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October 1, 2011

Monthly Update for October 2011

Bergeson & Campbell, P.C.


EPA Issues Draft Harmonized Test Guidelines For Antimicrobial Products: On September 15, 2011, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft test guidelines for Series 810 — Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water. 76 Fed. Reg. 57031. These draft test guidelines are intended to address efficacy testing for antimicrobial agents to be used on hard, inanimate, environmental surfaces; in the air; and in water, and that contain label claims as disinfectants and/or sanitizers. Data from these studies are used to support the labeling claims for public health related antimicrobial agents. Comments are due December 14, 2011.

State FIFRA Issues Research & Evaluation Group Meets In Arlington: On September 19-20, 2011, the Pesticide Operations Management (POM) Working Committee (WC) of the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) met in EPA offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (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 is available online. A copy of the meeting handouts is available upon request by sending an e-mail to Chad Howlin

Issues of potential interest discussed during the meeting included the following: Drift Labeling and AAPCO; Fumigation Label Workgroup; Self-contained Breathing Apparatus (SCBA) Requirements on Fumigation Labels; Web Distributed Labels; Office of Pesticide Programs (OPP) Distributor Label Product Name Initiative; High Yield Enforcement Actions; Office of Enforcement and Compliance Assurance (OECA) Supplemental Distributor Labels Enforcement Initiative; National Pollutant Discharge Elimination System (NPDES) Update; United States Department of Agriculture (USDA) Biopreferred Program; Update from OECA; Update from OPP; Forest Aerial Application Buffers; Program Assessment Rating Tool (PART) Measures; and Accessing EPA Information/Data by States. A more detailed memorandum is available online.

EPA Releases Final Health Assessment For TCE: On September 28, 2011, EPA released a final health assessment for trichloroethylene (TCE) to the Integrated Risk Information System (IRIS) database. The final assessment characterizes the chemical as carcinogenic to humans and as a human noncancer health hazard. TCE is a common synthetic chemical found in the environment, and widely used as a chlorinated solvent. EPA already has drinking water standards for TCE and standards for cleaning up TCE at Superfund sites throughout the country. According to EPA, the assessment has undergone several levels of peer review, including agency review, interagency review, public comment, external peer review by EPA’s Science Advisory Board (SAB) in January 2011, and a scientific consultation review in 2006 by the National Academy of Sciences (NAS). More information on IRIS is available online.

EPA Issues Weight-of-Evidence Guidance For Endocrine Disruptor Screening Program: On September 28, 2011, EPA issued final guidance on the weight-of-evidence (WoE) approach that it will use to evaluate the results of chemical screening and determine what substances merit further study as potential disruptors of endocrine systems. According to EPA, application of WoE analysis is an integrative and interpretive process routinely used by EPA to evaluate health and ecological toxicity in a manner that takes into account all relevant scientific and technical information. The principles and criteria for weighing and integrating different lines of evidence articulated in existing EPA documents are considered generally applicable to evaluating data from the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery. The assessments of the reliability of test results are to include such factors as:

  • Did the laboratory demonstrate that it can conduct Tier 1 assays reliably?
  • For assays not following Tier 1 protocols, is there confidence in the measurement of the endpoints evaluated?
  • Was the experimental design adequate — including such factors as the purity and stability of test material, dosing regimen, adequate numbers of tests, and appropriate species for testing?
  • Did the study include appropriate positive and negative controls to evaluate the experimental design and performance?
  • Was the rationale for dose selection clearly presented, and were the dose selections appropriate?
  • Was the proper statistical analysis selected, and was it performed correctly?

According to EPA, a summary statement for a WoE analysis would typically include, among other things, a description of uncertainties and the extent to which these uncertainties impact the conclusions, a description of inconsistent or conflicting data and whether there is an explanation for these discordant results, and a discussion of the studies considered key and why. The final WoE guidance document for the EPA EDSP is available online. A more detailed memorandum is available online.

EPA Issues Direct Final Rule On 36 Chemicals: On October 5, 2011, EPA issued direct final significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances which were the subject of premanufacture notices (PMN). 76 Fed. Reg. 51566. Four of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. These are: rutile, tin zinc, calcium-doped; rutile, tin zinc, sodium-doped; formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts; and formaldehyde, polymers with acetonephenol reaction products and phenol, potassium sodium salts. The generic names of the 32 other chemicals are:

  • n-arylamino-phenol-formaldehyde condensate;
  • linear alkyl epoxide;
  • hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic acid;
  • phenol, 2-ethoxy-4-(ethoxymethyl);
  • 1-propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-;trivalent chromium complexes of a substituted beta-naphthol amine azo dye;
  • olefinic carbocycle, reaction products with alkoxysilane;
  • olefinic carbocycle, reaction products with alkoxysilane, sulfurized;
  • olefinic carbocycle, reaction products with alkoxysilane, polysulfurized;
  • phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester;
  • phosphonic acid, P-[2-[bis(2- hydroxyethyl)amino]ethyl]-, 2-[bis(2-chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester;
  • branched and linear fatty alcohol ethoxylate;
  • alkylpolyhydroxy polymer;
  • bis-phenoxyethanol fluorene diacrylate;
  • aromatic bromide;
  • disubstituted phenol;
  • zirconium lysine complex;
  • fatty acids, reaction products with alkanolamine;
  • thiosulfuric acid (H2S2O3), manganese(2+) salt (1:1);
  • butanedioic acid, 2-methylene-, polymer with 2,5 furanedione, copper(2+) manganese(2+) sodium zinc salt, hydrogen peroxide-initiated;
  • substituted acrylamide;
  • vinyl carboxylic acid ester;
  • benzoic acid, 4-(dimethylamino)-, 1,1′-[(methylimino)di-2,I-ethanediyl] ester;
  • butyl aromatic bisurea;
  • aromatic hydrocarbon;
  • halogenated aromatic hydrocarbon;
  • benzene, 1,3-bis(1-chloro-1-methylethyl)-;
  • oxime, di-me silane;
  • oxime, me vinyl silane;
  • phenol, 4-(1,1-dimethylethyl)-2-nitro-; and
  • polycarbocyclic methacrylate.

The final action requires persons who intend to manufacture, import, or process any of these 36 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. This rule is effective on December 5, 2011.

EPA Issues DfE Assessment For Nonylphenol Ethoxylates: On September 28, 2011, EPA issued a draft Alternatives Assessment for Nonylphenol Ethoxylates (NPE) to address concerns over potential ecological and other effects from nonylphenol (NP) and NPEs. To implement part of the Chemical Action Plan issued on August 10, 2010, for NP and NPEs, the DfE Program prepared the draft Alternatives Assessment, Alternatives for Nonylphenol Ethoxylates. DfE’s Alternatives Assessment Program is intended to assist industries choose safer chemicals and provide a basis for informed decision-making by developing a detailed comparison of potential effects of chemical alternatives. The Alternatives Assessment highlights and builds on the DfE Progam’s extensive work on surfactants and alternatives to NPEs. The report includes criteria that define safe NPE-alternative surfactants, illustrates the availability of safer alternative surfactants via DfE’s hazard evaluation methodology, and documents progress made in the adoption of safer surfactants. Seven of the eight alternatives analyzed met the safer surfactants criteria developed by EPA’s partnership. The seven chemicals deemed safer than NPEs are:

  • C12-15 alcohols, ethoxylated (9EO) (CAS No. 68131-39-5);
  • Oxirane, methyl-, polymer with oxirane, mono(2-ethylhexyl ether); ecosurf EH-9 (CAS No. 64366-70-7);
  • D-glucopyranose, oligomeric, decyl octyl glycosides (CAS No. 68515-73-1);
  • Benzenesulfonic acid, C10-13-alkyl derivs., sodium salt (CAS No. 68411-30-3);
  • Sodium lauryl sulfate (CAS No. 151-21-3);
  • Polyoxy(1,2-ethanediyl), alpha-sulfo-omegadodecyloxy-, sodium salt (CAS No. 9004-82-4); and
  • Sorbitan monostearate (CAS No. 1338-41-6).

Octylphenol ethoxylate (10EO) (CAS. No. 9036-19-5) did not meet EPA’s DfE criteria because it was determined by EPA to be highly toxic to aquatic organisms, highly persistent, and broke down into chemicals that were even more toxic than the original compound was. DfE seeks comments on the draft Alternatives Assessment, which is available online. Comments are due by November 30, 2011.

EPA Issues Draft IRIS Toxicological Review Of Vanadium Pentoxide: On September 30, 2011, EPA announced a 60-day public comment period and a public listening session for the external review draft human health assessment entitled Toxicological Review of Vanadium Pentoxide: In Support of Summary Information on the Integrated Risk Information System (IRIS) (EPA/635/R-11/004A). 76 Fed. Reg. 60825. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). The listening session will be held on Thursday, November 17, 2011, during the public comment period for this draft assessment. The purpose of the listening session is to allow interested parties an opportunity to present scientific and technical comments on draft IRIS health assessments to EPA and other interested parties attending the listening session. Comments are due by November 29, 2011.

EPA Issues Draft IRIS Toxicological Review Of Biphenyl: On September 30, 2011, EPA announced a 60-day public comment period and a public listening session for the external review draft human health assessment titled Toxicological Review of Biphenyl: In Support of Summary Information on the Integrated Risk Information System (IRIS) (EPA/635/R-11/005C). 76 Fed. Reg. 60827. The draft assessment was prepared by NCEA within the EPA’s ORD. The listening session will be held on Wednesday, November 16, 2011. Comments are due by November 29, 2011.

House Subcommittee Holds Hearing On Environmental Regulation And Its Impact On The Economy: On October 6, 2011, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on “Chemical Risk Assessment: What Works for Jobs and the Economy?” According to the background memorandum, the hearing was intended to explore EPA’s IRIS, and the relationship between IRIS and EPA’s regulatory requirements, “specifically whether IRIS is producing high quality science-based risk assessments that are suitable for regulatory objectives, or policy judgments that could harm businesses and the public.” IRIS has been criticized for years, but has come under intense criticism and Congressional scrutiny lately. NAS released a report in April 2011 on EPA’s IRIS assessment for formaldehyde. Although EPA had asked NAS to review only the IRIS assessment, NAS included general comments on EPA’s IRIS development process. On July 14, 2011, the House Science, Space, and Technology Subcommittee on Investigations and Oversight, prompted in part by NAS’s report, held a hearing to better understand the process behind the development of IRIS assessments, whether EPA plans on adopting NAS’s recommendations, and whether EPA assessments are based on the best available evidence and evaluated in accordance with established protocols. Immediately prior to the hearing, on July 12, 2011, EPA announced plans to improve the IRIS process. The background memorandum for the October 6, 2011, hearing and witness testimony are available online. A more detailed memorandum providing a summary of the hearing is available online.

EPA Releases Publication On Development Of Quantitative Structure-Activity Relationship Models To Predict The Carcinogenic Potency Of Chemicals: EPA announced the release of the final report entitled Development of Quantitative Structure-Activity Relationship Models to Predict the Carcinogenic Potency of Chemicals. The report provides an alternate approach to risk assessment to prioritize and screen potential carcinogenic chemicals at hazardous sites for clean-up considerations. The report is available online.

OPP Posts InertFinder Online Database: On October 12, 2011, OPP posted an InertFinder online database for searching substances used as inert ingredients in pesticide products. InertFinder is searchable by chemical name or Chemical Abstracts Service (CAS) Registry Number, and provides information on the approval status of substances used as inert ingredients for use in food use, non-food use, and fragrance use pesticide products. The InertFinder is available online.


EPA Launches Greener Products Website: On September 20, 2011, EPA launched a Greener Products website. The site is designed to help consumers, retailers, manufacturers, and institutional purchasers identify products that claim to use less toxic chemicals, less energy, or less water, or have other beneficial environmental attributes. Interested parties can identify specific products that may meet their specifications or EPA programs, nongovernmental organizations (NGO), and federal procurement guidelines that can serve as resources. The Greener Products website is at


Study Examines Cell Entry Of One-Dimensional Nanomaterials: On September 18, 2011, Nature Nanotechnology posted an article entitled “Cell entry of one-dimensional nanomaterials occurs by tip recognition and rotation.” The authors state that materials with high aspect ratio, such as carbon nanotubes (CNT) and asbestos fibers, have been shown to cause length-dependent toxicity in certain cells because these long materials prevent complete ingestion, which frustrates the cell. The authors note that, while “iophysical models have been proposed to explain how spheres and elliptical nanostructures enter cells,” one-dimensional nanomaterials have not been examined. The authors show “experimentally and theoretically” that cylindrical one-dimensional nanomaterials, such as CNTs, enter cells through the tip first. The abstract states:

For nanotubes with end caps or carbon shells at their tips, uptake involves tip recognition through receptor binding, rotation that is driven by asymmetric elastic strain at the tube-bilayer interface, and near-vertical entry. The precise angle of entry is governed by the relative timescales for tube rotation and receptor diffusion. Nanotubes without caps or shells on their tips show a different mode of membrane interaction, posing an interesting question as to whether modifying the tips of tubes may help avoid frustrated uptake by cells.

The study is available for purchase online.

SNWG Releases Statement Concerning Nanosilver: The Silver Nanotechnology Working Group (SNWG) prepared a September 2011 statement concerning nanosilver and its long history of safe and regulated use. SNWG notes the similarities between nanosilver and other antimicrobial silver materials available in the marketplace. SNWG states that it “has interacted with the EPA in challenged exchanges on how best to regulate nanopesticides leading to a clear, reasonable, and responsible path for registration.” SNWG urges EPA and other agencies not to impose unwarranted barriers to emerging nanotechnology industries. Instead, SNWG asks that EPA and other agencies “nourish the benefits these can provide while screening finished products claiming pesticidal properties on a case by case basis for any environmental risk.” SNWG seeks “a sensible path forward for registering nanopesticides that is not burdensome for either the government or industry.” SNWG’s statement is available online.

Meeting Of Nano Interests Held In Washington, D.C.: On September 22, 2011, during a meeting of nano interests in Washington, D.C., the following people spoke:

  • Jeffrey Weiss, Senior Director, Technical Barriers to Trade, Office of the United States Trade Representative, “U.S. Trade Policy and Nanotechnology,” online;
  • Richard A. Canady, Ph.D., Director, Center for Human Health Risk Assessment Research Foundation, International Life Sciences Institute (ILSI), “NanoRelease and NanoCharacter Projects,” online; and
  • Maria J. Doa, Ph.D., Acting Director of Chemical Control Division, Office of Pollution Prevention and Toxics, EPA, “Regulation of Carbon Nanotubes under the Toxic Substances Control Act,” online.

OEHHA Posts Comments On Revised Proposed Regulation For Hazard Traits And Environmental And Toxicological Endpoints: The Office of Environmental Health Hazard Assessment (OEHHA) has posted comments received on its July 29, 2011, revised proposed regulation concerning the specification of hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in California’s Toxics Information Clearinghouse. The California Department of Toxic Substances Control (DTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. OEHHA’s August 2010 pre-regulatory draft regulation included a “nanomaterial hazard trait,” as well as other references to nanoparticles, which OEHHA removed from its December 17, 2010, draft regulation. The revised regulation does not refer to nanomaterials or nanoparticles, but includes the following definition regarding particle size or fiber dimension:

  1. The particle size or fiber dimension hazard trait is defined as the existence of a chemical substance in the form of small particles or fibers or the propensity to form into such small-sized particles or fibers with use or environmental release.
  2. Evidence for the particle size or fiber dimension hazard trait includes, but is not limited to: measures of particle size less than or equal to 10 micrometers in mass median aerodynamic diameter for inhalation exposure, or less than 10 micrometers in any dimension for dermal or ingestion exposure, or fibers with a 3:1 aspect ratio and a width less than or equal to 3 micrometers.

More information is available online.

Conference Participants Discuss Nanomaterials: During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular — we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”

Australia Publishes Literature Review Relating To Six Nanomaterials: Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, CNTs, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.” The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances. In the report, several “special features” of nanoparticle-induced toxicity are singled out for more detailed analysis:

  • The extent to which repeated-dose vs. single dose and/or in vitro studies can contribute useful information to undertake a health risk assessment;
  • How likely is it that fibrous nanomaterials can reproduce the adverse health effects of asbestos fibers;
  • Whether there is new information about the extent to which nanoparticles can be absorbed across unbroken skin;
  • Whether some nanoparticles represent a specific risk of neurotoxicity under conditions where they can actually reach the brain, or whether nanoparticle exposure can result in cardiovascular toxicity; and
  • Knowledge gaps which might help to inform health risk assessment, and in particular, whether advances in knowledge of the effects of surface modification, or other structure-activity relationships, or application of genomic techniques, might fill some of these gaps.

More information is available online.

EC Requests Guidance On Safety Assessment Of Nanomaterials In Cosmetics: The EC has asked the Scientific Committee on Consumer Safety (SCCS) to prepare a guidance document on the safety assessment of nanomaterials in cosmetics. In its request for guidance, the EC notes that a number of documents provide general guidance on the health risk assessment of manufactured nanomaterials, but experience with the assessment of specific substances is limited. The guidance, which is due February 2012, should address the essential elements that would be required in a manufactured nanomaterial safety dossier (i.e., physicochemical characterization, toxicological evaluation, exposure assessment). According to the EC, the guidance will facilitate the submission of safety dossiers at present, as well as assist in the implementation of the provisions of Article 16 of the Cosmetics Regulation (EC) No. 1223/2009/, “which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013.” The EC specifically requests guidance on:

  1. The essential elements that must form part of safety dossiers for the assessment of nanomaterials in cosmetic products, based on the data requirements for the pre-market notification listed in Article 16 of Regulation (EC) No. 1223/2009, i.e. taking into account points 3a to 3f of Article 16 (identification of the nanomaterial, specification, quantity, toxicological profile, safety data, and exposure).
  2. The possibility to develop criteria and conditions that would allow the safety assessment of nanomaterials on a category-based approach rather than on a case-by-case basis.
  3. The suitability of alternative methods already validated for the assessment of conventional chemical substances for the assessment of nanomaterials in light of the current (as of 2009) ban on animal testing in the European Union.
  4. The set of attributes unique to manufactured nanomaterials that will need to be addressed by newly developed and/or newly validated alternative methods for the testing of toxicological end points for which there will be a ban on the testing on animals after March 2013.

More information is available online.

Nanotechnology Regulatory Science Act Of 2011 Introduced In Senate: On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions. Pryor’s press release is available online.

Health Canada Announces Policy Statement Concerning Working Definition For Nanomaterial: On October 11, 2011, Health Canada announced the availability of its Policy Statement on Health Canada’s Working Definition for Nanomaterial. Health Canada received 29 comments from stakeholders on its March 2010 Interim Policy Statement, which it revised based on stakeholders’ feedback. According to Health Canada, other revisions were prompted by developments in international norms, evolving scientific evidence, and regulatory program needs. Health Canada states that it will update its Policy Statement “as the body of scientific evidence and international norms progress.” The Policy Statement on Health Canada’s Working Definition for Nanomaterial, summary of comments received, and frequently asked questions are available online. The Policy Statement states:

Health Canada considers any manufactured substance or product and any component material, ingredient, device, or structure to be nanomaterial if:

  1. It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale, or;
  2. It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.

For the purposes of this definition:

  1. The term “nanoscale” means 1 to 100 nanometers, inclusive;
  2. The term “nanoscale properties/phenomena” means properties that are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules, and bulk material; and
  3. The term “manufactured” includes engineering processes and the control of matter.


EPA Issues Guidance For Project Manager On Institutional Controls: On September 13, 2011, EPA circulated new guidance reviewing the effectiveness of institutional controls relating to remedial projects. The guidance, Recommended Evaluation of Institutional Controls: Supplement to the Comprehensive Five Year Review Guidance, provides recommendations for monitoring and inspecting institutional controls, and was sent to EPA Superfund national policy managers in all EPA regions. The guidance is intended for EPA remedial project managers. Examples of institutional controls include a building permit or another non-engineered component designed to minimize the potential for human exposure to contamination or to protect a remedy. Other examples of institutional controls include zoning restrictions, excavation permits, well drilling prohibitions, easements, and covenants. The controls are a subset of land-use controls, which include engineering and physical barriers, such as fences and security guards. EPA’s new guidance on evaluating institutional controls is available online.

EPA Announces Data Availability On Coal Combustion Residuals And Request For Comment: On October 12, 2011, EPA announced the availability of and invited comment on additional information obtained by EPA in conjunction with the proposed rule: Hazardous and Solid Waste Management System: Identification and Listing of Special Wastes; Disposal of Coal Combustion Residuals From Electric Utilities that was published on June 21, 2010. 76 Fed. Reg. 63252. The information is generally categorized as chemical constituent data from coal combustion residuals (CCR); facility and waste management unit data; information on additional alleged damage cases; adequacy of state programs; and beneficial use determination. EPA seeks comment on the validity and propriety of the use of all new information, data, and potential analyses. EPA only requested comment on the information either specifically identified in this notice or located in the docket for the notice. EPA stated that it is not reopening “any other aspect of the proposal or the underlying support documents that were previously available for comment.” Comments are due on or before November 14, 2011.

EPA Outlines Enforcement Discretion For CERCLA Liability Protection: On September 21, 2011, EPA issued a memorandum outlining how it intends to exercise its enforcement discretion for parties who would otherwise qualify for liability protection defenses under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The memorandum is intended to assist EPA personnel in exercising their enforcement discretion on a site-specific basis for parties who meet all requirements as bona fide prospective purchasers or contiguous property owners except for being “affiliated with any other person that is potentially liable” for contamination at a facility. The September 21, 2011, memorandum, Enforcement Discretion Guidance Regarding the Affiliation Language of CERCLA’s Bona Fide Prospective Purchaser and Contiguous Property Owner Liability Protections, was sent to EPA regional counsel and Superfund national policy managers. The Brownfields Amendments of 2002 to CERCLA provide bona fide prospective purchasers and contiguous property owners protection from liability under CERCLA as long as they meet certain statutory requirements. Before analyzing whether there is a prohibited affiliation, EPA personnel should consider four preliminary issues:

  • First, EPA personnel should consider if the party is a potentially responsible party at the facility as an owner or operator at the time of disposal, a transporter, or an arranger for the disposal of hazardous substances. If so, the party cannot be a bona fide prospective purchaser or contiguous property owner.
  • Second, EPA should consider whether the entity is the same as potentially responsible parties or is potentially liable under other principles of corporate law, such as successor liability. After careful analysis, the relationship between the potentially responsible party and the entity in question may lead EPA to decide not to treat that entity as a bona fide prospective purchaser or contiguous property owner.
  • Third, EPA should analyze whether a business entity asserting status as a bona fide prospective purchaser or contiguous property owner is the result of a reorganization of a liable party through bankruptcy or other corporate restructuring. If so, the entity may not be eligible for the liability protection.
  • Fourth, EPA personnel should carefully consider whether the party with whom a person may have an affiliation is actually a potentially responsible party at the facility. If not, the person may qualify for protective status.

The memorandum is available online.


REACH Testing Proposal Goes To Arbitration: On September 27, 2011, ECHA announced a REACH testing proposal will be sent to the EC for arbitration because of uncertainty about the application of testing guidelines. ECHA’s decision to request arbitration concerns a proposal to generate test data about 2,3 epoxy neodecanoate, which is used in a wide range of applications, including the processing of rubber and manufacture of plastics. Under REACH, testing proposals must be approved by a committee of experts from the European Union (EU) member states convened by ECHA to minimize animal tests. The committee met September 20-23, 2011, but was unable to agree on the testing proposal for 2,3 epoxy neodecanoate. ECHA reported the proposal will be sent to the EC for a final decision under a referral process detailed in Article 51(7). It is the first time the referral process has been used.

Russia Poised To Adopt Chemical Regulations Consistent With REACH: Russia, Kazakhstan, and Belarus are poised to adopt a unified system of chemical regulation consistent with EU’s REACH and the United Nations’ Globally Harmonized System (GHS) for classifying chemicals under the three countries’ new Customs Union. The same technical regulations will apply in the Eurasian Economic Community, which includes Kyrgyzstan, Tajikistan, and Uzbekistan as well as Russia, Kazakhstan, and Belarus, under an agreement to coordinate policy. As of July 1, 2011, the Customs Union agreement removed customs borders between Russia, Kazakhstan, and Belarus. The three countries are scheduled as of January 1, 2012, to become a single economic space with freer movement of goods, services, and workers under common policies and border procedures. The regulations will apply to existing chemical and new chemical products that are imported into or transiting through the Customs Union, regardless of country of origin. The legislation defines rules for market access, chemical product identification, classification, safety, consumer disclosure, and registration. Draft text of the Customs Union chemical regulation is available, in Russian, online.

EU Countries To Test Compliance With Chemicals Law: On October 10, 2011, enforcement authorities in EU countries announced agreement to pursue a joint project to test companies’ compliance with the REACH chemicals law. The project was approved at an October 3-5, 2011, meeting of the ECHA Forum for Exchange of Information on Enforcement. Two previous coordinated projects, known as REACH-EN-FORCE 1 and REACH-EN-FORCE 2, started in 2009 and 2010. ECHA reported that the third enforcement project will focus on “verification of [REACH] registrations by Only Representatives, and the cooperation with custom authorities controlling imports of substances.” Information about the ECHA Forum for Exchange of Information on Enforcement is available online.

ECHA Opens Public Consultation On Proposed Restriction For Four Phthalates: On September 19, 2011, ECHA opened a public consultation on a report submitted by Denmark that proposes a restriction for the placing on the market and use of certain articles containing four classified phthalates — di(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP). ECHA states that the phthalates are found primarily in polyvinyl chloride (PVC) as softeners, but they can also be found in low concentrations in other plastics and also in dispersions, paints, and varnishes. The phthalates are all reported to affect reproductivity. According to ECHA, the widespread use of phthalates is raising concern regarding human exposure from consumer articles, and the dossier addresses the combined exposure based on common effects seen with exposure to these phthalates. Denmark proposes a ban for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 percent by weight of any plasticized material. DEHP, DBP, and BBP are in the list of substances subject to authorization (Annex XIV). DIBP is included in ECHA’s second recommendation of substances to be included in that list. ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) will review and consider comments. The final opinions of the Committees on the proposed restriction are scheduled for September 2012. Based on these opinions, the EC will decide whether to introduce additional restrictions. ECHA notes that, although the six-month public consultation concludes on March 16, 2012, the Rapporteurs of RAC and SEAC would appreciate receiving comments by December 16, 2011, “to assist them in the detailed discussion of the restriction proposal in January 2012.” More information is available online.


Cement Sector Relief Passed In House: On October 6, 2011, the House of Representatives passed H.R. 2681, “The Cement Sector Regulatory Relief Act of 2011,” by a vote of 262-161. The Act, one of a number of house measures styled to help relieve regulatory burdens and save jobs, provides that National Emission Standards for Hazardous Air Pollutants (NESHAP) from the Portland Cement Manufacturing Industry and Standards of Performance for Portland Cement Plants, as well as Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources and other matters shall have no force or effect and shall be treated as though they had never taken effect. The Cement Relief measure requires EPA to issue in final within 15 months after enactment, regulations for the Portland cement manufacturing industry and Portland cement plants subject to such rules, that establish maximum achievable control technology standards, performance standards, and other requirements for hazardous air pollutants or solid waste combustion under the Clean Air Act (CAA); and identify non-hazardous secondary materials that, when used as fuels or ingredients in combustion units of such industry and plants, are solid waste under the Resource Conservation and Recovery Act (RCRA). EPA is required to establish a date for compliance with standards and requirements under such regulations, which shall be no earlier than five years after such regulation’s effective date after considering compliance costs, non-air quality health and environmental impacts and energy requirements, the feasibility of implementation, the availability of equipment, suppliers, and labor, and potential net employment impacts. The Act treats the date on which the Administrator proposes such a regulation establishing an emission standard as the proposal date for purposes of applying the definition of a “new source” to hazardous air pollutants requirements under the CAA.

House Passes TRAIN: The House passed by a vote of 249-169 and referred to the Senate the “Transparency in Regulatory Analysis of Impacts on the Nation Act of 2011” (TRAIN), H.R. 2401, that ostensibly amends the Energy Policy Act of 2005 to increase and extend appropriations for fiscal year (FY) 2012-FY 2016 for diesel emissions reduction, but also has provisions that opponents say would severely weaken the CAA and other environmental statutes. At issue in the legislation is a requirement that the President establish the “Committee for the Cumulative Analysis of Regulations that Impact Energy and Manufacturing in the United States.” The charge of the committee is to analyze and report on the cumulative and incremental impacts of covered rules and actions of EPA concerning air, waste, water, and climate change for each of calendar years 2016, 2020, and 2030. H.R. 2401 would require such analysis to include: (1) estimates of the impacts of such rules and actions on the global economic competitiveness of the United States, electricity prices, fuel prices, employment, and the reliability and adequacy of bulk power supply in the United States; and (2) a discussion and an assessment of the cumulative impact on consumers, small businesses, regional economies, state, local, and tribal governments, local and industry-specific labor markets, and agriculture.

The “covered rules” specified in H.R. 2401 include national standards for air quality and air pollutants and hazardous and solid waste and other rules promulgated under specified provisions of the CAA on or after January 1, 2009. The Act defines “covered action” as any action on or after such date by the EPA, a state, a local government, or a permitting agency as a result of the application of specified CAA provisions with respect to an air pollutant that is identified as a greenhouse gas.


OSHA Posts Interpretation Regarding When A Mixture Would Exceed The Threshold Quantity In A Covered Process: On September 26, 2011, the Occupational Safety and Health Administration (OSHA) posted a May 21, 2009, interpretation regarding when a mixture would exceed the threshold quantity in a covered process. OSHA responded to specific questions regarding the application of the Process Safety Management (PSM) standard, 29 C.F.R. Section 1910.119, in three flammable liquid handling scenarios. The interpretation is available online.

OEHHA Posts Notices On Prop 65: On September 29, 2011, OEHHA made available an update to its Frequently Asked Questions about Proposition 65, available online. OEHHA also announced the availability of a Status Report on No Significant Risk Levels for Carcinogens and Maximum Allowable Dose Levels for Chemicals Causing Reproductive Toxicity, September 2011. The document is available online.

EPA Issues Exposure Factors Handbook: 2011 Edition: On September 30, 2011, EPA publically released the final report entitled Exposure Factors Handbook: 2011 Edition. 76 Fed. Reg. 61098. The document was prepared by NCEA within EPA’s ORD. The Exposure Factors Handbook: 2011 Edition provides information on various physiological and behavioral factors commonly used in assessing exposure to environmental chemicals. The handbook was first published in 1989 and was updated in 1997. This edition incorporates information made available from 1997 up until July 2011. It also reflects the revisions made to the Child-Specific Exposure Factors Handbook, which was last updated and published in 2008. Each chapter in the Exposure Factors Handbook: 2011 Edition presents recommended values for the exposure factors covered in that particular chapter’s exposure route as well as a discussion of the underlying data used in developing the recommendations. The Exposure Factors Handbook: 2011 Edition (EPA/600/R-09/052F) is available online.

EC Bans Two Pesticides: On September 23, 2011, the EC published technical regulations banning from the EU market flufenoxuron and propargite, both pesticides. The EC determined the risk posed to consumers, workers, and aquatic organisms “could not be eliminated.” In addition, flufenoxuron reportedly has been found to have potential for bioaccumulation in the food chain, while propargite has been shown to pose long-term risks to mammals. Consequently, EU member states must withdraw by the end of 2011 any authorizations for use of the substances, with a transitional usage period extending no later than December 31, 2012.

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