Memoranda

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...

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,...

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...

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...

The U.S. Occupational Safety and Health Administration (OSHA) announced on March 20, 2012, that it has revised the Hazard Communication Standard (HCS), aligning it with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The final HCS rule will be implemented in various phases with full implementation by 2016 and, according to OSHA, will benefit workers by reducing confusion about chemical hazards in the workplace, facilitating safety...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2012, proposed significant new use rules (SNUR) that would require companies to report all new uses of five groups of chemicals, including in domestic and imported products and articles, to give EPA the opportunity, if warranted, to prohibit or limit the activity. The chemicals, which were part of the existing chemical action plans that EPA released in 2009 through 2011, are polybrominated diphenylethers (PBDE),...

On March 16, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of the long-awaited final test guidelines for Series 810 — Product Performance Test Guidelines, specifically public health uses of antimicrobial agents (OCSPP 810.2000), sterilants (OCSPP 810.2100), disinfectants (OCSPP 810.2200), and sanitizers (OCSPP 810.2300). These test guidelines are part of a series established by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use...

On March 14, 2012, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice concerning the results from the inert ingredient test orders issued under the Endocrine Disruptor Screening Program (EDSP). In January and February 2010, EPA issued test orders for the following nine chemicals currently used as inert ingredients in pesticide products: acetone; isophorone, di-sec-octyl phthalate; toluene; methyl ethyl ketone; butyl benzyl phthalate; dibutyl phthalate;...

Bergeson & Campbell, P.C.’s (B&C) thoughts are below on what may be headed our way in 2011 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). In short, the general trends established by the Obama Administration during the past two years are expected to continue notwithstanding the 2010 election results. At the same time, the impact of the election results, notably with the new Republican majority in the House...

On March 1, 2012, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced a work plan of 83 chemicals for further review under the Toxic Substances Control Act (TSCA). EPA identified seven chemicals for risk assessment in 2012, and intends to complete some of these assessments this year and initiate new assessments from the work plan in the coming years. EPA stated that, this Spring, it plans to identify specific chemicals...

If anyone is thinking big penalties under the Toxic Substances Control Act (TSCA) are a thing of the past, think again. On February 7, 2012, the U.S. Environmental Protection Agency (EPA) announced that Dover Chemical Corporation has agreed to pay a $1.4 million civil penalty for the unauthorized manufacture of chemical substances at facilities in Dover, Ohio, and Hammond, Indiana. The settlement resolves alleged violations of TSCA premanufacture notice (PMN) obligations for the production of...

On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM) convened a workshop at which invited U.S. Environmental Protection Agency (EPA) staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting (CDR) rule. EPA has recently issued a written report on its responses to the byproduct scenarios BCCM submitted. The written report is posted with EPA’s CDR training...

On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM) convened a workshop at which invited U.S. Environmental Protection Agency (EPA) staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting rule. For those of you who were unable to listen in, the recorded audio for the workshop is available on B&C’s website....

On January 18, 2012, the California Office of Environmental Health Hazard Assessment (OEHHA) issued final regulations that “specify the hazard traits, toxicological and environmental endpoints and other relevant data to be included” in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (DTSC) will develop. The Clearinghouse will be used, in part, to help DTSC identify chemicals of concern in consumer products as part of its...

On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM) convened a workshop at which invited U.S. Environmental Protection Agency (EPA) staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting rule. The following documents are available on B&C’s website: A recording of the workshop will be added to B&C’s website in the next few days. We wish to thank...

In a January 13, 2012, letter to U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson, Representatives Fred Upton (R-MI), Chair of the House Energy and Commerce Committee, and John Shimkus (R-IL), Chair of the Energy and Commerce Subcommittee on Environment and the Economy, asked EPA to postpone the Chemical Data Reporting (CDR) implementation and compliance deadlines from February 1, 2012, to align it with the future CDR submission periods — June...