Monthly Update for September 2012


The Acta Group (Acta), Bergeson & Campbell, P.C.'s (B&C) consulting affiliate, will hold a complimentary webinar on September 19, 2012, to outline and discuss changes to the European Union (EU) regulations for companies marketing biocidal active substances and biocidal products in the EU. More information is available online.

TSCA/FIFRA/IRIS/EPCRA

EPA Publishes Peer Review Plans For Chemicals: On August 17, 2012, the U.S. Environmental Protection Agency (EPA) released its plans to peer review various analyses of risks believed to be posed by seven chemicals/chemical groups. The seven chemicals or groups of chemicals are part of the 83 chemicals EPA announced it would review last March. The seven chemicals are: antimony trioxide; HHCB (1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2 -benzopyran); long-chain chlorinated paraffins; medium-chain chlorinated paraffins; methylene chloride; n-methylpyrrolidone; and trichloroethylene. EPA reportedly developed the peer review plans to comply with the Office of Management and Budget's (OMB) 2004 Information Quality for Peer Review bulletin, which directs agencies to develop peer review plans for "influential" scientific information. The plans describe the focus of the risk assessment being conducted on each chemical or group of chemicals, indicate how peer reviewers will be selected and how the peer review will be conducted, and provide the time line for the reviews. When EPA's draft risk assessments are available, EPA will publish a notice in the Federal Register and provide a 60-day period for public comment on those analyses prior to their peer review. The peer review plans are available online under "Office of Chemical Safety and Pollution Prevention."

EPA To Accept Alternative Estrogen Test For EDSP: On August 21, 2012, the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announced that it has received responses to the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method recommendations on the usefulness and limitations of the LUMICELL® ER (BG1Luc ER TA) test method to identify human estrogen receptor (ER) agonist and antagonist activity of chemicals. 77 Fed. Reg. 50510. According to the notice, the responses are favorable and, as a result, EPA intends to accept data from a new, alternative estrogen receptor binding test rather than only results from a test that is part of EPA's Endocrine Disruptor Screening Program (EDSP). According to NTP, concurrence letters from EPA and other federal agencies have paved the way for this new, alternative test method. Information about the BG1Luc assay, including federal agencies' responses, is available online. EPA information about tests for its EDSP is available online.

EPA Issues Final Rule Revising Pesticide Tolerance Crop Grouping Program III: On August 22, 2012, EPA issued a final rule revising the current pesticide tolerance crop grouping regulations, which allow for the establishment of tolerances for multiple related crops based on data from a representative set of crops. 77 Fed. Reg. 50617. The rule expands upon existing stone fruit and tree nut crop groups by establishing new crop subgroups and adding new commodities. This is the third in a series of planned crop group updates expected to be promulgated over the next several years. The final rule is effective October 22, 2012.

EPA Announces SFIREG POM Working Committee: On August 24, 2012, the Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG), Pesticides Operations and Management (POM) Working Committee announced that it will convene a two-day meeting, beginning on September 17, 2012, and ending on September 18, 2012. 77 Fed. Reg. 51533. The notice announces the location and times for the meeting and sets forth the tentative agenda topics. Tentative agenda topics include, among other topics, reconciling State Lead Agency (SLA) referrals to EPA for enforcement vs. SLA efforts to fix violative labels in a timely manner; risk mitigation on seed bag tags; persistent herbicides in compost (sources); methomyl issue paper; and update on Insect Repellency Mark Initiative.

EPA Issues Microbial Pesticide Definitions, Applicability Clarification, And Test Guideline: On August 30, 2012, EPA issued a final rule clarifying the distinction between "isolates" and "strains," and clarifying the requirements applicable to new isolates, which are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 77 Fed. Reg. 52610. EPA also revised regulatory text to include several minor corrections to words and references. EPA also announced the availability of a final microbial pesticide test guideline that further explains the existing data requirement to deposit a sample in a nationally recognized culture collection. The final rule is effective October 29, 2012.

OPP Posts New Topic To Enable The Label Online Discussion Forum: On September 1, 2012, the Office of Pesticide Programs (OPP) posted a new topic covering the use of the term "new" on pesticide product labeling to the Enable the Label online discussion forum. According to EPA, pesticide registrants regularly request to add the term "new" to their labeling when registering a new product or making some change to their product. EPA states that, generally, when it has approved the use of "new" on pesticide labeling, it allowed the term to appear for a period of six months following the approval of the labeling. This six-month period may lapse before the product reaches the consumer market, however, because there is often a delay between EPA's approval and when a product is first sold and distributed, resulting in registrants not ever being able to use the term "new." EPA is considering allowing registrants seeking to amend their labeling to request the use of "new" with a projected start date for when a six-month time period to use the term would begin. EPA states that it is interested in receiving comments on this issue. Comments are due November 30, 2012, to opp_labeling_consistency@epa.gov. Comments may also be posted to the OPP label discussion forum. More information is available online.

EPA Proposes To Exempt Two Microorganisms From Reporting Requirements: EPA published a proposed rule on September 5, 2012, that would add two additional microorganisms to the list of recipient microorganisms that are eligible for exemptions under the Toxic Substances Control Act (TSCA) from full reporting for the manufacture (including import) of new microorganisms. 77 Fed. Reg. 54499. EPA states that it received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting procedures under TSCA for new microorganisms that are being manufactured for introduction into commerce. According to EPA, based on its evaluation of the petitions, it has made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism provided that certain criteria for the introduced genetic material and the physical containment conditions are met. Comments on the proposed rule are due November 5, 2012. Requests for an informal public hearing are due October 5, 2012. If EPA receives a written request for an informal hearing, EPA will hold it in Washington, D.C., and announce the details in a future Federal Register notice.

ACI Launches Cleaning Product Ingredient Inventory: On September 6, 2012, the American Cleaning Institute (ACI) launched its Cleaning Product Ingredient Inventory, which is available on the ACI Science website. The Ingredient Inventory is the first milestone in ACI's Cleaning Product Ingredient Safety Initiative, which seeks to identify publicly available human and environmental data sets for every chemical ingredient used in every formulated consumer cleaning product manufactured by its members, to develop exposure assessments consistent with the use of each ingredient and to present a screening-level risk assessment demonstrating the safe use of each ingredient. The Ingredient Inventory represents the first step in this effort -- defining the universe of chemicals used in ACI members' consumer cleaning products. The Ingredient Inventory was compiled by surveying 900 ACI members' laundry care, dish care, and hard surface cleaning products, consolidating the ingredient names and providing a unique identifier, typically a CAS Registry Number. The result is a comprehensive inventory of over 900 ingredients used in ACI members' consumer cleaning products.

EPA Issues Direct Final Rule Revisions On PCBs Manifesting Regulations: On September 6, 2012, EPA issued a direct final rule to update and clarify several sections of the Polychlorinated Biphenyl (PCB) regulations associated with the manifesting requirements, which uses the Resource Conservation and Recovery Act (RCRA) Uniform Hazardous Waste Manifest, under TSCA. 77 Fed. Reg. 54818. The changes are intended to match, as much as possible, the manifesting requirements for PCBs under TSCA to the manifesting requirements for hazardous waste under RCRA, of which the regulatory changes to implement the Uniform Hazardous Waste Manifest form were promulgated on March 4, 2005. This direct final rule will be effective December 5, 2012. If adverse comments are received, EPA will publish a timely withdrawal in the Federal Register informing the public that the amendment in this direct final rule will not take effect. EPA also issued a proposed rule on September 6, 2012, intended to achieve the same revisions. 77 Fed. Reg. 54863. Comments are due by November 5, 2012.

EPA Provides Notification Of External Peer Review Meeting For The Draft Framework For Human Health Risk Assessment To Inform Decision Making: On September 12, 2012, EPA Office of the Science Advisor announced that Versar, Inc., an EPA contractor, will convene an independent panel of experts to review the draft document, Framework for Human Health Risk Assessment to Inform Decision Making. 77 Fed. Reg. 56202. The final Framework is intended to foster increased implementation of existing Agency guidance for conducting human health risk assessments and improve the utility of risk assessment in the decision-making process. In developing the draft Framework, the relevant recommendations presented in the National Research Council's (NRC) report Science and Decisions: Advancing Risk Assessment have been taken into consideration. Specifically, the recommendations that EPA formalize and implement planning, scoping, and problem formulation early in the risk assessment process and that the Agency adopt a framework for risk-based decision-making are included in this Framework. The meeting will be held on October 9, 2012, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202. Please consult the Federal Register for additional details.

EPA Settles Enforcement Actions For Sales Of Unregistered Pesticides: On September 13, 2012, EPA announced the settlement of three enforcement actions against pesticides distributors for violations related to the sale or distribution of unregistered and misbranded pesticides. All three cases involved the sale and distribution of plant growth regulators, which are regulated as pesticides under FIFRA.

FIFRA defines plant growth regulators as substances intended to accelerate or retard the growth of plants. Among other things, substances considered to be plant regulators may include hormone additives intended to stimulate plant root growth or fruiting, such as gibberellins, auxins, and cytokinins derived from seaweed. Products containing these additives are often marketed as fertilizers, but such claims do not exempt products from regulation as pesticides.

Two companies agreed to pay $17,160 and $12,000 penalties for the sale and distribution of unregistered plant growth regulators and fungicides, while a third company agreed to pay a $237,573 civil penalty for the sale and distribution of unregistered pesticide products, including plant regulators, insecticides, and fungicides. Under FIFRA, distributors of pesticides must ensure that pesticides intended for distribution within the U.S. are registered if the distributor claims the substance can be used as a pesticide or if the product is intended to be used for a pesticidal purpose, including as a plant regulator.

Academies Panel To Hold First Meeting On IRIS: The National Academies announced that the NRC committee established to review scientific, technical, and procedural changes EPA is implementing to its Integrated Risk Information System (IRIS) program will convene its first meeting on September 17-18, 2012. The meeting is generally closed to the public, but a portion of the September 17, 2012, afternoon session will be open to the public. Dr. Kenneth Olden, National Center for Environmental Assessment (NCEA) Director, will speak. The committee will focus on development of the IRIS assessments with focus on EPA's weight-of-evidence analyses. More information about the meeting is available online.

OPP Updates Internal Memoranda On CSFs For TGAIs And EPs And MUPs: On September 13, 2012, OPP announced on its website that it updated its internal memoranda on confidential statements of formula (CSF) for technical grade active ingredients (TGAI) and end-use products (EP) and manufacturing use products (MUP). According to the September 11, 2012, memorandum concerning CSFs for TGAIs, some TGAI registrants have proposed an alternative to providing multiple, alternate CSFs reflecting each manufacturing site and each country in which the product is produced. Instead, registrants proposed providing an attachment to the CSF that lists additional sites at which the TGAI may be manufactured and additional countries in which the TGAI is produced. OPP states that it has determined that this approach will still allow it "to fully evaluate the proposed products to make a sound regulatory decision," as well as "help to alleviate the agency's handling and tracking of many pages of alternate CSFs and help to reduce registrant burden." OPP will now accept an attachment to a basic or an alternate CSF listing alternate manufacturing sites and production countries. The memorandum is available online. In the September 11, 2012, memorandum concerning CSFs for EPs and MUPs, EPA states that some EP and MUP registrants proposed an alternative to providing multiple, alternate CSFs reflecting each potential formulation site, each potential country where production may occur, and each potential supplier of a specified inert ingredient. Instead, registrants proposed to:

  • Identify in Box 2 of the CSF the name, title, company name, address, and telephone number of the appropriate company contact for production-related questions. Optionally, companies can also provide an attachment to the CSF that lists production sites;
     
  • Provide an attachment to the CSF that lists alternate countries in which the EP is formulated; and
     
  • Provide an attachment to the CSF that lists alternate suppliers of the inert ingredients.

OPP states that it has determined that this approach will allow it "to fully evaluate the proposed products to make a sound regulatory decision," and will also "help to alleviate the agency's handling and tracking of many pages of alternate CSFs and help to reduce registrant burden." OPP will, therefore, now accept attachments to a basic or an alternate EP/MUP CSF. The memorandum is available online.

EPA Announces TSCA Section 8(d) Webinar: EPA has announced it will hold a refresher webinar on September 20, 2012, from 1:00 - 3:00 PM EDT, on the use of the TSCA Section 8(d) and 8(e) electronic reporting tools. The webinar will provide a walkthrough of the CDX registration process and the 8(d) and 8(e) reporting tools. Time will be allotted for questions related to the reporting tool. Questions related to specific reporting requirements will not be covered during this webinar. More information is available online.

GREEN CHEMISTRY

DTSC Extends Public Comment Period On Proposed Safer Consumer Products Regulations: On August 20, 2012, the California Department of Toxic Substances Control (DTSC) announced that it was extending the 45-day public comment period for its proposed Safer Consumer Products Regulations (Proposed Regulations) published on July 27, 2012. In response to numerous requests to extend the comment period due to the Proposed Regulations' length and complexity, DTSC will accept public comments until 5:00 p.m. on October 11, 2012. DTSC, however, still held a public hearing on the proposed regulations on September 10, 2012. An audio recording of the hearing, the comment extension notice, and background documents on the Proposed Regulations are available online.

Memoranda providing background information are available online. The Proposed Regulations are available online.

DTSC Director Speaks At Safer Consumer Products Summit: On September 6, 2012, DTSC Director Debbie Raphael spoke during the Safer Consumer Products Summit regarding the Proposed Regulations. Points raised during the Summit include:

Timing: The comment period was extended from September 11, 2012, to October 11, 2012 (see item above). Raphael stated that DTSC was not inclined to provide any further extensions of the comment period. Although DTSC has previously stated that if substantial changes are made to the regulations the modified full text will be made available for comment for at least 15 days prior to adoption, Raphael stated that DTSC expects to provide a second comment period for which the timing for comment submission will be more than 15 days. DTSC is planning on adopting final regulations in early 2013.

"Chemicals of Concern" (COC) List: Raphael confirmed that the list of 1,200 COCs will not be posted until the regulations are issued in final. DTSC will also at that time publish a list of approximately 185-200 COCs where DTSC will focus its attention before January 1, 2016, in prioritizing Priority Products (PP). The list of 1,200 COCs is derived from several existing lists that list chemicals on the basis of exhibiting at least one of seven hazard traits or one of three exposure indicators. The list of 200 COCs from which DTSC will prioritize and evaluate PPs will be those COCs that exhibit one of the hazard traits and one of the exposure indicators. Section 69503.3(g).

Alternatives Analysis Threshold: DTSC has removed any specific default thresholds (e.g., 0.01 percent by weight) or "de minimis level" with regard to the presence of the COC in the PP and instead uses an "Alternatives Analysis Threshold," defined as a concentration by weight specified by DTSC. DTSC chose this approach based on comments that defaults needed more flexibility and expects to seek public comments on what a threshold should be. Raphael clarified that these thresholds will not be limited to intentionally added substances. There were some comments during the Summit that suggested that public comments on a threshold may politicize the issue and that a default threshold, with the possibility of arguing to increase or decrease the threshold may be a better approach (and one that is used in other regulatory regimes, including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)). In response to questions posed, Raphael stated that it was not DTSC's intent consistently to make the threshold the minimum detection limit and that this point could be clarified in a response to any written comments submitted on this issue.

Alternative Analysis (AA): Raphael emphasized that AAs must focus not only on identifying alternatives to COCs but on identifying safer alternatives and avoiding regrettable substitutes. DTSC expects to release guidance to assist companies in identifying alternatives, weighing the alternatives against 13 different regulatory criteria, and selecting an alternative. Many acknowledged that weighing criteria, assessing trade-offs, and making these determinations could be one of the most challenging aspects of these Proposed Regulations. Representatives from several companies discussed the different mechanisms by which they now conduct AAs and the problems they encounter, including but not limited to data gaps that make chemical comparisons difficult and selecting alternatives that will not later be restricted (thus starting the process again).

Regulatory Responses: Raphael noted that the range of regulatory responses that DTSC can take in response to an AA and its active participation is perhaps the most "groundbreaking" element of the Proposed Regulations. One point that Raphael clarified is that in cases where product information must be communicated to consumers, there is no requirement that this must be done through labeling.

NANOTECHNOLOGY

EU-OSHA Posts Literature Review On Risk Perception And Communication On Nanomaterials In The Workplace: On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found "serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces." The review intends to:

  • Summarize the general principles and theories of risk perception and communication, referring to relevant trends and current guidance on these topics;
     
  • Identify the stakeholders involved in risk perception and communication for nanomaterials in the workplace, and appraise relevant research, studies, surveys, and risk communication initiatives that have been done to date at national and international levels; and
     
  • Consider the gaps in knowledge and limitations of the risk communication initiatives in this area, and suggest ways these might be addressed, with a view to proposing how to communicate with workers and employers on the potential risks of nanotechnologies and highlighting the difficulties involved.

EU-OSHA states that risk communication strategies need to help employers make informed decisions about their workplaces and put adequate prevention measures in place, and to empower individual workers to take personal control of their own situations to protect themselves adequately. More information is available online.

PNAS Posts Study Concerning Soybean Susceptibility To Manufactured Nanomaterials: The Proceedings of the National Academy of Sciences (PNAS) posted on its website on August 20, 2012, an article entitled "Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption." According to the authors, no single study to date has examined the full implications of growing plants to full maturity in field soil contaminated by manufactured nanomaterials. The PNAS study does so for soybeans in farm soil amended with two metal oxide manufactured nanomaterials. The abstract states: "The results provide a clear, but unfortunate, view of what could arise over the long term: (i) for nano-ZnO, component metal was taken up and distributed throughout edible plant tissues; (ii) for nano-CeO2, plant growth and yield diminished, but also (iii) nitrogen fixation -- a major ecosystem service of leguminous crops -- was shut down at high nano-CeO2 concentration." The authors conclude that, "[j]uxtaposed against widespread land application of wastewater treatment biosolids to food crops, these findings forewarn of agriculturally associated human and environmental risks from the accelerating use of" manufactured nanomaterials. More information is available online.

IZA Responds To PNAS Study On Effects Of Nanoparticles On Soybean Plants: The International Zinc Association (IZA) prepared a response to a recent article entitled "Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption" and posted on the PNAS website. IZA states that while the article and related reports highlight that nano-zinc oxide improves crop productivity and zinc concentration in plants, they suggest that the concentration of zinc in plants is negative and poses potential risks to humans. According to IZA, "increased crop production and zinc concentration in plants is an encouraging result and one we would anticipate -- indeed, these are the two key objectives of adding zinc fertilizer to crops." IZA notes that the appendix to the PNAS article states: "ngesting 100g dry soybean mass from our study would deliver approximately 8mg Zn, which is well below the tolerable UIL for adults. Since children would consume less, as their protein requirements are less than adults, they should also not be at risk. Bioaccumulation levels would need to be approximately five times more total Zn than we report to reach bean Zn concentrations that are harmful to human health." IZA states:

In conclusion, although we find the results of this study, specifically increased crop production and zinc uptake, to be very positive, we have great concern over the inappropriate interpretation of the these results. The risk of over-exposure to zinc in any capacity is negligible compared to the life­threatening reality of underexposure to zinc -- which is far and away the bigger, more immediate danger. The misplaced concerns created by this report and the subsequent articles are capable of overshadowing the real problem of zinc deficiency in humans and crops, a serious global issue affecting food security and children's lives.

IZA's response is available online. The appendix to the PNAS article is available online.

SCCS Calls For Experts On The Safety Assessment Of Nanomaterials In Cosmetic Products: On August 31, 2012, the European Commission's (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on the market. In case of concern, the EC will request SCCS to provide an opinion. According to the EC website, to meet the expected demand for safety assessments, the Commission Health and Consumers Directorate General intends to identify relevant experts who will assist the work of the SCCS. The Working Group is looking for experts with knowledge in relation to nanomaterials, particularly those used in cosmetic products, in the following areas:

  • Characterization;
     
  • Chemistry;
     
  • Systemic toxicity;
     
  • Genotoxicity;
     
  • Human exposure (including inhalation);
     
  • In vitro and alternative methods; and
     
  • Risk assessment for human health.

The deadline for submission for the call for experts is October 15, 2012. More information is available online.

Titanium Dioxide Reference Material Developed: On September 5, 2012, the National Institute of Standards and Technology (NIST) announced that it has developed nanoscale titanium dioxide reference materials for use in environmental, health, and safety studies. NIST's reference materials are used to calibrate and test analytical instruments. NIST's announcement, which has links to purchasing and other information, is available online.

NRC Report On Science For Environmental Protection Examines Nanotechnology: On September 5, 2012, NRC released a pre-publication version of a report entitled Science for Environmental Protection: The Road Ahead. EPA asked NRC to assess EPA's overall capabilities "to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities." The report discusses nanotechnology as an example of using emerging science to address regulatory issues and support decision-making. The Committee states that, to have the capacity to address emerging tools, technologies, and challenges, EPA "will need to have enough internal expertise to identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions; determine what existing tools and strategies can be applied to answer those questions; determine the needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the science to make recommendations based on hazards, exposures, and monitoring." According to the report, the example of engineered nanomaterials "illustrates some of the problems and pitfalls of current approaches to emerging technologies." While EPA provided early funding regarding the use of nanotechnology in remediation, the report states that it missed the opportunity to support research addressing the environmental health and safety of nanomaterials, pollution prevention in the production of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay in early intervention include "insufficient federal agency leadership, emphasis, and policy regarding proactive rather than reactive approaches to safer design." If EPA intends to promote and guide early intervention in the design and production of emerging chemicals, materials, and products, the report states, "it will need to commit to this effort beyond its regulatory role." The NRC report is available online.

OECD Concludes Existing Test Methods And Assessment Approaches Appropriate For Nanomaterials: On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled "Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities." The brochure notes that "[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials." According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD's activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation. The brochure is available online.

NNCO Will Hold Webinar On Nano.gov Website: In a September 13, 2012, Federal Register notice, the Office of Science and Technology Policy (OSTP) announced that the National Nanotechnology Coordination Office (NNCO) will hold a webinar on September 20, 2012, to provide an open forum to answer questions and hear suggestions related to the National Nanotechnology Initiative's (NNI) public website, which was redesigned in April 2011. 77 Fed. Reg. 56681. According to the notice, NNCO is seeking public comment and recommendations on potential updates to, improvements on, and opportunities for public engagement through Nano.gov. The webinar will address the following questions:

  1. How is Nano.gov useful to you and your stakeholders/colleagues/peers?
     
  2. What do you like on Nano.gov? Which pages are most useful to you? Why?
     
  3. What would you like to see improved? Are there pages you do not understand? Confusing information? Poor layout? Difficult to use?
     
  4. Are there pages that you feel are missing from Nano.gov? What other types of pages would you like to see? What information would you like to find on Nano.gov that is not currently there?
     
  5. Are there similar websites that present information in a way that you find more useful, exciting, attractive, or user-friendly?

More information is available online.

ISO Preparing Labeling Guidance For Manufactured Nano-Objects And Products Containing Manufactured Nano-Objects: The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term "nano" in product labeling. The European Committee for Standardization (CEN) was initially developing the guidance and, under CEN, the guidance would have included business-to-employee and business-to-business communications. During a June 2012 meeting, TC 229 decided to focus the guidance on consumer labeling, however. Other ISO guidance documents will address other kinds of business communications. More information is available online.

REACH

ECHA Begins Consultation On 54 Potential SVHCs: On September 3, 2012, the European Chemicals Agency (ECHA) announced the beginning of a public consultation on 54 potential substances of very high concern (SVHC). According to ECHA, the EC requested ECHA prepare Annex XV dossiers for 37 substances on their behalf, while Austria, Germany, the Netherlands, Poland, Slovakia, Sweden, and the United Kingdom put forward proposals for the identification of 17 substances. Comments should provide information concerning the identity of the substances or on their persistent, bioaccumulative and toxic (PBT)/very persistent and very bioaccumulative (vPvB) or "equivalent concern" properties. The Member State Committee will consider comments when seeking agreement on the identification of all proposed substances as SVHCs. ECHA states that the Committee will not consider comments on carcinogenic, mutagenic, and/or toxic for reproduction (CMR) properties where harmonized classification is laid down in Annex VI of the regulation on classification, labeling, and packaging of hazardous substances and mixtures (CLP Regulation). ECHA invites the submission of information on the uses of the substances, including data on tonnages per use and exposures or releases resulting from these uses, as well as on the availability of safer alternative substances and techniques and the structure of supply chains. ECHA will consider this information when recommending SVHCs for inclusion in the Authorization List (Annex XIV). ECHA notes that 84 SVHCs are currently included in the Candidate List. According to ECHA, the proposed SVHCs "may take the total number above the policy target of 136 set for the end of 2012. Inclusion on this list imposes new information requirements on manufacturers and importers of listed substances and on suppliers of preparations and articles containing the substances." Below is a list of substances proposed for identification as SVHC and reasons for their proposal:

Substance Name Proposed SVHC Property
Bis(pentabromophenyl) ether (DecaBDE) PBT; vPvB
Pentacosafluorotridecanoic acid vPvB
Tricosafluorododecanoic acid vPvB
Henicosafluoroundecanoic acid vPvB
Heptacosafluorotetradecanoic acid vPvB
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated -- Covering well-defined substances and UVCB substances, polymers and homologues Equivalent level of concern - probable serious effects on the environment
4-Nonylphenol, branched and linear -- Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof Equivalent level of concern - probable serious effects on the environment
Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) Equivalent level of concern - probable serious effects on human health
Cyclohexane-1,2-dicarboxylic anhydride (Hexahydrophthalic anhydride - HHPA) Equivalent level of concern - probable serious effects on human health
Hexahydromethylphathalic anhydride, Hexahydro-4-methylphathalic anhydride, Hexahydro-1-methylphathalic anhydride, Hexahydro-3-methylphathalic anhydride Equivalent level of concern - probable serious effects on human health
Methoxy acetic acid Toxic for reproduction; equivalent level of concern -probable serious effects on human health and the environment
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear Toxic for reproduction
Diisopentylphthalate (DIPP) Toxic for reproduction
N-pentyl-isopentylphtalate Toxic for reproduction
1,2-Diethoxyethane Toxic for reproduction
N,N-dimethylformamide; dimethyl formamide Toxic for reproduction
Dibutyltin dichloride (DBT) Toxic for reproduction
Acetic acid, lead salt, basic Toxic for reproduction
Basic lead carbonate (trilead bis(carbonate)dihydroxide) Toxic for reproduction
Lead oxide sulfate (basic lead sulfate) Toxic for reproduction
[Phthalato(2-)]dioxotrilead (dibasic lead phthalate) Toxic for reproduction
Dioxobis(stearato)trilead Toxic for reproduction
Fatty acids, C16-18, lead salts Toxic for reproduction
Lead bis(tetrafluoroborate) Toxic for reproduction
Lead cynamidate Toxic for reproduction
Lead dinitrate Toxic for reproduction
Lead oxide (lead monoxide) Toxic for reproduction
Lead tetroxide (orange lead) Toxic for reproduction
Lead titanium trioxide Toxic for reproduction
Lead Titanium Zirconium Oxide Toxic for reproduction
Pentalead tetraoxide sulphate Toxic for reproduction
Pyrochlore, antimony lead yellow Toxic for reproduction
Silicic acid, barium salt, lead-doped Toxic for reproduction
Silicic acid, lead salt Toxic for reproduction
Sulfurous acid, lead salt, dibasic Toxic for reproduction
Tetraethyllead Toxic for reproduction
Tetralead trioxide sulphate Toxic for reproduction
Trilead dioxide phosphonate Toxic for reproduction
Furan Carcinogenic
Propylene oxide; 1,2-epoxypropane; methyloxirane Carcinogenic; Mutagenic
Diethyl sulphate Carcinogenic; Mutagenic
Dimethyl sulphate Carcinogenic
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine Toxic for reproduction
Dinoseb Toxic for reproduction
4,4'-methylenedi-o-toluidine Carcinogenic
4,4'-oxydianiline and its salts Carcinogenic; Mutagenic
4-Aminoazobenzene; 4-Phenylazoaniline Carcinogenic
4-methyl-m-phenylenediamine (2,4-toluene-diamine) Carcinogenic
6-methoxy-m-toluidine (p-cresidine) Carcinogenic
Biphenyl-4-ylamine Carcinogenic
o-aminoazotoluene Carcinogenic
o-Toluidine; 2-Aminotoluene Carcinogenic
N-methylacetamide Toxic for reproduction
1-bromopropane; n-propyl bromide Toxic for reproduction

Comments are due October 18, 2012. More information is available online.

LEGISLATIVE DEVELOPMENTS

U.S. And Canada Sign Amended Great Lakes Water Quality Agreement: On September 7, 2012, EPA Administrator Lisa P. Jackson and Canada's Minister of the Environment Peter Kent signed an amended version of the Great Lakes Water Quality Agreement. First signed in 1972 and last amended in 1987, the Agreement is a binational agreement for the U.S. and Canada to cooperate in protecting the Great Lakes. The overall purpose of the Agreement is "to restore and maintain the chemical, physical and biological integrity of the waters" of the Great Lakes and the portion of the St. Lawrence River that includes the Canada-United States border. The revised Agreement is intended to help facilitate U.S. and Canadian action on threats to Great Lakes water quality. It includes strengthened measures to anticipate and prevent ecological harm. New provisions address aquatic invasive species, habitat degradation, and the effects of climate change, and support continued work on existing threats to people's health and the environment in the Great Lakes Basin such as harmful algae, toxic chemicals, and discharges from vessels. The Agreement is available online.

House Passes Electronic Hazardous Waste Manifest Bill: On September 11, 2012, the House passed the Hazardous Waste Electronic Manifest Establishment Act (S. 710), which would amend RCRA by replacing the 30-year old paper hazardous waste manifest system with an electronic system. The Senate passed the bill in August, but there are differences between the two versions of the bill. For example, the House bill would require manifest user fees, while the Senate version would appropriate funds for the program and would also require a contractor to assume the startup costs for the tracking system. The differences must be resolved in a Senate-House conference. It appears likely that lawmakers will reach agreement and that President Obama will sign the bill into law.

House Committee Holds Hearing On EPA Chemical Facility Security Program: On September 11, 2012, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing to review the progress of the Chemical Facility Anti-Terrorism Standards (CFATS) program. Using the anniversary of 9/11 as a backdrop, Commerce Committee Chair Fred Upton (R-MI) opened the hearing by stating: "Six years ago this month we authorized the CFATS program, conscious that the next terrorist incursion could come from within a chemical plant instead of onboard an airplane. It is one of many facets of our complex economy that we look at differently in the shadow of 9/11, even as we recognize its important role in our nation's system of commerce." The hearing followed a previous subcommittee hearing, held on February 3, 2012, to discuss an internal Department of Homeland Security (DHS) memo that exposed flaws and achievement gaps within the CFATS program. In response to this memo, several members of Congress asked the Government Accountability Office (GAO) to review the program and determine what steps DHS is taking to address the identified problems through its Infrastructure Security Compliance Division (ISCD) Action Plan. During the hearing, the Subcommittee received an update from DHS on the status of the CFATS program, progress made, and remaining work to be accomplished. The GAO also testified on its ongoing report, which is examining DHS' execution of the Action Plan. Rand Beers, Under Secretary of the National Protection and Programs Directorate (NPPD) at DHS, gave an optimistic report on DHS' progress, testifying: "At my direction, the program's leadership outlined its priorities, the challenges it believes the program faces, and a proposed path forward to address those challenges and accomplish program objectives. As the Directorate with oversight responsibility for the CFATS program, NPPD is continually evaluating the program to identify areas for improvement and correcting course when necessary to ensure proper implementation. I am pleased to inform you that NPPD has made progress on all 95 of the action items now included in the ISCD Action Plan and as of September 4, 2012, has completed 59 of them." Despite DHS' assurances that CFATS is correcting its course, many members of the Subcommittee expressed frustration with the program's delay and lack of action. Cathleen Berrick, Managing Director of the Homeland Security and Justice Team at GAO, gave an update on GAO's analysis of the ISCD Action Plan. According to her testimony, the program still has a long way to go toward accomplishing its mission. Berrick stated: "What will dictate whether or not it's successful is whether it's able to execute its mission, and I think they are still in the early phases of positioning themselves to be able to do that." Testifying on behalf of Dow Chemical and the American Chemistry Council (ACC), Timothy Scott explained the need for continued collaboration between DHS and industry to reduce the risk of terrorist attacks through the CFATS program. "Industry and DHS have made progress in improving the security of the chemical sector," stated Scott. Matthew Leary, testifying on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA), echoed the need for collaboration to make CFATS a successful program. "The CFATS framework is sound, but DHS's implementation has been flawed. This is largely because DHS has drifted away from the spirit of the public-private partnership on chemical security that it has so often hailed as a keystone of the CFATS program," stated Leary. Not all of the witnesses agreed, however, on the utility of the program. On July 25, 2012, dozens of environmental and labor groups petitioned EPA to use its authority under the Clean Air Act's (CAA) general duty clause risk management plan clause to mandate the installation of inherently safer technologies (IST) at regulated chemical facilities. These groups have argued that EPA must be further involved in the CFATS program, a view not shared by many on the Subcommittee or industry.

Bill Seeks To Blunt EPA Enforcement Of CAA General Duty Clause: Senator Pat Roberts (R-KS) on September 11, 2012, introduced legislation that he believes will clarify "poorly defined environmental law in an effort to lessen arbitrary fines issued against energy producers and manufactures by EPA." The bill (S. 3529) seeks to redress what Senator Roberts believes is EPA overstepping its regulatory limits under the CAA's general duty clause. "Despite never completing a rule making process or defining important terms necessary for proper compliance, the EPA has continually issued fines throughout the country for failure to comply with the General Duty Clause." The CAA's general duty clause provides that owners or operators of facilities using, possessing, storing, or distributing certain chemicals have a "general duty" to identify hazards that might result from a chemical release and to take precautions to prevent such releases. Although EPA has yet to define this provision in detail, it has still fined numerous facilities that EPA deems to have violated it. Senator Roberts' bill would require EPA to complete a rulemaking process clearly better defining the requirements under the clause before finding any facility in violation. It would also require definitions for extremely hazardous substances, appropriate hazard assessment techniques, and how to design and maintain a safe facility. The bill also requires EPA to issue guidelines ensuring its enforcement procedures are uniform across the country. The bill mirrors companion legislation introduced in the House in August.

Senate Committee Holds Hearing On Nuclear Waste Disposal: On September 12, 2012, the Senate Committee on Energy and Natural Resources held a hearing on nuclear waste storage. The primary focus of the hearing was S. 3469, the Nuclear Waste Administration Act of 2012. The bill seeks to establish a new organization to manage nuclear waste, provide a consensual process for siting nuclear waste facilities, and ensure adequate funding for managing nuclear waste. Introduced by Committee Chair Jeff Bingaman (D-NM), the bill specifically is intended to implement the recommendations of the Blue Ribbon Commission that Department of Energy Secretary Chu appointed to review the nuclear waste program. The Blue Ribbon Commission issued its final report in January 2012. Witnesses at the hearing included:

  • Lieutenant General Brent Scowcroft, Co-Chairman, Blue Ribbon Commission on America's Nuclear Future;
     
  • Dr. Richard A. Meserve, President, Carnegie Institution for Science;
     
  • Dr. Peter B. Lyons, Assistant Secretary for Nuclear Energy, U.S. Department of Energy;
     
  • Mr. Henry B. Barron, President & CEO, Constellation Energy Group; and
     
  • Mr. Geoffrey H. Fettus, Natural Resources Defense Council.

Witness testimony and an archived webcast of the hearing may be viewed online.

MISCELLANEOUS

Environmental Council Of The States Introduces New Resolutions At Annual Meeting: The Environmental Council of the States (ECOS) adopted almost a score of new resolutions during its annual meeting on August 27-29, 2012, in Colorado Springs, Colorado. ECOS is the national non-profit, non-partisan association of state and territorial environmental agency leaders. Established in 1993, the purpose of ECOS is to improve the capability of state environmental agencies and their leaders to protect and improve human health and the environment of the U.S. The resolutions adopted by ECOS are as follows:

  • Resolution 00-12: Change to the United States Environmental Protection Agency's "Once In, Always In" Policy.
     
  • Resolution 03-7: The Need for Actions to Achieve Further Progress on Reducing Impacts to Water Quality from Atmospheric Mercury.
     
  • Resolution 03-11: State Support of the Interstate Technology & Regulatory Council.
     
  • Resolution 06-9: National Training Strategy Implementation and Funding.
     
  • Resolution 06-10: Department of Defense's Formerly Used Defense Sites Program Budget.
     
  • Resolution 09-2: Mercury Reduction, Stewardship, and Retirement.
     
  • Resolution 09-5: Funding for Clean Air Act Programs Under Sections 103 and 105.
     
  • Resolution 09-6: Advancing State Green Chemistry Programs for Sustainable Economic Development and Protection of Public Health and the Environment.
     
  • Resolution 09-8: Advancing Green Infrastructure, Energy Efficiency and Clean Energy Production through Wastewater and Drinking Water Facilities.
     
  • Resolution 12-3: Regarding New Source Performance Standards for Residential Wood Burning Devices.
     
  • Resolution 12-4: Regarding New Source Performance Standards for Residential Coal Burning Devices.
     
  • Resolution 12-5: Principles of Extended Producer Responsibility and the Definition of Product Stewardship.
     
  • Resolution 12-6: Urging Collaboration between Federal Agencies and States to Manage High-Level Radioactive Waste and Spent Nuclear Fuel.
     
  • Resolution 12-7: Dialogue on Munitions Response.
     
  • Resolution 12-8: Support for the National Mercury Switch Recovery Program to Reduce Mercury in the Environment and Provide Flexibility to the States.
     
  • Resolution 12-9: PCBs in Products.
     
  • Resolution 12-10: Funding the Border 2020 Program.

The resolutions are available via ECOS' website.

Executive Order Calls For Increasing Use Of Heat And Power: On August 30, 2012, President Obama signed an Executive Order (EO) intended to enhance the use of combined heat and power (CHP). The EO directs certain executive departments and agencies to convene national and regional stakeholders to identify, develop, and encourage the adoption of investment models and state best practices for industrial energy efficiency and CHP, to provide technical assistance to states and manufacturers to encourage investment in industrial energy efficiency and CHP, and achieve other goals. The EO is available online.

SEC Publishes Final Rule on Conflict Minerals: On September 12, 2012, the Securities and Exchange Commission (SEC) published a final rule in the Federal Register regarding disclosure and reporting obligations with respect to the use of conflict minerals to implement the requirements of Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank). 77 Fed. Reg. 56274. More information on the rule and its requirements and implications is available online.

CPSC To Hold Safety Academy: On September 20, 2012, the U.S. Consumer Product Safety Commission (CPSC) will hold its first "Safety Academy." The Academy will provide attendees an opportunity to hear first-hand discussions about current requirements, testing and certification of children's products, the mandatory toy standard, and compliance issues. The program will be helpful whether you are new to the product safety world or a seasoned veteran. The CPSC Safety Academy will be held from 8:00 a.m. to 4:00 p.m. at the Commission headquarters at 4330 East West Highway in Bethesda, Maryland. Seating is limited. There is no charge for the event. The following are the various panels: F963 Toy Standards, Testing-Mandatory Testing, Component Parts Testing, Flammable Fabrics, Drawstrings, Sleepwear, Compliance Update, Navigating the CPSC Import Process, The Nuances of 6(b), and Fast Track Process-Compliance. The registration link is available online.

Early Registration Begins For First International Forum On Commercializing Global Green: Early registration has begun for the Society for the Commercial Development of Industrial BioTechnology's (SCD-iBIO) first international forum, Commercializing Global Green: From Raw Materials to International Brands. B&C is a proud sponsor of the forum, which will be held November 12-14, 2012, in Philadelphia, Pennsylvania. On November 13, 2012, Lynn L. Bergeson will participate in a panel entitled "Market Development: Best Practices/Lessons Learned." The forum will include discussions along the entire value chain, from raw materials to branded consumer products. Attendees will hear about pilot, scale-up, and engineering issues, as well as lessons learned in commercial and market development. Finally, discussions will conclude with ways to ensure reliability and sustainability of biobased products and guidance on creating global brands. More information 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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