Monthly Update for August 2012


TSCA/FIFRA/IRIS/EPCRA

EPA IRIS Announces Availability Of Literature Search For Benzo(a)Pyrene: On July 16, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of a literature search for benzo(a)pyrene (CAS No. 50-32-8). 77 Fed. Reg. 41784. EPA is also requesting scientific information on health effects that may result from exposure to this chemical substance as part of EPA's Integrated Risk Information System (IRIS). EPA will accept information related to benzo(a)pyrene as well as any other compound being assessed by the IRIS Program. No deadline was set by EPA.

EPA Issues SNUR For Phenol, 2,4-dimethyl-6-(1-methylpentadecyl): On July 16, 2012, EPA issued a final significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for the chemical substance identified as phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5). 77 Fed. Reg. 41692. The rule requires persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule is effective August 15, 2012.

EPA Denies PCB Petition: On July 18, 2012, EPA denied a request submitted by the Basel Action Network, the Sierra Club, and the Center for Biological Diversity (petitioners), requesting that EPA take certain actions to protect human health and the marine environment from polychlorinated biphenyls (PCB) that leach from ships sunk through the U.S. Navy's sinking exercises (SINKEX) program. 77 Fed. Reg. 42181. EPA denied the petition based on its view that PCB-contaminated materials removal should be regulated under the Marine Protection, Research, and Sanctuaries Act, not TSCA.

William Jordan Named Deputy Director For Programs, Office Of Pesticide Programs: On July 19, 2012, EPA announced that William Jordan has been selected to be the Deputy Director for Programs in the Office of Pesticide Programs (OPP), beginning July 22, 2012. Since 1998, Jordan has been the Senior Policy Advisor to the Director where he has served under a number of Office Directors. Prior to joining the immediate office staff, Jordan served in a number of senior leadership positions in OPP. From 1996 to 1998, Jordan was the Associate Director of the Antimicrobials Division and from 1995 to 1996, he served as Acting Director of the Field Operations Division, where he oversaw the full implementation of the new Worker Protection Standard. From 1988 to 1995, Jordan was Chief of the Policy and Special Projects Staff where he led a multi-Agency team to address external stakeholder concerns which became the cornerstone for passage of the Food Quality Protection Act (FQPA) in 1996. From 1976 to 1988, Jordan was an Attorney Adviser in EPA's Office of General Counsel (OGC) and in 1980 he served on the staff of the President's Commission for a National Agenda for the Eighties producing a book-length report on governmental regulation in the 1980s. Jordan received his B.A. from Princeton University and his J.D. from Georgetown University.

EPA Issues SNURs For Rutile, Tin Zinc Substances: On July 23, 2012, EPA issued SNURs under TSCA for the chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623-01-2) and rutile, tin zinc, sodium-doped (CAS No. 389623-07-8), which were the subject of premanufacture notices (PMN) P-06-36 and P-06-37 and a TSCA consent order issued by EPA. 77 Fed. Reg. 42990. The rule requires persons who intend to manufacture, import, or process either of the chemical substances for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. EPA believes that this action is necessary because new uses of the chemical substances may be hazardous to human health. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. The final rule is effective August 22, 2012.

EPA Announces Availability Of External Review Draft Of Framework For Human Health Risk Assessment To Inform Decision Making: EPA's Office of the Science Advisor (OSA) announced on July 30, 2012, a 60-day public comment period for the external review draft of A Framework for Human Health Risk Assessment to Inform Decision Making. 77 Fed. Reg. 44613. The document was developed as part of an Agency-wide program by the EPA Risk Assessment Forum. The draft document describes a framework for conducting human health risk assessments that are thought responsive to the needs of decision-making processes at the EPA. EPA released the draft document to obtain public comment prior to external peer review. The document will undergo independent peer review during an expert peer review meeting that will be convened, organized, and conducted by an EPA contractor later this year. Comments are due September 28, 2012.

EPA Collects Significant Penalties For Chemical Reporting Violations: On July 23, 2012, EPA reported that it has collected approximately $2.3 million in civil penalties since 2007 for violations of the TSCA Inventory Update Reporting (IUR) rule. Enforcement of rules for the 2006 reporting cycle has led to 43 civil actions. According to EPA, three recent cases for alleged failure to report 2006 data resulted in prices of almost $400,000: Bethlehem Apparatus Co. opted for a quick resolution of the complaint against it by paying in June a proposed penalty of $103,433; Chemtura Corp. also opted for a quick resolution by paying in June a proposed penalty of $55,901; and Haldor Topsoe Inc. paid a proposed penalty of $202,779 on July 2, 2012. EPA's announcement of its enforcement activities for the 2006 IUR rule cycle is available online.

Three New Questions And Answers Added To Label Consistency Website: EPA's Pesticide Labeling Consistency Committee announced on July 25, 2012, that it posted on its web page answers to three new questions: (1) using the term "resists pests" as an advertising claim; (2) using foreign language on labeling; and (3) placing directions for use inside the box of a small package. EPA acknowledges that the complex nature of the information on pesticides labeling gives rise to questions. EPA's Labeling Consistency Committee investigates such issues and provides answers to them. The three new questions and answers add to more than 250 already existing on generic labeling policy issues, which can be found online.

EPA Announces Availability Of 2011 Toxics Release Inventory Preliminary Dataset: On July 30, 2012, EPA announced the availability of the new 2011 Toxics Release Inventory (TRI) data. The 2011 TRI preliminary dataset contains the most current TRI data available and reflects toxic chemical releases and pollution prevention activities that occurred at TRI facilities during the 2011 calendar year. The data are available in Envirofacts, EPA's environmental information center, and in downloadable files on the TRI website. To access the data, go to online. This web page includes quick links for accessing the data, guidance on understanding and using the data, and a sample Envirofacts data search.

EPA And USDA Announce First-Ever Microbial Risk Assessment Guidance: On July 31, 2012, EPA and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) announced the first-ever Microbial Risk Assessment (MRA) Guideline. This new MRA Guideline lays out an overarching approach to conducting meaningful assessments of the risks to Americans posed by pathogens in food and water. This new Guideline is expected to improve the quality of the data collected by public health scientists charged with protecting Americans from pathogen-related risks in food and water. More information on the Guideline is available online.

EPA Announces Availability Of Fact Sheet On Understanding The TSCA Articles Exclusion Policy For Chemical Data Reporting: On August 3, 2012, EPA announced that it has developed a fact sheet to bring together existing guidance on classifying articles under TSCA and determining the applicability of EPA's articles exclusion policy for Chemical Data Reporting (CDR) rule purposes. The fact sheet is available online. If you have questions about reporting, call the TSCA Hotline at 202-554-1404, or send your question via e-mail to ecdrweb@epa.gov.

EPA Plans To Post Names Of Chemicals Acceptable For Use In Labeling Program: On August 6, 2012, EPA announced plans to post the names of chemicals that are acceptable for use in products that qualify for the Design for the Environment (DfE) labeling program. The chemical list will be made available as "a resource for product formulators and consumers," according to EPA. Chemicals that will be posted on EPA's list include ingredients in DfE-labeled products and chemicals that meet the DfE criteria, EPA stated. No proprietary information will be posted. According to EPA's website, products may carry the DfE logo only if they have met protective standards. The announcement to interested parties is available online.

EPA And USDA Seek To Expand Public Engagement In Proposed Revisions To ESA Consultation Process Within Registration Review: On August 3, 2012, EPA, USDA, and the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (FWS) (together, the Services) announced the availability of proposed revisions to the Endangered Species Act (ESA) consultation process as it is conducted within the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Registration Review process. The written proposal is available online. EPA states it will publish shortly a notice in the Federal Register announcing the 60-day public comment period for the proposal, though this notice has not yet been published. The revisions would expand opportunities for public involvement in the registration review process. More information is available online.

EPA Announces Proposed SNUR For Perfluoroalkyl Sulfonate And Long-Chain Perfluoroalkyl Carboxylate: EPA issued on August 15, 2012, a proposed rule to amend the SNUR for perfluoroalkyl sulfonate (PFAS) chemical substances (available at 40 C.F.R. § 721.9582) to add seven PFAS chemical substances that have completed the new chemical review process under TSCA, but have not yet commenced production or import, and to designate (for all listed PFAS chemical substances) processing as a significant new use. 77 Fed. Reg. 48924. EPA is also proposing a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would designate manufacturing, importing, or processing for use as part of carpet or for treating carpet (e.g., for use in the carpet aftercare market) as a significant new use. The term LCPFAC refers to the long-chain category of perfluorinated carboxylate chemical substances with perfluorinated carbon chain lengths equal to or greater than seven carbons. The category of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. Comments are due October 15, 2012. More information is available online.

OPP Assessment Changes Adjuvant-related Pesticide Guidance: Following review of industry-sponsored examinations of historical data concerning the effect of adjuvants on pesticide residue levels, EPA's OPP, Health Effects Division (HED) has concluded that the effect is sufficiently small that special field trials including adjuvant use are not required for adequately protective tolerances and risk assessments. Historically, EPA required registrants either to include product label prohibitions on adjuvant use or to use adjuvants when developing field trial data. As a result of HED's conclusion, EPA has stated it will make the following changes to its practices: (1) EPA will no longer require an adjuvant restriction on labels; (2) amendment applications to modify the adjuvant provisions of existing labels will be eligible for fast-track review; (3) future Registration Review (RR) Data Call-Ins (DCI) will not include studies intended to identify the effect of adjuvants on residue levels; and (4) studies intended to identify the effect of adjuvants on residue levels will be eliminated from existing RR DCIs.

GREEN CHEMISTRY

DTSC Releases Proposed Safer Consumer Products Regulations: On July 27, 2012, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products Regulations (Proposed Regulations). The Proposed Regulations, subject to a 45-day comment period, are the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative. The Proposed Regulations have been through several iterations, including an "informal draft" that was released in October 2011, and other drafts released on June 23, 2010, and November 16, 2010. DTSC describes the Proposed Regulations as a "preemptive strategy that reduces the use of toxic substances in the design of products and industrial processes with the aim of creating safer and sustainable products that do not threaten human health or persist in the environment." Memoranda providing background information are available online. The Proposed Regulations are available online.

DTSC will hold a public hearing on the proposed regulations on September 10, 2012. For written comments to be considered, they must be submitted no later than 5:00 p.m. on September 11, 2012. After the close of the comment period, if substantial changes are made, the modified full text will be made available for comment for at least 15 days prior to adoption.

NANOTECHNOLOGY

EPA Extends Due Date For Comments On Nanosilver Registration Review: According to a July 10, 2012, memorandum added to the registration review docket for nanosilver, the Federal Register notice announcing the opening of the docket erroneously listed the comment period end date as August 19, 2012. The EPA memorandum states that the comment period has been extended to September 10, 2012, "to allow for a full 60-day comment period [that] is standard for registration review docket openings." The memorandum is available online.

EPA Publishes Final Nanomaterial Case Study For Nanoscale Silver In Disinfectant Spray: On August 1, 2012, EPA posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states "is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials." According to EPA, "[t]he complex properties of various nanomaterials make evaluating them in the abstract or with generalizations difficult if not impossible." EPA notes that the case study does not represent a completed, or even preliminary, assessment of nanosilver. Instead, it and other similar case studies are intended to support research planning efforts for nanomaterials. The case study is organized around the comprehensive environmental assessment framework, which structures available information pertaining to the product lifecycle, transport, transformation and fate processes in environmental media, exposure-dose in receptors, and potential impacts in these receptors. If information is available, the case study also includes other direct and indirect ramifications of both primary and secondary substances or stressors associated with a nanomaterial. Through a structured collective judgment method, expert stakeholders used EPA's draft case study to identify and prioritize research gaps that could inform future assessments and risk management efforts. Some of the research gaps pertain to nanosilver in disinfectant spray; others to nanosilver irrespective of its application, and still others to nanomaterials in general. More information is available online.

SCENIHR Issues Call For Information And Experts On Health Effects Of Nanomaterials Used In Medical Devices: On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials:

  • Carbon nanotubes in bone cements;
     
  • Nanopaste hydroyapatite powder for bone void filling;
     
  • Polymer setting material with nanoparticles in dental cements;
     
  • Polycrystalline nanoceramics in dental restorative materials;
     
  • Nanosilver or other nanomaterials used as coatings on implants and catheters; and
     
  • Nanosilver used as an antibacterial agent.

The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices.

The evaluation will take into account different categories of medical devices, including:

  • Non-invasive medical devices, e.g., devices coming into contact with the intact skin; and
     
  • Invasive devices such as woundcare materials, implantable medical devices, dental and bone fillings and cements, and injectable nanomaterials.

In the assessment, where relevant, the EC invites SCENIHR to differentiate between free, fixed, and encapsulated nanomaterials. SCENIHR invites interested parties to submit information that could assist it with the assessment. Information is due October 10, 2012. The EC states that it is currently preparing a proposal for a revision of the medical devices directives, which could include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR's opinion is March 2013. More information is available online.

SCENIHR posted on August 10, 2012, a call for experts on medical devices containing nanomaterials. To allow for a comprehensive assessment, SCENIHR encourages experts in various scientific fields related to the safety of medical devices containing nanomaterials to apply. SCENIHR states that "[e]xperience in risk assessment would be an advantage." The deadline for submission for the call for experts is October 1, 2012. More information is available online.

Pace Environmental Law Review Issues Call For Papers: The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or policy. Authors should send an abstract and cover letter to pelracq@law.pace.edu. The deadline for submissions of article proposals is September 30, 2012.

FDA

FDA Seeks Comment On Food Additive Petition: On July 17, 2012, the Food and Drug Administration (FDA) announced that Representative Edward J. Markey has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. 77 Fed. Reg. 41953. FDA expressly requests comments on the petitioner's request that FDA amend the food additive regulations to no longer permit the use of BPA-based epoxy resins as coatings in packaging for infant formula. For the purposes of this petition, FDA considers the use of BPA-based epoxy resins as coatings (as described in Section 175.300(a)) in packaging of infant formula to mean a metal substrate (single use) or any suitable substrate (repeated use) being coated with BPA-based epoxy resins as a continuous film or enamel, serving as a functional barrier between the infant formula (powder or liquid) and the substrate. FDA requests comments that address whether these uses of BPA-based epoxy resins have been completely abandoned, such as information on whether infant formula packaging containing BPA-based epoxy resins as coatings is currently being introduced or delivered for introduction into the U.S. market. Further, FDA requests comments on whether the uses that are the subject of the petition (BPA-based epoxy resins as coatings in infant formula packaging) have been adequately defined. Comments are due by September 17, 2012.

FDA Amends Food Additive Regulations: On July 17, 2012, FDA issued a final rule amending indirect food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. 77 Fed. Reg. 41899. The rule was triggered by a 2011 petition filed by the American Chemistry Council asking FDA to amend the food additive regulations for PC resins to no longer allow the use of BPA in baby bottles and sippy cups because companies no longer use BPA for these particular two applications. FDA states in the notice that safety was not an issue. The rule is effective July 17, 2012. Objections and requests for a hearing are due by August 16, 2012.

LEGISLATIVE DEVELOPMENTS

House Bill Would Relax Environmental Requirements For Power Plants: By voice vote on August 1, 2012, the House of Representatives passed the "Resolving Environmental and Grid Reliability Conflicts Act of 2012." The Act amends the Federal Power Act to provide that an emergency order issued under such Act should require generation, delivery, interchange, or transmission of electric energy only during times necessary to meet such emergency and serve the public interest; should, to the extent reasonable, be consistent with any other applicable federal law, including any environmental law or regulation; and should endeavor to minimize any adverse environmental impacts. Any omission or action taken by a party to comply with such an order that results in noncompliance with any federal, state, or local environmental law or regulation would not be considered a violation of, or subject such party to any civil or criminal liability under, such law or regulation. If there are conflicts with environmental rules, an amendment to the Act limits the Order to a 90-day period.

Waste Tracking Scale-Up On Track: On July 31, 2012, the House Energy and Commerce Committee approved the House version of the "Hazardous Waste Electronic Manifest Establishment Act" passed earlier by the Senate (S. 710). The measure amends the Solid Waste Disposal Act to require the EPA Administrator to establish a hazardous waste electronic manifest system within three years that may be used by a hazardous waste generator or transporter, an owner or operator of a hazardous waste treatment, storage, recycling, or disposal facility, or any other person that: (1) is required to use a manifest to comply with any federal or state requirement to track the shipment, transportation, and receipt of hazardous waste or other material shipped from the generation site to an off-site facility for treatment, storage, disposal, or recycling; (2) elects to use the system to complete and transmit an electronic manifest format; or (3) submits to the system for data processing purposes a paper copy of the manifest (or data from such a paper copy). The Senate bill authorizes the EPA Administrator to: (1) impose service fees on users to pay for developing, operating, maintaining, and upgrading the system, including any costs incurred in collecting and processing data from any paper manifest submitted to the system after the date on which the system enters operation; and (2) deposit the fees into the Hazardous Waste Electronic Manifest System Fund (a revolving fund established by this Act). The Administrator would adjust such fees to a level that will result in the collection of an amount that is sufficient to cover system-related costs and minimize the accumulation of unused amounts in the Fund. The House Committee passed a version that would provide as an alternative to that funding $2 million for 2013 through 2015. Among other provisions, EPA is empowered to enter into information technology contracts with appropriate entities for the provision of system-related services if a contractor agrees to assume the initial risk of the information technology investment. Any such contracts would be limited to a term of no more than ten years.

Cancer Free Labeling: Representative Theodore Deutch (R-FL) has introduced the "Cancer Free Label Act of 2012." The stated purpose of the Act is to enable consumers to reduce their exposure to carcinogens by allowing manufacturers to affix a Cancer-Free label to products that do not contain known or probable carcinogens if they comply with a voluntary process that does not require public disclosure of trade secrets. The head of each federal department or agency that regulates a product that might be so labeled would establish in that department or agency a program to permit such labeling. The heads of each federal department or agency that regulates a candidate product would be directed to coordinate development of an easily recognizable label to be affixed to a product to signify that the product has been approved for labeling as "Cancer-Free." That label would include a notice stating that the product does not contain known or likely carcinogens that increase the risk of cancer. It would be unlawful to introduce or offer for introduction into interstate commerce a product affixed with a "Cancer-Free" label if the head of each federal department or agency that regulates the product has not approved an application for the labeling of the product as "Cancer-Free"; or if the product contains any substance that is not listed. An application would be approved if such department head determines that the application accurately lists all substances contained in the product; the product does not contain any carcinogens; and the product does not contain any substances that display carcinogenicity upon degradation, upon interactions with other substances contained within the product or exposed to the product, during storage or transportation, or during intended use of the product, as determined by such head based on previous findings made by such department or agency. The Act contains provisions for protecting the confidentiality of information submitted to get approval of labels and provides that agency heads are to conduct random testing of covered products for which applications are submitted for approval to ensure that the applications accurately list all the substances contained in such products; conduct random audits of facilities in which such covered products are manufactured; and take reasonable measures to ensure compliance with agency guidance issued relating to manufacture, storage, and transportation of such products. The head of each federal department or agency may charge a reasonable fee for the submission and approval of an application. As used in the legislation, the term "carcinogen" means a substance listed in the National Toxicology Program (NTP) Report on Carcinogens (RoC) as known to be a human carcinogen or reasonably anticipated to be a human carcinogen; or a substance described in the EPA IRIS as carcinogenic to humans or likely to be carcinogenic to humans. The requirements of the Act apply to any product offered for sale that is regulated by the FDA, EPA, USDA, or the Consumer Product Safety Commission (CPSC).

Moratorium On Aerial Surveillance: On August 1, 2012, Senator Mike Johanns (R-NE) introduced S. 3467, a bill to establish a moratorium on aerial surveillance conducted by the EPA Administrator The measure would prohibit any surveillance from the air, including surveillance conducted from fixed-wing aircraft, helicopters, drones, or remote-controlled aircraft, or the use of aerial or satellite images, regardless of whether the images are publicly available. The moratorium would extend for a one-year period beginning on the date of enactment, and would apply to EPA conducting aerial surveillance in exercising any authority.

Red Tape And Small Business Job Creation: By a vote of 245-172, the House on July 26, 2012, passed the "Red Tape Reduction and Small Business Job Creation Act." In passing the measure, Oversight and Government Reform Committee Chair Darrell Issa (R-CA) stated: "The Obama Administration has issued some 106 rules in its first three years that collectively will cost taxpayers more than $46 billion annually in compliance and lost productivity. This is four times the number of major regulations and five times the cost of rules issued in the prior administration's first three years. In more than 30 hearings, examinations and public forums, our Committee has heard loud and clear from job creators across the country who tell us that red tape imposed by the federal government chokes economic expansion and hurts job creation. Nonpartisan research surveys report that the American public feels the same way -- with an overwhelming majority saying federal regulations are a major reason why the economy is struggling. This bill helps unwind much of this unnecessary red tape and frees entrepreneurs and business owners to do what they do best: create jobs and opportunity." The bill imposes a freeze on economically significant regulations that are purported to harm the economy until the unemployment rate stabilizes at six percent or below, and on any measure that would cost the economy $50 million or more in a year. It also permanently blocks administrations, during the "lame duck" post-election period in which they are not serving a subsequent term, from issuing economically significant regulations, according to the Oversight Committee. The bill also ensures that parties impacted by government red tape have a right to intervene before agencies agree to binding legal settlements that mandate new regulations. This is intended by the majority to ease the use of judicial decrees or settlement agreements to force new regulations outside the regular process. Finally, the bill also requires that independent federal agencies, such as the Federal Communications Commission and National Labor Relations Board, comply with the same review requirements as other agencies as well as increased public transparency concerning unfunded mandates imposed on state and local governments. The bill is said to face an uncertain future in the Senate and the threat of a White House veto if it does pass in the Senate.

Bill Would Block Carbon Dioxide Standards: Representative David McKinley (R-WV) introduced H.R. 6172 on July 24, 2012. The bill would prohibit the EPA Administrator from finalizing any rule imposing any standard of performance for carbon dioxide emissions from any existing or new source that is a fossil fuel-fired electric utility generating unit unless and until carbon capture and storage is found to be technologically and economically feasible. The measure details that the needed finding would be the result of action by at least three of the four officials that is published in the Federal Register, and a report is submitted to the Congress finding that carbon capture and storage is technologically and economically feasible for fossil fuel-fired electric utility generating units. The officials listed are (1) the Administrator of the Energy Information Administration; (2) the Comptroller General of the United States; (3) the Director of the National Energy Technology Laboratory; and (4) the Under Secretary of Commerce for Standards and Technology.

Guidelines On Scientific Information: Representative Donald Manzullo (R-IL) introduced on June 18, 2012, a bill to require each federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy (OSTP) of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by that agency. The bill, H.R. 5952, provides that the guidelines have to be in place by January 1, 2013.

Agency Regulatory Analysis: Senator Rob Portman (R-OH) introduced on August 1, 2012, the Independent Agency Regulatory Act, a measure that enables the President, by Executive Order, to require an independent regulatory agency to comply, to the extent permitted by law, with regulatory analysis requirements applicable to other agencies. Among the requirements that the Portman bill specifies are: (1) the identification of the problem that the agency intends to address by a new rule (including, where applicable, the failures of private markets or public institutions that warrant new agency action) and an assessment of the significance of that problem; (2) an examination of whether any existing rule (or other law) has created, or contributed to, the problem that a new rule is intended to correct and whether the existing rule (or other law) should be modified to achieve the intended goal of the new rule more effectively; (3) the identification and assessment of available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, or providing information upon which choices can be made by the public; (4) consideration, in setting regulatory priorities and to the extent reasonable, of the degree and nature of the risks posed by various substances or activities within its jurisdiction; (5) design of rules in the most cost-effective manner to achieve the regulatory objective and, in doing so, consideration of incentives for innovation, consistency, predictability, the costs of enforcement and compliance (to the Federal Government, regulated entities, and the public), flexibility, distributive impacts, and equity; and (6) assessment of the costs and the benefits of the intended rule and, recognition that some costs and benefits are difficult to quantify, proposal or adoption of a rule only upon a reasoned determination that the benefits of the rule justify its costs. Additional assessments would be required for "Economically Significant Rules." The compliance or noncompliance of an independent regulatory agency with the requirements of an Executive order issued under this Act would not be subject to judicial review, and nothing in the bill would be construed to limit the authority of the President with respect to independent regulatory agencies under any other applicable law.

House Votes To Exempt Some Farmers From Rule On Spills: The House passed H.R. 3158, "The Farmers Undertake Environmental Land Stewardship Act" or the FUELS Act, a measure intended to exempt some farmers from the EPA Spill Prevention, Control, and Countermeasure rule. The Fuels Act requires for the rule to apply that there be a certificate that any farm subject to the requirements have an individual tank with a storage capacity greater than 10,000 gallons, an aggregate storage capacity of at least 42,000 gallons, or a history that includes a spill; or that a farm have an aggregate storage capacity greater than 10,000 gallons but less than 42,000 gallons and no history of spills. The measure then exempts from all requirements of such rule any farm with an aggregate storage capacity of at least 10,000 gallons and no history of spills, as well as all containers on separate parcels that have a capacity that is less than 1,320 gallons from the aggregate storage capacity of a farm.

Grants For Nebulizers: Representative Laura Richardson (D-CA) introduced H.R. 6284, the "Breath of Fresh Air Act," on August 2, 2012. Intended to combat asthma, particularly in children, the measure would require the Secretary of Education to carry out a program under which the Secretary would make grants to local educational agencies to purchase nebulizers for use in elementary and secondary schools. Those local bodies would be responsible for providing matching funds from non-federal sources in an amount equal to not less than 25 percent of the amount of the grants. In making grants, the Secretary is directed to give priority to local educational agencies having jurisdiction over a geographic area with respect to which the Director of the Centers for Disease Control and Prevention (CDC) has determined that the prevalence of asthma is at least 10 percent higher than the national average, and that do not already have at least one nebulizer in each school served by the local educational agency.

Senate Holds Hearing On Use Of Flame Retardant Chemicals: On July 17, 2012, the Senate Committee on Appropriations, Subcommittee on Financial Services and General Government held a hearing on the Effectiveness of Furniture Flammability Standards and Flame Retardant Chemicals.

Inez Tenenbaum, CPSC Chair, testified that CPSC issued a Notice of Proposed Rulemaking for a "Standard for the Flammability of Residential Upholstered Furniture" on March 4, 2008. CPSC's proposed rule does not specify any particular materials or designs, and does not require the use of any flame retardant chemicals to achieve compliance with its proposed standard. Tenenbaum also discussed ongoing testing that CPSC is undertaking to investigate the fire safety of household items and stated that fire-retardant foams do not appear to offer a significantly greater level of open-flame safety than do untreated foams.

In his testimony, James Jones, Acting Assistant Administrator in the Office of Chemical Safety and Pollution Prevention at EPA, explained how 62,000 chemicals were grandfathered into TSCA when it was enacted. He stated that TSCA does not have a mandatory program where EPA must conduct a review to determine the safety of existing chemicals, but that EPA is currently developing a strategy, scheduled for completion by the end of this year, that will assist with chemical assessments and identify those that pose the greatest potential concerns. EPA is looking at three flame retardant chemicals in particular -- Bis(2-Ethylhexyl)-3,4,5,6-tetrabromophthalate (TBPH), 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate (TBB), and Tris(2-chloroethyl)phosphate (TCEP) -- and anticipates initiating risk assessments of these chemicals in 2013.

Senator Lautenberg (D-NJ) expressed his interest in knowing the potential benefits for EPA if Congress were to enact TSCA reform. Jones responded that it would be immensely helpful if the loophole allowing foreign individuals to bring Significant New Use Notices (SNUN) to EPA without safety data were closed and stated that giving EPA the authority to get health and safety data for existing chemicals is critically important for its ability to demonstrate that chemicals are safe. He also highlighted the importance of having the tools to manage effectively risks from chemicals once identified. Senator Durbin (D-IL) contrasted chemical manufacturing to the production of prescription drugs, which must be shown by manufacturers to be both safe and effective before they can be distributed. Jones pointed out that under the proposed TSCA reform, manufacturers would have to provide information to EPA that demonstrates the safety of chemicals before EPA makes a decision regarding the use of the chemicals, thus shifting the burden off EPA and onto the manufacturers.

In the second half of the hearing, August Schaefer, Senior VP and Public Safety Officer at Underwriters Laboratories Inc., played a video for the Subcommittee that demonstrated that with furniture utilizing a flame suppressant technology such as a flame barrier, the time to flashover is increased to greater than 20 minutes, while furniture constructed with California Technical Bulletin 117 (TB 117) compliant fire retardant-treated foam shows measurable time to flashover, but not a meaningful difference from contemporary furniture constructed with a non-fire retardant foam. TB 117 represents the only mandatory flammability standard for residential furniture in the U.S.

Andy Counts, CEO of American Home Furnishings Alliance, stated that flame retardant chemicals are found in upholstered furniture only because of the existence of TB 117. He also pointed out that focusing on smolder ignition minimizes the reliance on flame retardant chemical treatments, which generally requires the treatment of fabrics and cushioning materials with halogenated compounds. Counts also described the Upholstered Furniture Action Council's (UFAC) voluntary program to set a successful industry fire standard. He stated: "Unlike TB 117, the UFAC program does not require the use of any 1 U. flame retardant chemicals. Also unlike TB 117, the UFAC program has undergone round robin testing and has shown to be repeatable and reproducible."

Senator Lautenberg asked Peter Van Dorpe, Chicago Fire Department District Chief, whether the health of firefighters could be protected by reforming federal chemical laws to reduce toxic substances in the home. Van Dorpe stated that the fire service needs regulators to take what is already known about making products safer and apply it to all products, pointing out that most fires occur in one- and two-family homes, which are not subject to the same safety regulations as other occupancies.

MISCELLANEOUS

Inspector General Issues Memo Stating EPA Needs Stronger Oversight Of State Agencies: On July 13, 2012, the EPA Inspector General issued a memorandum stating that EPA needs more oversight of state environmental regulation. The memorandum, EPA's Fiscal Year 2012 Management Challenges, listed oversight of states, standards for brownfields revitalizations, and chemical risk assessment as three of the areas where the Agency faces serious management and performance challenges. The memorandum was directed to EPA Administrator Jackson as an annual obligation for the EPA Office of Inspector General. It notes that EPA makes recommendations to states and takes independent actions when states choose not to act. But then it states: "We found that EPA does not maximize its resources so that it can take the most stringent step -- revoking state authorization -- when a state is underperforming." Of particular interest, the memorandum notes that EPA is lacking in the ability to assess and manage chemical risks from such materials as nanomaterials and endocrine disruptors. The EPA Inspector General's report is available online.

OMB Seeks Comment On Regulations: On July 18, 2012, Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA), requested comment on regulations needing streamlining, simplifying, improving, or deleting. President Obama made regulatory reform a continuing responsibility of all executive branch departments and agencies, Sunstein wrote in a blog post on the White House Office of Management and Budget (OMB) website. Executive Order No. 13610 requires federal agencies to engage with the public to obtain suggestions about which regulations should be reassessed, modified, improved, streamlined, or eliminated, Sunstein wrote. In addition, all agencies must report regularly to the public on their progress, he wrote. Agencies' next reports are due this fall. Sunstein's video blog seeks comment on any regulation in need of review. Sunstein's blog post on regulations in need of review is available online.

Greenpeace And Others Petition EPA To Require IST: On July 25, 2012, approximately 50 labor and environmental groups sent a petition requesting EPA to use its authority under the Clean Air Act (CAA) to require chemical facilities to install inherently safer technologies (IST). The petition states that Section 112(r)(7)(A) and the general duty clause of the CAA grant EPA authority to mandate the installation of IST, defined as a group of processes that improve safety by reducing or eliminating hazards through permanent alterations to a facility's systems. EPA has yet to comment on the petition. The petition to EPA is available online.

ECHA Publishes Guidance In A Nutshell On Data Sharing: The European Chemicals Agency (ECHA) announced on July 31, 2012, that it has published a new Guidance in a Nutshell on data sharing following the update of the guidance on the same subject. ECHA states that the new guidance intends to introduce, in simple and concise terms, the data sharing obligations for registrants of both phase-in and non-phase-in substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. It briefly describes the main principles of data sharing and the mechanisms that should be followed by companies that either are required to or are willing to share data under the provisions of REACH. It also introduces the joint submission obligations for companies that have to register the same substance. More information is available online.

DOT Proposes Rule Aligning Hazardous Materials Regulations With International Standards: On August 15, 2012, the U.S. Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) proposed a rule to amend the Hazardous Materials Regulations (HMR) to maintain alignment with international standards. 77 Fed. Reg. 49168. PHMSA is proposing to adopt numerous revisions to the HMRs, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. PHMSA believes that these revisions are necessary to harmonize the HMRs with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods -- Model Regulations and subsequently address a petition for rulemaking. The proposed rule is part of PHMSA's ongoing biennial process to harmonize the HMRs with international regulations and standards. Comments on the proposed rule are due by October 15, 2012.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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