On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth...
The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) hosted a webinar today concerning a web-based tool that EPA plans to make available to allow submission of Toxic Substances Control Act (TSCA) Section 8(e) notices via the Internet through EPA’s Central Data Exchange (CDX) portal. EPA plans to make slides from today’s webinar available online. EPA increasingly is seeking submission of notices and reports electronically...
April 23, 2012
FDA Issues Two New Draft Guidance Documents on Nanotechnology in Food Substances and Cosmetics
On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents on the use of nanotechnology in food and cosmetic products — “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process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 are Color Additives,” which is available online, and “Guidance...
April 20, 2012
George Washington University Regulatory Studies Center Convenes Panel Discussion on Moving Forward with IRIS Reform
On April 18, 2012, the George Washington University Regulatory Studies Center convened a panel discussion entitled Moving Forward With IRIS Reform: Implementing National Academies’ Roadmap for Revisions. Panelists included Dr. Lynn R. Goldman, Dean of the School of Public Health and Health Services and former Assistant Administrator for Toxic Substances at the U.S. Environmental Protection Agency (EPA); Rebecca Clark, M.P.H., Acting Director of EPA’s National Center for...
April 19, 2012
EPA Issues PR Notice Concerning SDSs As Pesticide Labeling to Address Non-Alignment with OSHA’s New HCS (U.S. Implementation of GHS)
The U.S. Environmental Protection Agency (EPA) is scheduled to publish on April 20, 2012, a Federal Register notice announcing the availability of Pesticide Registration Notice (PR Notice) 2012-1, entitled “Material Safety Data Sheets as Pesticide Labeling.” EPA issued the PR Notice on April 9, 2012, and EPA intends it to provide guidance to registrants concerning the relationship between EPA-approved labels for pesticides registered under the Federal Insecticide,...
April 17, 2012
EPA Issues Interim Guidance on the Elements of an Offer to Pay for the Use of Inert Ingredient Data
Since the establishment of the Endocrine Disruptor Screening Program (EDSP) and the U.S. Environmental Protection Agency’s (EPA) issuance of EDSP test rules for pesticide active ingredients and pesticide inert ingredients, questions have been raised regarding the procedures for addressing the compensability of data on inert ingredients. For example, on March 14, 2012, EPA published a Federal Register notice concerning the results from the EDSP inert ingredient test orders, in...
In light of the European Chemicals Agency’s (ECHA) recent release of Version 2.0 of its Guidance on Data Sharing, which provides assistance to companies placing substances onto the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation (EC regulation 1907/2006), and other developments, Bergeson & Campbell, P.C. has updated its memorandum on EU and international data compensation and sharing mechanisms. This...
On April 3, 2012, the European Chemicals Agency (ECHA) released Version 2.0 of its Guidance on Data Sharing to provide further assistance to companies placing substances onto the European Union (EU) market under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC regulation 1907/2006). The revised Guidance, available online, is a must read for entities wishing to optimize and protect their investment in chemical testing data. The original version...
Bergeson & Campbell, P.C. (B&C) wishes to remind the firm’s clients and friends that effective April 6, 2012, the U.S. Environmental Protection Agency (EPA) requires all chemical manufacturers or importers that submit a Toxic Substances Control Act (TSCA) Pre-manufacture Notice (PMN), a Microbial Commercial Activities Notification (MCAN) or other biotechnology notice for genetically modified microorganisms, a Notice of Commencement of Manufacture or Import (NOC), Significant New...
April 18, 20121:30 – 3:30 p.m. (EDT) Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. will hold a complimentary webinar 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...