Memoranda

Exactly three months from the date the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its Toxic Substances Control Act (TSCA) Work Plan initiative, EPA on June 1 announced an additional 18 chemicals scheduled for assessment during 2013 and 2014. EPA states that it selected the chemicals for a variety of reasons, similar to those it used to identify the seven Work Plan chemicals to assess in 2012. The chemicals span the...

At the request of California Governor Jerry Brown (D), the California Department of Toxic Substances Control (DTSC) withdrew its October 31, 2011, informal draft Safer Consumer Products regulations, as well as a revised formal draft scheduled for release in April. Brown reportedly had concerns regarding the scope of the regulations, the treatment of confidential business information, and duplication of existing federal and state regulations. Brown asked DTSC to issue new informal draft...

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed revised recommendations on permissible exposure limits (PEL) from FACOSH’s Emerging Issues Subcommittee. FACOSH is authorized by the Occupational Safety and Health Act and Executive Order (EO) 11,612, as amended, “to advise the Secretary [of Labor] on all matters relating to the occupational safety and health of federal employees,” including providing advice on...

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed revised recommendations on permissible exposure limits (PEL) from FACOSH’s Emerging Issues Subcommittee. FACOSH is authorized by the Occupational Safety and Health Act and Executive Order (EO) 11,612, as amended, “to advise the Secretary [of Labor] on all matters relating to the occupational safety and health of federal employees,” including providing advice on...

On May 3-4, 2012, the Pesticide Program Dialogue Committee (PPDC) convened its semiannual meeting in the U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. This memorandum summarizes the presentations and topics discussed during the meeting, which were organized into 12 sessions: Copies of most slides and handouts from the meeting are available on the PPDC website. Session I. Update Regarding Strategic Plans, Budget, and PRIA 3 Steve Bradbury, Director, Office of...

On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of...

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...

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...

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 March 29, 2012, India’s Department of Chemicals and Petrochemicals (DCPC), located within the Ministry of Chemicals and Fertilizers, announced the availability of a draft National Chemical Policy, 2012. The draft Policy is intended to facilitate the growth and development of the chemical sector in India. DCPC states that the policy “accords high importance” to research and development (R&D), technology up-gradation, safety and sustainability, pollution and environmental...

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...

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 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...

President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development,...