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B&C Consortia Management, L.L.C. (BCCM) and its affiliate groups, Bergeson & Campbell, P.C. (B&C) and The Acta Group (Acta), are pleased to announce that BCCM is now an associate member of the Toxicology Forum (Tox Forum). The Tox Forum is an international organization focused on addressing problems in toxicology through open dialogue among government, academia, industry, policymakers, and other interest groups. Tox Forum meetings are well-known for robust scientific discussions...

On August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on the market. In case of concern, the EC will request SCCS to provide an opinion. According to the EC website, to...

The Acta Group (Acta), Bergeson & Campbell, P.C.'s (B&C) consulting affiliate, will hold a complimentary webinar on September 19, 2012, to outline and discuss changes to the European Union (EU) regulations for companies marketing biocidal active substances and biocidal products in the EU. More information is available online. TSCA/FIFRA/IRIS/EPCRA EPA Publishes Peer Review Plans For Chemicals: On August 17, 2012, the U.S. Environmental Protection Agency (EPA) released its plans...

The United States Environmental Protection Agency (US EPA) has taken some bold steps recently to strengthen its authority over existing chemicals -- using its expansive, but much maligned, authority under the Toxic Substances Control Act (TSCA). TSCA is an old statute, and believed by many to be out of date. But in “repurposing” its interpretation of its TSCA authority, US EPA has confirmed that the statute is more than a paper tiger

NRDC challenges EPA’s FIFRA registration of nanosilver.

The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for Standardization (CEN) was initially developing the guidance and,...

Lynn L. Bergeson will chair a session of the first Sustainable Nanotechnology Organization (SNO) conference, which will be held November 4-6, 2012, in Arlington, Virginia. The conference will address the critical aspects of sustainable nanotechnology, including lifecycle assessment, green synthesis, green energy, food and agriculture, nanomedicine, industrial nanotechnology, environmental and biological fate, and the overall sustainability of engineered...

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.

September 19, 201210:00 a.m. – 12:00 p.m. (EDT)15:00 p.m. – 17:00 p.m. (BST)The Acta Group (Acta), Bergeson & Campbell, P.C.'s (B&C) consulting affiliate, will hold a complimentary webinar on September 19, 2012, to outline and discuss changes to the European Union (EU) regulations for companies marketing biocidal active substances and biocidal products in the EU. The new Biocides Regulation (EC regulation 528/2012) adopted on May 22, 2012, and effective September 1, 2013,...

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...

TSCA/FIFRA/IRIS/EPCRA EPA IRIS Announces Availability Of Literature Search For Benzo(a)Pyrene: On July 16, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of a literature search for benzo(a)pyrene (CAS No. 50-32-8). 77 Fed. Reg. 41784. EPA is also requesting scientific information on health effects that may result from exposure to this chemical substance as part of EPA's Integrated Risk Information System (IRIS). EPA will accept information related to...

EPA's recent proposals to apply its Significant New Use Rules (SNUR) authority under the Toxic Substances Control Act (TSCA) to “articles” raises legal and policy issues, and presents challenges to EPA and industry. Here is why.

In July, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products regulations, the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative. Below is a summary of the core elements of the proposed regulations -- chemicals of concern (COC), priority products (PP), alternative analysis (AA), and regulatory responses.

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...