FEDERAL ISSUES
TSCA/FIFRA/NTP/EPCRA
EPA Adds More Chemicals And Chemical Facilities To Public Database: On May 17, 2009, as part of Administrator Lisa P. Jackson’s commitment to increase public access to information on chemicals, the U.S. Environmental Protection Agency (EPA) added more than 6,300 chemicals and 3,800 chemical facilities regulated under the Toxic Substances Control Act (TSCA) to a public database called Envirofacts. The Envirofacts database is EPA’s single point of access on the Internet for information about environmental activities that may affect air, water, and land in the U.S., and provides tools for analyzing the data. It includes facility name and address information, an aerial image of the facility and surrounding area, a map location of the facility, and links to other EPA information on the facility, such as EPA’s inspection and compliance reports that are available through the Enforcement Compliance History Online (ECHO) database. EPA also reports that it is adding historic facility information for another 2,500 facilities.
EPA Announces Draft PR Notice Concerning False Or Misleading Pesticide Product Brand Names: On May 19, 2010, EPA published a Federal Register notice announcing the availability of, and seeking public comment on, a draft Pesticide Registration (PR) Notice entitled “False or Misleading Pesticide Product Brand Names.” 75 Fed. Reg. 28012. According to EPA, the draft PR Notice is intended to provide guidance to applicants, registrants, and distributors concerning pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. The draft PR Notice will be posted online, in docket EPA-HQ-OPP-2010-0282. The revised draft PR Notice clarifies how statutory and regulatory provisions that prohibit pesticide labeling from being false or misleading apply to product brand names. EPA states that, under Sections 12(a)(1)(E) and 2(q)(1)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and 40 C.F.R. Sections 156.10(b)(2) and 156.10(a)(5), “products with brand names that, in a false or misleading manner, state or imply safety, efficacy or comparative claims, or are otherwise false or misleading in any particular, are considered to be misbranded and may not be sold or distributed.” The revised draft PR Notice explains the statutory and regulatory requirements that a pesticide product brand name, either by itself or containing or located in close proximity to a company name or trademark, not be false or misleading. The draft PR Notice includes examples of potentially false or misleading product brand names. EPA states that it “will be applying these regulations as interpreted in this notice when evaluating applications for new products or brand names, reviewing otifications for alternate or changed brand names, reviewing applications for registration, or conducting registration reviews.” EPA encourages applicants and registrants to review their product names in light of its guidance, and, if warranted, take corrective action within two years of the issuance of the final PR Notice. After the final implementation date, EPA may consider the guidance in the final PR Notice when determining whether a product is misbranded under FIFRA. EPA notes that the draft PR Notice is intended to provide guidance to EPA personnel and decisionmakers and to pesticide registrants. While the requirements in FIFRA and EPA regulations are binding on EPA and the applicants, the draft PR Notice “is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants and applicants may assert that the guidance is not appropriate categorically or not applicable to a specific pesticide or situation.” The original comment period was extended and comments are now due by August 17, 2010.
EPA Releases Exposure Assessment Of Polybrominated Diphenyl Ethers: On May 24, 2010, EPA released a final report titled, “An Exposure Assessment of Polybrominated Diphenyl Ethers” (EPA/600/R08/086F). 75 Fed. Reg. 28804. The document was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD) in support of objectives identified in EPA’s 2006 Polybrominated Diphenyl Ethers (PBDEs) Project Plan. The document provides an assessment of the exposure of Americans to PBDEs, a class of brominated flame retardants. It includes chapters on use and production of PBDEs, environmental fate, environmental and exposure media concentrations, and an exposure assessment, including background exposures and exposures to special populations. EPA’s exposure assessment for PBDEs is available online.
EPA Releases Dioxin Recommendations: On May 21, 2010, EPA released a draft reanalysis of key issues about the toxicity of 2,3,7,8,-tetrachloridibenzo-p-dioxin (TCDD), more commonly known as dioxin. 75 Fed. Reg. 28610. EPA noted that the draft 1,850-page document, “EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to National Academy of Sciences Comments,” is not a complete reassessement of TCDD and related, or “dioxin-like,” compounds. It provides EPA’s preliminary responses to a report, Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment, which the National Academies issued in 2006. That report described TCDD as among the most toxic anthropogenic substances ever identified. TCDD is the most studied of the dioxins. The report urged EPA to more clearly explain its reasoning for choosing certain data and analytic approaches and to more fully describe the uncertainties in its draft reassessment begun in 1991 and not yet issued as final. The document will be peer reviewed by the Agency’s Science Advisory Board (SAB) in a meeting scheduled for July 13-15, 2010. Comments are due August 19, 2010. On June 14, 2010, EPA announced a listening session for July 9, 2010. 75 Fed. Reg. 33615.
EPA Changes Policy On CBI Claims: On May 27, 2009, EPA announced that it will begin a “general practice” of reviewing confidentiality claims for chemical identities in health and safety studies, and in data from health and safety studies, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B. 75 Fed. Reg. 29754. According to EPA, TSCA Section 14(b) “does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Where a chemical identity does not explicitly contain process information or reveal portions of a mixture, EPA expects to find that the information would clearly not be entitled to confidential treatment. EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — in accordance with this guidance on August 25, 2010. Though EPA claims that it is not required to solicit comment for this action, comments received before this date will inform its reviews.
EPA Releases Draft Toxicological Review Of Formaldehyde: On June 2, 2010, EPA announced a 90-day public comment period and a public listening session for the external review draft human health assessment titled, “Toxicological Review of Formaldehyde Inhalation Assessment: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-10/002C). 75 Fed. Reg. 30825. The draft assessment was prepared by NCEA within the EPA ORD. EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. A committee of the National Research Council (NRC), acting under the auspices of National Academy of Sciences (NAS), will conduct an independent scientific peer review of the EPA draft human health assessment of formaldehyde. The peer review committee will hold meetings, some of which may involve public sessions. Public sessions will be announced before each meeting online on the National Academies website. The public comment period and NAS scientific peer review are separate processes that provide opportunities for all interested parties to comment on the assessment. Comments are due August 31, 2010. A listening session is scheduled for July 27, 2010. For more information on how to register for the listening session, please consult the Federal Register.
RCRA/CERCLA
EPA Proposes Rule For Identification Of Non-Hazardous Secondary Materials That Are Solid Waste: On June 4, 2010, EPA issued a proposed rule identifying which non-hazardous secondary materials that are used as fuels or ingredients in combustion units are solid wastes under the Resource Conservation and Recovery Act (RCRA). 75 Fed. Reg. 31844. EPA proposed a definition of non-hazardous solid waste that would be used to identify whether non-hazardous secondary materials burned as fuels or used as ingredients in combustion units are solid waste. EPA proposed that non-hazardous secondary materials that have been discarded, and are therefore solid wastes, may be rendered products after they have been processed (altered chemically or physically) into a fuel or ingredient product. EPA believes the proposed rule is necessary to identify units for the purpose of developing standards under Clean Air Act (CAA) Sections 112 and 129. EPA concurrently proposed air emission requirements under CAA Section 112 for industrial, commercial, and institutional boilers and process heaters, as well as air emission requirements under CAA Section 129 for commercial and industrial solid waste incineration units. Comments are due by July 19, 2010.
CAA/CWA
U.S. Geological Survey Releases Survey Of Source Water From Public Wells: On May 21, 2010, the U.S. Geological Survey (USGS) issued a report on source water for public water wells that highlighted the presence of a broad range of contaminants that reach levels of “potential health concern” in more than 20 percent of the untreated waters. The report, “Quality of Water from Public-Supply Wells in the United States, 1993-2007,” states that naturally occurring contaminants, such as radon and arsenic, accounted for about three-quarters of contaminant concentrations that exceeded some type of health benchmark. The benchmarks used were the maximum contaminant levels established by EPA or, for unregulated substances, health-based screening levels developed by USGS in collaboration with EPA. The top ten contaminants, in order of frequency, are: radon, radium, arsenic, gross alpha-particle radioactivity, manganese, strontium, boron, dieldrin, nitrate, and perchloroethene (commonly known as perchloroethylene). Only the last three are primarily man-made, and one of those three, dieldrin, is no longer in commercial use. The report is available online.
EPA Regions Will Propose Draft NPDES General Permit: On June 4, 2010, EPA proposed a draft National Pollutant Discharge Elimination System (NPDES) general permit for point source discharges from the application of certain pesticides to U.S. waters. 75 Fed. Reg. 31775. Once final, the permit will be available to operators in those areas where EPA is the NPDES permitting authority. According to the notice, the action responds to the Sixth Circuit Court’s ruling that vacated an EPA regulation that excluded discharges from the application of pesticides to or over, including near, U.S. waters from the need to obtain a Clean Water Act (CWA) NPDES permit if the application is done in accordance with other laws. EPA requested and was granted a two-year stay of the court’s mandate to provide time to draft and implement the permit. The stay of the mandate expires on April 9, 2011; where after, NPDES permits will be required for all point source discharges to U.S. waters of biological pesticides, and chemical pesticides that leave a residue. EPA is soliciting public comment on all aspects of the draft NPDES permit, as well as a list of specific issues. EPA scheduled three public meetings: June 14, 2010 (Albuquerque, New Mexico); June 16, 2010 (Boise, Idaho); and June 21, 2010 (Boston, Massachusetts). EPA will hold a public hearing in Washington, D.C., on June 23, 2010. The focus of each meeting and the hearing is to present the draft general permit and the basis for the draft permit requirements, and to answer questions concerning the draft permit. At these meetings, any person may provide written or oral statements and data pertaining to the draft permit. Written comments are due July 19, 2010. EPA proposed the draft general permit for four specific pesticide use patterns. EPA notes that the specified use patterns may not represent every pesticide application activity for which a discharge requires NPDES permit coverage. The four use patterns included in the draft permit are generally consistent with what was addressed in the 2006 final rule. EPA states: “Neither the Court’s ruling nor EPA’s issuance of this general permit affects the existing CWA exemptions for irrigation return flow and agricultural stormwater runoff, which are excluded from the definition of a point source under Section 502(14) of the CWA and do not require NPDES permit coverage.”
The draft general permit will regulate discharges to U.S. waters from the application of biological pesticides, and chemical pesticides that leave a residue for the following pesticide use patterns: mosquito and other flying insect pest control — to control public health/nuisance and other flying insect pests that develop or are present during a portion of their life cycle in or above standing or flowing water. Public health/nuisance pests in this use category include but are not limited to mosquitoes and black flies; aquatic weed and algae control — to control weeds and algae in water and at water’s edge; aquatic nuisance animal control — to control invasive or other nuisance species in water and at water’s edge. Aquatic nuisance animals in this use category include, but are not limited to fish, lampreys, and mollusks; and forest canopy pest control — aerial application of a pesticide over a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pest effectively, a portion of the pesticide unavoidably will be applied over and deposited to water. In addition to comments on all aspects of the draft general permit and fact sheet, EPA is soliciting comments on the following aspects of the permit: number of entities covered under this permit; activities covered; limitations on coverage; sharing of responsibilities; notices of intent; technology-based effluent limitations; water quality-based effluent limitations; monitoring; and annual reports. More information is available online.
EPA Sets National Air Quality Standard For Sulfur Dioxide: On June 2, 2010, EPA announced a final new health standard for sulfur dioxide (SO2). This one-hour health standard will protect millions of Americans from short-term exposure to SO2, which is primarily emitted from power plants and other industrial facilities. According to EPA, it is setting the one-hour SO2 health standard at 75 parts per billion (ppb), to protect against short-term exposures ranging from five minutes to 24 hours. EPA is revoking the current 24-hour and annual SO2 health standards because the science indicates that short-term exposures are of greatest concern and the existing standards would not provide additional health benefits. EPA is also changing the monitoring requirements for SO2. The new requirements assure that monitors will be placed where SO2 emissions impact populated areas. Any new monitors required by this rule must begin operating no later than January 1, 2013. EPA is expecting to use modeling as well as monitoring to determine compliance with the new standard. The final rule also changes the Air Quality Index to reflect the revised SO2 standard. More information is available online.
EPA Issues Final “Tailoring” GHG Permitting Rule: On June 3, 2010, EPA issued a final rule to address greenhouse gas (GHG) emissions from stationary sources under CAA by phasing-in the deadlines by which facilities must obtain permits for GHG emissions. 75 Fed. Reg. 31514. Specifically, this controversial final rule sets thresholds for GHG emissions that define when permits under the New Source Review (NSR) Prevention of Significant Deterioration (PSD) and Title V Operating Permit programs are required for new and existing industrial facilities. A more detailed summary is available online. The rule is effective on August 2, 2010.
EPA Proposes NESHAP For Industrial, Commercial, And Institutional Boilers And Process Heaters: On June 4, 2010, EPA proposed a revised EPA promulgated National Emission Standards for Hazardous Air Pollutants (NESHAP) for new and existing industrial/commercial/institutional boilers and process heaters. On June 19, 2007, the United States Court of Appeals for the District of Columbia Circuit vacated and remanded NESHAP for industrial/commercial/institutional boilers and process heaters. 75 Fed. Reg. 32006. The proposed rule responds to the court’s vacatur and remand. The proposed emission standards for control of mercury emissions from coal-fired area source boilers and the proposed emission standards for control of polycyclic organic matter emissions from all area source boilers are based on the maximum achievable control technology (MACT). The proposed emission standards for control of mercury emissions from biomass-fired and oil-fired area source boilers and for other hazardous air pollutants (HAP) are based on EPA’s proposed determination as to what constitutes the generally available control technology or management practices. EPA also clarified that gas-fired area source boilers are not needed to meet the 90 percent requirement of CAA Section 112(c)(3). Finally, EPA proposed that existing area source facilities with an affected boiler with a designed heat input capacity of 10 million Btu per hour or greater undergo an energy assessment on the boiler system to identify cost-effective energy conservation measures. The action would require all major sources to meet HAP emissions standards reflecting the application of the MACT. EPA is also proposing that existing major source facilities with an affected boiler undergo an energy assessment on the boiler system to identify cost-effective energy conservation measures. The original comment period has been extended to August 3, 2010.
EPA will hold three public hearings on the proposed rules to address emissions from boilers, process heaters, and certain solid waste incinerators. These hearings will occur in Arlington, Virginia, on June 15, 2010; Houston, Texas, on June 22, 2010; and Los Angeles, California, on June 22, 2010. More information is available online.
EPA Releases Final Document Related To Review Of National Ambient Air Quality Standards For Carbon Monoxide: On June 7, 2010, the Office of Air Quality Planning and Standards (OAQPS) announced the availability of a final document titled, “Quantitative Risk and Exposure Assessment for Carbon Monoxide (REA).” 75 Fed. Reg. 32178. The REA describes quantitative analyses that have been conducted as part of the review of the National Ambient Air Quality Standards (NAAQS) for carbon monoxide (CO). The document will be available online.
FDA
FDA Posts MAPP On Reporting Format For Nanotechnology-Related Information: On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review,” available online. The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions. According to the MAPP, this information “will be entered into a nanotechnology database under construction and ultimately be used to develop policy regarding these products.” Information to be collected includes whether the application contains nanomaterials; what type of nanomaterial is included in the product; whether the nanomaterial is a reformulation of a previously approved product; whether the nanomaterial is part of the drug substance or the drug product; whether the particle size was described in the application and what the reported particle size is; whether the techniques used to assess particle size are thoroughly described with respect to their adequacy; whether the nanomaterial is soluble or insoluble in an aqueous environment; and what other properties of the nanomaterial were measured and reported in the application, and how those properties were measured. The MAPP was effective June 3, 2010.
REACH
ECHA Clarifies The Definition Of Intermediates: In a June 1, 2010, press release, the European Chemicals Agency (ECHA) announced that Member States have alerted ECHA and the European Commission (EC) “to industry positions on intermediates, which appear not to be in line with the definition of intermediates in [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation] and the guidance on intermediates.” The purpose of the guidance document, agreed among all authorities, is to explain to industry when a chemical substance can be solely registered as an intermediate and when a standard registration is required. ECHA’s press release is available online. Based on interpretation issues, ECHA has published additional guidance, Definition of intermediates as agreed by Commission, Member States and ECHA on 4 May 2010. This document reiterates that an intermediate is a substance used in the manufacturing of another substance whereby the intermediate is itself transformed into that other substance. It also clarifies that substances used in the production of articles cannot be regarded as intermediates. The document contains a number of examples intended to help industry in determining whether their substances are intermediates. According to ECHA, the definition “is coherent with the approach taken on intermediates under the previous European chemicals legislation.” The definitions document is available online. The document includes specific examples of what are and are not intermediates, as defined by REACH, in the following categories: substances used as reactants; substances used as catalysts; substances used as processing agents; intermediates and substances in mixtures; substances used as curing agents; substances used as surface treating agents; and substances used as desiccants. The document was agreed between the EC, ECHA, and the Member State Competent Authorities. It will be reflected in an update of the guidance on intermediates, which is in process and planned for publication after November 30, 2010.
ECHA Announces New FAQs Page: ECHA has updated its web page on frequently asked questions (FAQ) about REACH. New FAQs include whether substances banned under Regulation (EC) No. 2037/2000 (on substances that deplete the ozone layer) are subject to (pre-)registration; whether registration of an isolated intermediate pursuant to Article 17(2) or Article 18(2) has to be updated due to a change of tonnage band; the appropriate registration deadline for phase-in substances manufactured or imported for the first time either less than 12 months before or after the relevant registration deadline; whether an importer of a polymer, who has the obligation to register a monomer or other substance chemically bound to the polymer, has to submit spectral data and a chromatogram of the original substance used in the manufacture of the polymer; when the registration number has to be communicated down the supply chain; and when an SDS with annexed exposure scenario has to be provided to customers. The updated FAQs page is available online.
ECHA Summarizes Details And Location Of Information Regarding CLP Notification: In an ECHA e-News release dated May 19, 2010, ECHA provides a brief summary and Internet links to several important press releases to assist notifiers. The release provides a brief overview of the duties that are required to be met under notification along with access to documents and web pages that provide assistance on performing Classification, Labelling and Packaging (CLP) notifications in association with the CLP Regulation (1272/2008). The Overview of Duties section looks at the Who, What, and How of CLP notification that will be used to populate the Classification and Labelling Inventory. It shows the duties that are placed on European Union manufacturers and importers and provides details on what should be included in a notification and how that notification is undertaken. This information can be found online. To assist notifiers in better understanding the process, ECHA has provided guidance to answer the question on “How” to notify. ECHA has two documents available: Data Submission Manual: Part 12 — How to Prepare and Submit a Classification and Labelling Notification using IUCLID; and REACH-IT Industry User Manual: Part 15 — Manage your Group of Manufacturers or Importers. In the case of the latter, a few significant additions are worth noting. The term “Group of Manufacturers or Importers” (Group of MI), whereby joint notifications can be made under CLP, is clarified along with further guidance on how REACH-IT can be used for notifications. Both documents are available online.
Also available is Practical Guide 7: How to notify substances in the Classification and Labelling Inventory, which offers further clarification on how to notify substances in the Classification and Labelling Inventory. In the event that a REACH-IT account has not been previously created, this document provides a process description, namely four steps — creating a REACH-IT account, creation of a notification group, and if required, preparation and submission of the Classification and Labelling notification. This information is available online.
Also available is an Excel Tool that will assist notifiers in generating Classification and Labelling notification files in the XML format that can be submitted via REACH-IT. The Excel Tool is available for download online.
NANOTECHNOLOGY
EP Committee Votes On Proposed Recast Of The RoHS Directive: On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. Although the proposal by rapporteur Jill Evans would have added all brominated and chlorinated flame retardants, polyvinyl chloride, chlorinated plasticizers, and three phthalates — butyl benzyl phthalate, di(2-ethylhexyl) phthalate, and dibutyl phthalate — to the list of prohibited substances in Annex IV of the RoHS Directive, the Committee chose not to support a ban on these chemicals. The Committee adopted amendments adding nanosilver and multi-walled carbon nanotubes to Annex IV, however, despite the fact that nanomaterials were not included in earlier proposals. The Committee also adopted amendments that require equipment containing nanomaterials to be labeled, and for manufacturers to be required to provide safety data on the nanomaterials to the EC. Under Evans’s proposal, a second group of substances (arsenic compounds, beryllium and compounds, antimony trioxide, dinickel trioxide, bisphenol A, and organochlorines and organobromines other than flame retardants or plasticizers) would be added to Annex III as priority substances to be assessed in the next recast of the Directive as candidates for prohibition. The Committee voted to add these substances to Annex III, and also voted to expand the list by including the substances currently on the REACH candidate list of substances of very high concern, which is available online. The Committee voted in favor of an “open scope,” meaning that the RoHS Directive would apply to all electrical equipment, unless specifically excluded.
Under the amended proposal, the EC would review further the environmental and health impacts of substances added to Annex III, with possible restrictions being introduced thereafter. According to the EP Committee, any consideration of substances for possible restriction should be carried out under the responsibility of the EC, using the “delegated acts” procedure. The Committee noted that the EP and EC member states should also be able to propose substances to be examined. The Committee stated that the assessment criteria should include the substance’s potential health and environmental impact. The EP plenary vote on the amended proposal is scheduled for July 2010.
LEGISLATIVE DEVELOPMENTS
NNI Reauthorized: On May 28, 2010, the House of Representatives passed the America Competes Reauthorization Act of 2010 by a vote of 262-150. Among the important provisions of the Act is the reauthorization of the National Nanotechnology Initiative (NNI) that provides for the funding in science, innovation, and education in 15 federal agencies. For example, the Department of Energy Office of Science received funding for support of research in the basic physical sciences, while the National Science Foundation was allocated funding for fundamental research and education in all non-medical fields of science and engineering. The National Institute of Science and Technology (NIST) will be funded for research to move forward the technology infrastructure and support industry, and the NIST facilities will be reorganized to better meet the needs of industry in the future. So-called STEM education (science, technology, engineering and math) will be furthered by renewal of scholarships for teachers, to increase their competence in their fields. According to industry sources, over 750 organizations endorsed the legislation that passed on the third try after active debate on funding levels.
House Acts On Clean Energy Initiatives: The House of Representatives passed on May 28, 2010, legislation (H.R. 4213) that would extend through 2010 a variety of tax incentives aimed at spurring the development of efficient, renewable energy, and providing, among other things, additional tax deductions for teachers, low income housing tax credits, and business tax relief in over 20 categories.
Building Star Energy Efficiency Act Is Introduced: The Building Star Energy Efficiency Act of 2010 (H.R. 5476) sponsored by Representative Peter Welch (D-VT) and seven co-sponsors creates both rebates and financing incentives for the retrofit of existing commercial buildings to increase their energy efficiency. The measure was heralded by Representative Welch as a jobs-creation program. A bill of the same name was introduced in the United States Senate by Senator Jeff Merkley (D-OR) and nine co-sponsors on March 4, 2010 (S. 3079). Hearings on the Senate measure were held by the Energy and Natural Resources Committee on March 11.
Full Committee Refines Subcommittee Bill — Endocrine Disruptors: The House Energy and Commerce Committee ordered an amended water bill out of Committee on May 26, 2010. The measure, styled the Assistance, Quality, and Affordability Act of 2010 (H.R. 5320), would amend the Safe Dinking Water Act (SDWA) if passed by both houses and signed into law. In addition to establishing funding levels of $4.8 billion for three years, H.R. 5320 also redefines the scope of the provision in the Subcommittee draft dealing with the screening program for endocrine disruptors. The EPA Administrator is directed to publish a list of not fewer than 100 substances that may be present in drinking water for testing within one year and a plan for the identification of additional substances for testing within ten years from the date of enactment. The bill directs the Administrator to the SAB for advice and direction in publishing the plan and schedule, and tasks the Administrator to prioritize the substances selected based on the greatest public health concern posed. Testing is supposed to take place at the rate of 25 substances a year over a four-year period beginning two years from the date of enactment, and within that period EPA is also directed to consider any necessary revisions of testing protocols. Among other provisions is one to permit accelerated testing if needed, the creation of a public database that can be searched for information relating to the program, and the direction to coordinate activities with other federal agencies.
House Committee Looks To Adopt California Formaldehyde Emission Limits: On May 26, 2010, the House Energy and Commerce Committee voted 27-10 to amend TSCA to set emission limits for formaldehyde in hardwood plywood, medium-density fiberboard, and particleboard sold, supplied, offered for sale, or manufactured in the United States, regardless of whether such a material is in the form of an unfinished panel or incorporated into a finished good. The need to control formaldehyde emissions has been spurred by emissions measured from trailers supplied by the Federal Emergency Management Agency (FEMA) after Hurricane Katrina. The limits are to be based on the California standard, including its provisions relating to labeling, chain of custody requirements, sell-through provisions, ultra low-emitting formaldehyde resins, no-added formaldehyde-based resins, finished goods, third-party testing and certification, auditing and reporting of third-party certifiers, recordkeeping, enforcement, and laminated products. The measure provides that an individual or entity that violates any requirement shall be considered to have committed a prohibited act under TSCA.
Latest “Star” Program Proposed By Senator Bingaman: Senator Jeff Bingaman (D-NM) for himself and Senators Blanche Lincoln (D-AR), Scott Brown (R-MA), and Mark Pryor (D-AR) introduced on May 24, 2010, the Supply Star Act of 2010, intended to have the Secretary of Energy identify and promote preferred practices, companies, and, as appropriate, products that use highly efficient supply chains in a manner that conserves energy, water, and other resources. The legislation further provides that the Secretary will work to enhance industry and public awareness of the Supply Star program, collect and disseminate data on supply chain energy resource consumption, develop and disseminate metrics, processes, and analytical tools (including software) for evaluating supply chain energy resource use, and develop guidance at the sector level for improving supply chain efficiency. The Secretary is also directed to work with domestic and international organizations to harmonize approaches to analyzing supply chain efficiency, including the development of a consistent set of tools, templates, calculators, and databases; and work with industry, including small businesses, to improve supply chain efficiency.
Senate Rejects Murkowski Effort To Curb EPA: On June 10, 2010, the Senate voted 53-47 to reject a resolution offered by Senator Lisa Murkowski (R-AK) that would have blocked efforts by EPA to put into effect rules on permissible levels of GHG emissions from cars, trucks, refineries, power plants, and like facilities. The issue highlighted by the Murkowski resolution is the December 7, 2009, finding by EPA that such GHG emissions would endanger public health and welfare. The EPA finding was coupled with a Department of Transportation rulemaking that increased fuel economy standards, and the latter action also put into play CAA requirements for new emission controls. Another effort — S. 3072, the Stationary Source Regulations Delay Act, sponsored by Senator Jay Rockefeller (D-WVA) and six others — has been launched to restrict the immediate effect of the endangerment finding. That measure would prohibit the EPA Administrator during the two-year period beginning after this Act’s enactment from taking any action under CAA with respect to any stationary source permitting requirement or requirement concerning standards of performance for new stationary sources relating to carbon dioxide or methane. The Regulations Delay Act would also provide that no action taken by the Administrator before the end of the two-year delay shall be considered to make carbon dioxide or methane a pollutant subject to regulation under the CAA for any source other than a new motor vehicle or new motor vehicle engine.
MISCELLANEOUS
GAO Finds The Centers For Disease Control And Prevention (CDC) Relies On Flawed Information: According to the Agency for Toxic Substances and Disease Registry (ATDSR), the Government Accountability Office (GAO) stated that ATSDR has difficulties ensuring the quality of its health studies and has failed to ensure that it assesses the hazardous waste sites posing the greatest public health risks. GAO outlined in its report — ATSDR: Policies and Procedures for Preparing Public Health Products Should be Strengthened — what it and other witnesses described at a House Oversight Hearing on May 20, 2010. The Subcommittee focused on mistakes made in a 2004 analysis of blood-lead levels in children living in and around Washington, D.C. The report recommended Congress to eliminate an exemption for public health assessments from peer review given to ATSDR. Under the exemption, ATSDR’s public health assessments are not required to be peer reviewed, according to information the Subcommittee distributed at the hearing. Information about the hearing, including links to the reports on lead in Washington, D.C., water and the GAO report, is available online.
OSHA Proposes Substantive Revisions To Regulations Governing Walking-Working Surfaces And Fall Protection Systems: On May 24, 2010, Occupational Safety and Health Administration (OSHA) proposed a sweeping set of regulations intended to revise the walking-working surfaces standards and the personal protective equipment (PPE) standards in the OSHA regulations. 75 Fed. Reg. 28552. The proposal would revise 29 C.F.R. Part 1910 Subpart D (existing standards for walking-working surfaces) in three ways: revise the standards to reflect current industry practices and national consensus standards; harmonize provisions, when possible, with other OSHA provisions; and use performance-oriented language rather than specification-oriented language. It would also revise Subpart I to 29 C.F.R. Part 1910 to include new specific performance and use requirements for personal fall protection equipment. Existing regulations in Subpart I contain general requirements for all types of PPE, but it fails to contain criteria for fall protection PPE. OSHA’s May 24 proposal seeks to address that shortcoming. The scope of the proposed rule is extremely broad. If implemented, the proposed changes to the regulations would apply to all walking-working surfaces at all general industry workplaces, unless specifically excluded. The walking and working surfaces covered by the proposal are present in nearly every establishment. Comments on the 300 page long rule are due August 23, 2010.
CPSC Proposes Requirements For Testing Component Parts In Consumer Products: On May 20, 2010, the U.S. Consumer Product Safety Commission (CPSC) issued a proposed rule regarding the conditions and requirements for testing component parts of consumer products to demonstrate compliance of a consumer product with all applicable rules, bans, standards, and regulations to support a general conformity certificate or a certificate for a children’s product pursuant to Consumer Product Safety Act (CPSA) Section 14(a). 75 Fed. Reg. 28208. The proposed rule would establish the conditions under which a party certifying a product under CPSA Section 14 may rely on tests of component parts of the product, including materials used to produce it, as all or part of the basis for a valid certificate that the product complies with all applicable requirements enforced by CPSC. The proposed rule also would set out the conditions under which such tests of component parts can be conducted by persons other than the manufacturer, such as the manufacturer or supplier of the component parts. More information is available online. Comments are due August 3, 2010.
OECD Launches Chemical Toxicity Tool: On May 31, 2010, the Organization for Economic Cooperation and Development (OECD) launched an Internet-based public discussion forum for users of its (Q)SAR Application Toolbox. The computer modeling tools are designed to help governments, chemical manufacturers, and spare animals and some resources from excess testing by making it possible to extrapolate data on toxicity of chemicals, rather than conducting new tests. The toolbox uses Quantitative Structure-activity Relationship (QSAR) computer modeling techniques to group chemicals into categories. The EC and ECHA have urged use of QSAR techniques to avoid conducting animal tests for compliance with the European Union’s REACH law. Forum participants can exchange experiences and seek guidance on use of the toolbox. The forum is available online.
EPA Announces OPP New Director And Deputy Director: On June 3, 2010, EPA announced that Dr. Steven Bradbury will serve as the new Director of the Office of Pesticide Programs (OPP) effective immediately. Bradbury has been OPP’s Deputy Director for Programs since January 2009 and has been serving as the Acting Director of OPP for the last several months. Bradbury has 25 years of service at EPA and has served in several senior executive positions, including as head of OPP’s Special Review and Reregistration Division and the Environmental Fate and Effects Division. Prior to joining OPP, Bradbury served in EPA’s ORD. Bradbury has a B.S. in Molecular Biology from the University of Wisconsin-Madison and M.S. and Ph.D. degrees in Toxicology and Entomology from Iowa State University. EPA also announced that Bill Diamond will serve as Acting Deputy Director of OPP in the position now being vacated by Bradbury, also effective immediately. Diamond has been the Director of OPP’s Field and External Affairs Division (FEAD) since 2004, where he has managed programs for the protection of agricultural and pesticide workers; State/Tribal/Regional field implementation; risk communication and outreach; and the development of regulations. Diamond joined EPA in 1979, and over the years he has served in numerous management positions in OPP and the Office of Water. Diamond received his J.D. from Boston College and his undergraduate degree from Dartmouth.
CDTSC Holds Alternatives Assessment Symposium: On June 9, 2010, the California Department of Toxic Substances Control (CDTSC) held a conference entitled “Alternatives Analysis Symposium I: Issues and Evolution, Capitalizing on Success.” CDTSC states that the alternatives analysis process for chemicals used in consumer products is a “core element” of California’s Green Chemistry Initiative, and that identifying alternatives is a complex process, involving an analysis of a chemical’s impact on human health and the environment. According to CDTSC, the goal is to find a science-based solution that provides consumers with assurance that the product is safe. CDTSC held the Symposium to obtain public and expert input on the issue. Presenters included: Clive Davies, Director, EPA Design for the Environment (DfE); Libby Sommer, Environmental Scientist, EPA DfE; Lauren Heine, Science Director/Partner, Clean Production Action (CPA); Alex Stone, Chief Chemist, Washington State Department of Ecology (WDE); Don Versteeg, Environmental Toxicologist and Risk Assessor, Procter & Gamble Co.; and Jay Bolus, Chief Scientist, McDonnough Braungart Design Chemistry (MBDC). Links to the presentations are available online.
The CDTSC Symposium is the first in a series of three that will focus on alternatives analysis. The symposiums are free and open to the public, and will be webcast. Information on the symposiums will be posted online as it becomes available. More information is available online.