EPA Announces More Muscular Use of TSCA Section 6

/in , ,

TSCA/Section 6 restrictions:

June 7, 2012 Jim Jones, Acting Administrator, Office of Chemical Safety and Pollution Prevention, announced that EPA plans to use TSCA §6 to ban or restrict the use of chemicals that pose an unreasonable risk.  This is an extension of the Administrator’s 2009 Comprehensive Approach to Enhance the Agency’s Current Chemical’s Management Program.  At that time, the Agency announced a renewed focus on identifying chemicals of concern and initiating appropriate risk management, including regulatory action to restrict or ban chemicals.  Jones’ Office explained that the agency intends to use its existing authority to the best of its ability until Congress enacts TSCA reform.  It noted that TSCA reform is one of the Administrator’s highest priorities.

Jones statement was made at the Environmental Council of the States’ State Environmental Protection in 2012 forum.  He spoke extemporaneously.  For further information, Jones’ Office recommends reviewing the Comprehensive Approach and the Administrator’s Essential Principles for Reform of Chemicals Management Legislation.  See also the Administrator’s September 2009 remarks announcing both efforts.

EU Member State Committee Identifies 5 More SVHCs

/in ,

REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.

New TSCA Work Plan Chemicals

/in , ,

TSCA/Work Plan for Existing Chemicals/Chemical Risk Assessment

June 1, 2012 EPA announced the addition of 18 chemicals to its work plan for existing chemicals risk assessment. The 18 chemicals include flame retardants, fragrance chemicals, and chlorinated hydrocarbons.  Many of these chemicals are potentially carcinogenic, or pose reproductive or developmental toxicity.  In addition, some of these chemicals present persistent, bioaccumulative, and toxic potential or are found in consumer products.  New and existing work plan chemicals are listed on EPA’s website.

As part of the Agency’s strategy to manage existing chemicals (see EPA’s Existing Chemicals Program Strategy (PDF), EPA has been screening chemicals against risk criteria (see e.g., Identifying Priority Chemicals for Review and Assessment).  Chemicals are likely to be flagged for further review and assessment if screening indicates:

  • children’s health effects (e.g., chemicals with reproductive or developmental effects);
  • persistence, bioaccumulation, and toxicity (PBT);
  • carcinogenic effect ;
  • presence in children’s products;
  • presence in consumer products; and
  • detection by biomonitoring programs. 

In the June 1 announcement, EPA solicited unpublished health and safety studies on these chemicals.  Research should be submitted to docket EPA-HQ-OPPT-20110-516 by August 31, 2012. Health and safety studies comprise “any study of any effect of a chemical substance or mixture on health or the environment or on both,” including but not limited to:

  • Epidemiological or clinical studies;
  • Studies of occupational exposure;
  • In vivo and in vitro toxicological studies; and
  • Ecotoxicological studies;

Risks assessments on the new work plan chemicals will be conducted in 2013 and 2014.

European Chemical Industry Debuts Chemical Combination Screening Tool – Concludes Regulating Individual Chemicals is Usually Adequate

/in , ,

Chemical Mixture Risk Assessment:

May 31, the European Chemical Industry Council (Cefic) unveiled a tool for assessing the risks posed by chemical combinations: the Maximum Cumulative Ratio (MCR) (see e.g., news release, combination effects tools).  MCR compares the toxicity of individual chemicals to the cumulative toxicity of all chemicals in an exposure scenario.  Cefic argues that in most exposure scenarios the risk of one or two chemicals contribute nearly all risk of harm.  The organization notes that prioritization of chemical combinations is necessary to identify combinations of concern that warrant full risk assessment. 

Cefic references Maximum Cumulative Ratio (MCR) as a Tool for Assessing the Value of Performing a Cumulative Risk Assessment (in International Journal of Environmental Research and Public Health) for full discussion of the application of MCR.  The article comprises an investigation of the magnitude of toxicity from multiple chemical exposure that is missed in scenarios where no cumulative risk assessment is conducted.  U.S. Geological Survey water quality data were used for the evaluation. From 5 to 81 chemicals were present in the 3,000 samples analyzed.  The authors estimate that approximately 20 percent of cumulative toxicity –compared to component chemical toxicity– is missed where cumulative risk assessments are not conducted.  However, mixture toxicities were dominated by only a fraction of chemical compounds present.

Because risk is usually driven by one or two chemicals in a combination, Cefic believes that controlling individual substances through the current regulatory schemes will often control the risk from combination exposures.

Cefic notes that MCR is based on the WHO risk assessment framework (see e.g., Combined Exposure Risk Assessment Workshop Report) and relies on cumulative risk assessment theories from the European Scientific Committees (see e.g., Environmental Risk Assessment of Mixtures Symposium).

EPA Draft (IRIS) Ammonia Assessment Available for Public Comment

/in , ,

Integrated Risk Information System (IRIS):

Today, EPA released for a 60-day public comment period the draft IRIS assessment for ammonia.   Excerpts from the agency’s press release are provided below, and a copy of the draft assessment is avaialble here. 

IRIS is a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants. Through the IRIS Program, EPA attempts to provide the highest quality science-based human health assessments to support the Agency’s regulatory activities.  The IRIS database is web-accessible and contains information on more than 550 chemical substances.  Readers familiar with IRIS will recall the various criticisms of the agency’s evaluation process, which EPA has been attempting to address, as described in further detail here.  General background information on IRIS is available here.

+++++++++++++++++++++++++++++++

FOR IMMEDIATE RELEASE

June 1, 2012 

EPA Draft Ammonia Assessment Available for Public Comment

Draft assessment continues agency’s responsiveness to NAS recommendations 

WASHINGTON – The U.S Environmental Protection Agency today announced the release of its draft Integrated Risk Information System (IRIS) health assessment for ammonia. The draft assessment will be available for public comment for 60 days and will be sent for independent expert peer review.

Ammonia is used in agricultural fertilizers, the manufacture of pharmaceuticals and explosives, water purification, household cleaners, as a refrigerant, and in many industries. Scientific studies show that ammonia can affect the respiratory system. The draft assessment includes an estimate of the amount of ammonia a person can inhale daily throughout a lifetime that is not likely to cause harmful health effects, which is less stringent than the current value for ammonia on IRIS.

 The draft IRIS assessment for ammonia represents major progress for EPA in implementing the April 2011 National Academy of Sciences (NAS) recommendations for improving IRIS assessments. The draft assessment uses a new streamlined document structure that is more transparent and clear; includes a template for describing the literature search approach; identifies the strengths and weaknesses of analyzed studies; and describes how EPA applied their guidance, methods, and criteria in developing the assessment.

 When the assessment is final it will be posted to the IRIS database. IRIS is a publicly available online database that provides high quality science-based human health assessments used to inform the agency’s decisions on protecting public health and the environment.

  The IRIS database contains crucial information on more than 550 chemical substances and their impacts on human health. Governments and private entities use data from IRIS in conjunction with exposure information to help characterize the public health risks of chemical substances. These characterizations are then considered in risk management decisions to protect public health. 

Cefic Reports on EU Chemical Industry Sustainability Initiatives

/in , ,

Sustainability:

The European Chemical Industry Council (Cefic) published The Chemical Industry in Europe: Towards Sustainability on May 8. In the report, Cefic stresses the importance of applying sustainable chemistry to the entire product life cycle, beginning with consideration of raw material sourcing impacts, and including manufacturing, packaging, transport and distribution, sales and use, and post-use recovery or disposal. Towards Sustainability asserts that chemistry innovation is a catalyst for sustainable innovation in up- and downstream industries including consumer product sectors. In addition, the authors argue that “Industry’s ongoing focus on using renewable raw materials is helping identify new ways of protecting the environment.”

Towards Sustainability details chemical industry initiatives to reduce waste, drive down emissions, conserve resources, and improve energy efficiency. Major reductions in emissions purportedly have been achieved through optimizing production processes and implementing improved emission control technologies. Industry initiatives promote energy efficiency through the value chain. Many companies have applied new technologies and processes to use fewer raw materials and to reuse or recycle products in a closed loop system. In addition, reducing the amount of material in products without performance loss, down-gauging, has helped industry optimize resources. Also, partnerships throughout industry have turned waste into resources. According to the report, successes include:

  • an International Association for Soaps sustainability project which reduced water use during manufacture, emissions, packaging;
  • detergent manufacturers reduced the impact of shipping by reducing chemicals, packaging and energy used in product manufacturing;
  • excess heat and CO2 from fertilizer manufactures pumped to local greenhouses;
  • glucose-containing effluent generated by a one producer is used by a nearby chemical complex to maintain bacteria levels in its biotreatment plant; and
  • a new abatement system at an ink manufacturer reduced emissions from the stream by 98 percent.

The industry has also published technical information on abatement and recovery options for solvent emissions.

Featured in the report is a case study on the relationship between new chemical industry products and development of a sustainable construction sector. For example, Cefic explains, plastic insulating materials save many times the amount of energy used in production. The materials are stable and durable, and unaffected by moisture, rotting, or mold. And plastic materials are easily and completely recyclable or recoverable.

Towards Sustainability stresses the importance of sustainability to corporate viability. The authors quote securities analyst statements, such as

“Investors are beginning to acknowledge the impact of sustainability topics on a company’s financial valuation. By adopting effective product life cycle assessment strategies chemical companies can realign their portfolios towards sustainable innovation and at the same time provide financial investors with increased transparency about their commitment to sustainability.” Andrea Ricci , Equity Analyst -Sustainable Asset Management

The report also highlights Cefic members’ efforts to enhance chemicals management throughout the supply chain. Activities include:

  • an effort in the polyvinyl chloride industry to improve behavioral safety;
  • outreach by the solvents sector on safe working practices;
  • safe handling cyanides through the entire value chain; and
  • best practices outreach by the formaldehyde industry.

Towards Sustainability also reports that industry is working with academia, regulators and NGOs to identify alternatives to the use of animal testing. Cefic is a founding member of the European Platform for Alternatives to Animal Testing which focuses on meeting safety requirements while also reducing the use of and replacing animal testing.

Towards Sustainability can be downloaded from Cefic’s website.

DTSC Requests Nominations to Green Chemistry Category of GEELA 2012 Awards

/in ,

Green Chemistry:

The California Department of Toxic Substances Control is requesting nominations for the “Green Chemistry Category” of the Governor’s Environmental and Economic Leadership Award (GEELA) Program.  The so-called GEELA awards are California’s highest environmental honor.  More information is available in the excerpt below.  If readers know of any deserving candidate – and there undoubtedly many – please forward to the appropriate person a link to this blog entry.

+++++++++++++++

The Governor’s Environmental and Economic Leadership Awards

GEELA 2012

The Governor’s Environmental and Economic Leadership Award Program is California’s highest environmental honor. The program recognizes individuals, organizations, and businesses that have demonstrated exceptional leadership and made notable, voluntary contributions in conserving California’s precious resources, protecting and enhancing our environment, building public-private partnerships and strengthening the State’s economy. 

The Department of Toxic Substances Control (DTSC) invites your organization to submit entries for the 2012 GEELA Awards in the Green Chemistry category. This category focuses on businesses, academia and nongovernmental organizations that are leading innovation and development of safer, and more environmentally benign consumer products, formulations, and technologies. Entries should demonstrate benefits to human health and the environment through using less hazardous chemical components and processes. Lifecycle perspectives should also be presented, especially those incorporating pathways for reuse, recycling, and improved management of chemical components.   

Anyone wishing to apply for, or nominate an individual, organization, or business, for a 2012 Governor’s Environmental and Economic Leadership Award should submit an application by June 22, 2012.

For more information, visit:http://www.calepa.ca.gov/Awards/GEELA/2012/GrnChemApp.htm

Phil Moffat Will Speak at Informa Conference about REACH-like Programs Outside the EU and US

/in

Global Chemical Regulation:

Verdant Law is pleased to announce that Phil Moffat will be speaking at the upcoming Informa conference, “REACH and CLP:  Practical and Technical Strategies for American Exporters to Europe on REACH and CLP Requirements and the Impact of Future Regulatory Strategy.”  Mr. Moffat will talk about other chemical regulatory programs outside the EU and the US in his presentation, “Beyond REACH: Comparing and Approaching Upcoming REACH-like Regulations Across the World.”  The conference is being held August 1 – 2, at the Hilton North Raleigh/Mid Town Hotel in Raleigh, North Carolina, USA.  Additional details are available here. 

Update:  A copy of Mr. Moffat’s presentation is available here. Moffat_REACH_around_world

California DTSC Announces Two-Day Workshop on Alternatives Assessment

/in , ,

Green Chemistry/Alternatives Assessment:

The California Department of Toxic Substances Control (DTSC) has announced an upcoming two-day workshop on alternatives assessment, a key component of the department’s much-anticipated Safer Consumer Product Alternatives (SCPA) Regulations.  Those regulations are in turn a key component of the state’s vaunted Green Chemistry Initiative.  The timing of this announcement suggests that DTSC will soon release the official draft of the SCPA Regulations.  The workshop will be held in Chatsworth, California from June 4 -5, 2012. Registration information and other details are set out below.

______________

Alternatives Assessment 101

What: Two-Day Training

When: June 4-5, 2012

Where: Chatsworth, CA

California’s Safer Consumer Products draft regulation requires alternative assessments for certain priority chemicals and products. Would you like to know more about alternatives assessment?

 

 

If you have not performed an alternatives assessment-

 

 

This training is for you! Gain practical, hands-on experience and insights.

 

If you have already conducted alternatives assessments-

 

 

Strengthen your understanding, exchange experiences, and learn from your peers through this two day training from specialists in alternatives assessments.

This two day training from the University of Massachusetts (UM) is in partnership with California’s Department of Toxic Substances Control (DTSC). Participants will be introduced to the process of assessing safer alternatives for chemicals and products through sharing experiences with researchers from UM’s Toxics Use Reduction Institute (TURI) and the Lowell Center for Sustainable Production. DTSC staff will lead a discussion on the role of alternatives assessment in California’s draft Safer Consumer Products Regulation.

 

 

 

Visit for more information and to register:

http://sustainableproduction.org/proj.summerinstitute.overview.php

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Irene Hantman to Moderate ABA Panel on Federal Suspension and Debarment Authority

/in ,

Enforcement:

Verdant Law is pleased to announce that Irene Hantman will be moderating a panel on the federal government’s suspension and debarment authority.  The program, “Suspension and Debarment an Administrative Tool for Addressing NonCompliance: Perspective from EPA,” is sponsored by the ABA Sections on Administrative Law and Environment, Energy, and Resources.  It will be hosted at EPA Headquarters Tuesday, May 15, 2012 from 12:00 – 1:30 EST.  Additional details are set out below, and available here.

+++++++++++++++++++++++++++

Tuesday, May 15

Suspension and Debarment:   An Administrative Tool for Addressing NonCompliance: Perspective from EPA

The Section of Administrative Law, Environmental Law Committee and the Section of Environment, Energy and Resources In-House Counsel Committee invite you to attend a Brown Bag program 12:00-1:30 EST Tuesday, May 15, on the federal government’s suspension and debarment authority. Companies subject to these actions are unable to participate in government contracts, subcontracts, loans, grants, and other assistance programs. Being subject to such an action, or even the threat thereof, can have an immeasurable impact on a company, and can serve as a powerful incentive for a company to improve its compliance program. The effect of suspension and debarment by a Federal agency is government wide and can be extended to include subsidiaries and parent companies. Join SEER’s In-House Counsel Committee and EPA officials to learn how the Agency uses suspension and debarment as a tool for deterrence, what constitutes an actionable offense, and the regulatory framework. The program will also present industry perspectives and address control systems and remediation efforts.

Panelists are:

  • Stacey Dey-Foy, EPA
  • Irene Hantman, Verdant Law PLLC (Moderator)
  • Richard Pelletier, EPA
  • Steve Solow, Katten Muchin Rosenman LLP, Washington, DC
  • Mike Walker, EPA

To Register:

To attend this brown bag on-site free of charge at EPA or for remote participation contact Alice Mims: (202) 564-6069 or mims.alice@epa.gov.