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Monthly Federal Developments Memorandum
October 1, 2012

Monthly Update for October 2012

Bergeson & Campbell, P.C.

TSCA/FIFRA/IRIS/EPCRA

State FIFRA Issues Research And Evaluation Group Holds Meeting: On September 17-18, 2012, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) Pesticide Operations Management (POM) Working Committee (WC) held its semi-annual full committee meeting in the U.S. Environmental Protection Agency (EPA) offices in Crystal City, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and EPA in the development of pesticide policies and regulations. More information about SFIREG and its committees is available online. A more detailed memorandum is available online.

Issues of potential interest discussed during the meeting included the following: Office of Pesticide Programs (OPP) update; the use of the term “non-crop” on the label; risk mitigation measures beyond the applicator; personal protective equipment (PPE) garment standards; EPA stamping supplemental labels; and other topics.

NRC Committee On IRIS Process Holds Public Session: The National Research Council (NRC) Committee to Review the Integrated Risk Information System (IRIS) Process held its first meeting on September 17-18, 2012, opening with a public session on September 17, 2012. EPA has asked NRC to review the IRIS process and changes being implemented or planned by EPA, and recommend modifications or additional changes as appropriate to improve the scientific and technical performance of the IRIS Program. According to the Committee’s website, the Committee will focus on the development of the IRIS assessments rather than the review process that follows draft development. The Committee’s website states that, “ecause several reviews of IRIS assessments have expressed concerns about EPA’s weight-of-evidence analyses, the committee will review current methods for evidence-based reviews and recommend approaches for weighing scientific evidence for chemical hazard and dose-response assessments.” Speakers during the September 17 meeting included EPA’s Dr. Kenneth Olden, Director of the National Center for Environmental Assessment (NCEA), and Dr. Vincent Cogliano, Acting Director of the IRIS Program. The public session also included a discussion concerning weight-of-evidence. This discussion centered on the current methods and guidelines the IRIS Program follows in synthesizing data and how to best weigh the relevance of results when problems arise in the types of studies available for a particular chemical (e.g., lack of animal studies, issues with exposure route, or exposure levels). A more detailed memorandum is available online.

Design For The Environment List Of Safer Chemical Ingredients: On September 19, 2012, EPA posted a List of Safer Chemical Ingredients that contains chemicals that meet criteria applied by the Design for the Environment (DfE) Safer Product Labeling Program. This program recognizes products that are high-performance and cost-effective while using the chemical ingredients EPA has identified as “safer.” At present, more than 2,800 common household and other products carry the DfE Safer Product Label. This list of safer chemical ingredients is intended to help product manufacturers identify chemicals that the DfE program has evaluated and identified as safer alternatives. This list only includes chemicals in products that were voluntarily submitted for evaluation through the DfE Safer Product Labeling Program. According to EPA, there may be other chemicals not included in this list that are also safer. The list and additional information can be found online.

EPA Issues Direct Final SNURs: On September 21, 2012, EPA promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 107 chemical substances that were the subject of premanufacture notices (PMN). 77 Fed. Reg. 58666. Eight of these chemical substances are subject to TSCA consent orders issued by EPA. The direct final rule requires persons who intend to manufacture, import, or process any of these 107 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The eight chemicals EPA determined to potentially pose an unreasonable health or environmental risk are: dialkyl hydroxybenzenealkanoic acid ester (generic name), PMN No. P-00-346; ethoxylated alkylphenol sulfate, ammonium salt (generic name), PMN No. P-01-470; acetic acid, hydroxymethoxy-, methyl ester, reaction products with substituted alkylamine (generic name), PMN No. P-02-120; oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite (Ca(SiO3)), PMN No. P-02-285; HDI biuret, hydroxyethyl methacrylate prepolymer (generic name), PMN No. P-04-834; and three partially fluorinated alcohol substituted glycols (generic names), PMN Nos. P-10-58, P-10-59, and P-10-60. The other 99 chemicals subject to SNURs have a wide range of applications such as being used as curing agents, metal extractants, adhesive components, and film coating additives. The rule is effective on November 20, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before October 22, 2012.

EPA Reviews 19 Pesticide Registrations: On September 26, 2012, EPA announced that it will review 19 registered pesticides to ensure that they continue to meet the statutory standard for registration under FIFRA. 77 Fed. Reg. 59188. FIFRA Section 3(g) requires EPA to review the registrations of pesticides every 15 years to ensure they are based on up-to-date scientific knowledge. The 19 pesticides are:

  • Acetamiprid, Docket ID No. EPA -HQ-OPP-2012-0329;
     
  • Diflubenzuron, Docket ID No. EPA -HQ-OPP-2012-0714;
     
  • Halofenozide, Docket ID No. EPA -HQ-OPP-2012-0231;
     
  • Metribuzin, Docket ID No. EPA -HQ-OPP-2012-0487;
     
  • Norflurazon, Docket ID No. EPA -HQ-OPP-2012-0565;
     
  • Pendimethalin, Docket ID No. EPA -HQ-OPP-2012-0219;
     
  • Rimsulfuron, Docket ID No. EPA -HQ-OPP-2012-0178;
     
  • Tefluthrin, Docket ID No. EPA -HQ-OPP-2012-0501;
     
  • Thiacloprid, Docket ID No. EPA -HQ-OPP-2012-0218;
     
  • Triflusulfuron, Docket ID No. EPA -HQ-OPP-2012-0605;
     
  • 4-t-Amylphenol, and salts, Docket ID No. EPA -HQ-OPP-2012-0682;
     
  • Ammonium bromide, Docket ID No. EPA -HQ-OPP-2012-0683;
     
  • Didecyl dimethyl ammonium carbonate and didecyl dimethyl ammonium bicarbonate, Docket ID No. EPA -HQ-OPP-2012-0651;
     
  • Ammonium sulfate (Case No. 5073), Docket ID No. EPA -HQ-OPP-2012-0684;
     
  • Ammonia (Case No. 7440), Docket ID No. EPA -HQ-OPP-2012-0684;
     
  • 1,4 DMN, Docket ID No. EPA -HQ-OPP-2012-0670;
     
  • Cytokinins, Docket ID No. EPA -HQ-OPP-2012-0671;
     
  • Phosphoric acid and salts, Docket ID No. EPA -HQ-OPP-2012-0672; and
     
  • Harpin Proteins, Docket ID No. EPA -HQ-OPP-2012-0641.

EPA will accept public comments, including additional data to be considered in the registration reviews, until November 26, 2012.

EPA Announces SFIREG EQI Working Committee: On September 27, 2012, EPA announced that the AAPCO/SFIREG POM (EQI) Working Committee will hold a two-day meeting, beginning on October 15, 2012, and ending October 16, 2012. 77 Fed. Reg. 59396. Tentative agenda topics include: (1) persistent herbicide residues in compost and plant materials; (2) Endangered Species Act (ESA) update on activities in the Pacific Northwest and on Rozol for prairie dogs; (3) disposal of treated seed — environmental impacts; (4) reporting of bee kills — to and among states; (5) hydro-fracking and the use of biocides in the process; (6) endocrine disruptor screening update; (7) human and aquatic health benchmarks; and (8) 25(b) policy. Please consult the Federal Register for more details.

Bacterial Pesticide Clears Registration Review: On October 3, 2012, EPA concluded no additional data are required to support the registration of pesticides containing agrobacterium radiobacter (A. radiobacter). EPA determined continued use of A. radiobacter is unlikely to result in any unreasonable adverse effects to human health or the environment. EPA determined the substance, a naturally occurring soil bacterium, is unlikely to affect the endocrine system in humans and is not expected to affect any non-target species or their habitat. EPA reviewed A. radiobacter under its registration review process, which aims to review every pesticide active ingredient at least once every 15 years. The final decision document is available online.

EPA Issues SNURs For 78 Chemicals; Seven Already Managed Via Consent Orders: On October 5, 2012, EPA published direct final SNURs for 78 chemicals, including seven managed through consent orders, which were the subject of PMNs. 77 Fed. Reg. 61118. The rules require any company that intends to make or use the chemicals in a way EPA has designated to be new to notify EPA 90 days before doing so. EPA would then evaluate the proposed manufacturing process or use to determine whether it poses environmental or health risks that warrant regulation or other controls. EPA already has allowed the 78 new chemicals to go into production, with protective measures outlined either in consent orders or PMNs filed by specific companies. The SNURs being published under TSCA adopt those conditions so they would apply to other manufacturers that want to make the substances. Any manufacture or use of a chemical that does not take into account the protective measures would be considered a new use and require the 90-day notification to EPA. This rule will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.

Consumer Products Ingredients Dictionary Updated: On October 8, 2012, the Consumer Specialty Products Association issued an updated Consumer Product Ingredient Dictionary, which includes 487 monographs with information about ingredients in aerosol, air care, automotive, cleaning, and other products. It also includes trade as well as technical names for these chemicals. Some information, however, such as the Chemical Abstracts Service (CAS) numbers for the listed ingredients, the trade and simplified names for the ingredients, and the technical names are available for free. Information on the dictionary is available online.

EPA And ECOS Will Hold TRI Webinar: EPA and the Environmental Council of the States (ECOS) will hold a webinar, “Introduction to the Toxics Release Inventory for Communities,” on November 8, 2012, from 1:00-2:30 p.m. (EST). The webinar is intended to provide an introduction for community grassroots groups and others on how to access and use EPA’s Toxics Release Inventory (TRI) data. The webinar announcement states that “TRI can help address local community concerns about toxic chemical emissions, and associated environmental impacts.” The webinar will cover TRI basics, as well as EPA’s recent pilot project with four communities. More information will be available online. Registration for the webinar is available online.

EPA Will Hold IRIS Public Stakeholder Meeting: On November 13, 2012, EPA will hold a public stakeholder meeting on the IRIS Program. EPA invites stakeholders to participate in the meeting “to hear your views about IRIS and changes that are underway to improve the Program.” For those unable to attend the meeting in person, at EPA’s Potomac Yards conference facility in Crystal City, Virginia, participation via webinar/teleconference will be available. Registration for the meeting is available online. EPA states it will post additional details about the meeting on this website “in the near future.”

EPA To Host Antimicrobial Efficacy Workshop: On November 13-15, 2012, EPA’s Environmental Science Center in Fort Mead, MD, will host a laboratory-based technical workshop that will focus on new and revised test methods for evaluating the efficacy of disinfectant products and key related issues. The workshop is open to all who wish to attend, though participants must be knowledgeable of Biosafety Level II and III safety practices and procedures to participate in laboratory demonstrations and training. There is no registration fee. More information, including a draft agenda, is available online.

CBO Estimates Cost Of TSCA Reform Proposal: A Congressional Budget Office (CBO) report estimated that a proposal to reform TSCA by requiring chemical manufacturers to provide additional information about toxicity and usage would cost EPA an estimated $128 million over the next five years. The Safe Chemicals Act of 2011 (S. 847), sponsored by Senator Frank Lautenberg (D-NJ), would require EPA to spend approximately $30 million annually to cover the cost of additional personnel and administrative activities to meet the new requirements of that legislation, CBO estimated. EPA currently requires an average annual appropriation of $105 million to implement and enforce TSCA, the statute that authorizes EPA to require reporting, recordkeeping, and testing of chemical substances and mixtures. The legislation, approved by the Senate Environment and Public Works Committee in July, would require EPA to batch chemicals into groups and prioritize chemical evaluations based on existing risk information, reset the TSCA inventory to establish an up-to-date list of chemicals manufactured and processed in the U.S., and require chemical manufacturers and processors to provide EPA with additional information on their products. A copy of the CBO report is available online.

GREEN CHEMISTRY

FTC Releases Revised Green Guides: On October 11, 2012, the Federal Trade Commission (FTC) published in the Federal Register the long-awaited revised0 Guides for the Use of Environmental Marketing Claims (Green Guides). 77 Fed. Reg. 62122. This is a very important development and clients and friends marketing products in the “green” space need to be fully aware of the significant marketing, business, and legal implications of this document. The Green Guides were effective immediately.

FTC intends the Green Guides to help marketers ensure that the claims they make about the environmental attributes of their products are “truthful and non-deceptive.” FTC issued draft Green Guides for comment in 2010, and states that it received “nearly 340 unique comments and more than 5,000 total comments.” FTC modified sections on general environmental benefit, compostable, degradable, ozone, recyclable, and recycled content. FTC added new sections concerning carbon offsets, certifications and seals of approval, free-of claims, non-toxic claims, made with renewable energy claims, and made with renewable materials claims. While the Green Guides are administrative interpretations of law, and are not independently enforceable, they describe the types of environmental claims FTC may find deceptive under Section 5 of the FTC Act. Under Section 5, FTC can take enforcement action against deceptive claims, which could lead to FTC orders prohibiting deceptive advertising and marketing and fines if those orders are later violated. The Green Guides are available online, and a summary is available online. FTC posted a video online that highlights changes to the Green Guides. A more detailed memorandum is available online.

FTC notes that the availability of environmentally friendly products “is a win for consumers who want to purchase greener products and producers who want to sell them.” FTC has added sections to the Green Guides to address environmental claims that were not common when FTC last reviewed the Guides. FTC states that the revisions include cautioning marketers not to make “broad, unqualified claims that a product is ‘environmentally friendly’ or ‘eco-friendly’ because the FTC’s consumer perception study confirms that such claims are likely to suggest that the product has specific and far-reaching environmental benefits. Very few products, if any, have all the attributes consumers seem to perceive from such claims, making these claims nearly impossible to substantiate.”

NANOTECHNOLOGY

EU Report Aides Industry In Identifying Nanomaterials: On September 17, 2012, the European Commission’s (EC) Joint Research Center released a report on measurement methods available to chemical, cosmetics, and other manufacturers to help determine if they are making or working with a material that meets the EC’s recommended definition of a “nanomaterial” that may be subject to regulation. The EC in October 2011 adopted a definition that it recommended lawmakers use “when adopting new or implementing existing legislation.” The European Union’s (EU) cosmetics regulation is the first legislation to apply to nanomaterials. The EC adopted the Cosmetic Products Regulation (EU Regulation 1223/2009) in November 2009. As of 2012, cosmetics manufacturers are required to list any nanoparticles contained in products marketed in the EU. The Joint Research Center’s report, Requirements on Measurements for the Implementation of the European Commission Definition of the Term “nanomaterial,” is available online.

Denmark Intends To Create Database Of Products Containing Nanomaterials: Under a draft amendment to the Danish Chemicals Act, the Minister of the Environment would have the authority to write a detailed order establishing the rules for a national database of mixtures and articles containing or releasing nanomaterials. The order would also require producers and importers to report products containing or releasing nanomaterials. The information in the database is intended to form the basis of an evaluation of whether the content of nanomaterials in products on the Danish market poses a risk for consumers and the environment. The Ministry plans for the first reports to be due in early 2014. More information is available, in Danish, online.

CDC Seeks Comment On Proposed NIOSH Exposure Assessment And Epidemiological Study Of U.S. Workers: The Centers for Disease Control and Prevention (CDC) published a September 20, 2012, Federal Register notice seeking comment on a proposed National Institute for Occupational Safety and Health (NIOSH) exposure assessment and epidemiological study of U.S. workers exposed to carbon nanotubes (CNT) and carbon nanofibers (CNF). 77 Fed. Reg. 58396. The notice states that the proposed research is a cross-sectional study of the current U.S. workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in two phases: (1) an industry-wide exposure assessment study to evaluate worker exposure and further develop and refine measurement methods for CNT and CNF; and (2) a cross-sectional study relating the best metrics of CNT and CNF exposure to markers of early pulmonary or cardiovascular health effects. The study will include a questionnaire given by NIOSH personnel as a computer-assisted personal interview, followed by medical examinations to evaluate pulmonary function and blood pressure, and collect sputum and blood. NIOSH will conduct statistical analyses to determine the nature of the relation between exposure to CNT and CNF and these biomarkers of early effect, considering potential confounding factors such as smoking, age, gender, and workplace coexposures, including non-engineered ultrafine particles. CDC invites comments on whether the proposed research is necessary for the proper performance of its functions, including whether the information shall have practical utility; the accuracy of its estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information. Written comments are due within 60 days of the notice.

ICCM3 Adds Measures Concerning Nanotechnologies And Manufactured Nanomaterials To Global Plan Of Action: During the Third International Conference on Chemicals Management (ICCM3), which was held September 17-21, 2012, participants agreed to add the measures concerning nanotechnologies and manufactured nanomaterials to the Strategic Approach to International Chemicals Management (SAICM) Global Plan of Action. The measures include “exploring the development of registers/inventories and/or market assessment activities of manufactured nanomaterials,” and “promoting the availability of information on the presence of manufactured nanomaterials within the product supply chain and throughout the life cycle, which could include possible labelling, consistent with relevant international obligations, and/or other forms of guidance relating to consumer products containing manufactured nanomaterials.” Participants also agreed to a resolution to continue work on manufactured nanomaterials as an “emerging policy issue” under SAICM, and to develop international technical and regulatory guidance and training materials for their sound management. The Resolution invites the United Nations (UN) Committees of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to review the applicability of the GHS criteria to manufactured nanomaterials and, if necessary, to prepare a work plan for adapting them.

EC’s SCCS Scientific Opinion On Nano-Form Zinc Oxide Available For Comment: The EC’s Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration up to 25 percent in cosmetic products. SCCS concluded, on the basis of available evidence, that the use of zinc oxide nanoparticles with the indicated characteristics, at a concentration up to 25 percent as a UV-filter in sunscreens, “can be considered not to pose a risk of adverse effects in humans after dermal application.” SCCS notes that this does not apply to other applications that might lead to inhalation exposure to zinc oxide nanoparticles, such as sprayable products. SCCS states that the use of larger (non-nano) forms of zinc oxide as a UV-filter with a concentration up to 25 percent, as stated in its 2009 clarification, is safe and is not of any additional safety concern compared to the nano-forms assessed in the opinion. Regarding whether SCCS has any further scientific concern about the use of zinc oxide in cosmetic products, SCCS states: “In view of the lung inflammation induced by ZnO particles after inhalation exposure, the use of ZnO in cosmetic products which may result in inhalation is of concern.” SCCS also notes: “Any cosmetic products containing ZnO particles (nano or non-nano) with coatings that can promote dermal penetration will also be of concern.” Comments are due October 22, 2012. The opinion is available online.

EC Adopts Communication On Second Regulatory Review On Nanomaterials: On October 3, 2012, the EC announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of EU legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not.” Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: “Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.” According to the Communication, the EC “remains convinced that REACH [Registration, Evaluation, Authorization and Restriction of Chemicals] sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.” To improve the availability of information, the EC states that it “will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”

The Communication is accompanied by an EC Staff Working Paper on Types and Uses of Nanomaterials, Including Safety Aspects, which responds to the EP’s concern that the EC’s approach to nanomaterials is jeopardized by a lack of information on the use and safety of nanomaterials that are already on the market. The Staff Working Paper provides detailed information on the definition of nanomaterials, nanomaterial markets, uses, benefits, health and safety aspects, risk assessment, and information and databases on nanomaterials. According to the Staff Working Paper, in response to the EP’s call on the EC to compile a public inventory of the different types and uses of nanomaterials on the European market, the EC has compiled information on existing databases and intends to create an EC web platform on nanomaterial types and uses, including safety aspects. The Communication is available online.

Potassium Titanium Oxide SNUR Bans Manufacture Of Particle Size Less Than 100 nm: On October 5, 2012, EPA promulgated a final SNUR for potassium titanium oxide, which was previously the subject of a consent order under TSCA Section 5(e). 77 Fed. Reg. 61118. (See related item above.) EPA states that, based on test data on the PMN substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.

EPA Announces RCC Nanotechnology Webinar And Requests Nominations For Case Studies: The Canada-U.S. Regulatory Cooperation Council (RCC) will hold a webinar on November 28, 2012, on its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to EPA, the purpose of the RCC’s nanotechnology initiative is to increase, where possible, regulatory transparency and coordination between the U.S. and Canada respecting nanomaterials. The Nanotechnology Work Plan includes specific objectives, deliverables, and milestones for tangible progress within the RCC’s two-year mandate. During the November 28, 2012, webinar, RCC will provide additional background information, as well as updates on ongoing activities under the Nanotechnology Work Plan. Stakeholders should confirm their webinar attendance no later than October 25, 2012.

Under the Nanotechnology Work Plan, there is a pilot project to examine Canadian and U.S. risk assessment and risk management practices and approaches through an evaluation of case studies for specific nanomaterials. EPA states that Canada and the U.S. are considering a number of materials for the case studies and would welcome suggestions from stakeholders. Proposals of nanomaterials for consideration are due October 25, 2012, and must include:

  • Chemical name of the nanomaterial;
     
  • Whether the nanomaterial has been notified to/reviewed by either jurisdiction;
     
  • Commercial applications of the nanomaterial;
     
  • Information on exposure and environmental fate of the nanomaterial;
     
  • A complete list of available test data on the nanomaterial and related analogs, including environmental and human toxicity studies; and
     
  • Acknowledgment that, for the purposes of this exercise, both Canada and the U.S. will be able to exchange information freely, including confidential business information (CBI).

More information regarding the webinar and the request for nominations for case studies is available online. The Nanotechnology Work Plan is available online.

REACH

ECHA To Assess REACH Registration Dossiers: On September 17, 2012, the European Chemicals Agency (ECHA) announced that it may examine any registration dossier to verify if the information submitted by registrants is in compliance with the legal requirements. Compliance checks evaluate the substance identity description and the safety information in the dossier, including the chemical safety report (CSR) or specific parts of the dossier, for example the information related to the protection of human health. According to REACH, ECHA must check at least five percent of the registration dossiers of each tonnage band. Dossier selection for compliance check is either random or concern based (targeted). In the targeted compliance check, ECHA evaluates only a specific part of the registration dossier (e.g., either specific endpoints in IUCLID or in the CSR) based on a specified concern. This allows ECHA to target endpoints that are identified as relevant for the safe use of substances. Rather than evaluating the full dossier content at once, a part of the compliance checks will address for example targeted endpoints related to the Persistent, Bioaccumulative and Toxic (PBT) or Carcinogenic, Mutagenic or Toxic to reproduction (CMR) status of a substance. As a result of the targeted compliance check, registrants may receive multiple compliance check decisions to request additional information on the same dossier if it is non-compliant for more than one information requirement. Information on ECHA dossier compliance checks is available online.

EC Notifies WTO Of Intent To Add Substances To Annex XIV: The EC sent a September 18, 2012, notification to the World Trade Organization (WTO) announcing its intent to amend REACH Annex XIV to include trichloroethylene, chromium trioxide, acids generated from chromium trioxide and their oligomers, sodium dichromate, potassium dichromate, ammonium dichromate, potassium chromate, and sodium chromate. The notification states that, once the EC promulgates the regulation and it enters into force, the placing on the market and the use of these substances will be possible, after the date specified for each substance, only for those operators who have been granted an authorization and for those who have submitted an application for authorization before a given date but a decision has not yet been adopted. According to the notification, the EC intends to adopt the regulation in March 2013, and it would enter into force three days after publication in the Official Journal of the European Union. Comments are due to the WTO 60 days from the date of notification.

ECHA Expands Inventory: ECHA reported on September 27, 2012, that it has updated the EU public chemical classification and labeling inventory to contain all nonclassified information on hazardous substances available on the EU market. The inventory now contains 5.3 million classifications covering 120,000 substances. ECHA was required to prepare the inventory under the EU regulation on the classification, labeling, and packaging of chemicals (CLP Regulation (EC) No. 1272/2008), which implements in the EU the UN’s GHS. Companies were required to reclassify their substances and submit notifications to ECHA by January 4, 2011. The inventory seeks to provide an overview of the chemicals market in the EU and to provide a starting point for the standardization of substance classifications. ECHA stated that it will publish during 2013 a web-based discussion platform that companies can use to work on the harmonization of classifications. ECHA published a first version of the inventory in February. More information is available online.

ECHA Publishes Detailed Statistics On REACH Registration Dossiers And Registered Substances: On October 3, 2012, ECHA published a detailed statistical update on the EU registration numbers. The new statistics on REACH registrations provide various breakdowns of the total volume of registrations received from June 2008 until August 31, 2012. The total registration volume also includes notifications of substances submitted under the previous European chemicals legislation (NONS) and which are considered to be registered under REACH. ECHA is publishing this information to respond to inquiries received from stakeholders on the progress of the registration process. It hopes that by publishing the origin and types of the registrations received it is enhancing transparency. The data include:

  • The number of registrations and registered substances (phase-in, non-phase-in).
     
  • The number of substances notified to Member State competent authorities under the previous European chemicals legislation (Directive 67/548/EEC) and their current status under REACH.
     
  • The number of registrations by:
    • Registration type (full registration or intermediate registration);
       
    • Joint submissions or individual submissions;
       
    • Company size;
       
    • Company role in the supply chain; and
       
    • EU/European Environment Agency (EEA) countries.
       
  • The most frequently registered substances.
     
  • The registered substances by total tonnage band.

The statistics are published on ECHA’s website under the “Information on chemicals” section online, and can also be downloaded as PDF documents. EU registration numbers have been issued for 27,321 REACH registration dossiers covering 4,632 chemicals.

LEGISLATIVE DEVELOPMENTS

Senators Introduce Legislation To Reduce Clean Water Act Controls On Pesticide Applications: On September 20, 2012, a bipartisan group of Senators introduced a bill that seeks to lift Clean Water Act (CWA) permit requirements for pesticide applications. The Restoring Effective Environmental Protection Act (S. 3605) would clarify Congressional intent in the CWA by exempting from CWA permits pesticide applications that are regulated under FIFRA. The legislation is virtually identical to a bill introduced in the house (H.R. 872) that lawmakers passed in March 2011. Both bills would roll back a 2009 decision in the 6th Circuit Court of Appeals that required EPA to issue CWA permits for pesticide applications to, over, or near waters of the United States. The new permitting system went into effect in November 2011.

Congress Passes The Pesticide Registration Improvement Extension Act (PRIA) Of 2012: On September 20, 2012, Congress sent to President Obama for his signature the Pesticide Registration Improvement Extension Act (PRIA) of 2012. The bill (S. 3552) ensures that the existing PRIA will not expire, which would have resulted in severe funding challenges for EPA and would have left pesticide registration applications unresolved and in a state of limbo. The statute is now authorized through 2017. President Obama signed the measure on September 29, 2012.

EPA Advisory Board Reform: On September 28, Representative Ralph Hall (R-TX) introduced H.R. 6564, the EPA Science Advisory Board Reform Act of 2012. As provided in the bill, the reformed board would consist of nine members, selected from nominations received by the Administrator of EPA. The Administrator would be directed to ensure that there is a fair balance of scientific and technical points of view among the members. Also, ten percent of the members would have to be representatives of state, local, or tribal governments and no more than ten percent could be recipients of EPA grants or other agency arrangements. Qualified persons would not be precluded from serving due to affiliation with entities having a potential interest in board activities, if such interest is fully disclosed. A board member could not participate in an activity involving only a single entity represented by the member, however, and no board member could be involved in a board review and evaluation of his or her own work. Members would serve three-year staggered terms. Pursuant to the legislation, the board’s advice and comments, including dissenting views of board members and the response of the Administrator, would be included in the record with respect to any proposed risk or hazard assessment, criteria document, standard, limitation, or regulation and published in the Federal Register. Member committees and investigative panels would not have the authority to make decisions on behalf of the board and could not report directly to EPA. Public participation is mandated for major advisory activities. A key proviso is that in carrying out its advisory activities, the board should strive to avoid making policy determinations or recommendations, and, in the event the board feels compelled to offer policy advice, it should explicitly distinguish between scientific advice and policy advice, as well as clearly communicate uncertainties associated with the scientific advice provided to the Administrator. Two further duties of the board would be to ensure that advice and comments reflect the views of the members and encourage dissenting members to make their views known to the public and the Administrator, and to conduct periodic reviews to ensure that its advisory activities are addressing the most important scientific issues affecting the EPA.

President Signs Bill For Electronic Manifests For Hazardous Waste: On October 5, 2012, President Obama signed the Hazardous Waste Electronic Manifest System Establishment Act. Under the provisions of the Act, any person that generates or transports hazardous waste, or an owner or operator of a waste treatment, storage, recycling, or disposal facility will be required to use the electronic manifest and pay a reasonable service fee to help develop, operate, maintain, or upgrade the electronic system. One important use of the service fees will be to fund contracts for private vendors to install the necessary systems. Various sources have been quoted as saying that it will take at least three years to set up the system.

Bill Would Curb Certain EPA Clean Air Act Actions: Representative Rick Berg (R-ND) introduced H.R. 6501, the Energy Consumer Protection Act of 2012, on September 21, 2012. The bill would prohibit the Administrator of EPA from finalizing certain proposed rules under the Clean Air Act (CAA) if a state regulatory authority gives notice that such a rule will lead to a three percent or greater increase in the price of electricity for end-use consumers. A “proposed rule” as used in the measure is a rule that imposes any standard of performance under CAA Section 111 (42 U.S.C. § 7411) for emissions of any greenhouse gas from any existing source, or new source, that is a fossil fuel-fired electric utility generating unit. The term “greenhouse gas” means any of the following:

  1. Carbon dioxide;
     
  2. Methane;
     
  3. Nitrous oxide;
     
  4. Hydrofluorocarbons;
     
  5. Perfluorocarbons; or
     
  6. Sulfur Hexafluoride.

Stop The War On Coal: On September 21, the House of Representatives passed by a 233-175 margin the Coal Miner Employment and Domestic Energy Infrastructure Protection Act, commonly referred to as the “Stop the War on Coal Act of 2012” The bill, introduced by Representative Bill Johnson (R-OH) would prohibit the Secretary of the Interior, before December 31, 2013, from issuing or approving any proposed or final regulation under the Surface Mining Control and Reclamation Act of 1977 that would: (1) adversely impact employment in coal mines in the U.S.; (2) cause a reduction in revenue received by the federal government or any state, tribal, or local government, by reducing through regulation the amount of coal in the U.S. that is available for mining; (3) reduce the amount of coal available for domestic consumption or for export; (4) designate any area as unsuitable for surface coal mining and reclamation operations; or (5) expose the U.S. to liability for taking the value of privately owned coal through regulation.

Primacy Of States: Senator John Hoeven (R-ND) on September 19, 2012, introduced SB 3573, the Empower States Act of 2012, a measure designed to recognize the primacy of states in matters relating to safe drinking water, provide for the consideration of the economic impact of additional regulations, and provide for standards and requirements relating to certain guidelines and regulations relating to health and the environment. SB 3573 provides that the Administrator of EPA may bring a civil action in the appropriate U.S. district court to require compliance with any applicable requirement relating to safe drinking water, with an order or with any schedule or other requirement imposed pursuant to a variance or exemption granted under Section 1415 or 1416, if the order, schedule, or other requirement is requested by: (i) the chief executive officer of the state in which is located the public water system that is not in compliance with such regulation or requirement; or (ii) the state agency with jurisdiction over compliance by public water systems in the state with national primary drinking water regulations or state drinking water regulation. Furthermore, the Administrator may not take any enforcement action against a state that has primary enforcement responsibility for public water systems (within the meaning of Section 1413(a)) or a company or individual within the State pursuant to this subsection, Section 1423, or any other provision of law, unless (A) the Administrator determines that there is an imminent and substantial danger to the public health or environment; and (B) the state failed to take corrective action. The Administrator may not amend or revoke any program of a state with partial or total primary enforcement responsibility under this section unless the Administrator determines, by clear and convincing evidence, that the program fails to effectively protect drinking water in the state.

State Authority To Preserve Water Standards: Senator Joe Manchin (D-WV) introduced SB 3558 on September 19. The measure, the Clean Water Cooperative Federalism Act of 2011, would amend the Federal Water Pollution Control Act to preserve the authority of each state to make determinations relating to the state’s water quality standards. Among the provisions relating to states’ rights, the Administrator of the EPA would be unable to promulgate a revised or new standard for a pollutant in any case in which the state has submitted to the Administrator and the Administrator has approved a water quality standard for that pollutant, unless the state concurs with the Administrator’s determination that the revised or new standard is necessary to meet the requirements of this Act. Also, with respect to any discharge, if a state or interstate agency having jurisdiction over the navigable waters at the point where the discharge originates or will originate determines that the discharge will comply with the applicable provisions of Sections 301, 302, 303, 306, and 307, the Administrator may not take any action to supersede the determination. In addition, the Administrator could not withdraw approval of a state program or limit federal financial assistance for the state program, on the basis that the Administrator disagrees with the state regarding the implementation of any water quality standard that has been adopted by the state and approved by the Administrator; or the implementation of any federal guidance that directs the interpretation of the state’s water quality standards. There are also provisions relating to permits for dredged or fill material, the reporting of harmful pollutants, and the requirement for an analysis of the effect of EPA actions on employment or economic activity.

MISCELLANEOUS

UN Agency Creates Forum To Address Conflicts Between Trade And Environment Rules: On September 27, 2012, the UN Conference on Trade and Development (UNCTAD) announced it has created an international forum that has been set up to address disputes involving conflicts between global trade rules and environmental measures adopted at the national level. A number of high-profile trade on environment disputes have recently been brought before WTO dispute panels, including complaints in the United States, EU, Japan, and Mexico against China’s export restrictions on raw materials and rare earths, and a joint EU-Japanese complaint against alleged discriminatory sourcing requirements and illegal subsidies in Ontario’s green energy program. Recently, Argentina initiated WTO dispute proceedings on August 17, 2012, targeting Spanish rules requiring that quotas for biofuels used in transportation be met exclusively with EU fuel.

CDC Updates Data On Levels Of Chemicals In Humans: On September 26, 2012, CDC Division of Laboratory Sciences released the updated data online for its Fourth National Report on Human Exposure to Environmental Chemicals. That report is part of an ongoing assessment of the U.S. population’s exposure to environmental chemicals. The new information updates biomonitoring data released in 2009 by CDC. The Fourth Report provides data on the U.S. population’s exposure to 212 chemicals. CDC’s report does not draw any conclusions about the health effects of the exposures, stressing that “the presence of an environmental chemical in a person’s blood or urine does not necessarily mean that it will cause effects or disease.” The Updated Tables in this release include several chemicals that have results available from one or more of the three survey periods of 2005-2006, 2007-2008, and 2009-2010. Since publication of the Fourth Report on Human Exposure to Environmental Chemicals 2009, the following chemicals have results updated for the first time: dialkylphosphate metabolites or organophosphorus insectides; polycyclic aromatic hydrocarbons; and volatile organic compounds, including disinfection byproducts. CDC has learned that the analytical standard for 2-(N-Methyl-perfluorooctane sulfonamido) acetic acid, Me-PFOSA-AcOH, used for all CDC projects since the early 2000’s had a lower purity than previously described. As a result, a correction factor equal to 0.872 has been applied to Me-PFOSA-AcOH for the National Health and Nutrition Examination Survey (NHANES) periods 1999-2000, 2003-2004, 2005-2006, 2007-2008, and 2009-2010. Consequently, the data tables in the Updated Tables for Me-PFOSA-AcOH show results that are slightly different from the data tables presented in the Fourth Report on Human Exposure to Environmental Chemicals 2009, Updated Tables, February 2012, and in all of the previous Reports. CDC’s updated Fourth National Report on Human Exposure to Environmental Chemicals is available online.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

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