All Knowledge & Insights By Date

The French Ministry of Ecology and Sustainable Development published an order in the August 10, 2012, Journal Officiel de la République Française concerning the content and submission requirements for the annual declarations of information relating to nanoparticle substances, as substances or as part of a mixture. The order comes into force on January 1, 2013, and provides details on how companies should meet the mandatory declaration obligations.

On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces.” The review intends to: Summarize the general principles and theories of risk perception...

On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials: Carbon nanotubes in bone cements; Nanopaste hydroyapatite powder for bone void filling; Polymer setting material with...

On August 1, 2012, the U.S. Environmental Protection Agency (EPA) posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states “is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials.” According to EPA, “[t]he complex properties of various nanomaterials make evaluating them in the...

On July 25, 2012, the Senate Committee on the Environment and Public Works approved Senator Frank Lautenberg’s (D-NJ) amended Safe Chemicals Act of 2011 (S. 847) in a 10-8 partisan vote. While the bill does not explicitly mention nano, potentially relevant provisions remain in the amended text. These include the bill granting the Administrator the ability to determine that a variant of a chemical substance that exhibits one or more special substance characteristics either “is a use that...

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 Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific...

According to a July 10, 2012, memorandum added to the registration review docket for nanosilver, the Federal Register notice announcing the opening of the docket erroneously listed the comment period end date as August 19, 2012. The U.S. Environmental Protection Agency (EPA) memorandum states that the comment period has been extended to September 10, 2012, “to allow for a full 60-day comment period [that] is standard for registration review docket openings.”

The British Standards Institution (BSI) announced on July 9, 2012, the availability of three new standards and the development of a fourth standard intended to help mitigate the risks involved in manufacture and disposal of nanotechnology products. The three new Publicly Available Specifications (PAS) are: PAS 134:2012 — Terminology for carbon nanostructures, 2nd edition: Revised to help ensure the use of a consistent language across the disparate industries and...

The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”: A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help...

The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider the implications for use in legislation. RIVM intends the report to provide the basis...

On July 6, 2012, the U.S. Environmental Protection Agency (EPA) announced the establishment of a registration review docket for nanosilver. EPA states that registration review is its “periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.” Registration review dockets...

On July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to help compliance with the requirements for the safety assessment of nanomaterials intended for use in cosmetic products.  The...

The United Nations (UN) Food and Agriculture Organization (FAO) and World Health Organization (WHO) have released a draft paper entitled State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors for comment. FAO and WHO commissioned the paper with the objective of summarizing and analyzing the information that has become available since their 2009 expert meeting and determining possible courses...

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2012, the availability of an external review draft document entitled Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (EPA/600/R-12/043A). EPA states that the draft document “does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify...

The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach....

On April 16, 2012, the Natural Resources Defense Council (NRDC) filed its brief in its lawsuit against the U.S. Environmental Protection Agency (EPA) concerning EPA’s conditional registration for HeiQ AGS-20, an end-use product containing nanosilver. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA, seeking to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles and prevent EPA...

The Health Council of the Netherlands announced on May 22, 2012, the availability of a draft report proposing the implementation of an exposure registry and a system of health monitoring when working with engineered nanoparticles. The draft report states that, due to the concerns and lack of knowledge, the Health Council “considers it prudent” to create an exposure registry. The Health Council recommends that the exposure registry be created for “insoluble and poorly in...

The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in registration dossiers. Currently, according to ECHA, the...

On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment.  ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned aspects such as occupational exposure estimation and dose-response characterization for human...

The International Organization for Standardization (ISO) has published a Technical Report (TR) providing guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment.  ISO states that TR 13014:2012, Nanotechnologies — Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, “is intended to assist health scientists and experts to understand, plan, identify, and address relevant...