Continue Reading

ITA Seeks Comments Concerning Regulatory Cooperation between the U.S. and EU

Posted in Federal, International, Legal/Regulatory Issues, United States
In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S.… Continue Reading

NIH and FDA Will Fund Research on Nanoparticles

Posted in Federal, Research, United States
In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press… Continue Reading

FDA Will Hold Public Workshop on Medical Devices and Nanotechnology

Posted in Federal, Legal/Regulatory Issues, United States
On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input… Continue Reading

Safe Cosmetics Act Would Allow FDA to Require Labeling of Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would: Monitor developments in the scientific understanding of any… Continue Reading

FDA Posts MAPP on Reporting Format for Nanotechnology-Related Information

Posted in Federal, Legal/Regulatory Issues, Research, United States
On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers… Continue Reading

FDA Responds to EWG’s Letter Concerning Sunscreen Guidelines

Posted in Federal, Legal/Regulatory Issues, United States
In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged… Continue Reading

American Academy of Dermatology Annual Meeting Includes Presentation on Nanotechnology in Cosmetic Products

Posted in Legal/Regulatory Issues, Research, United States
During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have… Continue Reading

FDA Spokesperson Says Regulatory Authority Is Sufficient to Address Nanotechnology

Posted in Federal, Legal/Regulatory Issues, United States
According to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to… Continue Reading

PEN Report on Oversight of Next Generation Nanotechnology Recommends New Federal Agency

Posted in Federal, Legal/Regulatory Issues, United States
On April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence… Continue Reading

FDA Assessing Feasibility of Using Nanotechnology Test to Detect Anthrax Following a Bioterrorist Attack

Posted in Federal, United States
On March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The… Continue Reading

FDA Announces Nanotechnology Collaboration

Posted in Federal, Legal/Regulatory Issues, United States
On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase… Continue Reading

FDA Panel States FDA Wants More Information before Issuing Guidance

Posted in Federal, Legal/Regulatory Issues, Research, United States
During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them… Continue Reading