Monthly Update for June 2011
EPA Issues Direct Final Rule Regarding Electronic Reporting Requirements: On May 27, 2011, the U.S. Environmental Protection Agency (EPA) issued a direct final rule amending the procedures for requests for modification or revocation of Toxic Substances Control Act (TSCA) Section 5 significant new use notification (SNUN) requirements by establishing electronic submission requirements. 76 Fed. Reg. 30835. EPA issued a final rule in the Federal Register on January 6, 2010, introducing electronic reporting requirements for TSCA Section 5 submissions and supporting documents. The regulatory text inadvertently did not include amendments to the reporting requirements for submissions of requests for modifications or revocations of SNUN requirements. This direct final rule includes the amendment that was originally intended by EPA. This direct final rule is effective July 26, 2011, without further notice, unless EPA receives adverse comment on or before June 27, 2011.
USDA Reports Small Amount Of Food Tested In 2009 Exceeded EPA Residue Limits: On May 24, 2011, the U.S. Department of Agriculture (USDA) reported that the amount of pesticide residues found on foods and in water in 2009 constituted a very small portion of the food samples tested exceeded EPA limits. The report, issued by USDA’s Agricultural Marketing Service, contains data collected in 2009 from 12 states on pesticide residues on foods, including fresh and processed fruit and vegetables, beef, catfish, grains, and rice, as well in groundwater and treated and untreated drinking water. Only 0.3 percent of the food samples tested exceeded EPA-allowed levels of pesticide residues on foods also known as tolerances. According to the report, 2.7 percent of the food samples had residues of pesticides with no established tolerances in 2009. None of the residues in water samples exceeded EPA maximum contaminant levels, health advisory levels, or established criteria for freshwater aquatic organisms, stated USDA. The 12 states that provided data in 2009 were California, Colorado, Florida, Maryland, Michigan, Minnesota, Montana, New York, Ohio, Texas, Washington, and Wisconsin. The USDA report on pesticide residues on food in 2009 is available online.
EWG Asks EPA To Seek Biomonitoring Data: On June 2, 2011, the Environmental Working Group (EWG) called upon EPA to require under TSCA more information from chemical companies on human exposure studies. The June 2 letter to EPA Administrator Jackson states there is “a dearth” of information on exposure to industrial chemicals and even less information on exposure of children during critical stages of development. EWG urged EPA explicitly to request all available biomonitoring data from industry. EWG also urged EPA to prepare a TSCA Section 8(d) rule for biomonitoring data. Under TSCA Section 8(d), chemical manufacturers, importers, and processors are required to report all health and safety data available on chemicals that have been added to a list maintained by EPA. The EWG letter is available online.
EPA Issues Preliminary Plan For Reviewing Regulations: On May 26, 2011, EPA released its Preliminary Plan for Periodic Retrospective Reviews of Existing Regulations in response to President Obama’s request in Executive Order 13563 to review and streamline regulations. EPA specifically listed 31 rules, and divided them into early actions and longer term actions. Early actions include: (1) Lead Renovation, Repair, and Painting Program: considering new post-work requirements designed to ensure cleaning meets clearance standards; (2) Sanitary Sewer Overflow (SSO) and peak flow wet weather discharges: clarifying permitting requirements; (3) Vehicle fuel vapor recovery systems: eliminating redundancy; (4) Gasoline and diesel regulations: reducing reporting and recordkeeping; (5) Regulatory certainty for farmers: working with USDA and states; (6) Modern science and technology methods in the chemical regulation arena: reducing whole-animal testing, reducing costs and burdens, and improving efficiencies; (7) Electronic online reporting of health and safety data under TSCA; Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and Federal Food, Drug, and Cosmetic Act (FFDCA): reducing burden and improving efficiencies; (8) National Priorities List rules: improving transparency; (9) Quick changes to some TSCA reporting requirements: reducing burden; (10) Integrated pesticide registration reviews: reducing burden and improving efficiencies; (11) National Pollutant Discharge Elimination System (NPDES): coordinating permit requirements and removing outdated requirements; (12) Vehicle regulations: harmonizing requirements for: fuel economy labels, greenhouse gas and fuel economy standards, and vehicle emission standards; (13) Multiple air pollutants: coordinating emission reduction regulations and using innovative technologies; (14) New Source Performance Standards (NSPS) reviews and revisions: setting priorities to ensure updates to outdated technologies; (15) Innovative technology: seeking to spur new markets and utilize technological innovations; and (16) The costs of regulations: improving cost estimates.
Longer term actions include: (1) E-Manifest: reducing burden; (2) Electronic hazardous waste Site ID form: reducing burden; (3) Consumer confidence reports for primary drinking water regulations: providing for the open exchange of information; (4) Reporting requirements under Section 303(d) of the Clean Water Act (CWA): reducing burden; (5) Export notification for chemicals and pesticides: reducing burden and improving efficiencies; (6) Water quality trading: improving approaches; (7) Water Quality Standards regulations: simplifying and clarifying requirements; (8) State Implementation Plan (SIP) process: reducing burden; (9) Clean Air Act (CAA) Title V Permit programs: simplifying and clarifying requirements; (10) National primary drinking water regulations (NPDWR) for lead and copper: simplifying and clarifying requirements; (11) Adjusting threshold planning quantities (TPQs) for solids in solution: reducing burden and relying on scientific objectivity; (12) Certification of pesticide applicators: eliminating uncertainties and improving efficiencies; (13) Polychlorinated biphenyls (PCB) reforms: improving efficiencies and effectiveness; (14) Contaminants under the Safe Drinking Water Act (SDWA): coordinating regulatory requirements; and (15) Section 610 reviews: coordinating requirements.
Under the Plan, EPA will review toxicological test methods, jointly review groups of pesticides, consider revising certain pesticide and chemical reporting obligations, and reconsider lead renovation clearance levels, as part of its efforts to determine whether it should modify, streamline, expand, or repeal regulations. EPA also stated it plans to propose to increase the amount of information pesticide and chemical manufacturers could report electronically, determine whether requirements for export notifications on pesticides and chemicals could be eased, propose changes to improve the efficiency of pesticide applicator certifications, and review regulations affecting PCBs. President Obama’s Executive Order 13563 directed each federal agency to develop a preliminary plan to make its regulatory programs more effective or less burdensome while still achieving their objectives. The EPA Preliminary Plan for Periodic Retrospective Reviews of Existing Regulations is available online.
EPA Schedules SFIREG Full Working Committee: On May 25, 2011, EPA announced the Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG) would hold a two-day meeting, beginning on June 20, 2011, and ending June 21, 2011, in Washington, D.C. 76 Fed. Reg. 30343. Tentative agenda topics include: fumigation label review process; revision of State and Tribal Assistance Grants (STAG) Funding; revised State Label Issues Tracking System (SLITS) process; Association of Structural Pest Control Regulatory Officials update; Association of American Pesticide Safety Educators (AAPSE) report; Tribal Pesticide Program Council (TPPC) report; and EPA/Office of Water update on pesticide general permit. Please review the Federal Register for details.
EPA Establishes National Tribal Toxics Committee To Address Risks From Toxic Chemicals: On May 31, 2011, EPA announced that it has established a National Tribal Toxics Committee (NTTC) to give Indian tribes greater input on issues related to chemical safety, toxic chemicals, and pollution prevention. EPA intends that this effort will empower tribal communities to protect their health and environment from potential risks of chemicals. Creation of the NTTC is part of EPA Administrator Lisa P. Jackson’s emphasis on improving chemical safety, building strong tribal partnerships, and expanding the conversation on environmental justice. The NTTC convened its first meeting in Washington, D.C. on June 1-2, 2011. More information on the NTTC and for a list of tribes is available online.
EPA Announces Intent To Ban Pesticide Products: On June 7, 2011, EPA announced its intent to ban sales of the most toxic residential rodenticides, as well as the sale of most loose bait and pellet products. EPA is also requiring that all newly registered rat and mouse rodenticides poison marketed to residential consumers be enclosed in bait stations that render the pesticide inaccessible to children and pets. In 2008, EPA gave producers of certain rodenticides until June 4, 2011, to research, develop, and register new products that would in EPA’s view be safer for children, pets, and wildlife. There are now seven new products on the market with new bait delivery systems. EPA announced its intent to initiate cancellation proceedings under FIFRA against companies that elected not to conform their products to EPA’s recommendations. EPA also intends to ban the sale and distribution of rodenticide products containing brodifacoum, bromadiolone, difethialone, and difenacoum directly to residential consumers reportedly because of their toxicity and the secondary poisoning hazards to wildlife. These rodenticides will still be available for use in residential settings, but only by professional pest control applicators. The compounds will also be allowed for use in agricultural settings. Bait stations will be required, however, for all outdoor, above-ground uses to minimize exposure to children, pets, and wildlife.
EPA Removes Confidentiality Claims For More Than 150 Chemicals: On June 8, 2011, EPA made public the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential. For these 104 studies, the chemical identity will no longer be redacted, or kept from public view. The chemicals involved are used in dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead. In 2010, EPA challenged industry to declassify voluntarily unwarranted claims of confidential business information (CBI). EPA also issued new guidance outlining plans to deny confidentiality claims for chemical identity in health and safety studies under TSCA. Based on this guidance, EPA notified a number of companies in February 2011 that it had determined that their CBI claims were not eligible for confidential treatment under TSCA and that EPA intended to make the information public. The health and safety studies include some declassified by EPA and other voluntary declassifications by companies in response to EPA’s challenge. EPA is committed to posting new declassified materials under TSCA on EPA’s website on a regular basis. In addition to these actions, EPA over the past several months has taken a number of other steps to make chemical information more readily available. EPA provided the public, for the first time ever, with free access to the consolidated TSCA Inventory on the EPA and Data.Gov websites. EPA also launched a new chemical data access tool that gives the public the ability electronically to search EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals that they may come in contact with every day. More information is available online.
NTP Announces 12th RoC: On June 10, 2011, the National Toxicology Program (NTP) announced the availability of the 12th Report on Carcinogens (RoC), which includes eight new substances. NTP added formaldehyde and a botanical known as aristolochic acids as known human carcinogens. NTP added six other substances — captafol, cobalt-tungsten carbide (in powder or hard metal form), certain inhalable glass wool fibers, o-nitrotoluene, riddelliine, and styrene — as substances that are reasonably anticipated to be human carcinogens. The RoC is a congressionally mandated document that is prepared for the Health and Human Services Secretary by NTP. The RoC identifies agents, substances, mixtures, or exposures in two categories: “known to be a human carcinogen”; and “reasonably anticipated to be a human carcinogen.” NTP notes that a listing in the RoC “does not by itself mean that a substance will cause cancer. Many factors, including the amount and duration of exposure, and an individual’s susceptibility to a substance, affect whether a person will develop cancer.” With these additions, the 12th RoC now includes 240 listings. It is available online.
EPA Provides Alternative Standard For Carbamate Waste Treatment: On June 14, 2011, EPA published a direct final rule and a proposed rule concerning the land disposal restrictions (LDR) treatment standards for hazardous wastes from the production of carbamates and carbamate commercial chemical products, off-specification or manufacturing chemical intermediates, and container residues that become hazardous wastes when they are discarded or intended to be discarded. 76 Fed. Reg. 34147 and 76 Fed. Reg. 34200. Currently, under the LDR Program, most carbamate wastes must meet numeric concentration limits before they can be land disposed. EPA states that the lack of readily available analytical standards makes it difficult to measure whether the numeric LDR concentration limits have been met, however. Therefore, under the direct final rule, it is providing as an alternative standard the use of the best demonstrated available technologies (BDAT) for treating these wastes. In addition, the direct final rule removes carbamate Regulated Constituents from the table of Universal Treatment Standards. The direct final rule will be effective August 12, 2011, without further notice, unless EPA receives adverse written comment by July 13, 2011. If EPA receives adverse comments, it will publish a timely withdrawal in the Federal Register informing the public that the specific amendments in the direct final rule for which EPA received adverse comments will not take effect. EPA states that, because it published a proposed rule, as well as the direct final rule, it will not institute a second proposal or allow for another comment period on the action.
EPA Promulgates Technical Amendments Concerning Pesticide Tolerances: EPA promulgated a June 15, 2011, final rule concerning pesticide tolerances. The technical amendments will correct cross-references, remove expired tolerances, “reserve” paragraphs within sections that no longer have any tolerances listed due to the removal of expired tolerances, and remove sections that no longer have any tolerances due to the removal of expired tolerances. According to EPA, these changes “have no substantive impact on any requirements. As such, notice and public comment procedures are unnecessary.” The final rule is effective June 15, 2011.
News From The Office Of Pesticide Programs: Tina Levine, Ph.D., Director of the Health Effects Division, has announced that she will be resigning as of July 1, 2011. More information will be provided once further details are released.
EPA Improves Access to Information on Hundreds of Chemicals: On June 15, 2011, EPA announced that it is making it easier to find data about chemicals. EPA is releasing two databases — the Toxicity Forecaster database (ToxCastDB) and a database of chemical exposure studies (ExpoCastDB) — that scientists and the public can use to access chemical toxicity and exposure data. Improved access supports EPA Administrator Lisa P. Jackson’s priorities of protecting Americans’ health by assuring the safety of chemicals and expanding the conversation on environmentalism. ToxCastDB users can search and download data from over 500 rapid chemical tests conducted on more than 300 environmental chemicals. ToxCast uses advanced scientific tools to predict the potential toxicity of chemicals and to provide a cost-effective approach to prioritizing which chemicals of the thousands in use require further testing. ToxCast is currently screening 700 additional chemicals, and the data will be available in 2012.
ExpoCastDB consolidates human exposure data from studies that have collected chemical measurements from homes and child care centers. Data include the amounts of chemicals found in food, drinking water, air, dust, indoor surfaces, and urine. ExpoCastDB users can obtain summary statistics of exposure data and download datasets. EPA will continue to add internal and external chemical exposure data and advanced user interface features to ExpoCastDB.
The new databases link together two important pieces of chemical research — exposure and toxicity data — both of which are required when considering potential risks posed by chemicals. The databases are connected through EPA’s Aggregated Computational Toxicology Resource (ACToR), an online data warehouse that collects data on over 500,000 chemicals from over 500 public sources.
Users can now access 30 years worth of animal chemical toxicity studies that were previously only found in paper documents, data from rapid chemical testing, and various chemical exposure measurements through one online resource. The ability to link and compare these different types of data better informs EPA’s decisions about chemical safety. More information about the databases is available: ToxCastDB: online; ExpoCastDB: online; and ACToR: online.
GREEN CHEMISTRY DEVELOPMENTS
New Green Ribbon Science Panel Subcommittees To Discuss Safer Consumer Product Alternatives Regulations: Three Subcommittees of the Green Ribbon Science Panel (Panel) have scheduled several teleconferences between May 31 and June 16, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations, as required by AB 1879. These teleconferences are open to the public and comments may be provided. The Panel had previously convened three Subcommittees to discuss issues related to chemical identification and prioritization; product identification and prioritization; and de minimis and unintentionally-added chemicals. These issues were discussed by the full Panel when it met on May 5-6, 2011. During that meeting, the Panel discussed developing new subcommittees that would focus on issues related to the alternatives assessments (AA) process in anticipation of the next full Panel meeting. More information is available online.
Presentations Available From EC’s Fourth Annual Nanotechnology Safety For Success Dialogue Workshop: Presentations from the fourth annual Nanotechnology Safety for Success Dialogue Workshop, which was held on March 29-30, 2011, in Brussels, Belgium, are now available online. The European Commission (EC) convened the Workshop to:
- Take stock of the fast advancing science needed for appropriate and effective policies; and
- Analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design.
Workshop sessions included detection, measurement, and characterization of manufactured nanomaterials; regulatory definitions: approaches and perspectives; assessing the risk of manufactured nanomaterials; and reporting. The presentations are available online.
SNWG Responds To BfR’s Statement Concerning Nanosilver: The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment’s (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion. According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver — the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver — and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union (EU) regulatory process. SNWG’s statement is available online.
ISO Publishes Standard For Nanomaterial Risk Evaluation: The International Organization for Standardization (ISO) has published a new standard, ISO/TR 13121:2011, which describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials to protect the health and safety of the public, consumers, workers, and the environment. According to ISO, the standard offers guidance on the information needed to make sound risk evaluations and risk management decisions. The standard also includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders. The standard offers methods organizations can use to be transparent and accountable in how they manage nanomaterials, and describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials. The standard is available for purchase online.
OECD Provides Snapshot On Current And Planned Activities On The Safety Of Manufactured Nanomaterials: On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the ISO, Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO). The document is available online.
White House ETIPC Releases Policy Principles Concerning Regulation And Oversight Of Nanotechnology And Nanomaterials: On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that occur at the agency level. According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). OSTP states that the goals of all of these documents “are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.” The principles concerning regulation and oversight of applications of nanotechnology and nanomaterials are available online. Bergeson & Campbell, P.C.’s (B&C) June 9, 2011, memorandum is available online.
EPA Proposes Policy On Nanoscale Materials In Pesticide Products: EPA released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use FIFRA Section 6(a)(2) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register. More information is available online. B&C’s June 10, 2011, memorandum is available online.
FDA Issues Draft Guidance On Nanotechnology: Agency Will Accept Public Comment For 60 Days: On June 9, 2011, the Food and Drug Administration (FDA) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. FDA announced the availability of the Draft Guidance in the June 14, 2011, Federal Register. 76 Fed. Reg. 34715. FDA states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is “intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products.” Comments on the Draft Guidance are due August 15, 2011. The Draft Guidance is available online. B&C’s June 10, 2011, memorandum on the Draft Guidance is available online.
EPA Issues Final Rule Repealing Grandfather Provision For PM Less Than 2.5 Micrometers: On May 18, 2011, EPA issued a final rule that repeals the “grandfather” provision for particulate matter less than 2.5 micrometers (PM2.5) under the Federal Prevention of Significant Deterioration (PSD) permit program. 76 Fed. Reg. 28646. The grandfather provision allowed facilities under certain circumstances to satisfy the PSD permit program requirements for PM2.5 by meeting the requirements for controlling particulate matter less than 10 micrometers (PM10) and analyzing impacts on PM10 air quality as a surrogate approach based on an EPA policy known as the “1997 PM10 Surrogate Policy.” At that time, EPA stated it was difficult to monitor and calculate fine particle emissions. EPA codified the policy in a 2008 final rule that implemented the fine particle standards under the New Source Review program. EPA states the policy is no longer needed because technical tools and test methods exist to show compliance with fine particle standards. On February 11, 2010, EPA also proposed to end early the 1997 PM10 Surrogate Policy in EPA-approved state PSD programs during the remainder of the SIP development period, which ended on May 16, 2011. EPA took no final action on that aspect of the proposal. The final rule is effective on July 18, 2011.
EPA Creates Searchable Online Database On Drinking Water Violations: On May 16, 2011, EPA launched a searchable online database that allows the public to see whether a community meets federal drinking water standards. The tool lists drinking water suppliers that EPA considers serious violators because of a combination of unresolved problems. According to EPA, serious violators make up 4 percent of the nation’s public water systems but have been decreasing in number due to more efficient enforcement by states and other agencies. The website also includes a 2009 report on national compliance and enforcement among public drinking water systems. EPA hosted a webinar on May 17, 2011, on how to search for local water quality information, how to compare state-by-state data, and how to perform other searches. The tool, called Enforcement and Compliance History Online, also tracks violations of the CWA, the CAA, and hazardous waste laws. The database is available online.
EPA Announces Public Meeting Regarding Preliminary Regulatory Determinations For The Third Contaminant Candidate List (CCL 3): On May 31, 2011, EPA announced a public meeting on June 16, 2011, to obtain input on EPA’s process for Regulatory Determination 3 along with the contaminants and the technical information that EPA is considering. 76 Fed. Reg. 31271. The 1996 SDWA Amendments require EPA to determine every five years, whether to regulate at least five contaminants from the current Contaminant Candidate List (CCL) with a NPDWR. The process of making decisions about whether to regulate any of the unregulated contaminants on the CCL is called Regulatory Determinations. On October 8, 2009, EPA published the CCL 3 containing 116 unregulated contaminants. EPA is currently in the preliminary process of deciding whether to regulate at least five CCL 3 contaminants (i.e., Regulatory Determination 3). The purpose of this notice is to announce that EPA will be hosting a public stakeholder meeting on June 16, 2011, from 1 p.m. to 5 p.m. EPA expects to publish the preliminary regulatory determinations for at least five CCL 3 contaminants in mid-2012 and final regulatory determinations by August 2013. Please consult the Federal Register for details.
EPA Delays Implementation On Incinerator Rules: On May 18, 2011, EPA announced its decision to delay implementing new air pollution limits for large industrial boilers and solid waste incinerators indefinitely while EPA reconsiders portions of the rules and addresses legal challenges. 76 Fed. Reg. 28662. EPA reported that the additional time will allow it to solicit public comments and compile additional emissions data. The rules issued in March set national emissions standards for hazardous air pollutants (NESHAP) for major source industrial, commercial, and institutional boilers and process heaters and revise NSPS for commercial and industrial solid waste incinerators. EPA had set an effective date of May 20, 2011, for both rules, but now states it will delay implementation until it either completes its reconsideration process or until legal challenges to the standards have been resolved, whichever is earlier. The stay would not apply to EPA’s hazardous air pollutant (HAP) rule for smaller area source boilers, which it also is reconsidering. EPA will accept additional data on boiler and incinerator emissions until July 15, 2011.
EPA Proposes Secondary Lead Smelting NESHAP: On May 19, 2011, EPA proposed amendments to the NESHAP for Secondary Lead Smelting to address the results of the residual risk and technology review that EPA is required to conduct under the CAA. 76 Fed. Reg. 29032. The proposed amendments include revisions to the stack emissions limits for lead; revisions to the fugitive dust emissions control requirements; the addition of total hydrocarbons emissions limits for reverberatory, electric, and rotary furnaces; the addition of emissions limits and work practice requirements for dioxins and furans; and the modification and addition of testing and monitoring and related notification, recordkeeping, and reporting requirements. EPA also proposed to revise provisions addressing periods of startup, shutdown, and malfunction to ensure that the rules are consistent with a recent court decision. Comments must be received on or before July 5, 2011.
EPA Announces e-GGRT Testing Opportunity: On May 23, 2011, EPA announced that in June 2011, interested parties will have the opportunity to test the Electronic Greenhouse Gas Reporting Tool (e-GGRT) before the final version of the tool goes live. These web-based training sessions will provide users with information on the e-GGRT. E-GGRT is a web-based system that guides reporters through data entry and submission and contains built-in calculations. Reporters may choose to format their annual greenhouse gas report according to the e-GGRT XML schema. These reporters must meet the same registration and submission deadlines as all other reporters. All data are submitted to EPA electronically in e-GGRT, except the one-time Electronic Signature Agreement (ESA) which is submitted on paper. E-GGRT supports reporting required under Part 98; e-GGRT does NOT support recordkeeping requirements under Part 98.
EPA Requests Comment On Draft Guidance Regarding Control Of Emissions From New Highway Vehicles And Engines: On June 7, 2011, EPA requested comment on draft guidance and related interpretations concerning the application of certain emission certification regulations to those on-highway heavy-duty diesel engines that are using selective catalytic reduction systems to meet federal emission standards. 76 Fed. Reg. 32886. The document describes and seeks public comment on draft guidance for complying with adjustable parameter regulations at 40 C.F.R. Section 86.094-22 as they apply to certification of on-highway heavy-duty diesel engines using selective catalytic reduction (SCR) technology to meet emission standards for oxides of nitrogen (NOX). This draft guidance includes EPA’s interpretation of relevant regulatory provisions in light of available information on current and developing approaches for effective SCR controls. After considering any public comments received, EPA will issue the guidance and interpretations, and will use them in reviewing any application for certification application involving SCR received on or after the effective date of the guidance. The draft guidance contained in this document reflects the fact that manufacturers of heavy-duty engines and operators of trucks have gained significant experience in the design and use of SCR systems for these engines, and this experience should be reflected in the certification process. EPA invites public comment on the draft guidance and interpretations set forth in the Federal Register notice. Comments are due by July 7, 2011.
President Obama Announces Ken Kopocis As Nominee For Assistant Administrator For The Office Of Water: On June 10, 2011, President Obama announced Ken Kopocis as nominee for Assistant Administrator for the Office of Water. Kopocis has been the Senior Counsel on the House Committee on Transportation and Infrastructure since 2008. From 2006-2008, he served as the Deputy Staff Director for Infrastructure on the Senate Committee on Environment and Public Works. From 1993-2006, Kopocis was the Staff Director and Senior Counsel for the House Subcommittee on Water Resources and Environment for the Committee on Transportation and Infrastructure. From 1985-1993, he served as Assistant Counsel on the House Subcommittee on Water Resources and Environment for the Committee on Public Works and Transportation. According to the June 10, 2011, press release, Kopocis has worked on water issues in the U.S. Congress for over 25 years, and has played a role in crafting and defending numerous pieces of environmental legislation, including the CWA. He also previously served as an Attorney in the Government Accountability Office and at the General Services Administration. Kopocis holds a B.S. from the University of Nebraska-Omaha and a J.D. from the College of William and Mary. Kopocis would succeed Peter Silva, who resigned in February. Nancy Stoner, who previously was Deputy Assistant Administrator for Water, has been serving as Acting Assistant Administrator for Water since Silva resigned.
OSHA Reopens Public Record On Proposal To Add Reporting Requirement For Musculoskeletal Disorders: On May 17, 2011, the Occupational Safety and Health Administration (OSHA) announced its decision to reopen the public record on its proposed rule to revise the Occupational Injury and Illness Recording and Reporting Requirements regulation. 76 Fed. Reg. 28383. OSHA proposed to revise its Occupational Injury and Illness Recording and Reporting Requirements in January 2010 to restore a column to the OSHA 300 log that employers would have to check if an incident they already have recorded under existing rules is a musculoskeletal disorder, or MSD. The proposed rule would not change the existing record-keeping requirements about when and under what circumstances employers must record work-related injuries and illnesses. It would simply require an employer to mark the MSD column box on the OSHA 300 log if a case the employer already has recorded meets the definition of an MSD. OSHA reopened the record to allow comments on the small business teleconferences that OSHA and the Small Business Administration’s Office of Advocacy co-sponsored on April 11 and 12, and on the issues raised during the teleconferences. OSHA convened the teleconferences to gather information from representatives of small businesses about their experiences recording work-related MSDs and how they believe they would be impacted by OSHA’s proposed rule. The comment period has been reopened to June 16, 2011. OSHA has posted a summary of comments about the teleconferences in the public docket for this rulemaking online.
REACH Dossiers For Intermediate Chemicals Lack Sufficient Information: According to the European Chemicals Agency (ECHA), nine out of ten Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers for substances used only in chemical manufacturing processes do not provide sufficient information and will be returned to registrants. A review of 400 dossiers for chemicals for intermediate use, meaning for production of other chemicals, has shown that 86 percent failed to prove the substances were intermediates, stated ECHA. Under REACH, the registration of intermediates is subject to lesser information requirements and lower fees than standard registrations. ECHA stated it was processing about 5,000 intermediates dossiers, and the screening of the 400 dossiers was aimed only at determining their compliance with REACH Articles 17 and 18, which set out the criteria for substances to be registered as intermediates. An ECHA spokesman told BNA that 86 percent of the dossiers “had information on strictly controlled conditions and risk management measures poorly documented,” were unclear, or even contained substance descriptions “clearly indicating that they did not meet the definition of an intermediate as determined in REACH.”
EC Bans Cadmium In Plastics: On May 20, 2011, the EC adopted an amendment to the REACH chemicals law to ban the use of cadmium in jewelry and plastics, adding new restrictions on its use. The amendment, which is effective on December 20, 2011, also will outlaw cadmium in brazing alloys, which are used in a process similar to soldering. The Commission stated the measure was aimed at rigid polyvinyl chloride (PVC) products such as window frames and guttering, in which cadmium is used as a colorant or stabilizer. PVC manufacturers have developed alternatives and already are phasing out use of the toxic metal, the Commission stated. An exemption would permit the use of low levels of cadmium in recycled PVC products to help avoid the material going to landfills or being incinerated, according to the amendment. The use of cadmium in the EU already is subject to a number of restrictions, for example in paints and consumer goods, which are listed in Annex XVII of REACH. Cadmium also is banned from electrical and electronic products under the Restriction of Hazardous Substances (RoHS) Directive. The process to restrict cadmium in plastics and jewelry was started in 2007, before the REACH law took effect. Restriction proposals are now overseen by ECHA. The EC regulation amending REACH Annex XVII to include additional restrictions on the use of cadmium is available online.
ECHA Releases Background Document On Risk-Based Criteria For Selecting Chemicals To Be Evaluated: On May 26, 2011, ECHA released a Background Document on the selection of criteria to prioritize substances under REACH. The document, Selection Criteria to Prioritise Substances for Substance Evaluation, identifies the criteria to be used to prioritize substances. The Background Document is available online. Substances subject to substance evaluation are substances registered under the REACH regulation. The prioritized substances for evaluation will be placed on the so-called “Community Rolling Action Plan” (CoRAP). Prioritization of substances must be risk based. This Background Document identifies the first set of CoRAP selection criteria used for establishing the CoRAP. The selection criteria will be further refined along with the experience gained from the substance evaluation process. The plan will cover evaluations planned over the following three years, and will be updated annually. No single criteria is to be used in isolation to select a chemical for evaluation, according to ECHA. ECHA intends to issue a draft list of chemicals that Member states will evaluate by the end of October 2011. A final CoRAP list will be adopted by the end of February 2012.
ECHA Adds Seven New Substances To Candidate List: On May 31, 2011, ECHA announced it will add seven new substances to the Candidate List of substances of very high concern (SVHC) for authorization following the unanimous agreement of the Member State Committee (MSC) at its 18th meeting in Helsinki. The substances are: 2-ethoxyethylacetate; strontium chromate; 1,2-benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters (DHNUP); hydrazine; 1-methyl-2-pyrrolidone; 1,2,3-trichloropropane; and 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP). The substances are either carcinogenic, mutagenic, or reprotoxic (CMR) substances. DHNUP and DIHP will add two additional phthalates to the Candidate List. A new identification basis (toxic for reproduction) will be added for cobalt(II)chloride, which is already on the Candidate List because of its carcinogenic hazards.
2012 Budget Cuts For FDA: Action taken by the House Appropriations Subcommittee responsible for approving spending for FDA would hamper the ability of FDA to implement the provisions of the Food Safety Modernization Act, especially those sections relating to increased inspectional activities and FDA-ordered recalls of dangerous food. The Subcommittee majority proposes to cut $285 million in discretionary funding from funds requested. According to reports, $800 million would be made available to the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), with $50 million of that coming from user fees authorized in the aforementioned food safety legislation. Many food-related organizations are contesting the use of user fees to make up for appropriations shortfall, calling the fees a food tax that is circumventing the appropriations process.
Senate Committee Acts To Require Investigations And Actions On Disease Clusters: The Senate Environmental and Public Works Committee approved by an 11-7 vote the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76) sponsored by Senator Barbara Boxer (D-CA). The Disease Clusters legislation, as stated in the legislative summary, requires the Administrator of EPA to develop, publish, and update guidelines on an approach to investigate suspected or potential disease clusters, environmental pollutants or toxic substances associated with such clusters, or potential causes of such clusters and establish and operate Regional Response Centers and Response Teams. The legislation would ensure that the Office of Children’s Health Protection has a prominent role in developing and updating such guidelines and in establishing and operating such Centers and Teams and establishing Community Disease Cluster Advisory Committees to provide oversight, guidance, and advice relating to such investigations. According to the Act, any person may submit a petition to the EPA Administrator, the Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR), and the Director of the National Institute of Environmental Health Sciences (NIEHS) that requests that a Response Team conduct an investigation or take action to address the potential causes of disease clusters. The agencies have 90 days to respond to the petitions, either outlining their planned action or justifying a denial of the petition.
Legislation On Cost Of Regulations To Small Businesses Fails: A move to amend the Economic Development Revitalization Act to require regulatory agencies to estimate the economic consequences of regulations on small business failed to pass in the Senate on June 9, partly due to the fact that members felt it needed additional review, since there had been no hearing and the measure would impact such a wide variety of measures that more extensive review was needed.
Chemical Facility Provision Extended Again: By a vote of 233 to 188, the House of Representatives extended the Chemical Facility Antiterrorism Standards Program through fiscal 2012. Essential elements of the program are a complete security vulnerability assessment, site security plans, and protective measures to meet risk-based performance standards established by the Department of Homeland Security. Originally, the measure was scheduled to expire in October 2010, but it was extended by continuing resolutions and the 2011 spending bill.
House Leaders Support Fossil Fuel, Cut Back On Renewable And Energy Efficiency: House Appropriations Committee Republican leaders released legislation that would provide for increased funding for advanced technology coal, natural gas, and other fossil energy power and nuclear material. Democratic members reacted predictably, saying that the Republicans were ignoring the security issues raised by dependence on foreign, imported oil.
Bill Would Bar EPA From Drinking Water Act Enforcement In Small Utilities: Senator James Inhofe (R-OK) and four co-sponsors have introduced a bill that would prevent EPA from enforcing the provisions of the SDWA against small water utilities that do not have the wherewithal to comply. Instead of enforcement, the measure — the Small System SDWA of 2011 — would provide funds to entities serving less than 10,000 people over five years and would rekindle the technical assistance program and a pilot program that would provide information to small utilities on how to comply with federal law. The technical assistance would be aimed at methods for complying with the disinfectants and disinfection by-products rule.
Senator Seeks To Limit Payments For Suits Against Government: The Government Litigation Savings Act, S. 1061, introduced by Senator John Barrasso (R-WY), would restrict the applicability of the Equal Access to Justice Act providing reimbursement for attorney fees and expenses incurred by individuals and groups suing the federal government. The bill has a number of limitations. It would limit eligibility, limit repeat lawsuits, and impose tracking and reporting requirements applicable to those suing the government. Attorneys would be restricted to awards of $200,000 per suit, up to three recoveries per calendar year — absent special circumstances.
Payments For Water Act Violations: The Senate Judiciary Committee passed the Environmental Crimes Enforcement Act of 2011 by a vote of 13-3 on May 18, 2011, and sent it to the Senate floor. The measure, sponsored by Senator Leahy (D-VT), is identical to a bill he introduced in the last session on which the Senate did not act. The measure directs the United States Sentencing Commission to review and amend the Federal Sentencing Guidelines and policy statements applicable to persons convicted of offenses under the Federal Water Pollution Control Act (commonly known as the CWA) to reflect the intent of Congress that penalties for such offenses be increased to appropriately account for the actual harm to the public and the environment from such offenses. An important addition is a provision that amends the federal criminal code to require mandatory restitution to victims of crimes under the CWA. Restitution is presently available, but is discretionary, according to a February 15 press release issued by Senator Leahy.
EPA And Interior Defend Administration’s Energy Policy Before House Committee: On May 24, 2011, the House Committee on Oversight and Government Reform held a hearing and highlighted a new report that claims Obama Administration policies negatively impact domestic energy prices. Members heard testimony from EPA Administrator Lisa Jackson and Deputy Department of Interior (DOI) Secretary David Hayes. The hearing, led by Chairman Darrell Issa (R-CA), focused on oil production and exploration in the Gulf of Mexico, leases and permits for oil and gas drilling on public lands controlled by the Bureau of Land Management (BLM), and the development and use of hydraulic fracturing (hydro-fracking) technology for extracting natural gas from shale deposits. A copy of the Committee report is available online.
Deputy Secretary Hayes defended DOI action under the current Administration by highlighting that domestic oil production is at its highest levels since 2003 and that in the wake of the Deepwater Horizon oil spill, leases and permits are being issued for both shallow and deepwater drilling in the Gulf of Mexico that meet a new set of rigorous safety standards. In addition, onshore oil and gas production have increased by 5 percent from 2009 and 2010 amounts, respectively. Deputy Secretary Hayes also highlighted that BLM has leased more than 41 million acres of public land for oil and gas development and continues to process thousands of permits to drill on an annual basis. At the same time, the Administration is also pursuing the potential for renewable energy development, such as wind, solar, geothermal, clean coal, and natural gas, on public lands. A copy of Deputy Secretary Hayes’ testimony is available online.
Administrator Jackson addressed the Committee’s concerns over a study EPA is conducting on the possible links between hydro-fracking for natural gas and contamination of drinking water with chemicals such as benzene, toluene, and other hazardous material that are produced during the drilling and extraction process. Members of the Committee were concerned over the uncertainty the study may create while in development and the chilling effect it would have on companies willing to invest in natural gas exploration. Administrator Jackson testified that the EPA’s study was congressionally mandated and was publicly scoped and peer-reviewed to make the process as transparent as possible. She further ensured the members that states continue to be the delegated permitting authority for hydro-fracking operations and EPA only uses its authority to protect local residents if a driller endangers water supplies and the state has not acted. Finally, Administrator Jackson reiterated that EPA’s mission is to protect the health of the American people and the environment and will ensure that oil and gas exploration, production, and use are conducted in a manner that is consistent with this mandate and not look the other way when pollution happens. A copy of Administrator Jackson’s written testimony is available online.
Obama Administration Issues Memorandum Regarding Export And Trade Promotion, Public Participation, And Rulemaking: The Office of the U.S. Trade Representative (USTR) and OMB’s Office of Information and Regulatory Affairs (OIRA) issued a May 19, 2011, memorandum to U.S. departments and agencies to highlight the importance of regulatory transparency and openness to promoting international trade. The memorandum is important as it telegraphs the growing importance of trade considerations in domestic regulatory issues, and the Administration’s renewed emphasis on the significant role international collaboration has in domestic policy development.
The memorandum states that reducing unnecessary regulatory barriers to exports and trade will promote economic growth, entrepreneurship, job creation, and innovation. The memorandum describes several existing agency obligations that can reduce barriers to trade and contribute to economic objectives, such as economic growth, entrepreneurship, job creation, and innovation. These obligations include: conducting robust regulatory analysis; avoiding the creation of unnecessary barriers to trade; providing domestic and foreign stakeholders a meaningful opportunity to participate in the rulemaking process; and encouraging international collaboration. The memorandum is available online. More information is available online.
FDA To Make Enforcement And Compliance Activities Accessible Online: On May 27, 2011, FDA announced that it is disclosing more information about inspections and court actions, and now has a Web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online. The information includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections and a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. By the end of 2011, FDA will also begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall. Access to this information about FDA’s enforcement and compliance activities will provide the following to the public and regulated industry:
- More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections.
- Information about recall and enforcement activities that will help consumers make decisions about products.
- Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law.
- Information about food products that are not subject to a particular recall, which can help reduce consumer confusion.
FDA Commissioner Margaret A. Hamburg, M.D. launched FDA’s Transparency Initiative in June 2009 in response to the Obama Administration’s commitment to openness in government. After holding public meetings and inviting written comments, FDA issued a report proposing 21 actions to increase disclosures about agency activities. The actions stem directly from that effort and are among the first of the proposals to be implemented. FDA’s Transparency Initiative is available online, and the Inspections Database is available online.
OEHHA Proposes To Add Titanium Dioxide Particles, Alpha-Methyl Styrene To Proposition 65 List: On May 27, 2011, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced plans to add titanium dioxide particles and alpha-methyl styrene to the list of chemicals linked to either cancer or reproductive harm under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. The proposal is based on the Labor Code notification process. Titanium dioxide is used as a pigment in paints, papers, inks, sunscreen, and cosmetics. OEHHA intends to list only airborne, unbound particles of titanium dioxide that can be inhaled as a carcinogen. The International Agency for Research on Cancer (IARC) identified the titanium dioxide particles as causing cancer. The state Labor Code refers to the IARC listing. Alpha-methyl styrene is a high-production volume industrial chemical used in producing plasticizers, resins, and polymers. The chemical is referenced as a reproductive toxicant in the state’s Labor Code, which captures any chemicals within the scope of the federal Hazard Communication Standard. Comments on the proposed listings must be submitted to OEHHA by June 27, 2011.
Interim Rules Regarding Sustainable Acquisition Issued: On May 31, 2011, the U.S. Department of Defense (DoD), General Services Administration (GSA), and The National Aeronautics and Space Administration (NASA) issued Federal Acquisition Regulation (FAR) that are intended to ensure that 95 percent of new contract actions contain requirements for green and sustainable products. 76 Fed. Reg. 31394. The interim rule amends the FAR to implement Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, and Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management. It requires federal agencies to leverage agency acquisitions to foster markets for sustainable technologies, materials, products, and services. Federal agencies are additionally required to implement high-performance sustainable building design, construction, renovation, repair, commissioning, operation and maintenance, management, and deconstruction practices in applicable acquisitions. Contractors will be required to support the goals of an agency’s environmental management system. The rules make several revisions to sections of the FAR and additionally incorporates a 2007 Executive Order on environmentally friendly federal practices. If they do not use electronic submissions methods, contractors are required to submit paper documents on double-sided, 30-percent post-consumer fiber paper whenever practicable, a change from current regulations that only encourage the submission of paper documents on recycled paper, according to the notice. Other parts of FAR are revised to ensure agencies are including or considering sustainable acquisition requirements in their synopses and other acquisition planning documents. The rule requires contracts with private entities operating at government-owned or -leased facilities include provisions obligating them to comply with the order’s requirements to the same extent as the agencies, including developing programs to promote and implement cost-effective waste reduction. Another section of FAR is revised to require agencies to purchase recycled content and biobased products or require them in the acquisition of services, based on EPA or USDA benchmarks. Comments are due by August 1, 2011.
IARC Classifies Radiofrequency Electromagnetic Fields As Possibly Carcinogenic To Humans: In a May 31, 2011, press release, IARC announced that it classified radiofrequency electromagnetic fields as possibly carcinogenic to humans (Group 2B), based on an increased risk for glioma, a malignant type of brain cancer, associated with wireless phone use. The IARC Monograph Working Group met May 24-31, 2011, to assess the potential carcinogenic hazards from exposure to radiofrequency electromagnetic fields. IARC will publish the assessments as Volume 102 of the IARC Monographs, which will be the fifth volume in this series to focus on physical agents. The IARC Monograph Working Group discussed the possibility that these exposures might induce long-term health effects, in particular an increased risk for cancer, and reviewed and evaluated the available literature on the following exposure categories involving radiofrequency electromagnetic fields:
- Occupational exposures to radar and to microwaves;
- Environmental exposures associated with transmission of signals for radio, television, and wireless telecommunication; and
- Personal exposures associated with the use of wireless telephones.
The IARC press release includes the following results:
The evidence was reviewed critically, and overall evaluated as being limited among users of wireless telephones for glioma and acoustic neuroma, and inadequate to draw conclusions for other types of cancers. The evidence from the occupational and environmental exposures mentioned above was similarly judged inadequate. The Working Group did not quantitate the risk; however, one study of past cell phone use (up to the year 2004), showed a 40% increased risk for gliomas in the highest category of heavy users (reported average: 30 minutes per day over a 10-year period).
According to IARC, the July 2011 issue of The Lancet Oncology will include a concise report summarizing the main conclusions of the IARC Working Group and the evaluations of the carcinogenic hazard from radiofrequency electromagnetic fields, including the use of mobile telephones. More information is available online.
California Appellate Court Affirms Decision Supporting Proposition 65 Labor Code Listing Mechanism: On June 6, 2011, the California Court of Appeal for the First Appellate District affirmed the 2009 decision by the Alameda County Superior Court upholding OEHHA’s use of the Labor Code mechanism to add chemicals to Proposition 65. California Chamber of Commerce v. Schwarzenegger (Div. 1, No. A125493). This effectively means that the so-called Labor Code mechanism is a viable listing mechanism for Proposition 65 purposes.
The case concerns the methods by which Proposition 65 can be updated, and specifically whether OEHHA can add chemicals to the list by use of a methodology set forth in Section 25249.8(a) of the Health and Safety Code. The California Chamber of Commerce (CalChamber) contended this listing method is no longer operable and applied only to the creation of the initial Proposition 65 list. According to CalChamber, further changes to the list must be made using one of the three methods set forth in Section 25249.8(b) — the Expert Review method, the Authoritative Body method, or the Formally Required to be Labeled method. The trial court concluded the language of Section 25249.8 is unambiguous and the listing method set forth remains operable. While the appellate court did not agree the statutory language is completely unambiguous, it agreed “the Proposition 65 list not only can, but must be, updated by the method used here by the OEHHA and set forth in” Section 25249.8(a). The decision is available online. More information is available online.
CDC Announces Release Of Action Agenda Intended To Address Public Health And Chemical Exposures: On June 9, 2011, the Centers for Disease Control and Prevention (CDC) announced the release of Addressing Public Health and Chemical Exposures: An Action Agenda, which is available online. According to CDC, the Action Agenda, authored by the National Conversation Leadership Council, “includes clear, achievable recommendations to help government agencies and other organizations strengthen their efforts to protect the public from harmful chemical exposures.” The recommendations are organized in the following seven chapters:
- Chapter 1: Protecting public health by preventing harmful chemical exposures;
- Chapter 2: Collecting and using information on chemicals and population health to enable effective public health protection;
- Chapter 3: Achieving a more complete scientific understanding of chemicals and their health effects;
- Chapter 4: Promoting health and wellness in vulnerable communities affected by environmental chemical exposures;
- Chapter 5: Strengthening the public’s ability to participate effectively in environmental health decision making;
- Chapter 6: Strengthening the capacity of the public health sector and health provider workforce to address the needs of people exposed to harm from chemicals; and
- Chapter 7: Reducing harm from chemical emergencies through prevention, planning, and coordination.
The National Conversation on Public Health and Chemical Exposures was a collaborative initiative supported by CDC and ATSDR through which many organizations and individuals contributed to the Action Agenda.