Download PDF
November 1, 2011

Monthly Update for November 2011

Bergeson & Campbell, P.C.

TSCA/FIFRA/IRIS/EPCRA

EPA Releases New Pesticide Information Products: On October 19, 2011, the U.S. Environmental Protection Agency (EPA) released several new pesticide information and electronic products. E-dossier is the first new product. According to EPA, approximately 10-15% of submissions to the Office of Pesticide Programs (OPP) are electronic. E-dossier is a downloadable program that assists companies in making electronic submissions. Chem Search is an online search tool that provides users with a “one-stop” shopping for all publicly available pesticide chemical information. It contains data that have been published on OPP’s website and at regulations.gov, including information on registration and re-registration actions, cleared science reviews, and public comments. It also has more than 800 links, including links to tolerances in the electronic Code of Federal Regulations and links to other agencies’ websites, including the PubChem database of the National Institutes of Health. Finally, EPA released Inert Finder. This online tool allows users to search inert ingredients to determine if they have been approved for food, non-food, or fragrance uses. Inert ingredients are searchable in this database by name and by Chemical Abstracts Service (CAS) registration number. Results include status, approved status, synonyms, and food use tolerance information from the Code of Federal Regulations.

Steve Owens Announces His Departure From EPA: On October 25, 2011, Office of Chemical Safety and Pollution Prevention (OCSPP) Assistant Administrator Stephen A. Owens announced his resignation from EPA. More detailed information is available online.

EPA Issues Proposed And Final HPV Test Rules; EPA Seeks Innovative Use Of SNURs: The October 21, 2011, Federal Register includes two test rules concerning high production volume (HPV) chemicals: a final test rule for certain chemicals from the third group, and a proposed test rule and proposed significant new use rule (SNUR) for the fourth group of chemicals. See 76 Fed. Reg. 65385 and 65580, respectively. The proposed “SNUR plus test rule” represents a novel approach for EPA in handling HPV chemicals and may presage the approach used in the future. As discussed in the proposal, EPA is “considering issuing further coordinated proposals of test rules and SNURs . . . in conjunction with future” data releases from the Chemical Data Reporting (CDR) rule and “covering all newly-HPV chemical substances.” The final test rule applies to 15 of the 29 chemicals in EPA’s February 25, 2010, proposed rule, and will be effective November 21, 2011. Under the final test rule, manufacturers, importers, and processors are to subject to testing requirements to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemical substances. Test rule findings could not be made for the 14 removed chemicals. More detailed information is available online.

SAB Announces Initiatives Intended To Enhance Public Involvement In Advisory Activities: On October 28, 2011, the EPA Science Advisory Board (SAB) posted a list of fiscal year (FY) 2012 initiatives intended to enhance public involvement in advisory activities. According to the SAB website, in response to suggestions received at a June 1, 2011, session on public involvement, the SAB Staff Office developed additional practices to enhance public involvement in activities of the SAB, Clean Air Scientific Advisory Committee (CASAC), and Advisory Council on Clean Air Compliance Analysis (Council). More detailed information is available online.

EPA Issues Guidance On Waivers For Animal Testing Of Pesticides: On November 7, 2011, EPA released a guidance document that consolidates information on the criteria for waiving and bridging acute toxicity testing requirements for pesticide programs. The guidance document brings together criteria for the waiving and/or bridging of mammalian acute toxicity data that have previously appeared in separate documents, including pesticide registration notices, OCSPP guidance, and OPP memoranda. The guidance document describes the requirements for obtaining waivers for several kinds of animal testing, including acute oral toxicity, acute dermal toxicity, and acute inhalation toxicity tests. EPA intends to update the guidance as appropriate. The guidance document released by OPP is available online.

NTP Proposes To Revise RoC Review Process: The National Toxicology Program (NTP) published an October 31, 2011, Federal Register notice inviting written comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. 76 Fed. Reg. 67200. The RoC is a Congressionally mandated, biennial document that identifies agents, substances, mixtures, or exposure circumstances that may pose a hazard to human health by virtue of their carcinogenicity. Substances are listed in the report as either known or reasonably anticipated human carcinogens, and NTP includes a description of the substance, its uses, potential sources of exposure, the rationale for listing, and applicable federal regulations in a substance profile. According to the Federal Register notice, NTP is proposing changes to the RoC process to “enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner. The NTP also seeks to maintain critical elements of the existing process including external scientific and public involvement, scientific rigor, and external peer review.” Although the RoC is intended to be a biennial document, that has not been the case. NTP most recently published the 12th RoC in June 2011. It published the 11th RoC in 2005. NTP will hold a public listening session on the proposed review process on November 29, 2011, and the deadline to register for the session is November 21, 2011. Written comments on the proposed review process are due November 30, 2011. More detailed information is available online.

Toxic Substances Control Act (TSCA) CDR Requirements And e-Reporting: EPA will host a webinar to assist industry with the reporting process for the 2012 CDR rule on Wednesday, November 16, 2011, from 1:30 p.m. to 4:30 p.m. (EST). The webinar is intended for industry stakeholders who will be reporting in response to the CDR requirements. The webinar will include an overview of the 2012 reporting requirements, a discussion of joint reporting, a discussion of considerations related to the reporting of byproducts, and updated information about registering for electronic reporting and for using the electronic reporting tool. There will be time at the conclusion of the presentation to phone in with questions concerning the rule. More information about the CDR can be found online.

EPA Lifts Administrative Stay For Hydrogen Sulfide: On October 17, 2011, EPA announced that it is lifting the administrative stay of the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 toxic chemical release reporting requirements for hydrogen sulfide (CAS No. 7783-06-4). 76 Fed. Reg. 64022. Hydrogen sulfide was added to the EPCRA Section 313 list of toxic chemicals in a final rule published on December 1, 1993. On August 22, 1994, EPA issued an administrative stay of the reporting requirements for hydrogen sulfide in order to evaluate issues brought to EPA’s attention after promulgation of the final rule concerning the human health effect basis for the listing and EPA’s use of exposure analysis in EPCRA Section 313 listing decisions. The stay deferred the reporting requirements for hydrogen sulfide while EPA completed this further evaluation. EPA completed its further evaluation of additional information that has become available since the stay was put in place regarding the human health and environmental effects of hydrogen sulfide, and EPA published a position that the stay should be lifted on February 26, 2010. Based on EPA’s further evaluation and the consideration of the public comments received on the notice of intent, EPA continues to believe that the administrative stay should be lifted. By the current action, EPA is not revisiting the original listing decision, which was accomplished by final rule on December 1, 1993, but rather, lifting the administrative stay of the reporting requirements for hydrogen sulfide. The action was effective on October 17, 2011, and the first report on hydrogen sulfide is due on July 1, 2013, for reporting year 2012 releases.

EPA Issues Correction To Lifting Of Administrative Stay For Hydrogen Sulfide: On November 8, 2011, EPA issued a correction to the final rule lifting the stay of reporting requirements for hydrogen sulfide. 76 Fed. Reg. 69136. The Office of the Federal Register mistakenly lifted the stay of the reporting requirements for methyl mercaptan. The document also inadvertently left out language in the preamble and contained incorrect language in the amendatory instruction section. The notice affirms that the stay on the reporting requirements for methyl mercaptan was not lifted and sets out the language in the preamble and the amendatory instruction section as it should have printed.

GREEN CHEMISTRY DEVELOPMENTS

DTSC Releases Revised “Informal Draft” Safer Consumer Products Regulations: On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an “informal draft” Safer Consumer Products Regulations (SCPR). DTSC proposed these regulations after ten months of meetings following the California Secretary for Environmental Protection’s instructions to DTSC to stop working on issuing proposed regulations and instead “take additional time to be responsive to the concerns raised and revisit the proposed regulations.” Memoranda providing background information are available online. More detailed information is available online.

NANOTECHNOLOGY

Article Reports On Spontaneous Generation Of Nanoparticles From Silver And Copper Objects: On October 10, 2011, ACS Nano accepted an article entitled “Generation of Metal Nanoparticles from Silver and Copper Objects: Nanoparticle Dynamics on Surfaces and Potential Sources of Nanoparticles in the Environment,” in which the authors monitor nanoparticles and their transformations under a variety of environmental conditions. According to the authors, their studies reveal “unprecedented dynamic behavior” of silver nanoparticles on surfaces. The authors hypothesize that nanoparticle production occurs through a process involving three stages: (1) oxidation and dissolution of silver from the surface of the particle; (2) diffusion of silver ion across the surface in an adsorbed water layer; and (3) formation of new, smaller particles by chemical and/or photoreduction. The authors investigated non-nanoscale sources of silver, including wire, jewelry, and eating utensils placed in contact with surfaces, and found that they also formed new nanoparticles. According to the authors, copper objects display similar reactivity, suggesting that the phenomenon may be more general. The authors conclude that “discovery that [silver nanoparticles and copper nanoparticles] are generated spontaneously from manmade objects implies that humans have long been in direct contact with these nanomaterials and that macroscale objects represent a potential source of incidental nanoparticles in the environment.” More information is available online.

EPA Posts Guidance To Facilitate Decisions For Sustainable Nanotechnology: EPA posted a September 2011 guidance document entitled Guidance to Facilitate Decisions for Sustainable Nanotechnology, which was prepared by the National Risk Management Research Laboratory of the Office of Research and Development. EPA states that it developed the guidance to assist in assessing the sustainability of nanoproducts, and it is intended “to lay the groundwork for developing a decision-support framework through continual updates as research in this area progresses.” The foundation of EPA’s approach, according to the guidance, is to consider existing standards and methods for environmental, economic, and social assessments using a life cycle perspective and offer guidance by relaying first-hand knowledge of applying assessment tools to nanotechnologies, whenever possible. The guidance includes overviews of various assessment methodologies to help stakeholders make informed choices when selecting tools appropriate for their goals. According to EPA, the key steps to be included in the evolving framework include: characterizing a nanoproduct and identifying potential risks and impacts; identifying relevant stakeholders; defining the goal and scope of an assessment; assessing environmental, economic, and social impacts; evaluating sustainability criteria; developing and evaluating alternatives; and selecting and implementing a decision to support sustainability. EPA will review and update the guidance as additional information becomes available. The guidance is available online.

EC Adopts Recommendation On Definition Of Nanomaterial: The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union (EU) agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:

  1. “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.
     
    In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
     
  2. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

The Recommendation states that, by December 2014, the EC will review the definition “in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased.” The Recommendation is available online.

According to information on the EC website, it will use the definition primarily to identify materials for which special provisions might apply (e.g., for risk assessment or ingredient labeling). The EC notes:

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

More information regarding the definition is available online. The EC posted “[d]etailed and technical information” about the definition in a “Questions and Answers” document available online.

NNI Releases 2011 EHS Research Strategy: On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human exposure assessment; (3) human health; (4) environment; (5) risk assessment and risk management methods; and (6) informatics and modeling. The Strategy also considers the ethical, legal, and societal implications (ELSI) of nanotechnology. NNI held a webinar on October 20, 2011, to announce the release of the Strategy, and Lynn L. Bergeson served on the panel. The Strategy and additional information are available online.

EC Publishes Final Reports For REACH RIPoNs: The EC began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2, available online) and chemical safety assessment (RIPoN 3, available online). The EC states that, based on the scientific and technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA. The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity online. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”

EPA Seeks Information Concerning Discharges Of Nanosilver From Industrial Manufacturing: EPA published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. 76 Fed. Reg. 66286. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011. EPA is soliciting data on the manufacture, use, and environmental release of silver materials, including nanosilver. EPA requests information on:

  • Raw silver products, such as colloidal nanosilver;
     
  • Intermediates such as polymers or fibers embedded with silver, nanosilver, or silver compounds; and
     
  • End products, such as silver-embedded textile and plastic products, or appliances with nanosilver coated surfaces.

NCI Announces Public Private Industry Partnership Concerning Nanotechnology-Based Cancer Solutions: In an October 28, 2011, Federal Register notice, the National Cancer Institute’s (NCI) Alliance for Nanotechnology in Cancer announced the initiation of “Translation of Nanotechnology in Cancer” (TONIC), a public private industry partnership intended to promote translational research and development opportunities of nanotechnology-based cancer solutions. 76 Red. Reg. 66932. The notice states that an immediate consequence of this effort is the formation of a consortium involving government and pharmaceutical and biotechnology companies. The consortium will evaluate “promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients.” According to the notice, membership in the TONIC consortium will be limited to companies that: (1) have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval; and (2) are engaged in the development of nanotechnology-based formulations with application to imaging, diagnostics, and therapy.

ECHA Begins Consultation On Testing Proposal For Multi-Wall Carbon Nanotubes: On November 3, 2011, ECHA began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under REACH, manufacturers and importers must obtain information on toxic effects of substances. REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH. After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint. ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision. More information is available online.

ICON Announces Availability Of Presentation Slides From Training Course: On November 8, 2011, the International Council on Nanotechnology (ICON) announced the availability of the presentation slides from the modules for the training course entitled “Introduction to Nanomaterials and Occupational Health.” The course was developed under a grant from the Occupational Safety and Health Administration (OSHA), and is intended to prepare safety professionals to address issues that may arise in the nanomaterial workplace by providing a comprehensive review of current knowledge, frameworks for risk management, and tools for keeping up with the rapidly expanding knowledge base on nanomaterials’ health and safety impacts. The course modules include:

  • Introduction to Nanotechnology and Nanomaterials;
     
  • What Workers Need to Know about Nanomaterial Toxicology and Environmental Impacts;
     
  • Assessing and Controlling Exposure to Nanomaterials in the Workplace;
     
  • Risk Management Approaches for Nanomaterial Workplaces;
     
  • Regulations and Standards Relevant to Nanomaterial Workplaces; and
     
  • Tools and Resources for Further Study.

More information is available online.

NIA Will Hold Workshop On The EU Definition Of Nanomaterials: The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.'” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the EU definition will be implemented in European legislation and in EU member states, and what companies can do in the short-term to offset the cost of long-term compliance. More information is available online.

CWA/CAA

EPA Issues Direct Final Rule Amending SPCC Rule: On October 18, 2011, EPA issued a direct final rule amending the date by which farms must prepare or amend, and implement their Spill Prevention, Control, and Countermeasure (SPCC) Plans. 76 Fed. Reg. 64245. The date farmers were to have prepared or amended SPCC Plans was November 10, 2011. The direct final rule extends the date to May 10, 2013. A farm is defined under the SPCC as a facility on a tract of land devoted to the production of crops or raising of animals, including fish, which produced and sold, or normally would have produced and sold, $1,000 or more of agricultural products during a year. EPA published the rule without a prior proposed rule because it views this as a noncontroversial action and anticipates no adverse comment since this action provides owners and operators of farms an additional 18 months to prepare or amend, and implement their SPCC Plans.

REACH

ECHA Submits Draft Plan For First Substance Evaluation: ECHA submitted on October 21, 2011, the first draft Community Rolling Action Plan (CoRAP) to the member state competent authorities and ECHA Member State Committee. The draft CoRAP lists 91 substances proposed for review under the REACH evaluation process. The substances are divided for evaluation during 20122013, and 2014. The plan addresses substances suspected of posing risk to human health or the environment. The Committee will prepare an opinion on the draft plan in February 2012. From the publication of the final CoRAP, the respective member state responsible for the evaluation of each substance and the initial reasons of concern will have one year to evaluate substances specified for 2012 and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The other member states, ECHA, and the Member State Committee will review and agree on the draft decisions before they become effective. Registrants of substances listed on the final CoRAP have an opportunity to comment before any final decision to request further information will be taken. More information is available online.

ECHA states that, in many cases, the initial concerns are related to potential persistent, bioaccumulative, and toxic (PBT) properties, suspected endocrine disruption, or carcinogenic, mutagenic, and reprotoxic properties in combination with wide dispersive or consumer use(s). In general, the uses of the substances cover various areas and are not focused on any particular industrial, professional, or consumer uses. The 91 substances are:

YEARSUBSTANCE NAME
2012carbon tetrachloride
2012methanol
2012chloromethane
2012ethylene oxide
20124,4′-isopropylidenediphenol
20122-(4-tert-butylbenzyl)propionaldehyde
2012N-1-naphthylaniline
2012decahydronaphthalene
20121,3-diphenylguanidine
20124-methylanisole
2012Toluene
2012n-hexane
20122,2′-Iminodiethanol
2012decan-1-ol
20122,4,6-tribromophenol
2012Hydroquinone
2012Tributyl Phosphate
2012ziram
20122-Ethylhexanoic acid
2012Imidazole
2012dimethyl phosphonate
2012N-(1,4-dimethylpentyl)-N’-phenylbenzene-1,4- diamine
2012N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine
2012tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
2012triclosan
2012Octocrilene
2012hexyl salicylate
2012Silicon dioxide
2012m-Tolylidene diisocyanate
2012isoheptane
2012Phenol, methylstyrenated
20121,1′-(ethane-1,2-diyl)bis[pentabromobenzene]
2012Alkanes, C14-17, chloro
2012A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4- methylpyran-4-ol
20122-(phenylmethoxy)naphthalene
2012Polyhaloalkene
2013formaldehyde
2013Carbon disulphide
20133,5,5-trimethylcyclohex-2-enone
2013Biphenyl
20131,2-dichlorobenzene
2013Furfuryl alcohol
20134,4′-methylenediphenyl diisocyanate
2013Hexamethyldisiloxane
2013methylcyclohexane
2013Tetrahydrofuran
20131,3,5-trioxane
20131,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3- dicarboxylic anhydride
2013tetrachloroethylene
2013Diallyl phthalate
20131,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
2013di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
2013Silver
2013[1,3(or 1,4)-phenylenebis(1- methylethylidene)]bis[tert-butyl] peroxide
2013diisotridecyl adipate
2013Phenol, dodecyl-, sulfurized, carbonates, calcium salts, overbased
2013mixture of two components: 1. N-(1,3- dimethylbutyl)-N´-phenyl-p-phenylenediamine 2. N1-(1,3-dimethylbutyl)-N4-(4-(1-methyl-1- phenylethyl)phenyl)benzene-1,4-diamine
2013Public name to be agreed with the registrant
2013Public name to be agreed with the registrant
2013Mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol
20142-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether
2014dichloro(dimethyl)silane
20144,4′-sulphonyldiphenol
2014diethyl phthalate
20142,4-di-tert-butylphenol
2014methyl 4-hydroxybenzoate
20144-hydroxybenzoic acid
20142,2′,2”-nitrilotriethanol
2014p-cresol
2014Allyl alcohol
2014resorcinol
2014triphenyl phosphate
2014thiram
20142-aminoethanol
2014diuron
20141,1,1,3,3,3-hexamethyldisilazane
2014Gallium arsenide
2014tris(methylphenyl) phosphate
2014tert-butyl methyl ether
20141-ethylpyrrolidin-2-one
2014diundecyl phthalate
20142-ethylhexyl 4-methoxycinnamate
2014titanium dioxide
2014Ditolyl ether
2014diisodecyl azelate
20142-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4- stannatetradecanoate
20141,2-Benzenedicarboxylic acid, benzyl C7-9- branched and linear alkyl esters
20141,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters
20141,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl es-ters, C13-rich
2014Phenol, 4-nonyl-, branched
2014diundecyl phthalate, branched and linear

LEGISLATIVE

Senate Committee Will Hold Hearing On TSCA Reform Legislation: On November 17, 2011, the Senate Environment and Public Works Committee and the Committee’s Superfund, Toxics, and Environmental Health Subcommittee will hold a hearing on legislation intended to reform TSCA, the Safe Chemicals Act of 2011 (S. 847). Senator Frank Lautenberg (D-NJ), who introduced the legislation on April 14, 2011, and is Chair of the Subcommittee, will chair the hearing. The Safe Chemicals Act (SCA) is intended to modernize TSCA to require chemical companies to demonstrate the safety of industrial chemicals and EPA to evaluate safety based on the best available science. More information is available in our April 18, 2011, memorandum online. Since Lautenberg introduced the legislation in April, staff from his office and the office of James Inhofe (R-OK), Ranking Member of the Senate Environment and Public Works Committee, co-hosted several meetings with chemical trade associations and industry, as well as separate meetings with environmental organizations. The first meeting, held on June 21, 2011, focused on chemical safety standards. Other meeting topics included data requirements and prioritization approaches. A spokesperson for Inhofe stated that “substantial progress” was made during the meetings. The November 17, 2011, hearing will be the first held on the SCA. The participation of Inhofe’s office in the stakeholder meetings is significant and could indicate a possibility of a bipartisan agreement regarding TSCA reform in the Senate. The remarks of both Senators Lautenberg and Inhofe should provide some indication of whether real progress has been made on the many substantive issues surrounding past discussions of what any new TSCA program should contain. Even with substantial progress, however, the effective window for significant legislation of any kind is rapidly closing as jockeying for the next Presidential election is well underway.

House Subcommittee Will Hold Hearing On Fostering Quality Science At EPA: On November 17, 2011, the House Committee on Science, Space and Technology Subcommittee on Energy and Environment will hold a hearing entitled “Fostering Quality Science at EPA: The Need for Common Sense Reform.” Witnesses will include Dr. Paul Anastas, Assistant Administrator, Office of Research and Development, EPA; Mr. David Trimble, Director, Natural Resources and Environment, U.S. Government Accountability Office; and Mr. Arthur Elkins, Jr., Inspector General, EPA. According to the Subcommittee website, additional witnesses are to be announced. More information is available online.

House Committee Passes REINS Act: On October 25, 2011, the House Judiciary Committee on party lines approved H.R. 10, the Regulations from the Executive In Need of Scrutiny (REINS) Act. Under the bill, no regulation that has an annual economic impact of $100 million or more could take effect unless it was approved by both houses of Congress within 70 legislative days of being proposed. The same House Committee on November 3, 2011, also passed H.R. 3010, the Regulatory Accountability Act. The bill would require regulatory review of environmental laws and would specifically amend the Clean Air Act (CAA) to prohibit agencies such as EPA from setting standards that are based solely on health. Sponsored by Lamar Smith (R-TX), the measure would require agencies to give greater weight to both direct and indirect costs when rules are at the proposal stage, including any indirect economic impacts on industry sectors not directly regulated. The legislation would also provide more avenues for regulated entities to challenge rules. A companion bill, S. 1601, was introduced in the Senate but likely will not pass that body.

Cross State Air Pollution Rule Survives Senate Vote; Alternative Measure Introduced: EPA’s Cross State Air Pollution Rule survived a Senate vote on November 10, 2011. The Senate defeated by a vote of 41-56 a Republican proposal (S.J. Res. 27) that would have voided the EPA rule. But Senators Joe Manchin (D-WV) and Dan Coats (R-IN) introduced a measure that would pursue a compromise approach. On November 9, 2011, Senators Manchin and Coats introduced The Fair Compliance Act of 2011 (S. 1833). The bill would extend to January 1, 2017, the compliance date for both the Cross State Air Pollution Rule and EPA’s recently promulgated Maximum Achievable Control Technology (MACT) rule for utility boilers.

Bill Would Revise CAA SIP Process: Senator Mike Johanns (R-NE) on November 3, 2011, introduced a bill that would revise the CAA’s process for EPA’s approval or denial of State Implementation Plans (SIP). The bill (S. 1805) would specifically prohibit EPA from rejecting or otherwise determining to be inadequate a SIP in any case in which the state submitting the plan has not been given a reasonable time to develop and submit the plan in accordance with CAA. The bill was referred to the Committee on Environment and Public Works.

Farm Dust Bill Clears Subcommittee Hurdle: Despite EPA’s assurances that it is not seeking to regulate farm dust, legislation in the House continues to advance that would restrict EPA from regulating coarse particulate matter, such as dust. On November 3, 2011, the House Energy and Commerce Subcommittee on Energy and Power passed the Farm Dust Regulation Prevention Act of 2011 (H.R. 1633). The legislation would ban EPA from regulating coarse particulate matter for one year. Under the bill, the authority to regulate so-called “nuisance dusts” (dust from agricultural activities) would be stripped from EPA and delegated to states and local governments.

Nominations: The Senate on October 20, 2011, confirmed John Bryson (a founder of the Natural Resources Defense Council), as the next Secretary of Commerce. Gregory H. Woods was approved by the Senate Energy and Natural Resources Committee on November 10, 2011, as the general counsel of the Energy Department. The Committee also approved David Danielson as Assistant Secretary of Energy for Energy Efficiency and Renewable Energy, and Charles D. McConnell as Assistant Secretary of Energy for Fossil Energy.

Bill Exempts U.S. Airlines From Emissions Trading Scheme: On October 25, 2011, the House by voice vote passed a bill (H.R. 2594) that would exempt U.S. airlines from complying with a European system to reduce carbon emissions from airplanes. Under the system, known as the Emissions Trading Scheme, any airline operating within the EU would have to pay for its carbon emissions that are in excess of 97 percent of its average annual emissions between 2004 and 2006.

$2 Billion Approved By Senate For Carbon Storage: On November 1, 2011, the Senate approved a FY 2012 spending bill that appropriates approximately $2 billion for carbon capture and storage projects. The legislation (H.R. 2112) would provide funding through September 30, 2012, for Agriculture, Commerce, Transportation, and other federal departments. The $2 billion would be set aside for construction, acquisition, or improvement of coal-fired and other fossil-fueled electricity generating plants that capture and store their carbon dioxide emissions. The measure now goes back to the House for consideration.

Coal Residuals Reuse And Management Act: Senator John Hoeven (R-ND) introduced legislation intended to facilitate the recovery and beneficial use, and provide for the proper management and disposal, of materials generated by the combustion of coal and other fossil fuels. The Coal Residues Reuse and Management Act (S. 1751) would amend Subtitle D of the Solid Waste Disposal Act to authorize state agencies to create coal combustion residuals permit programs. These permits would authorize the management of residuals from the combustion of coal as non-hazardous waste under federal law.

MISCELLANEOUS

Expert Panel Agrees HBCD Should Be Restricted Under Stockholm Convention: In October, the Stockholm Convention’s Persistent Organic Pollutants (POPs) Review Committee agreed on the need to add the flame retardant hexabromocyclododecane (HBCD) to the Convention’s Annex A, a list of POPs subject to an eventual ban. That recommendation will be submitted for final approval to a meeting of the Convention’s parties in May 2013. POPs is a global treaty adopted in 2001 to protect human health and the environment from chemicals that remain intact in the environment for long periods, are widely distributed geographically, tend to accumulate in fatty tissue, and are believed to have adverse effects on human health or the environment. Currently, 176 countries are party to the treaty; the United States signed the Stockholm Convention in 2001 but the U.S. Congress has never ratified it.

Consumer Product Safety Commission Requests Comments On Plan To Review Regulations: On October 19, 20111, the Consumer Product Safety Commission (CPSC) announced it is considering the appropriate process and substance of a plan to review existing CPSC regulations. 76 Fed. Reg. 64865. CPSC has conducted reviews of rules in the past and intends to build on that experience to develop a plan of review that also satisfies recent direction from President Obama, as set forth in Executive Order (EO) 13579 entitled “Regulation and Independent Regulatory Agencies.” This EO states that independent regulatory agencies should follow certain key principles when developing new regulations and should review existing significant regulations. CPSC invites comments on the issues discussed in the notice to help it formulate a plan that builds on its past review efforts while incorporating the principles outlined in EO 13579. Comments must be submitted by December 19, 2011.

ATSDR Issues Revised Priority List: On November 3, 2011, the Agency for Toxic Substances and Disease Registry (ATSDR) released its revised Priority List of Hazardous Substances commonly found at Superfund sites that it is required to monitor under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA). 76 Fed. Reg. 68193. The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near National Priorities List (NPL) sites. CERCLA as amended also requires that the Priority List of Hazardous Substances be revised periodically. The announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed. CERCLA as amended also requires ATSDR to prepare and to revise periodically toxicological profiles on hazardous substances included in the Priority List. Thus, each Priority List substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP).

CPSC Launches Online Reporting Tool For Businesses: On November 8, 2011, CPSC announced the launch of new features to the SaferProducts.gov Business Portal that make it easier and more efficient for businesses to work with CPSC. These changes are a key part of the agency’s overall information technology modernization effort. A new, comprehensive online form allows manufacturers, private labelers, and importers to submit quickly required reports of potentially hazardous or defective products to CPSC. The online form makes it easier for businesses to report product hazards and to communicate information on consumer product safety issues with CPSC. Another improvement expands CPSC’s ability to correspond with all of the businesses registered on SaferProducts.gov using the Business Portal, instead of postal mail. All registered manufacturers, importers, and private labelers identified in incident reports will now receive notices electronically, regardless of whether the report is eligible to be published on SaferProducts.gov. Previously, businesses could only receive SaferProducts-eligible reports electronically. This new feature is an example of efficiencies and cost savings being achieved through CPSC’s information technology overhaul. With this release, the structure has been put in place to allow eventually businesses registered in the Business Portal to add brand names for products they sell or have sold. Along with brand names, the time periods during which the company sold each brand also can be identified. This information will help CPSC more easily contact the appropriate business when a report about a product is submitted to SaferProducts.gov. These enhancements to the SaferProducts.gov Business Portal are largely a response to requests and feedback CPSC received from businesses and trade associations. SaferProducts.gov was launched on March 11, 2011, allowing consumers to report and search for reports of harm or risks of harm. As of October 31, 2011, the site contains more than 4,100 consumer product-related reports. CPSC’s press release is available online.

CSB To Hold Meeting To Release Findings On Three Combustible Iron Dust-Related Accidents: On November 16, 2011, the U.S. Chemical Safety Board (CSB) will convene a public meeting in Gallatin, Tennessee, to present the findings of the CSB investigative team and collect additional information on three iron dust flash fires that occurred over a five month period in 2011 at the Hoeganaes facility. All incidents caused death or severe injuries. At the meeting, the CSB investigative team will present its findings on the circumstances of the accident to three CSB Board members and the public. The Board will ask questions of the team and invite comments from members of the public. The meeting will be videotaped and an official transcript will be included in the investigative file. Only after a vote of the Board will the investigation results be final. CSB investigations look into all aspects of chemical accidents, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

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.