Monthly Update for March 2010


TSCA/FIFRA/NTP

EPA Issues Draft IRIS Risk Assessment On Inorganic Arsenic: On February 19, 2010, the U.S. Environmental Protection Agency (EPA) announced a 60-day public comment period for a draft document entitled Toxicological Review of Inorganic Arsenic: In Support of the Summary Information on the Integrated Risk Information System (IRIS) (EPA/635/R-10/001) (Toxicological Review of Inorganic Arsenic). 75 Fed. Reg. 7477. The draft document was prepared by the National Center for Environmental Assessment (NCEA), EPA Office of Research and Development (ORD). The Toxicological Review of Inorganic Arsenic was submitted to the EPA's Science Advisory Board (SAB) for external peer review in 2005. In response to significant stakeholder interest, EPA submitted the 2010 draft Toxicological Review to the SAB for a "focused and expedited" peer review of EPA's responses to key SAB (2007) recommendations. The public is invited to comment on the document. SAB's peer review meeting will be announced in a separate forthcoming Federal Register notice. Comments must be received by EPA by April 20, 2010.

In a related development issued on March 1, 2010, EPA's SAB Staff Office announced a public meeting of a workgroup of the chartered SAB to conduct an expedited and focused review of EPA's draft Toxicological Review of Inorganic Arsenic. 75 Fed. Reg. 9205. The SAB workgroup will assess the adequacy of EPA's implementation of the SAB previous recommendations regarding the cancer risk assessment of inorganic arsenic. The meeting will be held on April 6-7, 2010, in Washington, D.C. Please consult the Federal Register for details. Comments are due by March 26, 2010, if they are to be considered by the SAB.

EPA Denies TSCA Petition On Baled Natural Rubber: On February 22, 2010, EPA announced its decision to deny a petition it received under Toxic Substances Control Act (TSCA) Section 21 from an individual on November 19, 2009. 75 Fed. Reg. 7586. The petitioner requested EPA to "establish regulations prohibiting the use and distribution in commerce of Hevea brasiliensis baled natural-rubber for the manufacture of tires, wherein said rubber fails to satisfy The American Society for Testing Materials Method ASTM D1076-06 (Category 5). The petition states that "mplementation of an EPA regulation that guides tire manufacturers to use Hevea brasiliensis baled natural-rubber that satisfies ASTM D1076-06 (Category 5) may affect the incidence of Hevea brasiliensis natural-rubber allergies and allergy induced autism." According to EPA, the petitioner failed to present or identify any direct evidence that Hevea brasiliensis natural-rubber antigens, or any other antigens, cause, induce, or affect autism. The petitioner also failed to demonstrate that there is a sufficient level of exposure to Hevea brasiliensis antigenic proteins from the use of Hevea brasiliensis baled natural-rubber in tires to cause adverse effects from this exposure. The petitioner, according to EPA, provided little information on the specific factors listed in TSCA Section 6(c) that must be considered for a TSCA Section 6 rulemaking.

EPA Proposes Amendments To TSCA Section 4 Enforceable Consent Agreement Procedures: On February 19, 2010, EPA proposed important revisions to the procedures for development of enforceable consent agreements (ECA) to generate test data under TSCA Section 4. 75 Fed. Reg. 7428. The proposed rule includes sweeping changes for when and how negotiations will be initiated, conducted, and concluded, and limits the timeframe within which these activities will take place. Companies that manufacture or process chemical substances and mixtures that have been, or potentially could be, subject to TSCA ECA negotiations, as well as other stakeholders that have participated in such negotiations in the past, should consider commenting on the proposal to ensure that ECA negotiation procedures remain a viable option to the development of Section 4 test rules. The effect of the changes as proposed could well be to limit significantly the ability of industry and interested others to negotiate testing agreements. Comments must be received on or before March 22, 2010. For further information, see our memorandum online.

OIG Report Concludes EPA Needs Coordinated Plan To Oversee Its TSCA Responsibilities: On February 18, 2010, EPA's Office of Inspector General (OIG) released a report entitled EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities, urging EPA to coordinate better risk assessment and oversight activities by establishing a management plan that contains new goals and measures that demonstrate the results of Office of Pollution Prevention and Toxics (OPPT) and Office of Enforcement and Compliance Assurance (OECA) actions. OIG conducted the evaluation to review EPA's implementation of TSCA by determining how well EPA's processes for oversight and regulation meet the objectives of TSCA, and whether the performance measures accurately reflect EPA's assurance that the objectives of TSCA are met. The OIG report is available online. For further information, see our memorandum online.

EPA Announces Integrated Science Assessment For Lead: On February 26, 2010, EPA announced that the ORD's NCEA is preparing an Integrated Science Assessment (ISA) as part of the review of the National Ambient Air Quality Standards (NAAQS) for Lead (Pb). 75 Fed. Reg. 8934. The ISA is intended to update and revise, where appropriate, the scientific assessment presented in the Air Quality Criteria for Lead, published on October 1, 2006. Interested parties are invited to assist EPA in developing and refining the scientific information base for the review of the Pb NAAQS by submitting research studies that have been published, accepted for publication, or presented at a public scientific meeting. All communications and information should be received by EPA by April 30, 2010.

EPA Proposes Test Rule For Certain High Production Volume Chemicals: On February 25, 2010, EPA proposed a test under TSCA that would require manufacturers, importers, and processors of certain high production volume (HPV) chemicals to conduct testing to obtain screening level data for health and environmental effects and chemical fate. 75 Fed. Reg. 8575. The proposed TSCA Section 4(a) test rule addresses some of the 207 remaining "orphan" HPV chemicals that were placed on the Priority Testing List by the Interagency Testing Committee (ITC). "Orphan" chemical substances are those HPV chemicals that were not sponsored for testing under the voluntary HPV Challenge Program or under certain international efforts.

According to EPA, of the 207 chemical substances, 159 no longer meet the HPV criterion; 3 already have data that meet needs identified in the proposed rule; and 16 appear to lack the exposure data necessary to support TSCA Section 4(a)(1)(B) findings. The remaining 29 chemical substances are addressed in this proposed TSCA Section 4(a) test rule, and include:

CAS No. Chemical Name
83-41-0 Benzene, 1,2- dimethyl-3-nitro-
96-22-0 3-Pentanone
98-09-9 Benzenesulfonyl chloride
98-56-6 Benzene, 1- chloro-4-(trifluoromethyl)-
111-44-4 'Ethane, 1,1'- oxybis[2-chloro-
127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt(1:1)
506-51-4 1-Tetracosanol
506-52-5 1-Hexacosanol
515-40-2 Benzene, (2-chloro-1, 1-dimethylethyl)-
2494-89-5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)
5026-74-4 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-
22527-63-5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester
24615-84-7 2-Propenoic acid, 2-carboxyethyl ester
25321-41-9 Benzenesulfonic acid, dimethyl-
25646-71-3 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate(2:3)
52556-42-0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, sodium salt (1:1)
61788-76-9 Alkanes, chloro
65996-79-4 Solvent naphtha (coal)
65996-82-9 Tar oils, coal
65996-89-6 Tar, coal, high-temperature
65996-92-1 Distillates (coal tar)
68082-78-0 Lard, oil, Me esters
68187-57-5 Pitch, coal tar-petroleum
68442-60-4 Acetaldehyde, reaction products with formaldehyde, by-products from
68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters
68988-22-7 1,4- Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, by-products from
70693-50-4 Phenol, 2,4-bis (1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-
72162-15-3 1-Decene, sulfurized
73665-18-6 Extract residues (coal), tar oil alk., naphthalene distn. residues

EPA is proposing to require testing of the chemical substances included in this proposed rule based on its preliminary findings under TSCA Section 4(a)(1)(B)(i) relating to "substantial" production and "substantial human exposure," and/or "substantial release to the environment," as well as findings under TSCA Sections 4(a)(1)(B) (ii) and (iii) relating to sufficient data and the need for testing. For 3 of the 29 chemical substances addressed in the proposed rule (including 2 for which EPA is not able to make a preliminary finding regarding substantial human exposure), EPA has found preliminarily that, under TSCA Section 4(a)(1)(B)(i), the chemical substance enters or may reasonably be anticipated to enter the environment in substantial quantities. Comments are due May 26, 2010.

EPA Publishes Final Clarification For Chemical Identification Describing Activated Phosphors For TSCA Inventory Purposes: On February 24, 2010, EPA published its final clarification under which certain activated phosphors that are not on the TSCA Section 8(b) Chemical Substance Inventory (TSCA Inventory) will be considered to be "new" chemical substances under TSCA Section 5, and thus will be subject to applicable notification requirements under TSCA Section 5. 75 Fed. Reg. 8266. According to EPA, the clarification is necessary because EPA's statements in this area have not been consistent. EPA states that, in certain letters and other statements issued by EPA from 1978 to 2003, EPA erroneously indicated that activated phosphors constitute mixtures of phosphors and dopants for purposes of the TSCA Inventory, and thus were not separately reportable as chemical substances under TSCA Section 5(a) new chemical notification requirements. For more detail, see our memorandum online. The final clarification is effective August 24, 2011.

EPA Announces Intent To Consider Lifting Administrative Stay Of Hydrogen Sulfide Reporting: On February 26, 2010, EPA announced that it is considering whether to lift the Administrative Stay of the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 toxic chemical release reporting requirements for hydrogen sulfide (Chemical Abstracts Service Number (CAS No.) 7783-06-4). 75 Fed. Reg. 8889. Hydrogen sulfide was added to the EPCRA Section 313 list of toxic chemicals on December 1, 1993. On August 22, 1994, EPA issued an Administrative Stay of the reporting requirements for hydrogen sulfide to evaluate issues brought to EPA's attention after promulgation of the final rule concerning the human health effect basis for the listing and the use of exposure analysis in EPCRA Section 313 listing decisions. Although the final rule listing hydrogen sulfide under Section 313 of EPCRA remained in force, the stay deferred the reporting requirements for hydrogen sulfide while EPA completed this further evaluation. According to the notice, EPA now has completed its evaluation, and believes that the Administrative Stay should be lifted. Comments are due on April 27, 2010.

EPA Makes Chemical Information More Accessible to Public: As part of Administrator Lisa P. Jackson's strong commitment to increase information on chemicals, for the first time, EPA is providing web access, free of charge, to the TSCA Inventory. The Inventory contains a consolidated list of thousands of industrial chemicals maintained by EPA. EPA is also making this information available on Data.Gov, a website developed by the Obama Administration to provide public access to important government information. Until now, the consolidated public portion of the TSCA Inventory has only been available by purchase from the National Technical Reports Library or other databases. By adding the consolidated TSCA Inventory to EPA's website and to Data.Gov, EPA is making this information readily available to the public at no cost.

For information about EPA's increasing transparency on chemical risk information, click here. For access to the entire TSCA Inventory, please click here.

Wendy Cleland-Hamnett Appointed Director Of OPPT: On February 24, 2010, EPA's Assistant Administrator Steve Owens announced that Wendy Cleland-Hamnett will serve as the Director of OPPT. Cleland-Hamnett has been with EPA for more than 30 years. She served as Acting Director of OPPT over the past year.

EPA Announces Name Change Of OPPTS Office: On March 2, 2010, EPA announced its intent to rename the Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Effective April 22, 2010 (Earth Day), OPPTS will become the Office of Chemical Safety and Pollution Prevention (OCSPP or OCSP2). Administrator Jackson has made assuring the safety of pesticides and toxics one of her highest priorities. The new name is intended to reflect the "critical work" EPA is undertaking in these two areas and underscore the important mission of the office. The new name also makes clear that pollution prevention is a key part of the office and reflects the strong focus Administrator Jackson is giving to pollution prevention.

CAA/CWA

Supreme Court Rejects Request To Review Decision Requiring Water Act Permits For Pesticides: On February 22, 2010, the Supreme Court rejected a request to review a lower court ruling that vacated an EPA exemption for Clean Water Act (CWA) permits for some pesticide applications. American Farm Bureau Federation v. Baykeeper, No. 09-533 (U.S. 2010); CropLife America v. Baykeeper, No. 09-547 (U.S. 2010). The Court denied a petition by the American Farm Bureau Federation and other groups and a similar petition by CropLife America, FMC Corp., Responsible Industry for a Sound Environment, the Southern Crop Production Association, and Syngenta Crop Protection. The Court did not explain its decision. CropLife America, the pesticide manufacturers organization, said in a press statement that despite the Supreme Court decision, it will "continue to pursue additional avenues to contain the 6th Circuit's ruling." The U.S. Court of Appeals for the Sixth Circuit order vacating the rule exempting pesticides from CWA permits is available online.

EPA Seeks Public Comment On The U.S. Greenhouse Gas Inventory: On March 15, 2009, EPA announced that it is seeking public comment on the annual Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2008 draft report. 75 Fed. Reg. 12232. This report will be open for public comment for 30 days after the Federal Register notice is published. The draft report shows that total emissions from greenhouse gases (GHG) were about 6,946 million metric tons of carbon dioxide (CO2) equivalent. Overall, emissions have grown by 13.6 percent from 1990 to 2008. GHG emissions declined from 2007 to 2008 by 2.9 percent. This downward trend was attributed to a decrease in carbon dioxide emissions associated with fuel and electricity consumption. The inventory tracks annual GHG emissions from 1990 to 2008 at the national level. The gases covered by this inventory include carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride. The inventory also calculates carbon dioxide emissions that are removed from the atmosphere by "sinks," e.g., through the uptake of carbon by forests, vegetation, and soils. This annual report is prepared by EPA in collaboration with experts from other federal agencies. After responding to public comments, the U.S. government will submit the final inventory report to the Secretariat of the United Nations Framework Convention on Climate Change (UNFCCC). The report will fulfill the annual requirement of the UNFCCC international treaty, ratified by the United States in 1992, which sets an overall framework for intergovernmental efforts to tackle the challenge posed by climate change. More information on the draft report and how to submit public comments is available online.

EPA Announces Secondary NAAQS For Oxides Of Nitrogen And Oxides Of Sulfur: On March 1, 2010, the Office of Air Quality Planning and Standards (OAQPS) announced the availability of a draft report, Policy Assessment for the Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur: First External Review Draft. 75 Fed. Reg. 11877. EPA released the draft document to seek early consultation with the Clean Air Scientific Advisory Committee (CASAC) and to solicit public comment on the overall structure and framing of key issues and areas of focus that will be discussed in a future, complete draft policy assessment document. Comments should be submitted on or before April 29, 2010.

REACH

New REACH-IT Software And Publication Of ECHA's Evaluation Report: On March 1, 2010, the European Chemicals Agency (ECHA) issued two News Alerts, one regarding the new REACH-IT system and the other regarding the release of an ECHA report evaluating Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossiers submitted in 2009 (Evaluation Report). The new REACH-IT system will go live on March 22, 2010. Please note that after that day, registrants will need to use the newest version of IUCLID (5.2) to submit their dossiers. The new version of REACH-IT includes many new features for industry such as the submission of Classification and Labeling (C&L) notifications, bulk C&L notifications, Legal Entity changes, cease manufacture declarations, and synchronization with the new IUCLID 5.2. Prior to the launch, a comprehensive data migration will take place and therefore REACH-IT will be closed for migration from Thursday, March 18, 2010, 09:00 (EET) to Monday, March 22, 2010, 12:00 (EET).

The Evaluation Report describes the progress ECHA has made in evaluating REACH registration dossiers in 2009. The Evaluation Report also provides recommendations to registrants so that they can improve the quality of their dossiers. In 2009, ECHA received 406 complete registration dossiers and initiated evaluation on 35 dossiers (27 compliance checks, 8 examinations of testing proposals). Fourteen compliance checks were concluded: in seven cases, a letter was sent to the registrant and in another seven cases, the compliance check was closed without further action. The first ECHA decision on a testing proposal was adopted on December 3, 2009 (ECHA/NA/09/33).

The Evaluation Report cans significant useful information for registrants and serves as a "what to avoid" guidance in preparing dossiers. Registrants are urged to familiarize themselves with the list of recommendations in the Evaluation Report, and to analyze thoroughly the legal requirements and the relevant guidance or manuals to improve the quality of the dossiers to avoid problems.

EU Agency Considers Restrictions On Eight Chemicals: On March 8, 2010, ECHA requested comments on eight chemicals that have been put forward by European Union (EU) countries as potential substances of very high concern. The substances are boric acid, which was nominated by Germany; disodium tetraborate and tetraboron disodium heptaoxide, both nominated by Denmark; and ammonium dichromate, potassium chromate, potassium dichromate, sodium chromate, and trichloroethylene, all nominated by France. The substances should be restricted because they have carcinogenic, mutagenic, or reprotoxic properties, according to France. To date, 29 substances have been entered on the candidate list, but none have been formally restricted. Comments are due April 22, 2010. More information on the substances proposed for inclusion on the REACH candidate list is available online.

NANOTECHNOLOGY

EC Requests Accelerated SCENIHR Scientific Opinion On The Scientific Basis For The Definition Of The Term "Nanomaterial": On March 1, 2010, the European Commission (EC) issued a request, via the accelerated procedure, for a scientific opinion on the scientific basis for the definition of the term "nanomaterial" from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). According to the EC, its services "urgently need to elaborate a working definition of the term 'nanomaterials' to ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions." The EC states that it needs "clarification on the size ranges and other relevant characteristics and corresponding metrics reported in the scientific literature, the types of physical and chemical properties particular to nanomaterials, the relevant thresholds, as well as the most appropriate metrics to express such thresholds." The deadline is May 2010. More information is available online.

FDA

FDA Responds To EWG's Letter Concerning Sunscreen Guidelines: In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group's (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen guidelines. In its March 2, 2010, response, FDA stated that most sunscreen products are currently marketed under an over-the-counter drug monograph entitled "Sunscreen Drug Products for Over-the-Counter Human Use." According to the letter, FDA received over 3,000 comments in response to its August 2007 draft sunscreen guidelines. FDA concludes its response by stating:

Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public.

FDA's March 2, 2010, letter is available online, and EWG's July 15, 2009, letter is available online.

LEGISLATIVE DEVELOPMENTS

Lawmakers Act To Preserve, Protect Great Lakes: Groups of Senators and Representatives have introduced bills in both houses of Congress that would provide $650 million annually to preserve and protect the Great Lakes. The legislation would authorize projects to remove contaminated sediment, control invasive species such as the Asian carp, reduce pollution, and restore habitats for fish and wildlife. The Great Lakes Ecosystem Protection Act of 2010 would also provide funds to continue the Great Lakes Legacy Act and fund the EPA Great Lakes National Programs Office. The measure also contains mechanisms to ensure input from stakeholders and an explanation from officials if they do not follow the recommendations provided by the Multi-stakeholder Management Committee.

Effort To Bolster Commercial Energy Efficiency: The Building STAR Energy Efficiency Act of 2010 has been introduced by Senators Jeff Merkley (D-OR) and Mark Pryor (D-AR). If enacted, the bill would authorize monies in the amount of $6 billion for high-efficiency heating systems and better insulation in commercial and multifamily residential buildings. For owners of small businesses and buildings, the bill would provide low interest loans to pay the up-front costs of doing retrofits. With the interest in job creation evident in each new piece of legislation offered, the Senators estimated that 150,000 jobs would be created. Energy bills would also be expected to go down by more than $3 billion and GHG and other pollution would be reduced by 21 million metric tons.

Move Initiated To Halt EPA Regulation Of GHG Emissions: Similar measures have been introduced in the House and Senate to delay for a two-year period any EPA regulation of GHG emissions from power plants and other stationary sources. The bills, sponsored by Senator Jay Rockefeller (D-WV) and Representatives Rick Boucher (D-VA), are being offered as an alternative to the resolution of disapproval being sponsored by Senator Lisa Murkowski (D-AK). That resolution would take away all EPA authority over GHG emissions under the Clean Air Act (CAA). At present, Senator Murkowski is said to be 11 votes short of those needed to pass her resolution.

New Chemical Security Measure Renews IST Debate: The Department of Homeland Security (DHS) is preparing a measure to reauthorize the chemical facility security program. One aspect of the program being touted by DHS is the requirement that facilities utilize "inherently safer technology" or IST. That safer technology, that might mean less toxic chemicals, could limit the extent of damage from security breaches. The bill would also provide for the extension of antiterrorism standards to drinking water and wastewater facilities. DHS and EPA have acknowledged that there is not yet total agreement concerning what constitutes IST, and industry has objected to enacting the concept into law at this point.

Senate Bill Seeks To Limit Power Plant Air Pollution: The CAA Amendments of 2010, sponsored by Senators Lamar Alexander (R-TN) and Tom Carper (D-DE), would limit air pollution in the form of sulfur dioxide, nitrogen oxide, and mercury emissions from power plants. The projected cuts in emissions are listed as a 90% reduction in mercury emissions by 2015, and an 80% drop in sulfur dioxide emissions (measured as a drop from 7.6 million tons in 2008 to 1.5 million tons in 2015). Nitrogen oxide emissions would be reduced from 3 million tons in 2008 to 1.6 million tons in 2015. Both the Senators and officials of EPA have stated that such reductions would save thousands of lives and lead to a realization of significant monetary benefits.

Excise Tax On Wind Energy: Democratic Governor Dave Freudenthal of Montana signed a bill on March 5 that would impose an excise tax of $1.00 per megawatt hour on energy generated by wind. The measure is meant to provide revenue and more equal treatment for different forms of energy production. The measure will take effect in 2012, allowing legislators time for further review of the plan. The tax, when it becomes effective, will not apply to wind turbines until they have been in operation for three years.

House Subcommittee Holds Hearing On Endocrine Disrupting Chemicals In Drinking Water: On February 25, 2010, the House Committee on Energy and Commerce Subcommittee on Energy and Environment held a hearing entitled "Endocrine Disrupting Chemicals in Drinking Water: Risks to Human Health and the Environment." The Subcommittee intended the hearing to examine the science and regulation of endocrine disruptors that may be found in sources of drinking water. Witnesses included: Jim Jones, Deputy Assistant Administrator, EPA OPPTS; Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S., Director, National Institutes of Environmental Health Sciences; Gina Solomon, M.D., M.P.H., Senior Scientist, Natural Resources Defense Council; and Christopher J. Borgert, Ph.D., President and Principal Scientist, Applied Pharmacology and Toxicology, Inc.

The witness testimony is available online.

Subcommittee members criticized the slow pace of EPA's Endocrine Disruptor Screening Program (EDSP). The Food Quality Protection Act of 1996 directed EPA to develop a screening program for endocrine disruptors, and EPA created the EDSP. The EDSP will use a two-tiered screening process: Tier 1 will identify chemicals that have the potential to interact with the endocrine system; and Tier 2 will determine the endocrine-related effects caused by each chemical and obtain information about effects at various doses. On April 15, 2009, EPA issued the final list of 67 chemicals selected for Tier 1 screening, and began issuing test orders in October 2009. Jones stated that EPA is still working to validate the Tier 2 assays, and that it expects to do so by 2012.

Jones testified that, under the Safe Drinking Water Act (SDWA), EPA has the authority to test substances that may be found in sources of drinking water to which a substantial population may be exposed. According to Jones, EPA is preparing a list of no less than 100 chemicals, "a draft of which will be released shortly." The list will be drawn from three sources: National Primary Drinking Water Regulations (NPDWR); the Contaminant Candidate List 3 (CCL 3); and pesticides that are on the reregistration schedule for 2007 through 2008. CCL 3 is a list of contaminants that are currently not subject to any proposed or promulgated NPDWRs, that are known or anticipated to occur in public water systems, and which may require regulation under SDWA. CCL 3 includes pesticides, other chemicals used in commerce, and disinfection byproducts and degredates.

Birnbaum emphasized four aspects of exposure to endocrine disruption: (1) the effect of low doses -- normal endocrine signaling involves very small changes in hormone levels, yet these changes can have significant biological effects; (2) the wide range of effects -- endocrine signals govern virtually every organ and process in the body; (3) the persistence of effects -- the effects of exposure to endocrine disruptors can be observed long after the actual exposure has ceased; and (4) the ubiquity of exposure -- both naturally occurring and manmade substances can be endocrine disruptors.

Solomon recommended that Congress take additional steps, including: require EPA to prioritize and screen chemicals in drinking water, including mixtures, for endocrine disrupting effects; restore adequate funding for the U.S. Geological Survey (USGS) Toxic Substances Hydrology Program and the USGS National Water Quality Assessment Program, so more data are available on contaminants in source water and drinking water; and reform TSCA to require testing of chemicals for toxicity, and require EPA action to regulate promptly hazardous chemicals.

Borgert emphasized the need for EPA and Congress to base any actions on sound science. Borgert outlined three fundamental tenets to which data must conform to be considered an established scientific observation: the identity and authenticity of scientific measurements must be verifiable within a defined range of precision; measurements and observations must not be confounded by extraneous factors and influences known to corrupt their accuracy and precision; and the measurements and observations must be replicable in independent hands.

Senate Passes Extender Measure: The Senate passed the American Workers, State and Business Relief Act of 2010 on March 10, 2010, by a vote of 62-36, with two not voting. The legislation will extend tax benefits that had been scheduled to expire this year. These benefits include credits to speed biofuel development and support for energy efficient improvements in home construction. Regarding biofuel, the measure will support several programs, including a one year extension of the $1.00 per gallon credit for biodiesel and the $1.00 per gallon credit for diesel fuel produced from biomass. Other programs extended through 2010 include unemployment insurance benefits and loan programs for small business, and the alternative fuel excise tax credit for natural gas and liquefied petroleum gas. Regarding homes, the bill will extend for one year the tax credit for the construction of energy-efficient new homes compared to indices for 2003. Various other programs involving credits are being extended, such as alternative fuels credits, alternative vehicle credit for "heavy" hybrids not used as passenger cars, and credits for small business refiners. The energy provisions are a part of the six titles and twelve subtitles in the Act.

Senate Subcommittee Holds Hearing To Obtain Business Perspectives On TSCA Reform: On March 9, 2010, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws." Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, convened the hearing with leaders of businesses that manufacture or use chemicals to examine their business perspectives on reforming TSCA. Only two other Senators participated in the hearing: Senators David Vitter (R-LA) and Sheldon Whitehouse (D-RI).

This hearing was one of the more interesting ones in the recent series of TSCA-related hearings. Most notably, Lautenberg mentioned in his opening remarks that some fear his soon to be introduced bill will allow regulation or elimination of chemicals based only on an assessment of hazard data. This has been a lynchpin issue, certainly for those in the chemical industry, who insist that risk assessment must be used under any new TSCA scheme and incorporate an exposure component. Lautenberg's remarks seemed to be an attempt to concede this point and reassure the industry representatives soon to testify. (And their testimony did stress the need to avoid any hazard-only approach.) His remarks also stated that he is extending "an invitation to play a part" in negotiating any final legislative proposal. If his expected bill does require risk assessments as the basis for regulation, there are many other related issues that will likely prove controversial, especially regarding what EPA is to do in the absence of reliable exposure estimates (e.g., cascading default assumptions concerning extra safety factors). As a starting point, however, given some of the rhetoric of previous hearings, this did seem to be an attempt at a major concession to the industry position. At the same time, late in the hearing, Lautenberg asked if PBT (persistent, bioaccumulative, and toxic) chemicals should be summarily banned "without a traditional risk assessment process" since the evidence is so clear that they are causing harm. The witnesses did not point out the possible inconsistency of this later statement with the need for risk assessment mentioned in the opening statement. Both at this hearing and the recent House hearing on PBT chemicals, few have mentioned that within the agreed upon international framework there is a process which functionally assumes that exposure considerations are embedded as part of the selection criteria. Here again, assumptions about the relevance of any exposures, the reliability of any exposure measurements, and assumptions about the risk implications of any measured exposures will drive debate about any attempts at restricting those chemicals' use on the international level. Witnesses included: Linda Fisher, Vice President, Safety Health and the Environment, DuPont; Howard Williams, Vice President, Construction Specialties, Inc.; Beth Bosley, Managing Director, Boron Specialties, on behalf of Society of Chemical Manufacturers & Affiliates; Dr. Neil C. Hawkins Sc.D., Vice President, EH&S and Sustainability, The Dow Chemical Company; Charlie Drevna, President, National Petrochemical and Refiners Association; and Kathy Gerwig, Vice President, Workplace Safety and Environmental Stewardship Officer, Kaiser Foundation Health Plan, Inc.

Governors, Business Groups Urge Curb On EPA Regulation Of GHGs: In separate letters dated March 10, 2010, 30 Governors and more than 90 business organizations urged the leadership of Congress to support legislative efforts to prevent EPA from regulating GHGs. In their letter, the Governors urged Congress to forestall EPA efforts to regulate because such regulation would be harmful to the states' economies in an especially critical time. The EPA efforts would cause the states a great deal in administrative time and expense, and would increase the cost of electricity and gas prices and manufactured goods. These costs would in turn harm the competitiveness of the U.S. economy. The Governors did not urge passage of particular legislation already introduced. The business groups did support such legislation. From a variety of measures already introduced or soon to be, the groups singled out as the best way to address the problem the resolution offered by Senator Lisa Murkowski (R-AK) to disapprove EPA's proposal to regulate GHGs. The resolution would take away the authority of EPA to regulate GHG.

MISCELLANEOUS

White House Issues Draft Guidance To Assess Emissions Impact Of Federal Actions: On February 23, 2010, the White House Council on Environmental Quality (CEQ) published notices announcing its issuance of draft guidance on climate effects in the form of three draft guidance documents released by the White House on February 18, 2010. 75 Fed. Reg. 8045; 75 Fed. Reg. 8046. The first draft document is intended to help federal agencies to analyze the impact of GHG emissions from federal actions that increase emissions by 25,000 tons per year or more of carbon dioxide-equivalent. According to the draft, agencies should consider emissions above this level as "an indicator that a quantitative and qualitative assessment may be meaningful to decision makers and the public." For actions that cause emissions to increase in an amount below 25,000 tons per year, CEQ "encourages Federal agencies to consider whether the action's long-term emissions should receive similar analysis." Comments are due May 24, 2010. The draft guidance is available online. A second draft document addresses categorical exclusions, actions that do not typically result in individual or cumulative significant environmental effects or impacts. Comments are due May 24, 2010. The draft guidance is available online. The third draft guidance document addresses mitigation and monitoring, and covers procedures for avoiding or minimizing the adverse environmental impacts associated with federal actions. The guidance can be found online. Comments are due April 9, 2010.

EPA Launches "Regulatory Gateway" Website: On February 18, 2010, EPA launched a website -- Regulatory Gateway -- that will give "the public additional opportunity to participate in the agency's rulemaking process... The online Rulemaking Gateway serves as a portal to EPA's priority rules, providing citizens with earlier and more concise information about agency regulations. It also allows users to search for EPA rules that relate to specific interests, including impacts on small business; children's health; environmental justice; and state, local and tribal government." According to EPA's press release, accessing Rulemaking Gateway will also provide information "as soon as work begins and provides updates on a monthly basis as new information becomes available. Time-sensitive information, such as notice of public meetings, is updated on a daily basis." The press release is available online. The Rulemaking Gateway is available online.

EPA Adds Energy Extraction To List Of Enforcement Priorities: On February 25, 2010, EPA's OECA listed six national enforcement priorities for the years 2011-2013, adding energy extracting as a priority while largely retaining existing enforcement efforts. EPA's enforcement priorities are:

  • Keeping sewage and untreated stormwater out of waterways;
  • Preventing animal waste from large farm operations from contaminating groundwater;
  • Protecting communities from toxic air pollution;
  • Investigating new source review violations at power plants, cement kilns, and glass and acid manufacturers;
  • Targeting pollution emissions from mining and mineral processing operations; and
  • Ensuring natural gas, coal mining, and petroleum operations comply with environmental laws.

More information on EPA's enforcement priority initiatives for the years 2011 through 2013 is available online.

Senate Committee Approves Nominee For EPA Inspector General Position: On March 4, 2010, the Senate Environment and Public Works Committee approved the nomination of Arthur Elkins to be EPA Inspector General. The nomination now moves to the full Senate for approval. Elkins serves as an associate general counsel in EPA's Office of General Counsel. Elkins also has served as the chief legal officer/general counsel for the Court Services and Offender Supervision Agency, a federal agency responsible for pretrial services and adult parole, probation, and supervised release in the District of Columbia. Prior to joining the federal government, Elkins was an assisting prosecuting attorney in the Cuyahoga County Prosecutor's Office in Ohio and an assistant public defender in the Cuyahoga County Public Defender Office.


 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-557-3800 • 202-557-3836 (fax) | lawbc.com
Contact • Twitter
 
Privacy Policy | Terms of Use | Cookie Policy | Attorney Advertising | Trademarks
©2020 Bergeson & Campbell, P.C.
All Rights Reserved.