Monthly Update for January 2014
Predictions For EPA’s Office Of Chemical Safety And Pollution Prevention: Bergeson & Campbell, P.C. (B&C®) outlines thoughts on what may be headed our way in 2014 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). We also offer a few thoughts on European and Asian developments pertinent to chemical regulatory matters.
Although President Obama is well into his second term, the 2014 off-year elections, combined with the bitter partisan atmosphere in Washington, D.C., will result in a continuing use of environmental issues to make distinctions between the two parties. Closely contested races in the Senate may especially cause somewhat unusual alliances and/or emphasis on various environmental issues, as both parties seek to have majority control in the newAC Congress. Beyond the election-driven rhetoric, life at EPA will be driven by the typical demands of the discrete issues that come before program management on a daily basis. An added and complicating concern may be the impact on these and all issues of continued budget cuts that challenge EPA’s ability to operate as it has in the past; even the simple ability to process approvals or conduct public meetings about non-controversial matters have become more difficult.
Our memorandum outlines broadly many of the issues we expect to come before OCSPP in the coming year. For more detail on any issue or to review events as they occur, we invite you to review our website at www.lawbc.com. Our website has many substantive memoranda and information to access B&C webinars on a broad range of topics of interest to the chemical, pesticide, and chemical products communities. As always, we would be pleased to expand upon any topic noted below upon request. A more detailed memorandum is available online.
ALJ Decision Imposing Large Fine For TSCA Section 8(e) Penalty May Provide New Guidance On What Constitutes Corroborative Information Under Section 8(e): On November 12, 2013, EPA released an Administrative Law Judge (ALJ) decision ordering Respondent Elementis Chromium Inc., f/k/a Elementis Chromium, LP (Elementis or Company), to pay a $2,571,800 civil penalty for violating Section 8(e) and Section 15(3)(B) of the Toxic Substances Control Act (TSCA). The decision is available online. Although the case is highly fact-specific, the decision, if upheld under any potential appeal, may be used potentially to support an expansion of Section 8(e) reporting requirements and thus is important for companies to understand when reviewing certain data for Section 8(e) reportability. A more detailed memorandum is available online.
EPA Extends Label Pilot Program Until 2015: EPA announced its decision to extend a pilot program until May 2015 allowing pesticide registrants to place certain environmental sustainability statements on certain pesticide product labels. EPA is also expanding the program to include a certification mark that identifies products made with “biobased ingredients.” The program allows pesticide registrants to place the Agriculture Department of Agriculture’s (USDA) BioBased Product Certification Mark on qualified products. The voluntary certification mark is intended to promote biobased products, which include ingredients derived from agriculture, forestry, or aquatic organisms, on the consumer market. EPA launched the label pilot program in 2010, allowing registrants of antimicrobial products to place certain factual statements on EPA-approved product labels. Pesticide registrants who wish to add the certification mark to their product label must first be certified through USDA’s BioPreferred Program. Registrants who wish to feature the mark on their products also must add a disclaimer statement clarifying that the certification mark does not imply safety of the product and advising users to follow all label instructions. More information on the Label Statement Pilot Program is available online.
EPA Releases Chemical Screening Data On 1,800 Chemicals: On December 17, 2013, EPA announced the release of the first batch of chemical screening data accessible through the new interactive Chemical Safety for Sustainability or iCSS Dashboard. According to EPA, the iCSS Dashboard provides access to data from innovative screening technologies for chemicals that are found in industrial and consumer products, food additives, and drugs. As part of the data release, EPA announced the ToxCast Data Challenges, a series of challenges inviting the science and technology communities to work with these data and provide solutions for how the new chemical screening data can be used to predict potential health effects. Challenge winners will receive awards for their innovative research ideas. The data were gathered through advanced techniques, including robotics and high-throughput screening, as part of an ongoing federal collaboration to improve chemical screening. The collaboration, Toxicity Testing in the 21st Century (Tox21), is comprised of EPA, the National Institutes of Environmental Health Sciences/National Toxicology Program, National Center for Advancing Translational Sciences, and the U.S. Food and Drug Administration. The information is useful for prioritizing chemicals for potential risk as well as predicting if chemical exposures could lead to adverse health effects. More information is available online. EPA convened the first in a series of stakeholder workshops on the iCSS Dashboard on January 14, 2014.
EPA Misses Deadlines For Implementing Inspector General Recommendations: On December 18, 2013, EPA’s Office of the Inspector General (OIG) issued a report, Compendium of Unimplemented Recommendations as of September 30, 2013 (November 15, 2013), that identifies “significant” recommendations that have not yet been timely implemented, and are at least one year or more past the completion date agreed upon by EPA and the Inspector General’s office. The OIG reviewed certain audit and evaluation reports issued to EPA from October 1, 2000, through March 31, 2013, to identify unimplemented recommendations that could have a “material impact” on the economy, efficiency, effectiveness, or integrity of EPA operations. EPA reportedly missed its deadline for developing a more detailed confidential business information (CBI) classification guide under TSCA. A 2010 OIG report recommended that EPA improve its TSCA chemical risk assessment and oversight activities, including the development of CBI classification criteria to improve transparency and information sharing. EPA initially agreed to issue a new classification guide by January 31, 2012. OCSPP expects to propose a rule on CBI by the end of next year. EPA Office of Inspector General’s Compendium of Unimplemented Recommendations as of September 30, 2013, is available online.
EPA Launches E-Mail Tracking System For Pesticide Registration Applications: On December 31, 2013, EPA’s Office of Pesticide Programs (OPP) launched a new e-mail tracking system for pesticide registration applications. The system generates automated e-mails to pesticide registrants at seven different points in the registration decision process, including when EPA completes a technical screening of a registration application and when the Agency reaches its regulatory decision on the application. The seven milestones that will generate an automated e-mail are:
- EPA’s receipt of an application and assignment of a receipt number for the application;
- Assignment of Pesticide Registration Improvement Act (PRIA) fee category, waiver decision, completion of payment, expiration of a 21-day completeness screen, and establishment of a review start date and due date for consideration of the application;
- The date data are sent into review, with contact information for staff assigned to application;
- Expiration of a 45/90-day technical screening;
- Completion of the last science review;
- Pre-decisional determination date reached; and
- Regulatory decision completed.
More information on the electronic submission of pesticide registration documents to the EPA is available online.
EPA Schedules Technical Workshop On Antimicrobials: On January 8, 2014, EPA and the Consumer Specialty Products Association announced plans to host a two-day technical workshop focusing on efficacy testing methods for antimicrobial products. The workshop will be held February 18-19, 2014, at an EPA facility in Ft. Meade, Maryland. It will address methods for testing the efficacy of products that claim to be effective against clostridium difficile, a germ that the Centers for Disease Control and Prevention states can cause infections. The meeting also will include a presentation on strategies for new and revised methods of antimicrobial efficacy testing and a discussion on revisions to the AOAC use-dilution test method.
Final RCRA Rule Exempts Captured Carbon Dioxide From Hazardous Waste Regulation: On January 3, 2014, EPA issued a final rule that is intended to create a “consistent national framework to ensure the safe and effective deployment of carbon capture and sequestration (CCS) technologies.” 79 Fed. Reg. 350. CCS technologies allow carbon dioxide (CO2) to be captured at stationary sources, such as coal-fired power plants and large industrial operations, and injected underground for long-term storage in a process called geologic sequestration. The final rule exempts from hazardous waste regulation under the Resource Conservation and Recovery Act (RCRA) CO2 streams captured from emission sources and injected underground via Underground Injection Control (UIC) Class VI wells approved for the purpose of geologic sequestration under the Safe Drinking Water Act. Other conditions would also have to be met, such as compliance with applicable transportation regulations. Further, EPA clarifies that CO2 injected underground via UIC Class II wells for enhanced oil recovery (EOR) is not expected to be a hazardous waste management activity. EPA concluded that the careful management of CO2 streams under the specified conditions does not present a substantial risk to human health or the environment. EPA believes that the final rule will help provide a clear pathway for the deployment of CCS technologies in a safe and environmentally protective manner while also ensuring protection of underground sources of drinking water. EPA also released draft guidance for public comment that provides information regarding transitioning Class II wells used to inject CO2 for oil and gas development to Class VI wells used for carbon capture and sequestration. The rule is effective on March 4, 2014.
EPA Final Rule Amends CERCLA All Appropriate Inquiries Standard: EPA on December 30, 2013, issued a final rule amending the standards and practices for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 78 Fed. Reg. 79319. The final rule amends the “All Appropriate Inquiries Rule” at 40 C.F.R. Part 312 to reference ASTM International’s E1527-13 Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process to make clear that persons conducting “all appropriate inquiries” may use the procedures set forth in E1527-13 to comply with the All Appropriate Inquiries Rule. (A summary of E1527-13 is immediately below.)
ASTM Standard For Phase I Property Assessments Revises Important Definitions: On November 1, 2013, ASTM Standard E1527-13 took effect. The standard revises E1527-05, which addresses the evaluation of brownfields for potential liability. A key change in the new standard is that the modified definition of “recognized environmental condition” (REC) designates a specific kind of release to the environment in or on the property. The change is intended to align the standard under CERCLA and the “All Appropriate Inquiries Rule.” The 2013 standard also adds a new term, “controlled recognized environmental condition” (CREC). The term describes situations where a release has occurred and was satisfactorily addressed. The revised standard also clarifies that de minimis condition may not be used to describe a CREC. A de minimis condition refers to a minor spill that does not require a response action. E1527-13 also changes the definition for “historical recognized environmental condition” (HREC), which refers to a situation where a past release has been addressed completely to closure, with no significant remaining impacts and no ongoing land-use restrictions. The standard on the All Appropriate Inquiries Rule (ASTM E1527-13) is available for purchase at www.ASTM.org.
Federal Working Group On Chemical Plant Safety Seeks Public Input On Options For Policy, Regulation, And Standards Modernization: On January 3, 2014, a federal working group created under Executive Order 13650 issued a set of preliminary options intended to improve chemical plant security. In follow-up to the tragedy that struck West, Texas, in April 2013, President Obama signed Executive Order 13650, Improving Chemical Facility Safety and Security, which established the Chemical Facility Safety and Security Working Group. Section 6(a) of the Executive Order tasks the working group with considering options intended to improve and modernize key policies, regulations, and standards to enhance the safety and security of chemical facilities. The working group includes representatives from the Occupational Safety and Health Administration (OSHA), EPA, the U.S. Department of Justice, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), and other federal agencies. Based upon feedback the working group has received, it developed a preliminary list of options for improving chemical facility safety and security for further discussion and comment. Public comment on the options will be taken until March 31, 2014. According to a statement released by OSHA, the purpose of the recommendations is to provide preliminary options as a starting point for additional stakeholder discussion. The working group offers nine sets of options across several categories, including mandatory new safeguards. The working group is particularly interested in receiving comments on examples of where implementation of the same or similar options has been successful; information or data that would characterize the positive impacts the options might have, including additional benefits; potential limitations or unintended consequences of the options described; methods for implementing the options, including methods for potentially increasing benefits or reducing costs; or alternatives to the options that could achieve substantially the same result.
The options are arrayed under six broad topics: improving the Safe and Secure Storage, Handling, and Sale of Ammonium Nitrate; process Safety Improvement and Modernization; coverage of Additional Hazardous Chemicals or Categories of Chemicals under Process Safety and Security Regulations; chemical Reactivity Hazards; explosive Chemical Hazards; oil and Gas Facilities; coverage of Bulk Storage of Flammable Liquids under Process Safety and Security Regulations; process and Hazardous Chemical Security; and identifying Facilities Covered under Existing Process Safety and Security Regulations.
It is clear from the list of options that the agencies comprising the working group are considering additional regulations. For example, the working group states that “[t]he agencies are considering whether to initiate rulemakings for updating the PSM [Process Safety Management] standard and RMP [Risk Management Program] rule. EPA and OSHA have collaborated on implementation of these programs, and are considering a number of options for modernization of regulations, policy, and guidance that would maintain parallel requirements and ensure harmony between the regulations.” The agencies are also considering expanding the scope of chemicals regulated under the PSM standard and RMP rule.
EPA Re-Proposes Rule Imposing CO2 Limits On New Utilities: EPA on January 8, 2014, re-proposed its New Source Performance Standard (NSPS) rule establishing emission limits for CO2 from new fossil fuel-fired electric utility generating units, including coal-and natural gas-fired units. 79 Fed. Reg. 1430. EPA originally proposed NSPSs for this sector on April 13, 2012. 77 Fed. Reg. 22392. In response to the many comments EPA received, and also based on the receipt of new information, EPA decided that the proposed standards warranted substantial changes and thus issued the re-proposed rule while simultaneously withdrawing the 2012 proposed standards on January 8, 2014. 79 Fed. Reg. 1352. The new standards would impose separate conditions for fossil fuel-fired electric steam generating units (i.e., utility boilers and Integrated Gasification Combined Cycle (IGCC) units) and for natural gas-fired stationary combustion turbines. For utility boilers and IGCC units, EPA is proposing an emission limit of 1,100 pounds of CO2 per Megawatt Hour (lb CO2/MWh). The proposed emission limits for natural gas-fired stationary combustion turbines is 1,000 lb CO2/MWh for larger units and 1,000 lb CO2/MWh for smaller units. The comment period on the proposed standards closes on March 10, 2014.
EPA Issues Changes To Secondary Lead MACT Rule: EPA on January 3, 2014, issued a final rule that amends the Maximum Achievable Control Technology (MACT) rules for the secondary lead industry. 79 Fed. Reg. 367. Because EPA considers the changes non-controversial, it issued the changes in a direct final rule that becomes effective on March 4, 2014. In the event EPA receives adverse comment on the direct final rule, it also issued the rule as proposed changes on the same day. 79 Fed. Reg. 379. EPA is making four changes to the MACT standards; three of these are in response to issues raised during litigation on the standards. First, EPA inadvertently removed from 40 C.F.R. Part 63, Subpart X the requirement for facilities constructed or reconstructed on or before May 19, 2011, to comply with the previous version of the MACT rule between promulgation of the January 5, 2012, amendments and the subsequent compliance date for existing sources, which is January 6, 2014. Because existing sources remain subject to the pre-existing standards until the compliance date for the January 2012 standards, EPA is amending the rule to restore the deleted language. Second, EPA is responding to an issue raised in the litigation regarding the table of dioxin and furan congeners contained in the regulatory text. This table included incorrect values for some dioxin toxic equivalency factors (TEF) and omitted some congeners. EPA is proposing to change these TEFs to reflect the 2005 World Health Organization (WHO) TEFs. (These values can be found online.) Third, certain industry petitioners expressed concern that EPA changed one aspect of the emission standard for total hydrocarbons (THC) between proposing and finalizing the rule. In the 2011 proposed rule, the THC standard for furnace charging process fugitive emissions that are not combined with furnace process emissions did not require correction to 4-percent CO2. In the 2012 final rule, this standard inadvertently included correction to 4-percent CO2. EPA is proposing to correct this error. Fourth, petitioners asked EPA to clarify several monitoring provisions for total enclosures. Industry requested flexibility in defining the term “windward wall” when a total enclosure is not impacted by ambient wind. The regulatory text was unclear where to place monitors when ambient wind does not affect the total enclosure. Petitioners requested clarification on how to monitor irregularly shaped enclosures or enclosures that are divided into multiple areas all under negative pressure. Petitioners also asked EPA to clarify that data from differential pressure monitors should be used to calculate 15-minute averages. Petitioners also stated that EPA should clarify the meaning of “accuracy” in 40 C.F.R. § 63.548(k)(3).
Interstate Chemicals Clearinghouse Releases Chemical Alternatives Evaluation Guide: On January 8, 2014, the Interstate Chemicals Clearinghouse (IC2) released a guide to aid businesses and governments in the evaluation of possible alternatives to chemicals of concern. IC2 is an association of “state, local, and tribal governments along with supporting members for industry and the environmental community.” The IC2 Alternatives Assessment Guide presents three potential frameworks that could be used by companies and others to analyze the potential effects on human health and the environment of alternatives before they are used to replace chemicals of concern. The guide presents potential frameworks and modules, each evaluating a different aspect of potential alternatives, for selection by the user. The IC2 described the guide as providing a “buffet” of options, presenting all options, and allowing specific users to select the framework and modules that best suit the chemical or product under the evaluation. The guide is available online.
Journal Of Nanoparticle Research Publishes Article Describing Occupational Safety And Health Criteria For Responsible Development Of Nanotechnology: On December 7, 2013, the Journal of Nanoparticle Research published online an article entitled “Occupational safety and health criteria for responsible development of nanotechnology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), describe five criterion actions that they believe should be practiced by decision-makers to ensure the responsible development of nanotechnology: “(1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers’ exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits.” According to the authors, because of the current “unknowns and concerns about nanomaterials,” “it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments.” The article notes: “The findings and conclusions of this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health.” The article is available online.
IARC Releases More Information Regarding Review Of “Some Nanomaterials And Some Fibres”: The International Agency for Research on Cancer (IARC) has posted additional information concerning IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres.” As reported previously, the Working Group will meet September 30 to October 7, 2014. The call for experts closes January 30, 2014. Requests for observer status are due June 3, 2014. The call for data closes September 3, 2014. In the call for data, IARC states that it seeks “studies that are relevant to the carcinogenicity of the agents that will be reviewed in this volume (carbon nanotubes, fluoro-edenite and silicon carbide). This includes all pertinent epidemiological studies and cancer bioassays, plus important mechanistic and other relevant data.” IARC notes that “[e]ligible studies should be published or accepted for publication in the openly available scientific literature. More information is available online.
EC Committee’s Preliminary Opinion On Nanosilver Available For Comment: On December 13, 2013, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) released its preliminary opinion on “Nanosilver: safety, health and environmental effects and role in antimicrobial resistance.” The opinion is intended to assess whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver, and whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms. SCENHR states that it “concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver.” Human exposure is direct, through food, hand-to-mouth contact, and skin, and may be life long. Silver nanoparticles “may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time.” SCENIHR thus cannot rule out “additional effects caused by widespread and long term use” of nanosilver. Regarding the hazard associated with the dissemination of the resistance mechanism following the use of nanosilver, SCENIHR notes that there is no documentation available, “representing a serious gap of knowledge.” According to SCENIHR, “[s]ince other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria — which is extremely relevant for developing resistance — the potential of [nanosilver] to induce similar effects should be given particular attention.” SCENIHR states that more data are needed to understand better the bacterial response to ionic silver and nanosilver exposure. SCENIHR could not determine whether resistant microorganisms will increase and spread in view of a more widespread use of nanosilver because the mechanisms resulting in nanosilver resistance are not well understood. Comments on the preliminary opinion are due February 2, 2014. More information is available online.
EC Proposal Would Require Novel Food Authorization For Engineered Nanomaterials: On December 18, 2013, the EC adopted three draft proposals on animal cloning and novel food. The draft proposal concerning novel food, which is available online, would revise the current regulation “with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.” An EC question and answer (Q&A) concerning the draft proposals, which is available online, includes the following Q&A concerning nanomaterials:
What are the requirements for nanomaterial?
Nanomaterial is materials engineered at the scale of atoms and molecules. The proposal specifies that engineered nanomaterials, as defined in the Regulation on Food Information to Consumers, require a Novel Food authorisation before being used in foodstuffs. This confirms that nanomaterials are covered by the Novel Food Regulation.
The EC’s December 18, 2013, press release states that the European Parliament and the Council will consider the draft proposal and adopt their positions “in due course.” According to the press release, the earliest the amendment would enter into force would be 2016. The press release is available online.
European Union (EU) Publishes, Then Withdraws Amendment To Food Labeling Regulation Concerning Definition Of Engineered Nanomaterials: The December 19, 2013, Office Journal of the European Union includes an amendment to Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials. Under the regulation, all ingredients present in the form of engineered nanomaterials must be indicated in the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets. The amendment defines engineered nanomaterials as “any intentionally manufactured material, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm.” Under the amendment, food additives covered by the definition “shall not be considered as engineered nanomaterials, if they have been included in the Union lists” as established by Commission Regulations (EU) No 1129/2011 and (EU) No 1130/2011. Fullerenes, graphene flakes, and single wall carbon nanotubes with one or more external dimensions below one nanometer “shall be considered as engineered nanomaterials.” “Intentionally manufactured” is defined as “the material is manufactured to perform/fulfil a specific function or purpose.” The December 19, 2013, notice is available online. The December 20, 2013, issue of the Official Journal of the European Union includes a corrigendum to the amendment to Regulation 1169/2011. The December 20, 2013, notice states: “The publication of Commission Delegated Regulation (EU) No 1363/2013 is to be considered null and void.” The December 20, 2013, notice is available online. The withdrawal of the amendment is reportedly the result of a procedural error by the EC. The EC is expected to republish the amendment in 2014.
NIOSH Publishes Nanotechnology Research And Guidance Strategic Plan: On December 20, 2013, NIOSH published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and commercialization of engineered nanomaterials.” NIOSH states that, for fiscal years 2013-2016, it will continue to fill information and knowledge gaps addressing the five NIOSH Nanotechnology Research Center (NTRC) strategic goals:
- Increase understanding of new hazards and related health risks to nanomaterial workers;
- Expand understanding of the initial hazard findings of engineered nanomaterials;
- Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches;
- Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies; and
- Assess and promote national and international adherence with risk management guidance.
To address these strategic goals and promote the responsible development of engineered nanomaterials, NIOSH states that the strategic plan will expand research activities in ten critical areas: toxicity and internal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk assessment; engineering controls and personal protective equipment (PPE); fire and explosion safety; recommendations and guidance; global collaborations; and applications. The strategic plan is available online.
EC Creates Website On Nanosubstance Information: On December 20, 2013, the EC established an online platform collating current sources of information on nanosubstances. Managed by the Commission’s scientific services, the Joint Research Center (JRC), the platform provides categorized links to information on regulatory frameworks governing nanosubstances and relevant policy initiatives, registries of products that contain nanosubstances, nano research projects and programs, initiatives dealing with the ethics of nanosubstances, and other general information on nanosubstances. The JRC said in a statement that information on nanosubstances is increasing but is “scattered on the internet across very different sources and located at several levels.” To manage the risks of nanosubstances, “structured access to information on nanomaterials and products containing nanomaterials is essential,” the JRC added. The review concluded that no new nano-specific regulations were needed in the EU, and that existing legislation, in particular the REACH chemicals law (Regulation No. 1907/2006 on the registration, evaluation and authorization of chemicals), was sufficient to manage the potential risks of nanosubstances. The JRC web platform on nanosubstances is available online.
EC Scientific Committee Memorandum On Relevance, Adequacy And Quality Of Data In Safety Dossiers On Nanomaterials Available For Comment: The EC Scientific Committee on Consumer Safety (SCCS) “Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials” is available for comment. The SCCS states that the current memorandum is intended to highlight the main considerations in relation to the relevance, adequacy, and quality of the data presented in safety dossiers on nanomaterials. The SCCS also intends the memorandum “to provide further guidance and clarity to future applicants so that preparation and evaluation of the safety dossiers can proceed without an undue burden on the part of either the applicants or the evaluators in the Committee.” The conclusion states that the relevance, adequacy, and quality of the data presented “are of utmost importance in relation to the smooth and transparent evaluation of safety of nanomaterials used in cosmetic products.” The “key message” is that the data provided “must be relevant to the types of nanomaterials under evaluation, sufficiently complete, and of appropriate standards to allow adequate risk assessment.” Comments are due February 17, 2014. The memorandum is available online.
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.
House Passes Bill Amending CERCLA; President Vows Veto: The House of Representatives on January 9, 2014, by a vote of 225-188, passed the Reducing Excessive Deadline Obligations Act (H.R. 2279). The legislation, a composite of three separately introduced bills, primarily seeks to amend CERCLA to give states a greater role in the remediation process and to require federal agencies to follow state and local laws during response activities. It would also delete a requirement under RCRA that EPA review its waste regulations every three years, a statutory provision that environmental groups have relied upon to force EPA to review its RCRA regulation of coal ash. The bill incorporates the text of the Federal and State Partnership for Environmental Protection Act (H.R. 2226) and the Federal Facility Accountability Act of 2013 (H.R. 2318). On January 8, 2014, the White House issued a Statement of Administration Policy vowing that the President would veto the legislation if it reaches his desk. The statement argues the legislation would impose restrictions on federal lands that would affect present or future use, affect prioritization of sites for cleanup, increase litigation, and delay ongoing reform efforts to CERCLA. Senate passage of the bill is highly unlikely.
House Bill Would Dilute EPA’s Authority To Regulate Electric Utilities Emissions: Representative Ed Whitfield (R-KY) on January 9, 2014, introduced a bill that would curtail EPA’s ability to regulate CO2 emissions from coal- and natural gas-fired electric utilities. The Electricity Security and Affordability Act (H.R. 3826) would bar EPA from promulgating final regulations on greenhouse gas emissions from power plants until Congress passes legislation dictating when the standards would become effective. In addition, the bill would require new technologies to be demonstrated commercially at six different power plants for at least one year before EPA could rely upon these technologies to establish emission standards.
Senate Forms New Climate Task Force: Senator Barbara Boxer (D-CA) on January 9, 2014, announced that the Senate has created a new Climate Task Force. The Task Force is intended to galvanize Senate Democrats behind reviving Senate legislation on climate change.
ECHA Adds Seven Chemicals To SVHC List: On December 16, 2013, the European Chemicals Agency (ECHA) added seven hazardous chemicals to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) list of substances of very high concern (SVHC). The seven substances are cadmium sulfide, disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminona phthalene-1-sulphonate) (C.I. Direct Red 28), disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl ]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38), dihexyl phthalate, imidazolidine-2-thione (2-imidazoline-2-thiol), lead di(acetate), and trixylyl phosphate. The addition of the substances brings to 151 the number of chemicals listed as SVHCs under REACH. Listing the substances triggers an obligation for producers or importers of products containing the substances at a concentration above 0.1 percent by weight to notify ECHA. Notifications must be submitted within six months. The substances could also be prioritized for inclusion in REACH Annex XIV. The ECHA SVHC list is available online.
EU Publishes 16 Exemptions To RoHS Directive: On January 9, 2014, the EC published 16 directives that each added an exemption to the 2011 Restriction of Hazardous Substances (RoHS) Directive. The RoHS Directive bans cadmium, hexavalent chromium, lead, mercury, and some brominated flame retardants from electrical and electronic equipment sold in the EU, but exemptions can be allowed for specific uses if replacement of a banned substance is “scientifically or technically impracticable,” or if the pertinent demonstrate that substitution would cause more environmental or health damage than continued use of the substances. The 16 directives implement exemptions for uses of lead, cadmium, and hexavalent chromium in medical equipment, spare parts recovered from medical equipment, and X-ray systems; certain uses of lead solders in circuit boards and magnetic connectors; lead alloys in monitoring and control instruments; and lead and mercury in certain fluorescent lamps. Each directive is effective January 29, 2014. The 16 directives specifying RoHS exemptions are available under “Directives” at online.
Obama Taps McCabe To Lead EPA Air Office: On December 19, 2013, President Obama announced his intent to nominate Janet McCabe to be EPA’s Assistant Administrator for Air and Radiation. McCabe had been principal deputy Assistant Administrator since 2009, and has been acting Assistant Administrator for the Air office since Gina McCarthy became EPA Administrator in July. Previously, McCabe was executive director of Improving Kids’ Environment Inc. and an adjunct faculty member in the Department of Health at the Indiana University School of Medicine from 2005 to 2009.
John C. Cruden Tapped To Be Assistant AG For Environment: On December 20, 2013, President Obama nominated John C. Cruden to be Assistant Attorney General for the U.S. Department of Justice Environment and Natural Resources. Cruden, now serving as the President of the Environmental Law Institute, had served as Deputy Assistant Attorney General from 1995 to 2011 and as chief of the Environmental Enforcement Section from 1991 to 1995 in the Environment and Natural Resources Division. He has also served as Acting Assistant Attorney General for Environment and Natural Resources during his tenure.
President Obama Nominates EPA Region 4 Administrator: On January 14, 2014, President Obama nominated Heather McTeer Toney as EPA Region 4 Administrator. Toney is a lawyer and served as Mayor of Greenville from 2004 to 2012. From 2010 to 2012, Toney also served as Chair of the EPA’s Local Government Advisory Committee, and in 2008-2009 Toney served as President of the National Conference of Black Mayors. A detailed biography is available online.
DOT Issues Proposed Rule To Adopt ASME Code: The Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on December 30, 2013, issued a proposed rule to amend the Hazardous Materials Regulations applicable to the design, construction, certification, recertification, and maintenance of cargo tank motor vehicles, cryogenic portable tanks, and multi-unit tank car tanks (ton tanks). 78 Fed. Reg. 79363. The proposed rule would allow the use of the American Society of Mechanical Engineers’ (ASME) Boiler and Pressure Vessel Code, Section XII for the design, construction, certification, recertification, and maintenance of cargo tank motor vehicles, cryogenic portable tanks and ton tanks. The proposed rule would also authorize the use of the 2013 edition of the National Board of Boiler and Pressure Vessel Inspectors’ National Board Inspection Code (NBIC) as it applies to the continuing qualification and maintenance of ASME constructed cargo tank motor vehicles, cryogenic portable tanks, and ton tanks. PHMSA will accept comments on the proposed rule until March 31, 2014.
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