Blogs

On August 29, 2016, the Energy Regulatory Commission of Mexico (CRE) published fuel regulation NOM-016-CRE-2016 in the Mexican Federal Register. This fuel standard allows for the blending and sale of up to 5.8 percent ethanol in the nation's fuel supply outside of Mexico City, Guadalajara, and Monterrey. These new regulations will go into effect 60 days after publication of the bill, marking the first ethanol mandate to impact rural areas of Mexico. Guadalajara currently has a 2 percent...

On September 1, 2016, the Safety Equipment Institute (SEI) announced that it was selected to manage the U.S. Department of Agriculture's (USDA) Biobased Certification Program for the next five years. SEI is a subsidiary of ASTM International (ASTM), and has previously held the five-year contract with USDA to administer the USDA certification program that labels products as "biobased." This announcement comes on the heels of an update of ASTM's test method (D6866), that...

On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions." This meeting will receive public comments on EPA's algae guidance document, and will inform the development of EPA's "Algae Guidance for The Preparation of TSCA Biotechnology Submissions"...

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance).  A draft of this guidance was issued in April 2016 and comments were sought at that time.  More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products....

The American Chemical Society (ACS), together with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and Honorary Co-Hosts Representatives Ken Calvert (R-CA) and Earl Blumenauer (D-OR), through ACS’ Science & the Congress Project have announced that they will be hosting a panel on “Alternatives to Animal Testing:  Emerging Uses and Policy Implications” on Tuesday, September 13, 2016, from Noon - 1:30 p.m. on Capitol Hill at the Cannon House Office...

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&A).  EPA added a series of Q&As of particular relevance given the fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry to request a risk evaluation for persistent, bioaccumulative, and toxic (PBT) chemicals listed in the 2014 TSCA...

The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant.  How do you prevent getting infected with the Zika Virus, and what insect repellents are best?  The first question is easy to answer:  public health experts agree that women who are pregnant or who might be pregnant should use insect repellents.  The answer to the second question is not so simple. I am a former senior official at the U.S. Environmental...

The 2016 Global Summit on Regulatory Science (GSRS) will be held September 7-9, 2016, in Bethesda, Maryland.  Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting will focus on nanotechnology standards and applications, building on an October 11, 2015, GSRS workshop.  The 2015 workshop focused on physico-chemical measurements and standards relevant to...

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are: New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several...

On August 25, 2016, researchers at the University of Michigan, led by research professor John M. DeCicco, Ph.D., published "Carbon balance effects of U.S. biofuel production and use," a study examining the impact of biofuel production on carbon dioxide (CO2) emissions. The study, funded in part by the American Petroleum Institute, examined USDA crop-production data and determined that the increasing use of biofuels has resulted in a net increase of CO2 emissions, with only 37 percent...

On August 24, 2016, Brazil's government announced that it would not be extending a tax break on ethanol sales that is due to expire in December 2016. During the 2015 Paris Climate Accord, Brazil pledged to increase cane-based ethanol and biodiesel to nearly 18 percent of its total energy mix by 2030, requiring an increase in annual ethanol production from 30 billion liters in 2015/2016 to 50 billion liters in 2030. The loss of the ethanol tax break prevents biofuel from being cost...

On August, 24, 2016, the U.S. Department of Agriculture (USDA) Foreign Agricultural Service released an annual report on the Philippines' biofuel industry and ethanol imports. In January 2007, The Biofuels Act or Republic Act (RA 9367) was signed, creating biofuels legislation in the Philippines that now mandate a ten percent ethanol blend and a two percent biodiesel blend. While the Biofuels Act gives priority to local ethanol, supply issues with local ethanol production have resulted in...

The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on colloidal silver (nano). Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment.  According to the EC, it has received 63 notifications of...

Monday, September 12, 20168:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time Register Today With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016. All chemical stakeholders doing...

On August 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice of the establishment of a Science Advisory Committee on Chemicals (SACC) under Section 9(a) of the Federal Advisory Committee Act and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The notice also solicits comments and requests nominations for new members of the SACC.  The SACC expects to...

The National Institute of Environmental Health Sciences (NIEHS) is funding a new interdisciplinary Nanosafety Research Center at the T.H. Chan Harvard School of Public Health (HSPH).  The main focus of the new HSPH-NIEHS Center is to bring together scientists from across disciplines — material science, chemistry, exposure assessment, risk assessment, nanotoxicology, and nanobiology — to assess the potential environmental health and safety implications of engineered nanomaterials. ...

ASTM International's Committee on Plastics recently approved revisions to standard D6866, Test Methods for Determining the Biobased Content of Solid, Liquid, and Gaseous Samples Using Radiocarbon Analysis. This standard was originally approved in 2004, and is used by the U.S. Department of Agriculture's (USDA) BioPreferred® Program, by EPA when it is determining the sustainability of plastics, and by other corporations using biobased plastics. D6866 is used to determine the percent...

On August 10, 2016, Red Trail Energy, LLC, a North Dakota ethanol producer, announced that it, along with the Energy & Environmental Research Center, had been awarded $490,000 to examine the integration of carbon capture and storage (CCS). The study will consist of installing and operating a commercial CCS system in a facility producing approximately 63 million gallons of ethanol and 180,000 tons of CO2, and tracking the technical and economic parameters required. The total project is...

On August 18, 2016, the U.S. Environmental Protection Agency's (EPA) Office of Inspector General (OIG) released a report stating that EPA has not complied with federal requirements to study the effects of the Renewable Fuel Standard (RFS). The report, "EPA Has Not Met Certain Statutory Requirements to Identify Environmental Impacts of Renewable Fuel Standard," found that while EPA is required to provide a report to Congress every three years on the impact of biofuels, there has not...

Section 6(h) of new TSCA addresses persistent, bioaccumulative, and toxic (PBT) chemical substances listed in the 2014 TSCA Work Plan.  For such chemicals, Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.”  As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as will other high-priority chemicals.  Instead, EPA will proceed immediately to...

The U.S. Army Engineer Research and Development Center (ERDC) is developing a web-enabled information and screening tool intended to help small businesses integrating or developing nanoscale materials address uncertainty related to regulatory compliance and environment, health, and occupational safety (EHOS) risks.  To that end, ERDC is conducting a brief survey to identify resources, regulations, and risks that are most important to companies and other organizations involved in product and...

On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos.  The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions."  EPA sought the six month extension on June 29, 2016, to allow time for EPA...

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors.  The results of the review are published in the August 2016 issue of Trends in Food Science & Technology in an article entitled “Nanomaterials for products and application in agriculture, feed and food.”  The article highlights include: Nanotechnology is applied in agricultural production, animal feed,...

On September 12, 2016, Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®); Richard E. Engler, Ph.D., B&C Senior Chemist; and Kathleen M. Roberts, Vice President of B&C Consortia Management, L.L.C. (BCCM), will present "The New TSCA: Information and Reporting (Sections 8 & 14)" in conjunction with Chemical Watch. This free webinar is the third in Chemical Watch's Toxic...

On August 10, 2016, India's Oil Minister Dharmendra Pradhan spoke at a conference in New Delhi about the future of India's biofuel market. He discussed how a target five percent biodiesel blend and a ten percent ethanol blend in gasoline could increase the biofuels market from 65 billion rupees to 500 billion rupees by 2022. The Indian biofuel industry is currently trying to achieve a five percent biobased blend for both diesel and gasoline, and aims to increase the availability of...

On August 10, 2016, the U.S. Department of Energy (DOE) announced a $30 million expansion of the U.S.-India Partnership to Advance Clean Energy Research (PACE-R). DOE is partnered with the Indian Ministry of Science and Technology (MST), and both departments are committing $1.5 million annually over the next five years to expand research into smart grid and energy storage technology. U.S. and Indian private sectors will match the government commitments, resulting in a total of $30 million in...

On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA).  Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016. During the meeting, EPA solicited public comment in particular on the following five issues: To be able to...

The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016.  A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor...

On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA).  Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance,...

On August 1, 2016, DOE released a Funding Opportunity Announcement (FOA) for $7 million to research fuel and engine co-optimization technologies. Funding will be provided through the Co-Optimization of Fuels and Engines (Co-Optima) initiative, a collaboration between DOE's Bioenergy Technologies Office (BETO) and Vehicle Technologies Office (VTO), bringing together national laboratories and industry to conduct tandem fuel and engine research, development, and deployment assessments. This...

On August 2, 2016, DOE announced up to $11.3 million in funding to support the development of biomass-to-hydrocarbon biofuels conversion pathways. Three projects will receive the funding under MEGA-BIO: Bioproducts to Enable Biofuels to produce high-value bioproducts as well as economically competitive biofuels. The projects selected to receive this funding are: The Dow Chemical Company, working with LanzaTech and Northwestern University, to develop a process to convert biomass-derived synthetic...

On August 8, 2016, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee in the Federal Register. The purpose of the meeting is to develop advice and guidance promoting research and development (R&D) for biofuel and bioproducts production. A tentative agenda includes: Update on U.S. Department of Agriculture (USDA) Biomass R&D Activities   Update on DOE, Office of Energy Efficiency and Renewable Energy...

On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken with the proposed modernization of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework). The letter argues that an overly permissive regulatory framework for genetically engineered (GE) products has resulted in negative consequences, and that GE...

On August 11, 2016, the Bloomberg BNA Daily Environment Report quoted Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), on the implication of additional fees created by Toxic Substance Control Act (TSCA) reform. Companies that pay the costs of generating toxicity, exposure and other data should not be “double billed” through additional fees to review the resulting...

The comment deadline of August 15, 2016, is approaching on the June 14, 2016, notice of availability of the draft Pesticide Registration Notice (PRN) 2016-X issued by the U.S. Environmental Protection Agency (EPA), in consultation with the U.S. Department of Agriculture (USDA).  Draft PRN 2016-X proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use.” Federal Insecticide, Fungicide, and...

Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference.  The EU-U.S. NanoEHS workshop, “Enabling a Sustainable Harmonized Knowledge Infrastructure Supporting NanoEHS Assessment,” will be held October 24, 2016.  The objective of the workshop is to facilitate networking, knowledge sharing, and idea development on the requirements and implementation...

Under European Commission (EC) funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects. The TC seeks responses from companies manufacturing or processing manufactured nano-objects by September 5, 2016, to an online questionnaire relating to current disposal practices for manufactured nano-objects in waste. The guidelines are...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly...

Don't miss the upcoming European Commission (EC) Knowledge Exchange Platform (KEP) workshop "From bio-waste to bio-based products: the potential for regional innovation development." This Brussels-based session of the KEP Bioeconomy Showcasing Event will present the EC's biotechnology initiative and policy framework, as well as case studies on regional growth of biobased products. This workshop is scheduled for October 11, 2016, as part of the European Week of Regions and...

On July 25, 2016, the the Honorable Navdeep Bains, Minister of Innovation, Science, and Economic Development and the Minister responsible for the Federal Economic Development Agency for Southern Ontario announced a $12 million investment in Bioindustrial Innovation Canada. The Centre for the Commercialization of Sustainable Chemistry Innovations will be supported through the funding, and will help businesses quickly bring biobased products from final testing stages to the commercial market. This...

On July 29, 2016, the U.S. Department of Commerce's Economic Develop Administration (EDA) announced $4.4 million in grants to diversify and grow Maine's economy. This funding is intended to provide immediate assistance to rural communities that have been impacted by recent mill closures, focusing specifically on the forest sector of the economy. Bio-Based Maine, in partnership with the University of Maine, will receive $519,930 of the funding for a $856,549 project to develop a road map...

On July 27, 2016, the U.S. Environmental Protection Agency (EPA) Administrator signed the final rule Formaldehyde Emission Standards for Composite Wood Products, setting formaldehyde emission standards for hardwood plywood, medium-density fiberboard, and particleboard, as well as for finished products containing these products. This final rule discusses alternatives to regulated composite wood products, specifically mentioning Ecovative Design, LLC's packaging, building materials, and...

On July 29, 2016, President Obama signed into law Senate Bill 764 (S. 764), creating a national bioengineered food disclosure standard. This law requires companies to provide information on food packaging directing customers to a website or phone line for more information about genetically modified organisms (GMO) that are present in the food product. S. 764 also contains specific language preempting State regulations on "labeling of whether a food (including food served in a restaurant or...

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).  Canada will use the proposed approach to:  (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the...

On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and...

On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.”  This SAP was convened to advise...

The White House Office of Science and Technology Policy (OSTP) announced on July 29, 2016, that federal agencies released a white paper describing the collective federal vision for the emerging and innovative solutions needed to realize the Nanotechnology-Inspired Grand Challenge for Future Computing announced in October 2015.  The white paper, a collaboration by the U.S. Department of Energy (DOE), National Science Foundation (NSF), Department of Defense (DOD), National...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed changes to the existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as well as changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator...

On July 21, 2016, the European Court of Auditors released Special Report No 18/2016: The EU system for the certification of sustainable biofuels. This report assessed the existing biofuels sustainability certification framework of the European Commission (EC) and highlighted key issues with the system. Issues with the certification framework could undermine the European Union's (EU) 2020 goals for renewable energy. The report determined that the EC does not properly track working conditions...