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Monthly Federal Developments Memorandum
September 1, 2013

Monthly Update for September 2013

Bergeson & Campbell, P.C.

TSCA/FIFRA/IRIS/EPCRA

EPA Releases New Neonicotinoid Labels: In a letter dated August 15, 2013, the U.S. Environmental Protection Agency (EPA) released new pesticide labels restricting some applications of four neonicotinoid insecticides as of the 2014 growing season. The labels include a bee advisory box and icon warning of potential harm to pollinators, with information on routes of exposure and spray drift precautions. The labels affect products containing the insecticides imidacloprid, dinotefuran, clothianidin, and thiamethoxam. For crops under contracted pollination services, the label prohibits applications when bees are foraging and plants are flowering. EPA developed the revisions based largely on the advice of its Pesticide Program Dialogue Committee, which determined that while existing labels contain protections for bees and pollinators, the language was believed to be inconsistent in some cases across products and lacking enforceability.

EPA Releases Draft IRIS Assessment On Effects Of Benzo[a]pyrene: On August 21, 2013, EPA released its external review draft assessment of the human health effects of benzo[a]pyrene (BaP) (CAS No. 50-32-8). 78 Fed. Reg. 51719. The draft will be discussed October 23-24, 2013, at a public meeting to address several analyses EPA is conducting under its Integrated Risk Information System (IRIS) program. BaP is a volatile chemical found in coal tar pitch, according to the Occupational Safety and Health Administration (OSHA). The revised draft proposes a less stringent potency risk estimate of 1 milligram per kilogram body weight per day (mg/kg/day) than the one calculated in 1994, which set the total slope factor at 7.3 mg/kg/day. EPA is also proposing a first-time inhalation unit risk and a dermal cancer slope factor. EPA also provides first-time non-cancer risk exposures for BaP by oral and inhalation exposure routes. The BaP assessment is an important element in EPA’s efforts to update its Relative Potency Factor approach for assessing mixtures of polycyclic aromatic hydrocarbons. Impacted industries include cooking, roofing, road paving, aluminum smelting, and wood preserving, according to OSHA. The draft BaP assessment is posted at www.epa.gov/ncea. Comments are due by October 21, 2013.

EPA Announces Peer Review Of NMP And DCM TSCA Workplans: On August 23, 2013, EPA announced the scheduling of peer reviews and the identities of peer reviewers for N-Methylpyrrolidone (NMP) and Dichloromethane (DCM) TSCA Workplan Chemical Risk Assessments. 78 Fed. Reg. 52525. Comments on the peer reviewers are due by September 13, 2013. Comments on the assessments are due by October 22, 2013.

EPA Issues IRIS Assessment For Biphenyl: On August 27, 2013, EPA issued a final assessment of biphenyl. The assessment set a reference dose (RfD) for biphenyl of 0.5 mg/kg/day. RfDs are EPA’s estimate of a concentration people could ingest daily over their lifetime without harm from noncancerous health problems. The final RfD is higher than the 0.2 mg/kg/day level EPA proposed in 2011 and higher than the final RfD of 0.05 mg/kg/day the Agency established in 1989. EPA’s final toxicological review for biphenyl is available online.

EPA Issues Final Rule On Electronic Reporting Of Toxics Release Inventory Data: On August 27, 2013, EPA issued a final rule requiring facilities to report non-trade-secret Toxics Release Inventory (TRI) forms to EPA using electronic software provided by EPA. 78 Fed. Reg. 52860. The only exception to this electronic reporting requirement is for the few facilities that submit trade secret TRI information that will continue to submit their trade secret reporting forms and substantiation forms in hard copy. EPA is also requiring facilities to submit electronically via the Internet any revisions or withdrawals of previously submitted TRI reporting forms. Additionally, EPA will no longer accept submissions, revisions, or withdrawals of TRI reporting forms submitted for reporting years prior to reporting year 1991. For trade secret submissions, EPA will continue to accept only revisions or withdrawals of previously submitted trade secret information on paper forms, though only for reporting years back to reporting year 1991. The final rule is effective on January 21, 2014.

EPA Requests Nominations For Experts To Review IRIS Assessments: On August 28, 2013, the EPA Science Advisory Board (SAB) staff office requested public nominations of scientific experts to augment the SAB Chemical Assessment Advisory Committee (CAAC) to form three panels. 78 Fed. Reg. 53144. The panels will review EPA’s draft Toxicological Review of Ammonia, EPA’s draft Toxicological Review of Trimethylbenzenes, and EPA’s draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide In Support of Summary Information on IRIS. Nominations should be submitted by September 18, 2013.

EPA Schedules SFIREG Meeting: On September 3, 2013, EPA announced the scheduling of an Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee meeting beginning on September 16, 2013, and ending September 17, 2013. Please consult the Federal Register for more details.

EPA Seeks Comment On Draft Federal Strategy On Bed Bugs: On September 4, 2013, EPA invited comment on the Draft Federal Strategy on Bed Bugs, which provides guidance for how the various levels of government can contribute to minimizing the negative effects of bed bug infestations on human health and the economy. The Federal Bed Bug Work Group, which was established based on a recommendation from the first National Bed Bug Summit in April 2009, developed the Draft Strategy. The current Work Group comprises representatives from the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), EPA, the Department of Housing and Urban Development (HUD), and the U.S. Department of Agriculture (USDA). The Draft Strategy is organized into five priority areas for bed bug control: prevention; surveillance and Integrated Pest Management (IPM); community efforts; education and communication; and research. For each of these priority areas, the Draft Strategy defines the problem, recommends actions, and discusses ways to measure the success of these actions. It also advocates for a logical, integrated approach to bed bug management, with a focus on cooperation among all levels of government and the community. EPA states that when communities customize implementation at the local level, they are able to draw on their own unique characteristics and strengths to develop a more robust management program. Effective implementation of this strategy should decrease costs to the community and achieve a better level of bed bug control. The Draft Federal Strategy on Bed Bugs is available online. Comments are due September 18, 2013.

EPA Submits Draft Final Rule To USDA Concerning Protection Of Data Submitters’ Rights: EPA published a notice in the September 6, 2013, Federal Register announcing that it has forwarded to the Secretary of the USDA a draft final rule entitled “Pesticides; Satisfaction of Data Requirements; Procedures to Ensure Protection of Data Submitters’ Rights.” 78 Fed. Reg. 54841. The notice states that the draft regulatory document is not available to the public until after it has been signed and made available by EPA. On November 5, 2010, EPA proposed revising its regulations governing procedures for the satisfaction of data requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). More information regarding the proposed rule is available in our November 8, 2010, memorandum, which is available online.

EPA Withdraws Proposed TSCA Rules From OMB Review: On September 6, 2013, EPA withdrew two rulemakings from review by the Office of Management and Budget (OMB). EPA submitted to OMB on May 12, 2010, its proposed rule regarding a list of chemicals of concern and on December 27, 2011, its proposed rule regarding premanufacture notice (PMN) amendments concerning claiming chemical and microorganism identity as confidential in data from health and safety studies submitted under the Toxic Substances Control Act (TSCA) prior to the commencement of manufacture. According to an EPA statement, it withdrew the rules because they are no longer needed. EPA intended to use its authority under TSCA Section 5(b)(4) to create a list of chemicals of concern. EPA states that it no longer needs this rulemaking because it now has the list of TSCA Work Plan Chemicals, which currently includes 83 substances. Rather than simply list chemicals of concern, EPA stated it is assessing the risks of chemicals identified under the TSCA Work Plan and using regulations or other means to reduce risks if warranted. Regarding claiming chemical and microorganism identity as confidential business information (CBI) in health and safety studies, EPA states: “The information included in these studies are extremely useful in reviewing new chemicals prior to introduction into the marketplace. Limiting CBI claims on this information may result in fewer submissions of these important studies.” According to the statement, EPA “continues to try to reduce unwarranted claims of confidentiality and has taken a number of significant steps that have had dramatic results.” These steps include “tightening policies for CBI claims and declassifying unwarranted confidentiality claims, challenging companies to review existing CBI claims to ensure that they are still valid, and providing easier and enhanced access to a wider array of information.” An article written by Lynn Bergeson, entitled “Reality Bites: EPA Withdraws Two Draft Chemical Rules,” is available online.

EPA Launches New Web Tool On Chemical Information: On September 9, 2013, EPA held a webinar to launch ChemView, a new web tool on chemical information. According to EPA, ChemView will significantly improve access to chemical specific information developed by EPA and data submitted under TSCA. ChemView displays key health and safety data in an online format intended to facilitate comparison of chemicals by use and by health or environmental effects. The search tool consolidates available TSCA information and provides more streamlined access to EPA assessments, hazard characterizations, and information on safer chemical ingredients. It allows searches by chemical name or Chemical Abstracts Service (CAS) number, use, hazard effect, or regulatory action. It has the flexibility to create tailored views of the information on individual chemicals or compare multiple chemicals sorted by use, hazard effect, or other criteria. The new portal will also link to information on manufacturing, processing, use, and release data reported under the Chemical Data Reporting (CDR) Rule and TRI. EPA states that ChemView is targeted toward individuals who are familiar with data on chemicals, such as product formulators. By increasing health and safety information, as well as identifying safer chemical ingredients, manufacturers will have the information to better differentiate their products by using safer ingredients. The tool currently provides easier access to information on approximately 1,500 chemicals. In the months ahead, EPA intends to add additional chemicals, functionality, and links, including to the EPA Office of Research and Development’s (ORD) Dashboard online tool. When fully populated, the portal will contain data for several tens of thousands of chemicals. EPA has incorporated stakeholder input into the design, and welcomes feedback on the current version of the site. ChemView is available online.

GAO Report Recommends EPA Improve Oversight Of Conditional Registrations: The U.S. Governmental Accountability Office (GAO) released a report on September 9, 2013, entitled Pesticides: EPA Should Take Steps to Improve Its Oversight of Conditional Registrations. In 2010, environmental and other groups claimed EPA overused conditional registrations and did not have a reliable system to identify whether the required data had been submitted. The report examines: (1) the number of conditional registrations EPA has granted and the basis for these; (2) the extent to which EPA ensures that companies submit the required additional data and EPA reviews the data; and (3) the views of relevant stakeholders on EPA’s use of conditional registrations. According to the report, the total number of conditional registrations granted is unclear, as EPA reports that its data are inaccurate for several reasons. First, the database used to track conditional registrations does not allow officials to change a pesticide’s registration status from conditional to unconditional once the registrant has satisfied all requirements, thereby overstating the number of conditional registrations. Second, EPA staff has misused the term “conditional registration,” incorrectly classifying pesticide registrations as conditional when, for example, they require a label change, which is not a basis in the statute for a conditional registration. The extent to which EPA ensures that companies submit additional required data and EPA reviews these data is unknown. Specifically, according to the report, EPA does not have a reliable system, such as an automated data system, to track key information related to conditional registrations, including whether companies have submitted additional data within required time frames. As a result, pesticides with conditional registrations could be marketed for years without EPA’s receipt and review of these data. The report states that the surveyed stakeholders — representatives of consumer, environmental, industry, legal, producer, science, and state government groups — generally responded that EPA needs to improve its conditional registration process. Stakeholder views differed on the benefits and disadvantages of conditionally registering pesticides, however. While some consumer, industry, legal, producer, and state government stakeholders stated that the conditional registration process promotes innovation by bringing new technologies to the marketplace more quickly, some consumer, environmental, legal, science, and state government stakeholders voiced concerns that conditional registration allows products with safety that has not been fully evaluated into the marketplace. GAO recommends, in part, that EPA consider and implement options for an automated system to track better conditional registrations. EPA agreed with GAO’s recommendations and noted specific actions it will take to implement them, including:

  • Automating data related to conditional registrations. This includes developing new codes for identifying conditional registration decisions; training staff on use of the new categories and making the training available online for guidance; and changing its databases to allow staff to check more easily whether there are any outstanding requests for data on any pesticide active ingredients. EPA stated that it plans to develop a more comprehensive system for tracking conditional registrations. EPA noted that its ability to do so depends on the availability of funding and the complexity of incorporating changes in the databases, however;
     
  • Developing a standard operating procedure for staff to follow when entering data into the computerized tracking system about the statutory basis for registration decisions. EPA expects to complete the procedure by the end of 2013. The status of products previously approved under conditional registration authority is also being reviewed and updated, as necessary; and
     
  • By the end of 2013, EPA will revise its website on conditional registration to clarify and update the information presented. The website will also include an outline of ongoing agency work to strengthen its conditional pesticide registration program.

The GAO report is available online.

EPA Issues Final SNUR For Three Partially Fluorinated Alcohol Substituted Glycols: EPA promulgated a final significant new use rule (SNUR) on September 11, 2013, for three chemical substances that were the subject of PMNs and subject to a TSCA Section 5(e) consent order issued by EPA. 78 Fed. Reg. 55632. The substances are identified generically as “partially fluorinated alcohol substituted glycols,” and were the subject of PMNs P-10-58, P-10-59, and P-10-60. The significant new uses are industrial, commercial, and consumer activities. Under the final SNUR, the requirements are as specified in 40 C.F.R. Section 721.80(k) (manufacture and import of the PMN substances according to the chemical synthesis and composition section of the TSCA Section 5(e) consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities; manufacture and import of P-10-58 and P-10-59 only as intermediates for the manufacture of P-10-60), and (q). Persons who intend to manufacture (including import) or process any of the three chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule is effective October 11, 2013.

SFIREG EQI Committee Will Meet In October: EPA announced on September 11, 2013, that the SFIREG Environmental Quality Issues (EQI) Committee will meet October 21-22, 2013. 78 Fed. Reg. 55694. The tentative agenda includes the following topics:

  1. Removal of aminopyralid from use in northeastern states due to compost contamination;
     
  2. Availability of laboratory equipment to detect aminopyralid and similar pesticide residues in compost at biologically significant concentrations;
     
  3. Status of pollinator protection efforts;
     
  4. Bee incident updates and associated analytical detections;
     
  5. Endangered and threatened species update; and
     
  6. Demo of revisions to the Pesticides of Interest National Tracking System (POINTS).

Please consult the Federal Register for more details.

CAA

EPA Proposes Amendments To GHG Reporting Program: EPA published a proposed rule on September 11, 2013, that would amend the reporting and recordkeeping requirements and provide an alternative verification approach for the Greenhouse Gas (GHG) Reporting Program. 78 Fed. Reg. 55993. According to EPA, the proposed rule addresses concerns about the potential release of certain data that are inputs to emission equations for which the reporting deadline was deferred until March 31, 2015, while maintaining EPA’s ability to verify emissions and ensure compliance with the GHG Reporting Program. In addition, EPA is proposing confidentiality determinations for the newly proposed data elements in this action. Comments are due November 12, 2013. EPA will hold a public hearing if requested. Requests for a hearing are due September 18, 2013.

OSHA

OSHA Proposes Rules Lowering Silica Dust Exposures: On September 12, 2013, OSHA proposed a controversial rule lowering the 40-year-old permissible exposure limits (PEL) for crystalline silica particles. 78 Fed. Reg. 56274. OSHA states that approximately 2.2 million workers are exposed to respirable crystalline silica in various industries and occupations, including construction, sandblasting, and mining. OSHA’s current PELs for crystalline silica were adopted in 1971. OSHA notes also that the current PELs for construction and shipyard workers allow them to be exposed to risks that are “over twice as high as for workers in general industry.” The proposed rule would provide consistent levels of protection for workers in all sectors covered by the rule. Under the proposed rule, workers’ exposures would be limited to a new PEL of 50 micrograms of respirable crystalline silica per cubic meter of air (µg/m3), averaged over an 8-hour day. The new PEL would be the same in all industries covered by the rule. The proposed rule establishes an action level of 25 µg/m3. Sample results at or above this level would trigger the need for periodic exposure assessments and other requirements. The proposed rule also includes provisions for measuring how much silica workers are exposed to, limiting workers’ access to areas where silica exposures are high, using effective methods for reducing exposures, providing medical exams to workers with high silica exposures, and training for workers about silica-related hazards and how to limit exposure. These provisions are similar to industry consensus standards that many employers have been using for years, and the technology to protect workers is already widely available. According to OSHA, lowering silica exposure can generally be accomplished by using common dust control methods, such as wetting down work operations to keep silica-containing dust from getting into the air, enclosing an operation (process isolation), or using a vacuum to collect dust at the point where it is created before workers can inhale it. Comments are due December 11, 2013. OSHA plans to hold informal public hearings beginning on March 4, 2014, in Washington, D.C. OSHA will release a schedule prior to the start of the hearings. Peer reviewers of OSHA’s “Respirable Crystalline Silica — Health Effects Literature Review and Preliminary Quantitative Risk Assessment” will be present to hear testimony on the second day of the hearing, March 5, 2014. Interested persons who intend to present testimony or question witnesses at the hearings must submit a notice of their intention to do so by November 12, 2013. More information regarding the rulemaking is available online.

GREEN CHEMISTRY

DTSC Releases Proposed Safer Consumer Products Regulations: On August 28, 2013, California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC or Department) Safer Consumer Products Regulations (Regulations). The Regulations will take effect on October 1, 2013. The Regulations are the much anticipated regulatory implementation of California’s Green Chemistry Initiative. DTSC’s implementing regulations have gone through several iterations, including an initial draft released on June 23, 2010, a revised draft released on November 16, 2010, an “informal draft” released on October 31, 2011, proposed regulations released on July 27, 2012, revised proposed regulations released on January 29, 2013, another revised proposed regulations released on April, 10, 2013, and revisions proposed on August 23, 2013 (the 15-day comment period for these last comments are open until September 9, 2013, despite the issuance of final Regulations). Memoranda providing background information on past iterations are available online. The Regulations and Final Statement of Reasons are available online. A more detailed memorandum on the approved Regulations is available online.

NANOTECHNOLOGY

CRS Prepares Report On NNI: The Congressional Research Service (CRS) prepared an August 9, 2013, report entitled The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues. According to the report, from fiscal year (FY) 2001 through FY 2013, the federal government invested approximately $17.9 billion in nanoscale science, engineering, and technology through the U.S. National Nanotechnology Initiative (NNI). President Obama has requested $1.7 billion in NNI funding for FY 2014. While the 109th, 110th, and 111th Congresses considered legislation reauthorizing the NNI, none of the bills passed. The report recommends that if the 113th Congress considers legislation reauthorizing the NNI, it may wish to consider “budget authorization levels for the covered agencies; [research and development] funding levels, priorities, and balance across the program component areas; administration and management of the NNI; translation of research results and early-stage technology into commercially viable applications; environmental, health, and safety issues; ethical, legal, and societal implications; education and training for the nanotechnology workforce; metrology, standards, and nomenclature; public understanding; and international dimensions.” The report states that “[c]onsideration may also be given to the establishment of an independent review panel and to coordination of the timing for the [National Nanotechnology Advisory Panel] assessment, the [National Research Council (NRC)] assessment, and the [Nanoscale Science, Engineering and Technology] Subcommittee’s strategic plan for the NNI.” The report is available online.

Particle And Fibre Toxicology Publishes Results Of MWCNT Inhalation Study In Mice: On August 9, 2013, Particle and Fibre Toxicology published a study entitled “Extrapulmonary transport of MWCNT following inhalation exposure.” The authors report that inhalation exposure studies of mice were conducted to determine if multi-walled carbon nanotubes (MWCNT) distribute to the tracheobronchial lymphatics, parietal pleura, respiratory musculature, and/or extrapulmonary organs. The study states that tracheobronchial lymph nodes were found to contain 1.08 and 7.34 percent of the lung burden at 1 day and 336 days post-exposure, respectively. On average, according to the study, there were 15,371 and 109,885 fibers per gram in liver, kidney, heart, and brain at 1 day and 336 days post-exposure, respectively. The burden of singlet MWCNT in the lymph nodes, diaphragm, chest wall, and extrapulmonary organs at 336 days post-exposure was significantly higher than at 1 day post-exposure. The abstract offers the following conclusions: “Inhaled MWCNT, which deposit in the lungs, are transported to the parietal pleura, the respiratory musculature, liver, kidney, heart and brain in a singlet form and accumulate with time following exposure. The tracheobronchial lymph nodes contain high levels of MWCNT following exposure and further accumulate over nearly a year to levels that are a significant fraction of the lung burden 1 day post-exposure.” Although the authors are affiliated with the National Institute for Occupational Safety and Health (NIOSH), the study includes a disclaimer that the findings and conclusions in the study are those of the authors and do not necessarily represent the views of NIOSH. More information is available online.

Canada Issues SNAc For MWCNTs: On August 24, 2013, Canada issued a significant new activity (SNAc) notice for MWNCT. The notice states that MWCNTs are not included on the Domestic Substances List and that “a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999.” The notice defines substance as “short tangled multi-walled carbon nanotubes” that have the following characteristics:

  1. At least 90 percent of the substance is composed of elemental carbon;
     
  2. The nanotubes measure from 0.09 to 10 micrometres in length, with a 1.1 micrometre average; and
     
  3. The diameter of the nanotubes measures from 5 to 25 nanometres, with a 12 nanometre average.

A significant new activity in relation to the substance is:

  1. Its manufacture or import in a quantity greater than 100 kilograms (kg) per calendar year when it is to be used:
    1. In consumer products as defined in Section 2 of the Canada Consumer Product Safety Act, excluding solid plastic products; or
       
    2. In products intended for use by or for children from 0 to 6 years old; or
       
  2. In all other cases, its manufacture or import in a quantity greater than 10,000 kg per calendar year.

The notice states that despite the above restrictions, “the manufacture or import of the substance to be used to manufacture an export-only product is not a significant new activity when the manufacturing process of the product results in releases of the substance to the aquatic environment in a quantity not exceeding 1 kg per day per site after wastewater treatment.” In addition, the manufacture or import of the substance to be used as a research and development substance is not a significant new activity. Information that must be provided prior to the commencement of a proposed significant new activity includes analytical information to determine the length and diameter of the substance, as well as information describing the primary and secondary particle size, agglomeration or aggregation state, shape, chirality, surface area, and surface charge of the substance; a brief description of the manufacturing process that details precursors of the substance, reaction stoichiometry, nature (batch or continuous), and scale of the process; analytical information to determine the leachability potential of the substance and its precursors from any final product resulting from the significant new activity; and analytical information to determine the dispersibility of the substance in the most significant environmental media related to the significant new activity. If the substance will be manufactured or imported in a quantity greater than 10,000 kg per calendar, the notice specifies additional test data that must be submitted. Manufacturers or importers must identify “every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use, manufacture and import of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and risk management actions in relation to the substance imposed by the department or agency.” Finally, the notice requires submission of “all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.” More information is available online.

EPA Announces Proposed Decision To Register Nanosilver Pesticide Product: On August 27, 2013, EPA announced its proposed decision to register “Nanosilva,” a nanosilver-containing antimicrobial pesticide product. According to EPA, Nanosilva is a silver-based product “used as a non-food-contact preservative to protect plastics and textiles (e.g., in household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories) from odor and stain causing bacteria, fungi, mold and mildew.” EPA states that it evaluated exposure to nanosilver from Nanosilva “using data showing that plastics and textiles treated with the product released, at most, exceedingly small amounts of silver.” EPA also reviewed other information submitted by the applicant and used data from the scientific literature to evaluate the hazard of nanosilver. Based on its evaluation, EPA determined that Nanosilva “will not cause unreasonable adverse effects on people, including children, or the environment.” As a condition of registration, EPA is requiring the company to generate additional data. Comments on the proposed decision are due September 26, 2013. More information, including the Proposed Decision Memo, is available in the online docket, which is available online.

SCCS Extends Deadline For Comments On Opinions: The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) announced on September 4, 2013, that it has extended the deadline for comments on the opinion for titanium dioxide (nano form), addendum to the opinion on zinc oxide (nano form), and revision of the opinion on 2,2′-methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetr amethylbutyl)phenol) nano form. Comments are due September 18, 2013. The SCCS website states: “Please note that, according to the Rules of Procedure of the Scientific Committees, the opinions of the Scientific Committees on a particular subject will be considered closed and not subject to revision for a period of 3 years. Therefore, in order to most efficiently process its workload and manage its resources, the Commission does not plan to reopen a respective issue following the commenting period and the publication of the opinion.” More information is available online.

OECD Posts Two Reports In Series On The Safety Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) posted on September 9, 2013, a final report entitled Co-Operation on Risk Assessment: Prioritisation of Important Issues on Risk Assessment of Manufactured Nanomaterials, which is available online. This document follows on a report published by the Working Party on Manufactured Nanomaterials (WPMN) entitled Important Issues on Risk Assessment of Manufactured Nanomaterials, which identified a range of issues that the WPMN considered important in risk assessment and that should be addressed in the future. Because not all of these issues could be considered at the same time, WPMN circulated a survey to identify those issues for which further guidance should be developed as a priority. This document summarizes the survey results, the methodologies used to analyze the survey, and the identified priorities. These priorities will be the primary focus of projects pertaining to approaches for risk assessments of manufactured nanomaterials. On September 10, 2013, OECD posted a report entitled Environmentally Sustainable Use of Manufactured Nanomaterials, which presents the report of the September 14, 2011, workshop on the environmentally sustainable use of manufactured nanomaterials. The report includes a number of conclusions relevant for current and future OECD activities, especially those focused on life-cycle assessment (LCA) and nanomaterials, including: (1) basic structure and characteristics of LCA; (2) LCA application to nanomaterials at the research, scale-up, regulation, and market level; and (3) LCA application on nanomaterials data availability, reliability, comparability, and its generation. The report is available online.

NRC Releases Report On Advancing Research Agenda For EHS Aspects Of Nanomaterials: On September 12, 2013, NRC released a report entitled Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials. EPA asked the NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). The Committee to Develop a Research Strategy for EHS Aspects of ENMs was formed and released a report in January 2012, A Research Strategy for the Environmental, Health, and Safety Aspects of Engineered Nanomaterials. That report developed a research plan with short- and long-term priorities and estimated resources needed to implement the research plan. In the 2013 report, the Committee assesses the trajectory of research progress on the basis of indicators identified in its first report. According to the report, while some progress has been made in advancing the research agenda on the EHS aspects of ENMs, little work has been done to implement an integrated research strategy throughout the federal government. The Committee reiterates a conclusion from the first report, that accountability for implementing a research strategy “is hampered by the absence of an entity with sufficient management and budgetary authority to direct research efforts governmentwide.” The Committee “maintains that NNI would benefit from a clearer separation of authority and accountability for its environmental, health, and safety research enterprise in relation to its mandate to promote nanotechnology development and commercialization.” The report suggests “progress could be accelerated if a single agency with sufficient management and budgetary authority was designated to direct” EHS research efforts and ensure implementation of a coordinated plan among the federal agencies that make up the NNI. The report is available online.

NNI Posts Report On Symposium On Assessing The Economic Impact Of Nanotechnology: NNI has posted a report on its March 2012 international “Symposium on Assessing the Economic Impact of Nanotechnology.” NNI held the symposium in conjunction with the OECD, and the American Association for the Advancement of Science (AAAS) hosted it. Participants included scientists, engineers, policy analysts, private investors, technology leaders, and the general public from both OECD and emerging economies. Participants reported on initiatives for assessing the impact of nanotechnology and other technological fields. There was a consensus that more pilot initiatives and trials are needed to gain experience and knowledge and to aid in the development of good practices or guidelines for impact assessment. The report states that the data obtained would facilitate efforts to develop robust international documentary standards, which are critical to the broad commercialization and adoption of nanotechnology. According to the report, participants drew attention to the need to obtain information about impact without greatly increasing the burden on respondents. The report notes that the symposium emphasized the importance of measuring the full range of nanotechnology’s impacts, addressing risks, costs, and benefits. Impact analyses need to be on a sound footing in order to be undertaken on a global scale and comparable, the report states, and internationally agreed upon definitions of nanotechnology are needed. The participants concluded that nanotechnology “is sufficiently mature to justify the collecting of data to support the performance of economic impact assessments.” The report provides the reasoning behind the conclusion and identifies potential challenges involved. The report is available online.

ANSI-NSP Will Hold Free Webinar On New Nanotechnology Standards Database: The American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) will hold a free webinar on October 10, 2013, on its new nanotechnology standards database. ANSI-NSP intends the database to be “a free, comprehensive resource for individuals and groups worldwide seeking information about standards and other relevant documents related to nanomaterials and nanotechnology.” During the webinar, ANSI-NSP will discuss how the database can be used by groups and individuals as a resource, and will provide information about the short- and long-term goals associated with the creation of the database. Advance registration for the webinar is required and is available online.

NTP

NTP Draft RoC Monographs For Ortho-Toluidine And Pentachlorophenol Recommend Listing As Known Human Carcinogens: The National Toxicology Program (NTP) announced on August 21, 2013, that it will meet on October 7-8, 2013, to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-toluidine and pentachlorophenol and by-products of its synthesis (pentachlorophenol). 78 Fed. Reg. 51733. In the notice, NTP states that ortho-toluidine is an arylamine used (directly or as an intermediate) to manufacture herbicides, dyes, pigments, and rubber chemicals. It is currently listed as reasonably anticipated to be a human carcinogen in the 12th RoC. The draft Monograph for ortho-toluidine, which is available online, includes the following preliminary listing recommendation: “ortho-Toluidine is known to be a human carcinogen based on sufficient evidence from studies in humans in concert with (1) cancer studies showing site concordance for cancer in female and male rats and (2) mechanistic data demonstrating biological plausibility in humans.” NTP states in the Federal Register notice that pentachlorophenol currently is defined in the U.S. as a “‘heavy duty’ wood preservative that is used primarily in the treatment of utility poles and cross arms.” The candidate substance is defined as “pentachlorophenol and by-products of its synthesis.” The preliminary listing recommendation for pentachlorophenol states:

Pentachlorophenol and by-products of its synthesis are known to be a human carcinogen based on sufficient evidence from studies in humans showing a causal relationship between exposure to pentachlorophenol and NHL. This conclusion is supported by sufficient evidence in experimental animals, and supporting mechanistic evidence.

From the available evidence, the observed carcinogenicity in experimental animals cannot be explained by the presence of by-products alone, and pentachlorophenol is carcinogenic when analyzed separately and combined with by-products. The epidemiologic studies cannot separate effects of pentachlorophenol from any effects of its chlorinated dioxin by-products. Dioxin (specifically 2,3,7,8-tetrachlorodibenzo-p-dioxin) (Cogliano et al. 2011) has been linked to NHL in humans and it is reasonable that dioxin-like activity may contribute to the carcinogenicity of NHL observed in the cancer studies of exposure to pentachlorophenol. Most likely, tumor formation from this complex mixture is a contribution of pentachlorophenol and some of the by-products.

The draft Monograph for pentachlorophenol is available online. Comments on the draft Monographs are due September 25, 2013. The pre-registration deadline for the meeting or to make oral comments is September 30, 2013. More information is available online.

NTP Announces Availability Of Four Draft Technical Reports Scheduled For Peer Review: NTP announced on September 4, 2013, the availability of four draft NTP Technical Reports scheduled for peer review on October 29, 2013: vinylidene chloride, cobalt metal dust, tetrabromobisphenol A (TBBPA), and glycidamide. 78 Fed. Reg. 54476. According to NTP, the draft Technical Reports should be available by September 20, 2013, online. The peer-review meeting is open to the public and pre-registration is requested for both public attendance and comment. The deadline for public comments is October 15, 2013. The pre-registration deadline for the meeting or to make oral comments is October 25, 2013. More information is available online.

REACH

ECHA Publishes Final Report Of The Second REACH Enforcement Project: On September 4, 2013, the European Chemicals Agency (ECHA) announced the availability of the final report for the ECHA Forum’s second enforcement project (REF-2). REF-2 focused on checking the compliance of downstream users, particularly formulators of mixtures, with the requirements of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) regulations. From May 2011 until March 2012, the national enforcement authorities in 29 Member States or European Economic Area countries inspected 1,181 enterprises covering 6,900 substances, 4,500 mixtures, and 4,500 safety data sheets (SDS). The majority of the inspected companies were small- or medium-sized. More than half of the inspected companies were not only active as downstream users but also in additional roles, e.g. as manufacturers, importers, distributors, and only representatives. ECHA states that, in total, 67 percent of the inspected companies were non-compliant with one or more provisions of REACH or CLP. Non-compliance was most commonly related to contraventions of (pre-)registration (REACH, 8 percent), notification (CLP, 15 percent), failure to keep information (20 percent), and having deficient risk management measures (12 percent). While only 3 percent of companies failed to have the SDSs on site, 52 percent of the inspected SDSs showed deficiencies. According to ECHA, despite the high rate of defective SDSs, inspectors noticed an improvement in the formats used and availability of SDSs in comparison to earlier inspections. ECHA recommends that industry undergo a “learning phase” and increase its SDS stewardship to establish compliance in this area of responsibility. ECHA notes that industry “can also find some recommendations in the project report.” More information is available online.

ECHA Grants Registration Numbers To Over 9,000 2013 Registrations: ECHA announced on September 10, 2013, that it has granted registration numbers to 9,030 dossiers that were submitted by the second REACH registration deadline on May 31, 2013. This corresponds to 2,998 more substances being registered under REACH. The dossiers that have not received a registration number are cases where the registrant must resubmit the dossier following a request for further information from ECHA and cases that will be rejected because of non-payment of the related fees. According to ECHA, companies submitted 770 testing proposals in 376 dossiers. Of those, 563 were proposals to test on animals to fulfill the REACH information requirements listed in Annex IX. ECHA will evaluate all dossiers that include testing proposals relevant to Annex IX by June 1, 2016. All tests proposed on vertebrate animals will be subject to public consultation. ECHA notes that it received 301 confidentiality requests in 254 dossiers. The majority of claims concerned SDS information, which includes the name of the company, the registration number, and information on the uses of the substance. ECHA will assess all confidentiality claims before accepting them. ECHA states that it will add the non-confidential information from all of the 2013 registrations to the registered substances online database by the end of 2013. According to ECHA, by the end of August, it received 45 million euros in registration fees, exceeding its estimation of 31 million euros. ECHA reminds registrants to maintain and update their dossiers after receiving the registration number. Companies should also keep checking their REACH-IT account for any communication from ECHA. More information is available online.

BIOBASED/RENEWABLE PRODUCTS

BRAG™ Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s consulting affiliate, B&C® Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.

LEGISLATIVE DEVELOPMENTS

House Energy And Power Subcommittee To Examine President’s Climate Plan: The Energy and Commerce Subcommittee on Energy and Power, chaired by Representative Ed Whitfield (R-KY), on August 22, 2013, announced it will hold a hearing on September 18, 2013, to examine the Administration’s current and planned climate change activities, including the actions identified in President Obama’s Climate Action Plan. In announcing the hearing, entitled “The Obama Administration’s Climate Change Policies and Activities,” the Subcommittee stated that it has requested 13 federal agencies to testify. The Subcommittee requested testimony from EPA, the Department of Energy, the Department of Health and Human Services, USDA, the Department of the Interior, the Department of Transportation (DOT), DOD, the Department of State, the U.S. Agency for International Development, the Export-Import Bank of the U.S., the Office of Science and Technology, the National Oceanic and Atmospheric Administration, and the National Aeronautics and Space Administration.

House Committee Seeks Details On Social Cost Of Carbon: The House Committee on Oversight and Government Reform on August 20, 2013, sent a letter to the White House OMB seeking further detail on how the federal government calculated the so-called “social cost of carbon.” The letter is available online. This cost — set at a specified price per ton of carbon — is to be used by federal agencies to estimate the social and economic cost of carbon dioxide when establishing regulations to limit emissions of the GHG. Currently, the social cost of carbon is set at $38 per metric ton in 2007 dollars for the year 2015. The cost is purportedly a calculation of impacts such as net effect on agriculture, human health, and property damaged from extreme weather linked to climate change for each ton of carbon dioxide emissions. Federal agencies use the figure to help determine the economic impact of their regulations. A federal interagency working group, which included representatives from EPA, DOT, OMB, the Council on Environmental Quality, and other federal agencies, established the figure in a technical support document released May 31, 2013.

House Forms Bipartisan Caucus On Clean Water: The House of Representatives has formed a bipartisan caucus that will focus on clean and safe water technology and innovations. The caucus will be chaired by Representatives Tim Bishop (D-NY) and John Duncan (R-TN); both are supporters of EPA’s clean water infrastructure programs. Bishop is the ranking Democrat on the House Transportation and Infrastructure Committee’s Water Resources and Environment Subcommittee; Duncan is the panel’s former Chair. According to an August 2, 2013, letter sent to the leaders of the House Committee on Administration, Duncan and Bishop say the caucus “will serve as an informal group of members dedicated to issues related to clean and safe water technology and innovations and the education of members on clean water issues.” The caucus was formed at the request of the utility sector and will seek to gather legislators and stakeholders from the regulatory, finance, and related communities to consider the water sector’s broader policy recommendations.

MISCELLANEOUS

Senator Vitter Questions NIEHS/NTP Director About Involvement In Matters Related To Chemical Safety Policy: On September 12, 2013, in a letter to Dr. Linda Birnbaum, Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP, Senator David Vitter (R-LA), top Republican on the Environment and Public Works (EPW) Committee, asked about her involvement in various matters related to U.S. chemical safety policy, including her planned participation in a panel preceding the screening of a film featuring emotional and scare tactics regarding exposure to chemicals.

According to a statement by Senator Vitter, “[t]his is not the first time a high-level Administration official has planned to participate in an event where its intended goal is a complete 180 of the ‘objective, science-based approach’ the federal program is based on. This unquestionably biased film strays far from the facts and completely disregards serious efforts in the Senate to reform our nation’s outdated federal chemical policy, creating an ironic and worrisome juxtaposition to what the NTP is supposed to stand for.” Senator Vitter went on to say that he “would hope Dr. Birnbaum’s dedication to objective facts would outweigh the political overtones in her recent writings, and at this screening, that equates to simple pandering to an activist agenda.” The article Senator Vitter refers to in the letter is entitled “When Environmental Chemicals Act Like Uncontrolled Medicine,” which was published in the journal Trends in Endocrinology and Metabolism in July of this year, and the film that is being referred to is “Unacceptable Levels.” A copy of the letter is available online and a copy of the statement is available online.

NIOSH Issues Prevention Through Design (PtD) Comprehensive Report: On August 19, 2013, NIOSH announced that the first four education modules are available on the NIOSH website. NIOSH is preparing a summary of the work to date on the PtD initiative. A summary of the intermediate outcomes for each strategic area of focus (Research, Education, Practice, Policy, and Small Business) is available online.

OEHHA Posts Authoritative Bodies Tracking Table: The California Office of Environmental Health Hazard Assessment (OEHHA) posted on August 21, 2013, an authoritative bodies tracking table. The table contains information on the status of chemicals considered by OEHHA for addition to the Proposition 65 list under the authoritative bodies mechanism. The table lists the authoritative body, the document or documents providing the basis for the possible listing, the endpoint (toxic effect) relevant to the possible listing, and the next step in the listing process. OEHHA will update this table on a regular basis. The table includes the following chemicals under consideration for listing via the authoritative bodies mechanism:

ChemicalNext Step
ActionDue by
2,4-D and certain 2,4-D salts and estersRemoved from consideration July 26, 2013Complete
Emissions from combustion of coalListed, effective August 7, 2013Complete
Hydrogen cyanide and cyanide saltsListed, effective July 5, 2013Complete
TetraconazoleRemoved from consideration July 5, 2013Complete
Methyl isobutyl ketoneIssue a Notice of Intent to List if criteria are metFebruary 2014
Beta-MyrceneIssue a Notice of Intent to List if criteria are metFebruary 2014
PulegoneIssue a Notice of Intent to List if criteria are metFebruary 2014
TrichloroethyleneIssue a Notice of Intent to List if criteria are metFebruary 2014
Emissions from high-temperature unrefined rapeseed oilIssue a Notice of Intent to List if criteria are metFebruary 2014
Nitrite in combination with amines or amidesIssue a Notice of Intent to List if criteria are metFebruary 2014
Atrazine
 
Propazine
 
Simazine, and metabolites
 
DACT
 
DEA
 
DIA		Issue a Notice of Intent to List if criteria are metFebruary 2014
GenisteinIssue a Notice of Intent to List if criteria are metAugust 2014
Metam potassiumIssue a Notice of Intent to List if criteria are metAugust 2014
N,N-Dimethyl-p-toluidineIssue a Notice of Intent to List if criteria are metAugust 2014
Ethylene glycolIssue a Notice of Intent to List if criteria are metAugust 2014
StyreneIssue a Notice of Intent to List if criteria are metFebruary 2015

The complete table, including endpoint, authority, hyperlinked basis documents, and status, is available online. On September 6, 2013, OEHHA issued a notice of intent to list methyl isobutyl ketone. Comments are due October 7, 2013. More information is available online.

DOT Issues ANPRM On Improving Safety Of Rail Tank Cars That Transport Hazardous Materials: On September 6, 2013, DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comment on whether it should revise the Hazardous Materials Regulations (HMR) to improve the regulation of hazardous materials by rail. 78 Fed. Reg. 54849. The revisions PHMSA is considering are based on eight petitions it has received from the regulated community and four National Transportation Safety Board (NTSB) recommendations. Comments on the ANPRM must be submitted to PHMSA by November 5, 2013.

ITC Will Hold SME Roundtables And Public Hearings: On September 6, 2013, the U.S. International Trade Commission (ITC) announced the dates for a series of roundtables that it will hold, with the assistance of the Small Business Administration, across the U.S. The ITC is seeking information for a report that will identify trade-related barriers that U.S. small- and medium-sized enterprises (SME) perceive as disproportionately (compared to large firms) affecting their exports to the European Union (EU). Upcoming roundtables are scheduled for Raleigh (September 16, 2013), Atlanta (September 17, 2013), Denver (September 17, 2013), Albuquerque (September 18, 2013), Miami/Ft. Lauderdale (September 18, 2013), Houston (September 20, 2013), Salt Lake City (September 20, 2013), Los Angeles (September 23, 2013), Philadelphia (September 23, 2013), Irvine (September 24, 2013), New York (September 24, 2013), Sacramento (September 25, 2013), Boston (September 26, 2013), Fresno (September 27, 2013), and Providence (September 27, 2013). Public hearings will be held in San Jose, California, on September 26, 2013, and Washington, D.C., on October 8, 2013. The ITC suggests that SMEs that export or have considered exporting to the EU provide information concerning:

  • EU-wide barriers to trade that limit exports of any goods or services;
     
  • Specific trade barriers in individual EU countries; and
     
  • Ways to increase SMEs’ exports to the EU.

The ITC asks that SMEs list specific barriers and the products or services affected by the barriers, as well as which barriers seem most important in holding back exports. These topics will be discussed at the hearings and roundtables. 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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