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October 1, 2014

Monthly Update for October 2014

Bergeson & Campbell, P.C.


EPA Schedules SAP Meeting On Endocrine Activity: On September 16, 2014, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Integrated Endocrine Activity and Exposure-based Prioritization and Screening. 79 Fed. Reg. 55475. The meeting will be held on December 2–5, 2014, from approximately 9:00 a.m. to 5:00 p.m. EPA encourages that written comments be submitted by November 18, 2014, and requests for oral comments be submitted by November 25, 2014.

EPA Proposes Significant New Use Rule For Certain Nonylphenol And Nonylphenol Ethoxylates: On October 1, 2014, EPA’s Office of Pollution Prevention and Toxics (OPPT) proposed a Significant New Use Rule (SNUR) that will allow EPA to review and restrict certain nonylphenol (NP) and nonylphenol ethoxylate (NPE) chemicals. 79 Fed. Reg. 59186. For the 15 NPs and NPEs that are currently not on the market, EPA is proposing a SNUR to ensure that uses of these chemicals cannot start or resume without prior EPA review. EPA has taken steps to address NPs and NPEs, and this SNUR, when issued in final, will require that anyone intending to manufacture (including import) or process the chemical(s) notify EPA at least 90 days before they begin any significant new use. This notification allows EPA the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that use prior to entering the marketplace. EPA has taken several other steps, along with detergent manufacturers, to reduce the risks posed by NPs and NPEs. In 2010, in coordination with EPA’s Design for the Environment (DfE) Safer Detergent Stewardship Initiative program, the Textile Rental Services Association of America agreed to a phase-out of NPEs in industrial laundry detergents among its member companies, representing about 50 percent of that market. In May 2012, the DfE program released an Alternatives Assessment for Nonylphenol Ethoxylates, which identified eight safer alternatives to NPEs. Use of NPEs in industrial liquid and powder detergents has declined as a result of EPA’s on-going efforts to address the potential risks. Additional information on the proposed SNUR on NPs and NPEs can be found online. A more detailed memorandum is available online. Comments are due by December 1, 2014.

EPA Issues Final Rule Adding NP Category To EPCRA Chemical Release Reporting: On September 30, 2014, EPA issued a final rule adding a NP category to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) of 1990. 79 Fed. Reg. 58686. EPA added this chemical category to the EPCRA Section 313 list because EPA believes it has determined that this category meets the EPCRA Section 313(d)(2)(C) toxicity criterion. The chemicals in the category include:

Chemical Abstracts Service (CAS) NumberChemical Name
84852-15-34-Nonylphenol, branched
90481-04-2Nonylphenol, branched

According to EPA, NP is highly toxic to numerous species of aquatic organisms. EPA’s technical evaluation of NP showed that it can reasonably be anticipated to cause, because of its toxicity, significant adverse effects in aquatic organisms. The observed effects from NP exposure occur at very low concentrations demonstrating that NP is highly toxic to aquatic organisms. The final rule was effective on September 30, 2014, and applies for the reporting year beginning January 1, 2015 (reports due July 1, 2016).

EPA Redesigns Pesticide Registration Improvement Extension Act Website: On September 30, 2014, EPA redesigned the Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) website. The new website is available at The purpose of the redesign is to make PRIA 3 information more easily accessible to stakeholders and the public, regardless of the type of device being used. EPA made no technical or regulatory changes to PRIA 3.

HHS Releases Update On RoC Availability, 13th Edition: On October 2, 2014, the U.S. Department of Health and Human Services (HHS) released the 13th Report on Carcinogens (RoC). The RoC is a science-based, public health document that identifies substances in our environment that are considered cancer hazards. The report was prepared by the National Toxicology Program (NTP) for the HHS Secretary. Four substances are newly reviewed for this edition of the RoC, bringing the cumulative report to a total of 243 listings. The new listings include: 1-bromopropane, cumene, pentachlorophenol (and by-products of its synthesis), and o-toluidine. The RoC is available online. The press release announcing the report is available online.

EPA Announces Availability Of Guidance To Develop Data-Derived Extrapolation Factors: On October 3, 2014, EPA announced the availability of Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation (DDEF Guidance). 79 Fed. Reg. 59768. This document lays out methods for calculation of factors compensating for the application of animal toxicity data to humans (interspecies) and for compensating for sensitive populations (intraspecies). The use of data to conduct these extrapolations rather than rely on default values advances EPA’s policy of considering relevant data first when conducting its chemical assessments. The DDEF Guidance is available online.

EPA Posts New Information To ChemView: On October 7, 2014, EPA posted additional data and added new functions to its ChemView, EPA’s “publicly-accessible, one-stop online tool to find information for chemicals regulated under the Toxic Substances Control Act (TSCA).” The enhanced data functions include: improving the display and content for the Chemical Data Reporting (CDR) information, adding a new link that displays the pollution prevention information generated as part of the Toxics Release Inventory (TRI) program, and launching an administrative tool that will save EPA resources by streamlining the loading of future information. The updated database now includes the following new information: 244 consent orders, an additional 1,205 SNURs for new and existing chemicals, 16 additional chemicals with test rule data, and updates to the Safer Chemicals Ingredient List. This is the first time EPA has posted consent orders and new chemical SNURs to ChemView. ChemView now contains information on almost 10,000 chemicals. EPA will use the information from the survey to improve ChemView. The tool displays key health and safety information and uses data in a format that allows quick understanding, with links to more detailed information. Searches can be conducted by chemical name or CAS number, use, hazard effect, or regulatory action and has the flexibility to create tailored views of the information on individual chemicals. To view and search ChemView, visit online.

EPA Announces Agricultural Pesticide Spray Drift Reduction Technologies Voluntary Program: On October 15, 2014, the Office of Pesticide Programs (OPP) announced a voluntary program to document the effectiveness of agricultural pesticide spray application technologies on reducing pesticide spray drift. 79 Fed. Reg. 61865. Under the Drift Reduction Technology (DRT) Program, agricultural equipment manufacturers would conduct (or make arrangements for a testing facility to conduct) studies to determine the percent drift reduction according to a verification protocol. Once completed, the manufacturer would submit the study to EPA for review and evaluation. As verified, these reductions could then be quantitatively credited in the environmental risk assessments used to develop the drift reduction measures appearing on the label of the pesticide product. EPA will then review the manufacturers’ studies and, based on these data, it will assign spraying devices a rating on a four-star scale:

  • Four stars: Device can reduce spray drift by 90 percent or more.
  • Three stars: Device can reduce spray drift by between 75 percent to 89 percent.
  • Two stars: Device can reduce spray drift by between 50 percent to 74 percent.
  • One star: Device can reduce spray drift by between 25 percent to 49 percent.
  • No stars: Device can reduce spray drift by less than 25 percent.

EPA allows pesticide manufacturers to include labeling on their products that contain dual-use instructions, one for farmers using devices that have received stars through the DRT program and another for those using devices that do not have a DRT rating.


FDA Issues Four FSMA Supplemental Proposals: On September 29, 2014, the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) proposed changes to four rules as part of ongoing actions within the Food Safety Modernization Act (FSMA). The four proposals include “Proposed Supplemental Rule for Produce Safety,” 79 Fed Reg. 58433; “Proposed Supplemental Rule for Preventative Controls for Human Food,” 79 Fed. Reg. 58523; “Proposed Supplemental Rule for Preventive Controls for Animal Food,” 79 Fed. Reg. 58475; and “Proposed Supplemental Rule for Foreign Supplier Verification Program” (FSVP), 79 Fed. Reg. 58573. FDA intends with these revisions to make the criteria of these proposals more “flexible, practical and targeted.” Comments on all the proposed revisions are due December 15, 2014. FDA is planning to hold a public meeting on the revised proposals on November 13, 2014. For more details, see online.

FDA CDRH Issues Guidance For Industry: On September 24, 2014, FDA’s Center for Devices and Radiological Health (CDRH) issued a guidance document for Industry and FDA Staff on “Custom Device Exemption.” The guidance is intended to provide information about Section 520(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), including expanded definitions on specific terminology, FDA interpretations, and additional information on requirements for submitting Custom Device Annual Reports. For more details, see online.

FDA CFSAN Biennial Registration Renewal: On September 26, 2014, FDA’s CFSAN posted a notice that the Biennial Registration Renewal period would begin October 1, 2014, and end December 31, 2014. FDA through the FSMA amended the requirements for food facility registrations. Any facility that “manufactures, processes, packs or holds food for human or animal consumption in the U.S.” must register and renew that registration on an every other year basis. There are three guidance documents available for industry to assist in this process. For more information, see online.

FDA Issues CDRH Industry Guidance On Management Of Cybersecurity: On October 1, 2014, FDA’s CDRH issued a final guidance entitled “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.” The guidance is intended to provide industry information related to issues of cyber security that should be considered during the “design and development of medical devices.” In addition to the guidance document, FDA is hosting a webinar to provide further details and to answer questions on October 29, 2014. On September 23, 2014, FDA also announced that a public meeting with the Department of Homeland Security and the Department of HHS will be held on October 21-22, 2014, to discuss “Collaborative Approaches for Medical Device and HealthCare Cybersecurity.” 79 Fed. Reg. 56814. For more information, see Content of Premarket Submission for Management of Cybersecurity in Medical Devicesonline, and online.


EPA Deletes Reference To ASTM Phase I Assessment Standard In CERCLA “All Appropriate Inquiries” Rule: On October 6, 2014, EPA issued a final rule amending its “All Appropriate Inquiries” (AAI) rule under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) by removing a reference to a 2005 ASTM International standard for conducting Phase I environmental assessments. 79 Fed. Reg. 60087. The AAI rule, codified at 40 C.F.R. Part 312, provides limited liability relief under CERCLA to certain purchasers of properties that undertake “all appropriate inquiries” to determine whether the property is contaminated with hazardous substances. The AAI rule referenced the then existing ASTM International “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process” (ASTM E-1527-05) and authorized its use to comply with the rule. In 2013, ASTM International updated its standard practice and designated the ASTM E-1527-05 standard as a “historical standard.” EPA subsequently determined that a person’s use of the revised standard (ASTM E1527-13) would be compliant with the AAI rule. The October 6, 2014, final rule thus deletes the reference to “a standard that ASTM International no longer recognizes as current since it no longer represents the most recent consensus-based standard.” EPA states that it is taking the action because it wants “to reduce confusion associated with the regulatory reference to a historical standard that is no longer recognized by its originating organization as meeting its standards for good customary business practice.” EPA reiterates in the rule that parties following the ASTM E1527-13 standard will be deemed compliant with the AAI rule. EPA further states that parties can use other standards, methods, or customary business practices for conducting all appropriate inquiries, provided they comply with the standards and practices set forth in the AAI rule. The revised standard will take effect on October 6, 2015.

EPA Clarifies That Waste-Derived Brick Material May Be Regulated As Fuel When Burned: In a letter dated September 29, 2014, EPA’s Office of Solid Waste and Emergency Response (OSWER) clarifies that a nonhazardous, waste-derived “brick” intended to substitute for coal or biomass in stocker boilers may be regulated as a fuel rather than a solid waste when it is burned in certain kilns, incinerators, or boilers. The letter was sent to WERC-2 Inc. to provide regulatory clarity under EPA’s nonhazardous secondary materials rule. The material, EcoTac, consists of 20-40 percent plastics, 10-40 percent paper and cardboard, 5-10 percent organics, 5-10 percent polystyrene, and other residual waste products, according to the letter. It consists of 15 percent or less moisture, 0.3 percent or less of chlorine and comparable levels of sulfur to those of chlorine, according to the letter. Failure to maintain those specified conditions in the fuel source could mean the regulatory requirements for the material would change, according to EPA. EPA has issued over 20 comfort letters affirming its intent to regulate certain materials as fuels rather than as solid wastes under its final February 2013 nonhazardous secondary materials rule. Aspects of the regulation are currently being challenged in a federal appeals court by industry and environmental groups. Certain materials were categorically exempted from the stricter regulatory standards in that rulemaking — resinated wood, coal refuse that has been recovered from legacy piles, scrap tires that are not discarded and are managed by established tire collection programs, and dewatered pulp and paper sludges. Additional comfort letters have provided regulatory certainty for additional materials. The September 29, 2014, comfort letter from EPA to WERC-2 is available online.


EPA Extends Comment Period On Clean Power Plan: On September 17, 2014, EPA announced that it was extending the comment period on its historic Clean Power Plan proposed rule, the centerpiece of President Obama’s Climate Change Action Plan. EPA proposed the rule on June 18, 2014, with the original comment period closing on October 16, 2014. EPA has decided to extend the comment period to December 1, 2014. EPA stated that it was responding to requests from state agencies, lawmakers, and industry groups that sought additional time to prepare comments on the sweeping proposal. Despite the comment period extension, however, EPA Administrator Gina McCarthy stated that EPA still intends to promulgate the rule in final form in June 2015.

EPA Again Extends Comment Period On “Waters Of The United States” Proposed Rule: On October 6, 2014, EPA extended until November 14, 2014, the comment period on its controversial “Waters of the United States” (WOTUS) rule. 79 Fed. Reg. 61590. EPA proposed the WOTUS rule in April seeking to clarify its authority under the Clean Water Act (CWA) to regulate smaller water bodies such as streams and rivers that flow into larger water sources that EPA already regulates under the CWA. 79 Fed. Reg. 22188 (Apr. 21, 2014). In June, EPA extended the comment period on the WOTUS proposal to October 20, 2014. 79 Fed. Reg. 35712 (June 24, 2014). EPA has extended the comment period again to allow for public review of and comment on a forthcoming report from the EPA Scientific Advisory Board (SAB) addressing the connectivity of small bodies of water such as streams and wetlands.

Obama Administration Announces Executive Actions That Partner With Private Sector To Reduce Hydroflurocarbons Emissions: On September 16, 2014, the White House announced new private sector commitments and executive actions to reduce emissions of hydroflourocarbons (HFC). The commitments would reduce cumulative global consumption of these greenhouse gases (GHG) by the equivalent of 700 million metric tons of carbon dioxide through 2025, equivalent to 1.5 percent of the world’s 2010 GHG emissions and the same as taking nearly 15 million cars off the road for ten years, the White House stated. In addition, the Administration announced a set of executive actions to continue progress in reducing HFC emissions. The private sector commitments span the HFC supply chain, from manufacturers to retail outlets. Three industry associations and several companies, including Coca-Cola, Carrier, DuPont, and Honeywell, have pledged to reduce HFC production and/or emissions. The Administration’s new executive actions will help promote the use of safer alternatives to HFCs and encourage the development of new technologies. The executive actions fall into three main categories. The first would seek to promote the use of safer alternatives to HFCs in the federal government. This would include updating regulations for service and vendor contractors, requiring federal agencies to purchase safer and cleaner alternatives to HFCs whenever feasible, and transitioning to equipment that uses safer and more sustainable alternatives. Also, as part of its Green Proving Ground (GPG) program, the U.S. General Services Administration is inviting technology manufacturers and industry stakeholders, including those that offer HFC alternatives, to submit information on innovative and transformational building technologies that can be used in federal buildings. Technologies selected by the program, which conducts real-world evaluations of the performance of emerging building technologies to recommend deployment strategies towards achieving ambitious sustainability goals, will be matched with federally-owned buildings to pilot measurement and verification by objective third-party evaluators. The second main category of executive actions is focused on encouraging private sector investment in low-emissions technology. This will include EPA actions to expand the list of climate-friendly alternatives to both ozone-depleting substances and HFCs and expanding the Significant New Alternatives Policy (SNAP) program. EPA and the Alliance for Responsible Atmospheric Policy will also work with other interested governments, international agencies, private sector organizations, and civil society to organize a series of sector-specific workshops. EPA received a petition from the Alliance for Responsible Atmospheric Policy to create consistent refrigerant management regulations by applying the same rules that already exist for ozone-depleting refrigerants to HFCs. EPA recognizes that refrigerant management is an important way to reduce climate-damaging emissions from equipment used for air-conditioning and refrigeration, and will engage with stakeholders as it explores options for addressing the petition. The third category of executive actions includes investing in new technologies to support safer alternatives to HFCs. Under this action, the U.S. Department of Energy (DOE) will fund research and development of technologies and approaches that lead to energy reductions in U.S. buildings. The funding will encourage next generation, efficient cooling technologies, including examining HVAC technologies that use alternative refrigerants and those that move beyond using refrigerants altogether.

EPA Releases Annual GHG Emissions Data From Large Facilities; Releases Slightly Up: On September 30, 2014, EPA released its fourth year of Greenhouse Gas Reporting Program data, detailing GHG pollution trends and emissions broken down by industrial sector, geographic region, and individual facilities. In 2013, reported emissions from large industrial facilities were 20 million metric tons higher than the prior year, or 0.6 percent, driven largely by an increase in coal use for power generation. According to EPA, the Greenhouse Gas Reporting Program is the only program that collects facility-level GHG data from major industrial sources across the United States, including power plants, oil and gas production and refining, iron and steel mills, and landfills. The program also collects data on the increasing production and consumption of HFCs predominantly used in refrigeration and air conditioning. Over 8,000 large-emitters reported direct GHG emissions to the program in 2013, representing approximately 50 percent of total U.S. emissions. The data from these facilities show that in 2013:

  • Power plants remained the largest source of U.S. GHG emissions, with over 1,550 facilities emitting over 2 billion metric tons of carbon dioxide, roughly 32 percent of total U.S. GHG pollution. Power plant emissions have declined by 9.8 percent since 2010, but there was an uptick in emissions of 13 million metric tons in 2013 due to an increased use of coal.
  • Petroleum and natural gas systems were the second largest stationary source, reporting 224 million metric tons of GHG emissions, a decrease of 1 percent from the previous year.
  • Refineries were the third largest stationary source, reporting 177 million metric tons of GHG emissions, up 1.6 percent from the previous year.
  • Reported emissions from other large sources in the industrial and waste sectors increased by 7 million metric tons of GHG pollution, up 1 percent from 2012.


OSHA Launches National Dialogue On Hazardous Chemical Exposures And Permissible Exposure Limits: On October 9, 2014, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) on October 9, 2014, launched a national dialogue with stakeholders on ways to prevent work-related illness caused by exposure to hazardous substances. The first stage of this dialogue is a request for information (RFI) on the management of hazardous chemical exposures in the workplace and strategies for updating permissible exposure limits (PEL) that was published on October 10, 2014. 79 Fed. Reg. 61384. The comment period on the RFI closes on April 8, 2015. OSHA also created a new information portal on its web page devoted to the initiative and entitled “Preventing Occupational Illnesses Through Safer Chemical Management.” In the RFI, OSHA announced that it is reviewing its overall approach to managing chemical exposures in the workplace. OSHA is also seeking stakeholder input about more effective and efficient approaches that address challenges with the current regulatory approach. This review involves considering issues related to updating PELs, as well as examining other strategies that OSHA could implement to address workplace conditions where workers are exposed to chemicals. The notice describes possible modifications of existing processes, along with potential new sources of data and alternative approaches. OSHA states that it is particularly interested in information about how it may implement newer approaches to protecting employees from workplace exposures. OSHA states that 95 percent of the current PELs, which cover fewer than 500 chemicals, have not been updated since their adoption in 1971. The current PELs cover only a small fraction of the tens of thousands of chemicals used in commerce, many of which are suspected of being harmful, OSHA stated. Substantial resources are required to issue new exposure limits or update existing workplace exposure limits, as courts have required complex analyses for each proposed PEL. OSHA is seeking public comment regarding current practices and future methods for updating PELs, as well as new strategies for better protecting workers from hazardous chemical exposures. Specifically, OSHA requests suggestions on possible streamlined approaches for risk assessment and feasibility analyses and alternative approaches for managing chemical exposures, including control banding, task-based approaches, and informed substitution.


Guideline Published For The Danish Inventory Of Nanoproducts: In August 2014, the Danish Environmental Protection Agency published the Guideline for the Danish Inventory of Nanoproducts, which is intended to explain how manufacturers and importers of products for consumers should use the new Inventory. The Guideline describes who has a duty to report; which products must be reported; and how to collect information and perform the actual reporting to the Inventory. The Guideline uses questions to determine whether a product must be reported, including the following:

  1. Is your product covered by other regulations?
    If you are a manufacturer or importer of only one or more of the following products (mixtures or articles), you are not obliged to report these (see section 3), and you do not have to do anything further:
    2.1. Foodstuffs and food contact materials
    2.2. Animal feed
    2.3. Medicinal products
    2.4. Medical devices
    2.5. Cosmetics
    2.6. Pesticides
    2.7. Waste.

For manufacturers and importers that are not exempt, the Guideline includes a flow chart to help determine whether their products are nanoproducts that need to be reported to the Inventory. Manufacturers and importers of products for consumers that must be reported must report by August 30, 2015, for the period beginning June 20, 2014, and ending June 20, 2015. The Guideline is available online.

EPA Seeks Data On Nanomaterials Manufacturing: On September 16, 2014, announced the availability of the combined Final 2012 and Preliminary 2014 Effluent Guidelines Program Plans and EPA’s 2012 and 2013 Annual Effluent Guidelines Review Reports. The notice solicits public comment and input on the Preliminary 2014 Plan and the 2012 and 2013 Annual Review Reports. 79 Fed. Reg. 55472. The CWA requires EPA biennially to publish a plan for new and revised effluent guidelines, after public notice and comment, which identifies any new or existing industrial categories selected for effluent guidelines rulemaking and provides a schedule for such rulemaking. EPA typically publishes a preliminary plan upon which the public is invited to comment, and then publishes a final plan about a year later. The Final 2012 Effluent Guidelines Program Plan (Final 2012 Plan) and the Preliminary 2014 Effluent Guidelines Program Plan (Preliminary 2014 Plan) were prepared pursuant to CWA Section 304(m), and provide a summary of EPA’s review of effluent guidelines and pretreatment standards, consistent with CWA Sections 301(d), 304(b), 304(g), 304(m), and 307(b) and EPA’s evaluation of indirect discharges without categorical pretreatment standards to identify potential new categories for pretreatment standards under CWA Section 307(b). For the Preliminary 2014 Effluent Limitations Guidelines Plan, EPA requests comments and information on the following topics: data sources and methodologies – in general, the Preliminary 2014 Effluent Guidelines Program Plan with regard to the 2014 Plan EPA specifically seeks comment on: study of Centralized Waste Treatment (CWT) facilities, study of Petroleum Refineries, preliminary Category Review of Metal Finishing, and, importantly nanomaterials manufacturing and formulating. EPA reportedly is collecting data and information on the potential industrial wastewater discharge hazards associated with nanomaterials manufacturing and formulating. EPA “specifically requests public comment and stakeholder input relating to any information or data available on the wastewater hazards and discharges associated with the manufacture of nanomaterials and their use in manufacturing or formulating products, as well as any other information believed to be relevant.” Comments are due November 17, 2014.

OECD Issues Report Of The Questionnaire On Regulatory Regimes For Manufactured Nanomaterials 2010-2011: On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration. Australia, Canada, Denmark, the European Union, France, Germany, Italy, Netherlands, and the U.S. submitted fourteen responses for legislation covering chemical substances and/or products, including industrial chemicals, therapeutics, foods and drugs, and biocides, as well as occupational health and safety, consumer products, packaging, and labeling. Respondents agreed on using existing regulatory frameworks to regulate nanomaterials, although some jurisdictions, such as France, have developed reporting regimes specific to nanomaterials to gather information on uses and quantities. According to the responses, developing regulatory definitions “still seems to be a fairly challenging issue for regulatory bodies; however, regulatory definitions have been developed and now are being used by some jurisdictions.” The definitions tend to consider a 1-100 nanometer (nm) size range, unique properties when outside of 1-100 nm, both internal and external structure, and have addressed ways to differentiate between materials that are engineered nanomaterials and traditional chemicals that have nanoscale components by using percentage cut-offs. The Report is available online.

Dr. Chuck Geraci Appointed NIOSH Associate Director For Nanotechnology: In early October 2014, Dr. John Howard, Director of the National Institute for Occupational Safety and Health (NIOSH) announced that, effective October 6, 2014, Chuck Geraci, Ph.D., CIH, has been appointed NIOSH Associate Director for Nanotechnology. NIOSH states: “As Associate Director for Nanotechnology, Dr. Geraci will ensure that NIOSH maintains its outstanding national and international reputation for scientific achievement in the emerging area of nanotechnology implications for workers. He will also develop initial strategies for NIOSH to participate scientifically in the growing areas of advanced nano-manufacturing technology, advanced nanomaterial science, and in the new challenges arising from the rapid trend of converging technologies.” Dr. Geraci first worked for NIOSH from 1975 through 1987, leaving to work in the private sector. He returned to NIOSH in 2004 from the Procter and Gamble Company and served as the Chief of the Education and Information Division (EID) Document Development Branch until he assumed his current job of Nanotechnology Research Center (NTRC) Coordinator. As Chief of the EID Document Development Branch, he was instrumental in launching several key initiatives such as Prevention-though-Design, Skin Hazard Notations, and the Immediately Dangerous to Life or Health (IDLH) derivation. Over the past three years, Dr. Geraci has represented NIOSH on two key committees with the U.S. National Nanotechnology Initiative (NNI) — the U.S. Subcommittee on Nanoscale Science, Engineering, and Technology (NSET) and the Nanotechnology Environmental and Health Implications (NEHI) Working Group. He was instrumental in having NIOSH contributions to worker safety and health included in both the U.S. NNI Strategic Plan and the NEHI Environmental, Health, and Safety (EHS) Research Strategy. In addition to his work with the NNI, Dr. Geraci has been very successful in developing many partnerships with private companies involved in the development of nanomaterial processes and products, and extending these partnerships across NIOSH.

Dr. Geraci’s appointment is good news to the growing advanced manufacturing activity in the U.S., and it is encouraging to see that Chuck will be involved in the responsible growth on this next and natural progression of the use of nanomaterial science. Over the past eight years, Chuck has provided expert guidance to NIOSH and multiple private sector partners that has allowed them to understand the challenges and strategies needed to develop and introduce nanomaterial-enabled products safely and responsibly that will ultimately benefit society. Many of us who have worked with Chuck appreciate his ability to understand the complexities of launching a new technology in the private sector and the intricacies involved with the many aspects of government involvement, ranging from research to regulatory issues. Throughout the entire process, Chuck has been a source of good, science-based information, and assistance always offered quickly. Enthusiastically, and with good cheer. In many ways, this action demonstrates the strong desire NIOSH has to continue conducting research and working with the private sector to promote the safe and responsible development of nanomaterial science. All of us wish Dr. Geraci much success in his new assignment as the NIOSH Associate Director for Nanotechnology!

JRC Report Assesses Experiences With The EC Recommendation On The Definition Of Nanomaterial: The European Commission’s (EC) Joint Research Center (JRC) has published a report entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” — Part 2: Assessment of collected information concerning the experience with the definition. In the report, JRC assesses information collected between August 2013 and April 2014 from scientists, research institutes, regulatory bodies, non-governmental organizations, and industry regarding implementation of the EC recommendation on the definition of nanomaterial. The report builds on the first report of the series, entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” — Part 1: Compilation of information concerning the experience with the definition. The report states: “Based on the feedback received regarding the current definition, compiled in the first report of the series, and its assessment, presented in this second report, the JRC is now working on a set of indications on how the definition could be modified to improve its clarity, effectiveness and implementability. These recommendations will be included in a final report (Part 3 of the series), which is expected to be released later in 2014.” The report is available online.

EC Scientific Committee Clarifies Meaning Of “Sprayable Applications/Products” For Certain Nanomaterials: On September 30, 2014, the EC Scientific Committee on Consumer Safety (SCCS) posted a clarification on the meaning of the term “sprayable applications/products” for certain nanomaterials. According to the clarification, the EC Member States asked SCCS to clarify the meaning of the term “sprayable applications/products” in the conclusions of its safety assessments for carbon black CI 77266, titanium oxide, and zinc oxide. The clarification states:

Generally speaking, the term spray is broad and includes:

  1. aerosols dispenser, for which there is the definition contained in Directive 75/324: “non-reusable containers made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state“;
  2. spray bottles containing a pump that draws a liquid up from the bottom and forces it through a nozzle generating a stream or a mist.

According to the clarification, many cosmetic products are dispensed through a mechanical pump that, instead of aerosol/nebulization, produces a single dose of cream. The SCCS acknowledges a need to clarify whether “sprayable applications/products” would also include these pump dispensers for creams. In addition, the SCCS states that, for clarity of the next scientific opinions, it could adopt a harmonized terminology with the term “spray” meaning the production of aerosols and/or nebulization, and “pump dispensers” meaning the dispensing devices for single-dose cream. The clarification is available online.

EPA Submits Proposed Rule On Nanoscale Materials To OMB For Review: On October 6, 2014, EPA submitted a proposed rule to the Office of Management and Budget (OMB) entitled “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” The proposed rule links to a Spring 2014 Regulatory Agenda item that was revised after the proposed rule was submitted to OMB. The Regulatory Agenda item posted online in May 2014 referred to the development of a SNUR under TSCA Section 5(a)(2) that would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The Regulatory Agenda item now includes no reference to the SNUR, but describes only a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. A previous proposed rule had been under OMB review since November 22, 2010. Neither proposed rule has been publicly released. The Spring 2014 Regulatory Agenda item is available online.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C Consortia Management, L.L.C. (BCCM), 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


EPA Inspector General To Examine Green Chemistry: On October 2, 2014, EPA’s Office of Inspector General (OIG) announced it is reviewing the accomplishments of EPA’s Presidential Green Chemistry Challenge Awards. OIG will audit contributions EPA states its Green Chemistry program makes toward achieving the goals of OPPT. The OIG’s memo describing its project is available online.

White House Announces Efforts To Promote Green Infrastructure: On October 8, 2014, the Obama Administration announced executive actions and public- and private-sector efforts to promote resilience to climate change through natural resource management and investments in green infrastructure. Under the initiative, the federal government will make natural resources more resilient to climate impacts and enhance their ability to absorb carbon dioxide as part of a new “Climate and Natural Resources Priority Agenda.” The agenda is the product of an interagency Council on Climate Change Preparedness and Resilience formed by the President in November 2013. Federal agencies have also pledged to develop tools to help agencies and landowners understand how their natural resource management decisions affect resilience. Federal agencies will also work to conserve and restore soils, forests, grasslands, wetlands, and coastal areas that store carbon and improve the government’s system for tracking these carbon sinks. The U.S. Army Corps of Engineers (Corps), for example, is releasing the first estimates of existing carbon sequestration and sequestration potentials on the more than 20 million acres of land and water it manages. Public and private groups, such as the Trust for Public Land and Restore America’s Estuaries, will help with this effort to better understand and maximize how forests and oceans absorb carbon. As part of the Council’s agenda, federal agencies will also encourage communities to boost their resilience by investing in natural infrastructure, including green stormwater management. To manage municipal stormwater that is expected to increase in both volume and frequency with climate-change induced torrential rains, the agenda encourages the use of green infrastructure approaches, such as urban forests, porous pavements, rooftop gardens, and grassy swales, to reduce stormwater runoff that carries pollutants, toxic metals, and sediment. Twenty-six public and private organizations have joined an existing green infrastructure collaborative led by EPA in collaboration with six other federal agencies. One of those 26 groups, the American Society of Civil Engineers, has committed to promote and implement sustainable practices to manage stormwater. Meanwhile, the Association of Clean Water Administrators, which represents state and interstate water agencies, stated it would serve as a liaison between EPA and communities to identify challenges and opportunities for wider implementation of green infrastructure practices. The Obama Administration’s “Priority Agenda for Enhancing the Climate Resilience of America’s Natural Resources” is available online.


DOT Extends Comment Period On Reverse Logistics For Hazardous Materials Proposed Rule: On September 25, 2014, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) extended until November 10, 2014, the comment period on its proposed rule entitled Hazardous Materials: Reverse Logistics. 79 Fed. Reg. 57494. The proposed rule would add a section to the Hazardous Materials Regulations (HMR) creating regulatory provisions for the “reverse logistics” of hazardous materials. PHMSA proposes a definition for “reverse logistics” for hazardous materials that are intended to be returned to or between a vendor, distributor, manufacturer, or other person for the purpose of returning the product for credit, recalling a product, replacement of the product, or similar reasons. The primary aim of the proposal is to reduce the regulatory burden that applies to hazardous materials that are returned to retail or wholesale establishments. Under the current HMRs, a product that is a hazardous material that is returned to a retail establishment, for example, would generally be subject to full regulation under the HMRs. DOT proposes to create a new section — 49 C.F.R. Section 173.157 — that would apply specifically to reverse logistics. That new section would establish regulations for the shipment of hazardous material in the reverse logistics supply chain; define training requirements associated with reverse logistics shipments; provide authorized packaging for reverse logistics shipments; and set segregation requirements for reverse logistics shipments. The proposed rule would also amend the so-called “single shipper provision” at 49 C.F.R. Section 173.159(e) for shipments of lead acid batteries.


House Passes American Energy Solutions For Lower Costs And More American Jobs Act Despite White House Veto Threat: Before adjourning for the mid-term elections, on September 18, 2014, the House of Representatives passed the American Energy Solutions for Lower Costs and More American Jobs Act (H.R. 2). The bill is an amalgam of several energy-related measures that had been introduced in the 113th Congress. The most controversial provisions in the bill would block EPA’s proposed Clean Power Plan, and approve the Keystone XL pipeline, limit regulation of hydraulic fracturing, and expand offshore drilling. Most of the measures in H.R. 2 had already been passed by the House as separate bills. In a Statement of Administration Policy issued on September 16, 2014, the White House promised to veto H.R. 2 if it were presented to the President. “The Administration strongly opposes H.R. 2, which purports to promote and increase the Nation’s energy security, but which would undermine energy security and endanger human health and the environment,” the statement reads. The White House claims that H.R. 2 “would roll back policies that support the continued growth of safe and responsible energy production in the United States. It also would discourage environmental analysis and civic engagement in Federal decision-making. Furthermore, the bill would impose a system for automatic approval of natural gas pipeline projects that could lead to confusion, increased litigation, delay, and potential denial of the projects that the bill intends to expedite. It also would circumvent longstanding and proven processes for determining whether cross-border pipelines and electric transmission facilities are in the national interest by removing the presidential permitting requirement.” The White House’s criticism of the bill does not end there, however. “H.R. 2 would endanger public health and the environment by halting U.S. progress in cutting dangerous carbon pollution from power plants, prohibiting the Federal Government from ensuring that hydraulic fracturing activities taking place on Federal and Indian lands are managed in a safe and responsible manner, and requiring the implementation of a court-vacated rule that would not adequately protect drinking water and watersheds from strip mining.”

Senate Bill Seeks To Address Combined Sewer Overflows: A Senate bill introduced by Sherrod Brown (D-OH) on September 11, 2014, would provide up to $1.8 billion in grants to help communities tackle combined sewer and separate sanitary sewer overflows over the next five years. The Clean Water Affordability Act (S. 2797) also would give cities and towns experiencing combined sewer overflows up to 30 years to implement long-term control plans mandated by EPA. The grants authorized by the legislation could be used for a variety of purposes, including planning, designing, and constructing sewer systems to minimize both combined and separate sewer overflows. The bill also would allow permit holders that adopt EPA’s flexible integrated planning approach for managing stormwater and wastewater and to extend their National Pollutant Discharge Elimination System (NPDES) permits up to 25 years, instead of the current five-year permits. Under the bill, EPA would be required to revise within one year the outdated affordability guidance it uses as a metric to gauge whether communities can afford to meet CWA obligations. The bill also would require EPA to allow cities and towns to use green infrastructure to meet their obligations to reduce combined sewer overflows.

House Science, Space and Technology Committee Holds Hearing On Proposed Clean Power Plan: On September 17, 2014, the House Science, Space and Technology Committee held a hearing entitled “The Administration’s Climate Plan: Failure by Design.” Testifying before the Committee were John Holdren, Director, Office of Science and Technology Policy, Executive Office of the President, and Janet McCabe, Acting Assistant Administrator, Office of Air and Radiation, EPA. A web cast of the hearing, member statements, and witness testimonies are available online. The focus of the hearing was EPA’s proposed Clean Power Plan rule. Committee Chair Lamar Smith (R-TX) set the tone for the hearing in his opening statement, where he stated: “Extending well beyond the power plants themselves, this rule will increase the cost of electricity and the cost of doing business. It will make it harder for the American people to make ends meet.”

House Energy And Commerce Committee Asks DOE To Provide Information On EPA Clean Power Plan: The House Energy and Commerce Committee on September 23, 2014, sent a letter to DOE Secretary Ernest Moniz regarding the EPA proposed Clean Power Plan rule. The Committee GOP members stated that they are trying to determine whether EPA and DOE complied with the Energy Policy Act of 2005 (EPAct05) in issuing the proposed rule. The Committee has been particularly interested in whether or not EPA adhered to this statute when it was developing its proposed GHG standards for new power plants. In the letter to Moniz, Committee leaders wrote: “Information developed in our investigation has raised questions about EPA’s compliance with [the Energy Policy Act], which strictly prohibits consideration of carbon capture technologies at facilities that have received federal funding to be ‘adequately demonstrated’ under CAA Section 111. In particular, both documents reviewed by Committee staff and briefings with agency officials indicate EPA was not aware of these statutory limitations when it was developing the proposed standards. EPA’s failure to identify and faithfully apply statutory limitations when it decided to propose standards for new power plants in September 2013 raises questions about the underlying quality and integrity of its analyses.” The Committee asked DOE to provide the requested documents by October 7, 2014. In addition to Murphy, the letter was signed by full Committee Chair Fred Upton (R-MI), Energy and Power Subcommittee Chair Ed Whitfield (R-KY), Vice Chair of the Oversight and Investigations Subcommittee Michael C. Burgess, M.D. (R-TX), Chair Emeritus Joe Barton (R-TX), and full Committee Vice Chair Marsha Blackburn (R-TN). The letter is available online.

Senate Bill Seeks To Improve Safety For Rail Transport Of Hazardous Materials: Senator Robert Menendez (D-NJ) on September 18, 2014, introduced the Toxics by Rail Accountability and Community Knowledge (TRACK) Act (S. 2858) that he claims will improve hazmat-by-rail safety by implementing a series of recommendations made by the National Transportation Safety Board (NTSB) in its investigation into the cause of the 2012 Conrail freight train derailment and toxic chemical spill in Paulsboro, N.J. Railroads transporting hazardous materials, such as crude oil, would be required to conduct more training and would be subject to civil penalties for safety violations. The bill would establish strong penalties for railroads that violate safety standards; require up-to-date, accurate, and standardized hazardous materials information to better support first responders and emergency management officials; establish new safety procedures and qualifications to improve moveable bridge crossing safety; improve risk assessment and decision-making tools for railroads to ensure that safety is always the top priority; and enhance public education along rail routes that carry hazardous materials to ensure communities are prepared to respond in the event of an emergency. Chemical exposure and right-to-know would be enhanced through the bill. It would require a railroad carrier found to be at fault for a hazardous material release to monitor public health assessments conducted by federal, state, or local agencies following the accident, and report relevant health information to impacted individuals. The bill also requires railroads, in the instances where they have made legal settlements to individuals impacted by the hazmat leak, to offer to renegotiate such settlements if additional information comes out about long-lasting or irreversible health consequences. It establishes a civil penalty for a failure to offer to renegotiate a legal settlement in this circumstance. The bill also seeks to address commodity flow transparency. It would require DOT to issue a rulemaking requiring railroad carriers to disclose hazardous material commodity flow data to first responders, emergency response officials, and law enforcement personnel in the communities through which the hazardous material is transported, and to assist communities with the development of emergency response plans. It allows DOT to consider which hazmat information would be most relevant to be included in the commodity flow data, taking into account the volume of such hazardous materials and their threat to public health. Route risk assessments would also be required under the bill, which directs DOT, in collaboration with the Department of Homeland Security, and the American Short Line and Regional Railroad Association, to develop a route risk assessment tool for short line and regional railroads that allows for safety and security risk assessments to be performed by these carriers when alternative routes are not available. It establishes a program of audits to ensure that proper route risk assessments are carried out by short line and regional railroads. Railroads would also be required to implement safety management systems that include top-down ownership and policies, analysis of operational incidents and accidents, and continuous evaluation and improvement programs. DOT would further be required to issue a rule requiring railroads to deliver accurate and real-time data identifying the location of hazardous materials on a train to first responders, emergency response officials, and law enforcement in the event of a hazmat emergency. The bill prohibits a railroad or their employee from withholding this information — referred to as train consist information — from first responders during an emergency, and establishes a civil penalty for doing so.

Legislation Would Reauthorize Safe Drinking Water Act Revolving Loan Fund: Representatives Henry Waxman (D-CA) and Paul Tonko (D-NY) on September 18, 2014, introduced legislation that would reauthorize the Safe Drinking Water Act’s (SDWA) State Revolving Fund (SRF) program. The Assistance, Quality and Affordability Act of 2014 (H.R. 5534) would provide $100 million in technical assistance through a competitive bidding process to nonprofits that Waxman and Tonko claim will help small public water utilities comply with SDWA requirements. The SRF has not been reauthorized since the program was established under an amendment to the SDWA in 1996. The bill would prioritize funds for those communities most in need and for projects that promote the efficiency, sustainability, and long-term viability of water systems. It also directs states to give greater weight to applications that demonstrate asset management and financial planning, among other factors. The bill also would require EPA, FDA, the U.S. Geological Survey (USGS) and other federal agencies to conduct a study of pharmaceuticals and other drugs in drinking water supplies. States would also be required to adopt best management practices to streamline the SRF process.

60 House Democrats Urge EPA To Tighten Restrictions On Neonicotinoid Pesticides: On September 30, 2014, 60 House Democrats sent a letter to EPA urging it to restrict significantly the use of neonicotinoid pesticides. This class of pesticides has been linked to global declines in the populations of bees, butterflies, and other pollinator insects such as bees and butterflies. The letter, sent to EPA Administrator Gina McCarthy, makes the following policy recommendations:

  • Restrict and/or suspend the use of neonicotinoids on bee-attractive crops and ornamental applications. EPA should further restrict the times, methods of application, and locations of neonicotinoid use to protect pollinators. In instances where bees and other pollinators cannot be fully protected, lawmakers urged EPA to suspend the use of neonicotinoid products.
  • EPA should conduct the requisite cost-benefit analysis and reject applications to register any prophylactic insecticides when EPA determines that their prophylactic use would undermine basic Integrated Pest Management (IPM) principles, may harm organic farm production, or are not cost-effective, either for the farmer or the nation as a whole.
  • Fully comply with the Endangered Species Act (ESA) Section 7 consultation requirements before registering pesticides. For neonicotinoids already registered, EPA should initiate consultation for all threatened and endangered pollinators immediately.
  • Ensure pesticide labels are up to date and require a detailed bee hazard statement on the label of all neonicotinoid products, not on just foliar use products as is the case now.
  • Prior to registration of any new pesticide with high bee toxicity, require a comprehensive data set on pollinator toxicity, including both acute and chronic sublethal toxicity to native and managed bees at multiple life stages.
  • Pesticide seed treatments should be fully assessed for impacts. Furthermore, neonicotinoid-treated seeds should not be exempted from federal pesticide regulations, as EPA currently allows.
  • EPA should phase out conditional registrations and should set a strict deadline for registrants to submit required data for meeting EPA’s set conditions.
  • Rectify discrepancies between application rates for backyard garden products and agricultural products. EPA should direct pesticide registrants to review product labels to determine the extent of the discrepancy between backyard use rates and agricultural rates.
  • Re-categorize commercial neonicotinoid products as restricted use. The vast majority of neonicotinoid products are designated as general use.


OEHHA Seeks Input On Possible Proposition 65 Regulatory Actions: On September 16, 2014, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that as part of its ongoing efforts to update and improve Proposition 65 implementing regulations, it is requesting comment and information on possible regulatory actions and the priority level for each potential action. OEHHA encourages stakeholders to submit their ideas concerning the following concepts, or any others they wish OEHHA to consider:

  • Alternative risk levels for chemicals in foods (Section 25703(b));
  • Updating the Naturally Occurring regulation (Section 25501);
  • Updating and streamlining the Safe Use Determination process (Section 25104);
  • Clarifying regulatory provisions on averaging exposures (Sections 25701, 25721, 25801, 25821);
  • Chemicals that should be given priority in the development or update of Safe Harbor levels;
  • Where interpretive guidance is needed; and
  • Use of data on postnatal developmental exposures.

OEHHA is seeking comment on these concepts and others as possible agenda items for a future workshop. OEHHA states it will take information received into account as it prepares the workshop agenda and background material. Responses are due to OEHHA by 5:00 p.m. on November 17, 2014. According to the notice, OEHHA will provide additional opportunities for public input and comments. More information is available online.

U.S./Mexico Enter Into MOU On Product Safety: On September 24, 2014, Mexico’s Federal Consumer Protection Agency (PROFECO) and the United States Consumer Product Safety Commission (CPSC) signed a Memorandum of Understanding (MOU) aimed at reducing, through the exchange of information and cooperative activities, the risks of injuries and deaths associated with consumer products. More information is available at United States and Mexico Sign MOU on Product Safety. According to CPSC, the MOU will foster collaboration in the following areas: market oversight; exchange of public regulatory data when legally appropriate; joint review of safety risks; and alignment of requirements applicable to consumer product safety when feasible and conducive to enhancing product safety. In addition, the MOU is aimed at increasing the exchange of publicly available information, such as guides, policies, procedures, certain scientific and technical documents concerning consumer products, results of laboratory tests, and information on regulatory actions, including product recalls.

EPA Announces EPA’s Acting Deputy Administrator: On October 6, 2014, EPA Administrator Gina McCarthy announced Stan Meiburg as EPA’s new Acting Deputy Administrator. Meiburg had been Deputy Regional Administrator in Region 4 and is only the second person in EPA history to serve as Deputy Regional Administrator in two regions — serving in Region 6 prior to Region 4. Meiburg’s EPA career began in 1977 in Washington, D.C., as a program analyst. Meiburg went on to serve in Research Triangle Park and in Dallas before heading to Atlanta. Meiburg holds a BA from Wake Forest University and MA and Ph.D. degrees in political science from The Johns Hopkins University.

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