Environmental Law ReSource : Environmental Lawyer & Attorney : Reed Smith Law Firm : Climate Change, Sustainability

This post was written by David Wagner.

Underscoring the U.S. Environmental Protection Agency (USEPA) intent to issue rules regulating nanomaterials this year, the U.S. Government Accountability Office (GAO) raised some concerns and offered remedies in its report issued late last month titled, “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk”.

In the report, GAO (an investigative arm of the U.S. Congress) stated its concerns that products with nanomaterials may be entering the market without USEPA review of all available information on their potential risk. Moreover, USEPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the relevant statutes include volume-based regulatory thresholds that may be too high to effectively regulate the production and disposal of nanomaterials.

Before offering recommendations, the GAO report discussed the growing world market for products that contain nanomaterials, which is expected to reach $2.6 trillion by 2015. The report identified a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics, and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future. According to GAO, the extent to which nanomaterials present a risk to human health and the environment “depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials.”

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This post was written by David Wagner.

On June 18, the European Chemicals Agency added eight substances to its Candidate List of “Substances of Very High Concern” under REACH, bringing the total to 38. A chemical’s placement on the Candidate List may lead to the phase out or restriction of that substance. The newly added substances are ammonium dichromate, boric acid, disodium tetraborate, potassium chromate, potassium dichromate, sodium chromate, tetraboron disodium heptaoxide, and trichloroethylene.

Although these substances are not formally restricted, the addition of substances to the Candidate List triggers obligations for manufacturers and importers. Most noteworthy is the requirement to provide safety data sheets to their customers for listed substances. Producers of products containing the substances must also provide safe-use information to consumers on request.  Additional obligations, including future requirements, can be found here.

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This post was written by David Wagner.

For the application of pesticides, the U.S. Environmental Protection Agency (USEPA) is taking a new position – it now aims to bring pesticide applicators under the Clean Water Act’s (CWA) permitting program. Earlier this month, USEPA released a draft CWA National Pollutant Discharge Elimination System (NPDES) pesticide general permit for point source discharges from the application of pesticides to waters of the United States. Under the Bush Administration, USEPA had issued a rule stating that these Clean Water Act permits were not required for applications of pesticides to U.S. waters. An appeals court decision vacated the rule in April 2009 and triggered the development of this proposal.

USEPA estimates that the court’s decision will require approximately 365,000 pesticide applicators nationwide, including farmers, land managers and other entities, to obtain NPDES permits by April 2011. The draft pesticide general permit covers applicators of biological pesticides and chemical pesticides that leave a residue in four categories of pesticide uses:

• Mosquito and other flying insect pest control
• Aquatic weed and algae control
• Aquatic nuisance animal control
• Forest canopy pest control

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This post was written by David Wagner.

In the past two weeks, the European Chemicals Agency (ECHA) has revised its online registration tool and clarified several issues, including the definition of “intermediate”.

REACH-IT, the Agency’s online registration tool, will now allow the members of a joint submission, when attempting to register their substances, to submit their dossiers as soon as the lead dossier has been accepted for processing. Under REACH, companies producing or importing the same substance must prepare a joint registration and nominate a lead registrant who will submit the registration dossier to ECHA. Prior to the change, ECHA would have had up to three months to review and process the dossier before issuing a registration number. Under the initial procedure, companies other than the lead registrant would have been unable to submit their own registration without first receiving the registration number. Now, with the change, ECHA stated that “members of a joint submission do not need to wait until the lead registrant has been informed that his dossier is complete and received the registration number before members can submit their dossiers.”

Also, based on some confusion among industry groups, ECHA restated the meaning of the term “intermediate." ECHA underlined that “an intermediate is a substance used in the manufacturing of another substance whereby the intermediate is itself transformed into that other substance” and added that “substances used in the production of articles cannot be regarded as intermediates.” Intermediates must be registered under REACH but are subject to lesser data collection and submission requirements than non-intermediate substances.

Under REACH, by November 30, 2010, registration dossiers must be submitted for substances manufactured in, or imported into, the EU in volumes of 1,000 metric tons or more per year, and for some hazardous substances at lower volumes.

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This post was written by Nicolle Snyder Bagnell and Ariel Nieland.

During a Marcellus Shale public forum meeting held last week near Scranton, Pennsylvania, the Pennsylvania Department of Environmental Protection (DEP) proposed a new regulation to be added to the most recent draft of proposed legislation regulating well construction. Under the proposed regulation, gas drilling companies would have to provide information about chemical usage on a well-by-well basis. This new proposal would require each company, upon completion of well construction, to disclose in a report a list containing all the names and total volume of chemicals used in the hydraulic fracturing process. The new proposal will be presented at a Pennsylvania Environmental Quality Board meeting for discussion on May 19, 2010. Scott Perry, director of DEP's Bureau of Oil and Gas Management, explained that this proposed regulation was drafted in response to a growing desire by the public for increased transparency with respect to well site development.

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This post was written by Amanda Tao and David Wagner.

In the past month, China's Ministry of Environmental Protection has released two directories of substances requiring additional certifications and permitting for import and export. The directories address 154 chemicals and 16 ozone depleting substances. The Chemicals Directory for which Import and Export are Strictly Controlled updates a previous list to include nine more chemicals than the previous directory of 2008. The additional chemicals are Tributyltin-oxide, Tributyltin fluoride, Chlorotributylstannane Tributyltin chloride, Tri-n-butyltinmethacrylate, Tributyltin benzoate, Tributyltin linoleate and Tributyltin naphthenate. Companies importing or exporting any chemicals on the list must apply to the ministry for an environmental management certificate.

The Directory on Ozone Depleting Substances for which Import and Export are Strictly Controlled, released on January 6, 2010, requires companies seeking to import or export a listed substance to apply for the approval from the National Administration on Import/Export of Ozone Depleting Substances, and then apply for an import/export permit from licensing organizations authorized by the Ministry of Commerce and then present the permit to clear customs.
 

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This post was written by Todd Maiden and David Wagner.

On January 13, 2010, the European Chemicals Agency added 14 substances to its Candidate List of “Substances of Very High Concern” under REACH, nearly doubling the original list of 16. The determination to include new substances on the Candidate List was based on their hazardous properties, the volumes used and the likelihood of exposure to humans or the environment.

A chemical’s placement on the candidate list may lead to the phase out or restriction of that substance. Fifteen chemicals were placed on the Candidate List in October 2008 and, of those, seven were proposed for phase out or restriction in June 2009. The European Commission has not yet adopted a decision banning or restricting any of the substances.

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This post was written by David Wagner.

In the last several weeks, there’s been some back and forth between researchers and regulators on how REACH legislation will affect costs and loss of animal lives.  In a study published on August 26 in the journal Nature, the researchers reported that toxicity testing required by REACH will cost $13.6 billion, or six times more than estimated, and require 54 million research animals, or 20 times higher than the previous estimate.  The study reports that the European Union’s cost estimate was based on preregistration of 29,000 substances which was well below the actual preregistration total of 140,000 substances.  Accounting for redundancies and mistakes in preregistration, the study estimated that a conservative estimate puts preregistration at about 68,000 substances.  Using this number as the basis for its analysis, the study determined that REACH’s costs are likely to be substantially higher, largely because of a requirement to test chemicals’ effects on reproductive systems in two generations of animals -- a test that requires a large number of test subjects. But the study’s results have been challenged by the regulators.

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This post was written by Nick Elliot.

On 7 July 2009, the European Court of Justice (ECJ) delivered its first judgement relating to the interpretation and validity of a provision of the REACH Regulations (REACH). This legal challenge concerned the interpretation and validity of Article 6(3) of REACH concerning the registration requirements applicable to “monomer substances”. However, it should come as no great surprise that the ECJ firmly rejected the legal challenge in its entirety.

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This post was written by David Wagner.

On June 1, 2009, the European Chemicals Agency proposed that seven chemical substances should be phased out or restricted under the EU’s REACH law. The European Commission will finalize the proposal through a regulatory process and, if adopted, the seven substances would be included in REACH’s Annex XIV list of substances subject to authorization. As a result, the substances could not be placed on the EU market unless granted exemptions for specific uses.

The seven were selected from the Agency’s October 2008 list of 15 candidate substances and the determination was based on their hazardous properties, the volumes used and the likelihood of exposure to humans or the environment. The seven substances are musk xylene; solvent hardener 4,4'-diaminodiphenylmethane (MDA); flame retardant short chained chlorinated paraffins (SCCPs); flame retardant hexabromocyclododecane (HBCDD); and plasticizers bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), and dibutyl phthalate (DBP). These chemicals are the first substances that would be subject to restrictions under REACH.

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This post was written by David Wagner.

On May 9, 2009, parties to the Stockholm Convention on Persistent Organic Pollutants (Stockholm POPs) agreed to add 9 new substances to the treaty’s annexes of banned or restricted substances. The Stockholm POPs treaty is an international agreement that initially targeted 12 substances to be eliminated from global commerce, and this month’s decision is the first addition of chemicals to the treaty since the original listing was adopted in 2001.

The decision to add substances was made at the 4^th conference of the treaty’s parties. The additions include PFOS, a chemical used in many electronic applications, such as semiconductor chips, photo imaging, textiles, and fire fighting foam; lindane, a pesticide that has been used to combat head lice; chlordecone, an agricultural pesticide; and hexabromobiphenyl, an industrial chemical that has been used as a flame retardant.

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This post was written by David Wagner, Lou Naugle, Nick Elliot and Todd O. Maiden.

With REACH Pre-Registration closed for existing substances, the European Union’s new chemical regime has shifted to the stage called pre-SIEF or Pre- Substance Information Exchange Forum. Following a relatively brief pre-SIEF phase for each substance, a SIEF will form from a pre-SIEF after potential registrants have agreed they intend to register the same substance. Keep in mind that after a substance is Pre-Registered, an extended deadline for Registration, based on volume and nature of the substance, is established ranging from 2010 to 2018. In preparing for Registration, the key issues for potential registrants to understand include collaborating efficiently when sharing data, understanding the roles of the SIEF and consortia, protecting confidential business information, and complying with European Community competition law.

As an initial step, a Pre-Registrant should see who else has pre-registered the same substance. The information should be displayed on a substance specific pre-SIEF page available through the European Chemicals Agency’s REACH-IT portal. A substance’s pre-SIEF page should include information on substance identification and company contact information for each Pre-Registrant (e.g., the company contact person or the only representative. Companies that have pre-registered a substance will automatically become listed on the pre-SIEF page of this substance. The information on the substance’s pre-SIEF page may also identify the SIEF formation facilitator for that substance or provide contact information to initiate discussions on pre-SIEF organization or on the “substance sameness” assessment (discussed below). If you pre-registered through an only representative and do not have access to this information, you may want to contact your only representative for log-in and password information.   

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This post was written by David W. Wagner,  Marie Albertini, Nick R. Elliot, Todd O. Maiden.

REACH is the European Union's new chemical management regime that is having a global impact. In addition to significant obligations for EU companies involved in the manufacture, import, downstream use, or distribution of about 30,000 chemical substances, non-EU companies involved in supply chains importing into Europe are facing requirements under this law. And the law extends well beyond chemical manufacturers and importers, as it applies to any sector using chemical substances, including, for example, electronic equipment, plastics, telecommunication equipment, IT products, commodities that contain chemicals (such as petroleum products and metals), and many others.

The first REACH requirement—pre-registration—closes Nov. 30, 2008. Manufacturers and importers who pre-register their substances by this deadline can then take advantage of the extended time available to complete the registration process—up until June 2018 for low-volume, low-toxicity substances. If the pre-registration window is missed, then the consequences can be severe: substances will be considered to be “new” chemicals, and a full registration must be completed before the substance can be legally marketed in the EU. Moreover, companies involved in a global supply chain of a chemical substance may face supply chain pressure, or requests for disclosure of potential uses and exposure information.

Have you been working to comply with REACH? Are you taking steps to ensure your supply chain will continue unaffected by REACH? If you have questions or concerns, please contact us. Reed Smith has been providing legal and strategic advice to a variety of clients on a range of REACH issues, including:

• Advising multinational and U.S.-based companies on REACH’s legal implications and the principal mechanisms to participate in the pre-registration and registration processes
• Counseling a multinational computer technology and electronics corporation on pre-registration requirements, REACH's regulation of substances of very high concern, Member States' enforcement, and issues unique to articles
• Helping several U.S.-based companies with operations in the EU satisfy their pre-registration requirements, and advising on communications and contractual relations with their suppliers and customers
• Advising a commodities trader on its REACH obligations and helping to develop a compliance strategy

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Following its official launch on June 1, the European Chemicals Agency (ECHA) has started to accept pre-registrations of chemicals under the REACH (Registration, Evaluation and Authorization of Chemicals) legislation. The 200 staff working at the agency have a mammoth task ahead of them, given that some 200,000 pre-registrations are expected.

REACH is designed to cut health risks associated with everyday chemicals by requiring companies to register safety information with the ECHA, and if necessary to substitute dangerous chemicals with safer alternatives.

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As of July 1, 2008, deca-BDE flame retardants are prohibited from new electrical and electronic equipment sold on the European Union market. The prohibition follows the European Court of Justice’s (ECJ) decision that annulled (i.e., voided) an exemption for deca-BDE (decabromodiphenyl ether) under the EU’s Restriction of Hazardous Substances (RoHS) Directive. While underscoring a global trend away from the use of deca-BDE, the decision also provides some insight into the judicial scrutiny of environmental legislation in the EU.

Although the RoHS Directive restricts the use in certain electrical and electronic equipment of six chemicals, it does provide for exemptions. Based on a risk assessment performed under the Existing Substances Regulation and, importantly, not the RoHS Directive, the European Commission had granted an exemption for deca-BDE. 

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This post was written by David Wagner.

On Oct. 8, 2008, the European Commission amended REACH to remove nanoscale carbon and graphite from its list of exempted substances. The substances were originally listed in REACH's Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties. Following a review and a report by an expert committee, the Commission changed its position. According to the regulation, there is insufficient information for carbon (CAS No. 7440-44-0) and graphite (CAS No. 7782-42-5) to be listed in Annex IV, "in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion" in Annex IV. As a result, both substances are now required to be registered under REACH.

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This post was written by Todd O. Maiden and Eric M. McLaughlin.

On Sept. 29, 2008, California Gov. Arnold Schwarzenegger signed two green chemistry bills—AB 1879 and SB 509—into law. This new green chemistry law totally refocuses chemical regulation in California, from reacting to chemicals after they have already been used in manufacturing or industrial processes, to assessing and regulating the use of chemicals in the design stage. The regulatory system created by the law will evaluate chemical risks and impose tailored restrictions based on science and the real-life impacts of chemical usage, rather than instituting an abstract chemical ban. California’s green chemistry law will take effect Jan. 1, 2009, which means the rulemaking process for the numerous regulations needed to implement the system will begin in earnest.

To achieve the goal of a regulatory system based on science and the real-life impacts of chemical usage and exposure, the green chemistry law was drafted using a comprehensive and collaborative approach. Implementation of the regulations will involve an interagency consultative process, incorporating chemical-related research done by other government agencies, and comments from stakeholders and the public. This approach, combined with the notice and comment requirements of the California Administrative Procedure Act, is intended to eliminate the ad hoc rulemaking seen with other environmental laws, such as California’s Proposition 65. Additionally, the scope of the law includes all chemicals used in consumer products, unlike the current patchwork of California laws that address only select product categories, such as lead in jewelry and on lunchboxes, chemicals in food containers, and household products such as light bulbs and batteries.

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