Monthly Update for February 2011
EPA Issues Technical Correction On TSCA Section 4 Test Rule On Certain High Production Volume Chemicals: On January 26, 2011, the U.S. Environmental Protection Agency (EPA) issued a technical correction to a Toxic Substances Control Act (TSCA) Section 4 final rule EPA issued on January 7, 2011. 76 Fed. Reg. 4549. The test rule concerns testing of certain high production volume (HPV) chemical substances to obtain screening level data for health and environmental effects and chemical fate. EPA discovered a typographic error concerning the required date of submission for letters of intent to test and exemption applications. The correct date by which EPA must receive a letter of intent to test or an exemption application from manufacturers (including importers) in Tier 1 is March 9, 2011 (not February 7, 2011, as stated in Section 799.5087, paragraphs (c)(2) and (c)(4), of the initial publication).
EPA Proposes To Declare A Prion As A Pest Under FIFRA: On January 26, 2011, EPA proposed to declare a prion, i.e., proteinaceous infectious particle, a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to include expressly prion within the regulatory definition of pest. 76 Fed. Reg. 4602. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a prion-related product) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a Section 3 registration, Section 24(c) registration, or a Section 18 emergency exemption before it can be distributed or sold in the United States. The proposed rule would codify EPA’s current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. Comments must be received on or before March 28, 2011.
EPA Proposes Rule Amending Human Subjects Protections Rule: On February 2, 2011, EPA issued a proposed rule that would revise EPA’s February 6, 2006, final rule concerning protections for subjects in human research. 76 Fed. Reg. 5735. According to EPA, the proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The proposed amendments would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the proposed amendments would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). Comments are due on or before April 4, 2011. A more detailed memorandum is available online.
EPA Removes Confidentiality Claims On Studies Of Chemicals Submitted Under TSCA: EPA has notified five companies that the identities of 14 chemicals associated with a number of health and safety studies submitted under TSCA and claimed as confidential are not eligible for confidential treatment. The action comes as part of Administrator Jackson’s continued efforts to increase public access to chemical information to help Americans understand risks posed by chemicals in our environment. EPA put in place last year a plan to review confidentiality claims for the name of chemicals addressed in health and safety studies. Under the new procedures, EPA is moving to declassify many chemical identities so they are no longer confidential. According to EPA, more chemical names connected with health and safety studies will be released in the future. EPA plans to deny confidentiality claims for chemical identity in health and safety studies provided to the Agency under TSCA unless the chemical identity contains process or mixture information that is expressly protected by the law. The reports are made available on EPA’s website, but when the identity of the chemical has been claimed confidential by a company, the name of the chemical has been removed from the copy of the report that is made public. EPA has begun reviewing past confidential business information (CBI) claims for chemical identity in health and safety studies. Where EPA determines that the information is not eligible for confidential treatment under the law, the Agency will notify companies of the determination and that EPA will make the information public on the 31st day after receiving the determination unless the company challenges the disclosure in federal court. More information on EPA’s efforts to increase transparency, for a copy of the letter, and additional information on the notifications on declassifications is available online.
EPA Requests Comment On ICR For TRI: On February 11, 2011, EPA requested comment on several changes to the Information Collection Request (ICR) for Form R used by companies for Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 Toxics Release Inventory (TRI) Reporting. 76 Fed. Reg. 7841. EPA is soliciting comments regarding methodology revisions documented in the peer-reviewed technical document titled, “Revising TRI Burden to Ratio-Based Methodology,” which is available through the docket. The revised methodology, Ratio-Based Burden Methodology (RBBM), simplifies calculations, imposes internal consistency, and enhances transparency while retaining the components of the existing methodology and maintaining the overall total burden estimate as a starting point. EPA invites comments regarding evidence that would quantify the ratio of PBT/non-PBT burden for the TRI reporting community overall. Additionally, EPA is seeking comments on an alternate instruction for the revision of Form R Section 8.11 in which facilities report ongoing and newly implemented source reduction activities. The alternate instructions would limit the scope of “ongoing source reduction activities” to those implemented in the previous five years. EPA is also proposing to make several changes to the TRI reporting forms and associated instructions, but these changes are estimated to have a negligible effect on form unit burden. Comments are due by April 12, 2011.
Senate Subcommittee Holds Hearing On Assessing The Effectiveness Of U.S. Chemical Safety Laws: On February 3, 2011, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled “Assessing the Effectiveness of U.S. Chemical Safety Laws.” Subcommittee Chair Frank Lautenberg (D-NJ) last year introduced the Safe Chemicals Act of 2010, a bill that would have reformed TSCA by shifting the burden of proof to industry to show chemicals are safe, rather than EPA proving that they pose a risk. More information, including links to the written testimony of the witnesses, is available online. A more detailed memorandum is available online.
Respondents To House Committee Identify FIFRA And TSCA Regulatory Actions As Impediments To Job Growth: On February 10, 2011, during a hearing on “Regulatory Impediments to Job Creation,” the House Committee on Oversight and Government Reform released a preliminary staff report entitled Assessing Regulatory Impediments to Job Creation. In December 2010, Committee Chair Darrell Issa (R-CA) sent letters to over 150 businesses, industry organizations, and think tanks asking for examples of existing and proposed regulations that have negatively impacted job growth, as well as suggestions on reforming identified regulations and the rulemaking process. Issa received almost 2,000 pages in response, and the Committee staff prepared the preliminary report based on the responses. The report is available online. A more detailed memorandum is available online.
GREEN CHEMISTRY DEVELOPMENTS
DTSC Reconvenes Green Ribbon Science Panel To Discuss Safer Consumer Product Alternatives Regulations: The California Department of Toxic Substances Control (DTSC) has delayed implementation of its “Safer Consumer Product Alternatives” (SCPA) regulations following California’s Secretary for Environmental Protection Linda S. Adam’s letter stating that “DTSC has agreed to take additional time to be responsive to the concerns raised and revisit the proposed regulations.” Instead, DTSC and its regulation development team has reconvened the Green Ribbon Science Panel (Panel) to provide guidance on the SCPA regulations. To this end, the Panel held a teleconference on February 4, 2011, to discuss strategies for providing advice to DTSC. No substantive issues regarding the regulations were discussed, however. DTSC intends to post on its website shortly a sound file of the Panel’s teleconference. The next meeting of the Panel is tentatively scheduled for May 5-6, 2011, in Sacramento. Materials from the teleconference are available online.
Environmental Science & Technology Article Reviews History Of Nanosilver And Policy Implications: On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History: Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954. The article states that 53 percent of EPA-registered biocidal silver products likely contain nanosilver and most of the applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles. The authors state: “The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term ‘nano.'” More information is available online.
EU-OSHA Announces Control Banding Tool For Nanomaterials: On January 25, 2011, the European Agency for Safety and Health at Work (EU-OSHA) announced that French Agency for Environmental and Occupational Health Safety (ANSES) experts have developed a control banding tool specific to nanomaterials that can potentially be used in any work environment in which nanomaterials are manufactured or used. With control banding, new products are classified into “bands,” which are defined after comparison with the hazard level of known and/or similar products, while taking into account the assessment of exposure at the work station. The process combines a qualitative risk assessment with a risk control band and proposes minimum collective preventive measures to be implemented that are consistent with the estimated level of risk. EU-OSHA notes that, “n particular, the proposed tool is especially adapted to [small- and medium-sized enterprises (SME)] which do not necessarily have at their disposal the metrological characterisation equipment or detailed toxicological studies required for a proper risk assessment process.”
According to ANSES, the control banding tool is subject to the following limitations:
- This tool is intended to be applied only to routine handling and use of materials at the work station, as part of the company’s normal operations;
- It is suitable for any type of nanomaterial, provided that the quantities involved are neither too diluted, nor in too great a volume;
- Control banding can be used only to determine the risks to health. This approach does not address safety risks (fire/explosion risk), nor risks to the environment; and
- It is essential for the user of the control banding tool to be qualified adequately in chemical risk prevention (e.g., chemistry, toxicology), nanoscience, and nanotechnology. Using control banding without expertise, critical outlook, or support may lead to false assumptions and therefore to unsuitable choices concerning preventive measures, which could put exposed people at risk.
More information is available online.
Hohenstein Institute Finds Antibacterial Textiles Containing Nanosilver To Be Safe: The Hohenstein Institute announced on January 10, 2011, that it completed a field study of the effect of antibacterial clothing containing nanosilver on skin flora and microclimate. According to the Institute, natural skin flora were unaffected, even after long periods of wear. A total of 60 healthy volunteers participated in the six-week study. Special t-shirts were made for the study, with an antibacterial treatment on one side (verum), while the other half served as a non-antibacterial placebo. Researchers found that the skin flora and microclimate of healthy skin remained unaffected by the antibacterial t-shirts that were worn next to the skin: no damage to the skin flora could be detected, i.e. no change to the total number of bacteria on the skin or variation in the range of bacteria. The researchers concluded that the antibacterial textiles could, therefore, be classified as safe. The researchers noted that, nevertheless, the antibacterial textiles are effective against bacteria entering the fabric in perspiration, as shown in previous studies. The researchers intend to submit their data for publication in an internationally regarded specialist dermatology journal. More information is available online.
EC Announces Fourth Annual Nanotechnology Safety For Success Dialogue Workshop: The European Commission (EC) announced that it will hold the fourth annual Nanotechnology Safety for Success Dialogue Workshop on March 29-30, 2011, in Brussels, Belgium. According to the EC, many market modelers identify nanotechnologies as drivers of economic growth, and as a consequence, many governments have adopted ambitious plans intended to ensure the commercial success of nanotechnologies. At the same time, the number of potential and real applications is increasing rapidly. The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). A number of regulatory developments have taken place while the science was also advancing. The EC is convening 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.
Registration to participate on location or via web streaming is open until March 1, 2011. More information is available online.
NNI Announces Release Of Regional, State, And Local Initiatives Workshop Report: The National Nanotechnology Initiative (NNI) has announced the release of the report for its April 2009 regional, state, and local (RSL) initiatives. According to NNI, the goals of the workshop and the report are “to advance development of nanotechnology research, education, infrastructure, commercialization, and positive societal outcomes by exploiting synergies between the various regional, state, and local initiatives; by promoting the sharing of information and resources; and by developing mechanisms for cross-sector interactions.” With stakeholder input from government, academia, industry, and RSL initiatives across the country, the workshop report outlines mechanisms for information exchange and improved collaboration among all sectors engaged in nanotechnology. More information is available online.
ISO Adopts Standard For Inhalation Toxicity Testing For Nanoparticles: On January 27, 2011, the International Organization for Standardization (ISO) announced the availability of a new standard, ISO 10808:2010, entitled “Nanotechnologies — Characterization of Nanoparticles in Inhalation Exposure Chambers for Inhalation Toxicity Testing.” The standard is intended to ensure that the results of inhalation toxicity tests of airborne nanoparticles are reliable and harmonized worldwide. According to ISO, the standard “establishes a battery of inhalation toxicity testing chamber monitoring, including a differential mobility analyzing system (DMAS), for determining particle number, size, size-distribution, surface area and estimated mass dose, as well as morphological examination using transmission electron microscopy (TEM) or scanning electron microscopy (SEM) equipped with an energy dispersive X-ray analyzer (EDXA) for chemical composition.” More information is available online.
South Korea Includes Nanosubstances In Ten-Year Plan: The South Korean Ministry of Environment released on January 18, 2011, the National Chemicals Control Basic Plan, which it intends to help it implement the United Nations’ sustainable chemical control rules under the 2006 Strategic Approach to International Chemicals Management (SAICM). According to the Ministry, the Plan will reduce the amount of human carcinogens released into the environment annually by 32 percent by 2020, and will expand the national toxicity information database by 2020 to cover 34,000 chemical substances, or 80 percent of some 43,000 known to be in circulation, up from the current level of 15 percent. Under the Plan, nanosubstances are among priority chemicals that will be subject to in-depth hazard assessment, exposure analysis, and safety studies. More information is available online.
The Netherlands Will Require Nanotechnology Development To Include Investment In Risk Analysis: On January 31, 2011, State Secretary for Infrastructure and the Environment, Joop Atsma, announced that joint investments in the development of nanotechnology made by the public and private sectors in the Netherlands must devote at least 15 percent of the investment to risk analyses. According to a spokesperson, the new requirement includes an €80 million ($110.4 million) investment approved by the previous government and matched by the private sector. The independent Committee for Societal Dialogue on Nanotechnology recently released a report that found citizens have a positive attitude about the opportunities offered by nanotechnology, but are concerned about the risks.
NNI Releases 2011 Strategic Plan: During the week of February 7, 2011, the NNI and the White House Office of Science and Technology Policy (OSTP) released the 2011 NNI Strategic Plan. According to NNI, the Plan retains the “overall vision,” four goals, and eight program component areas outlined in the previous edition of the Plan, which was released in December 2007. For the first time, the Plan includes specific objectives under each goal, outlining concrete steps that NNI member agencies will take toward collectively achieving the NNI vision and goals. NNI member agencies will use the Plan to guide the coordination of their research, training programs, and resources. NNI states that the Plan incorporates a broad rage of stakeholder input obtained through NNI-sponsored workshops, a formal Request for Information published in the Federal Register, and the NNI Strategy Portal website. The Plan is available online.
EPA Seeks Comment On Vapor Intrusion As Component Of HRS: On January 31, 2011, EPA solicited stakeholder input regarding a potential addition of a vapor intrusion component to the Hazard Ranking System (HRS). 76 Fed. Reg. 5370. In a May 2010 report (EPA’s Estimated Costs to Remediate Existing Sites Exceed Current Funding Levels, and More Sites Are Expected to Be Added to the National Priorities List, GAO Report to Congressional Requesters, GAO-10-380, May 2010), the Government Accountability Office (GAO) concluded that if vapor intrusion sites are not assessed and, if needed, listed on the National Priorities List (NPL), there is the potential that contaminated sites with unacceptable human exposure will not be acted upon. GAO recommended that EPA determine the extent to which it will consider vapor intrusion in listing NPL sites and how this will affect the number of NPL sites listed in the future. The HRS is Appendix A to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated on July 16, 1982, pursuant to Section 105(a)(8)(A) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). The HRS is the principal mechanism EPA uses to list sites on the CERCLA NPL. EPA is considering adding a new screening mechanism to the HRS enabling sites with vapor intrusion contamination to be evaluated for placement on the NPL. The potential addition would enable the HRS directly to consider human exposure to contaminants that enter building structures through the subsurface environment. According to EPA, vapor intrusion is a concern because concentrations of vapors can rise to a point where the health of residents or workers in those buildings could be at risk. Sites on the NPL that have subsurface contaminant intrusion problems were placed on the NPL by evaluation of pathways other than a contaminant intrusion pathway. EPA intends to conduct public outreach activities, including facilitating public listening sessions, providing public information documents, and establishing a website with more information regarding this potential addition to the HRS. EPA requests comments only regarding this potential addition to the HRS, and is not considering changes to the remainder of the HRS. EPA will hold three listening sessions to allow interested parties to present feedback on the potential HRS addition. EPA welcomes the input that will be provided to the Agency by listening session participants. This input will be considered by the Agency as it determines the need for and nature of the addition to the HRS. Comments are due on or before April 16, 2011. The first listening session will be held in Arlington, VA on February 24, 2011. Please go online for specific information.
In a related development on February 8, 2011, EPA issued a notice announcing an ICR on regulatory burden the inclusion of vapor intrusion is expected to have on the Superfund HRS process. 76 Fed. Reg. 6783. Comments are due by April 11, 2011.
EPA Issues Notice For Public Meeting On Environmental Justice Considerations For Drinking Water Regulatory Efforts: On February 15, 2011, EPA announced it is hosting a public meeting to discuss and solicit input on environmental justice considerations related to several upcoming regulatory efforts. 76 Fed. Reg. 8674. Regulatory efforts include the long-term revisions to the Lead and Copper Rule (LCR) and the third Regulatory Determinations from the drinking water Contaminant Candidate List 3. EPA recently announced its intentions to develop drinking water regulatory actions for perchlorate and carcinogenic volatile organic compounds (VOC). The public meeting will be held in Washington, DC on Thursday, March 3, 2011, from 10:00 a.m. to 5:00 p.m. (Eastern).
EPA Releases Final Document Related To Secondary National Ambient Air Quality Standards For Oxides Of Nitrogen And Sulfur: On February 15, 2011, EPA’s Office of Air Quality Planning and Standards (OAQPS) announced the availability of a document titled, Policy Assessment for the Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Sulfur (Policy Assessment). 76 Fed. Reg. 8735. The Policy Assessment contains staff analyses of the scientific bases for alternative policy options for consideration by EPA prior to rulemaking.
ECHA Revises Number Of CLP Notifications Received: On January 18, 2011, the European Chemicals Agency (ECHA) reported that it had misstated the number of substances for which it received classification and labeling notifications at the beginning of the year under the European Union’s (EU) regulation on the classification, labeling, and packaging (CLP) of substances. Instead of receiving notifications for 24,529 substances, notifications had in fact covered 107,067 substances. The number of individual notifications remained the same at 3,114,835. ECHA said a number of files containing bulk submissions of substance classifications had been counted as single notifications. ECHA reported that it will publish a public inventory of the CLP notifications in May. More information on the EU’s CLP Regulation is available online.
EC Issues Guidance For Applying Exemption To REACH Ban: On January 28, 2011, the EC published a technical guidance on how users of chemicals can apply for exemptions to substance bans imposed under the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation. These substances can continue to be used in specific applications only if companies can show that it is impossible to substitute for them. Companies must also demonstrate that the substances can be used safely, or that there is a strong socioeconomic case for their continued use. Under the guidance, continued use can be authorized only after a further complex process. A committee convened by the ECHA will consider applications and recommend a final decision to be made by the EC. The guidance was slated for publication before the end of 2008, but it was delayed by a dispute with the EC about the information that applicants for authorization should provide. The guidance is available online.
Recent Developments Concerning Calculating SVHCs In Articles: Under REACH, the identification of a substance as a substance of very high concern (SVHC) and its inclusion on the Candidate List is the first step of the authorization procedure. Companies may have immediate legal obligations following such inclusion which are linked to the listed substance on its own, in preparations, and articles. Beginning June 1, 2011, producers, importers, and suppliers of articles must notify ECHA of the presence in articles of SVHCs that have been on the Candidate List for at least six months. ECHA recently held a technical meeting that focused on two approaches for calculating the 0.1 percent threshold concentration. The first approach is outlined in the current guidance, available online, and is supported by the EC. Under this approach, notification is required when all conditions of Article 7(2) are met:
- The substance is included in the Candidate List for authorization; and
- The substance is present in all articles produced or imported by one actor in an amount totaling over one ton per year (per producer or importer); and
- The substance is present in articles above a concentration of 0.1 percent weight-by-weight (w/w).
If, however, one or both of the following conditions are met, no notification is required:
- The producer or importer can exclude exposure of the substances to humans or the environment during normal or reasonable foreseeable conditions of use, including disposal;
- The substance has already been registered for that use.
The second approach is supported by six dissenting member states and Norway, and is noted in footnote 4 of the current guidance. The member states and Norway question the application of the 0.1 percent threshold to the entire article, rather than the individual articles, parts, or materials used to create a complex article.
During the technical meeting, industry representatives, enforcement authorities, and non-governmental organizations (NGO) presented comments concerning the application of each approach. No final conclusion about the approaches was made.
Following the technical meeting, and before the February 7-9 meeting of the Competent Authorities for REACH and Classification and Labeling (CARACAL), the EC distributed a summary of a new legal opinion from its legal services department. The EC maintains that the 0.1 percent threshold applies to the article as produced or imported, or as supplied.
After the CARACAL meeting, one member state representative stated that the member state had decided to support the EC’s position “from a practical viewpoint.” A spokesperson for a dissenting member state commented that the EC’s summary of the new legal opinion raised questions. As an example, the EC’s summary states: “The individual components cease to have an autonomous function once they are integrated into a complex article; it is the complex article that presents the function intended by the finished product.” The spokesperson noted that the REACH definition of articles discusses function, not “component” nor “autonomous.”
If the issue is unresolved, ECHA could update the articles guidance, and again note the dissenting view in a footnote. The Candidate List of substances is available online.
House Republicans Target EPA: Republicans in the first session of the 112th Congress are moving to scale back or eliminate a variety of administration programs to fulfill campaign promises to cut spending, reduce regulations that they claim are stifling business and innovation, and, as a result, create jobs. One of the agencies being subjected to close scrutiny is EPA. The Republicans are moving on at least three fronts with regard to EPA: jurisdiction, funding, and oversight.
EPA Funding: The funding issue arises now because the federal government is operating under a temporary spending resolution for fiscal 2011 that was approved by Congress in December. That resolution expires on March 4, 2011, and Congress is considering at what levels to fund the government for the balance of fiscal 2011, ending on September 30, 2011, as well as starting to consider funding for 2012. After the midterm election victory in the House, Republicans are looking to cut the funding for 2011. On February 9, 2011, Representative Harold Rogers (R-KY), Chair of the House Appropriations Committee, released a partial list of proposed cuts to amounts previously requested by President Obama. The proposed cuts include the following with respect to EPA:
- Unspecified: $1.6B
- Energy Star: $7.4M
- GHG Reporting Registry: $9M
- Cap and Trade Technical Assistance: $5M
- State and Local Air Quality Management: $25M
- Clean Water State Revolving Fund: $700M
- Drinking Water State Revolving Fund: $250M
- Brownfields: $48M
These proposed cuts, if enacted, would leave EPA with approximately 28 percent less funding than in 2010, with the amount available closer to the funds for EPA in 2009. By comparison, the cuts to EPA from the fiscal 2011 request are the third largest of the cuts Representative Rogers proposed. Only the cuts to the Jobs Training Program and the GSA Federal Buildings Fund are larger. For many conservative Republicans, even these cuts are inadequate.
EPA Jurisdiction: A number of Republicans, as well as Democrats from affected states, are moving again in the first session to either abolish or suspend the authority of EPA under the Clean Air Act (Act) to regulate greenhouse gas emissions (GHG). EPA claims science has given it the justification, and the Supreme Court has given it the authority, to regulate carbon dioxide as a pollutant and impose regulations governing virtually every aspect of American business and our daily life almost down to our lawn mowers. The Energy Tax Prevention Act was drafted primarily by Representative Fred Upton, (R-MI), Chair of the House Energy and Commerce Committee, and Representative Ed Whitfield (R-KY), Chair of the Energy and Power Subcommittee, with the participation of Senator James Inhofe (R-OK), the ranking member of the Senate Committee on Environment and Public Works. It was made available in discussion draft form on February 2. The proposal defines GHG to include: (1) water vapor; (2) carbon dioxide; (3) methane; (4) nitrous oxide; (5) sulfur hexafluoride; (6) hydrofluorocarbons; (7) perfluorocarbons; and (8) any other substance subject to, or proposed to be subject to, regulation, action, or consideration under this Act due to concerns regarding possible climate change. Concerning these substances, the limitation on EPA activity is straightforward and specific: “The Administrator may not, under this Act, promulgate any regulation concerning, take action relating to, or take into consideration the emission of a green house gas due to concerns regarding possible climate change. [Section 330(b)(1)(A)].” Under the Act, GHGs are not regarded as air pollutants under CAA Section 302(g), although they may be so considered for concerns other than possible climate change. The Republican proposal goes on to repeal numerous EPA actions relating to permitting and prevention of deterioration programs and related matters, including the Endangerment and Cause or Contribute Findings for Greenhouse Gases.
The legislation has many other provisions relating to the regulation of automobiles and other effects of actions on state powers.
ATSDR Introduces Toxic Substances Web Portal: The Agency for Toxic Substances and Disease Registry (ATSDR) reached out recently to promote its newly redesigned Toxic Substances Web Portal. The portal is intended to provide access to the latest research and other information about how toxic substances can affect health. The portal provides four ways to search for information. More information is available online.
President Obama Issues Executive Order To Ensure Economic Growth: On January 18, 2011, President Obama issued an Executive Order requiring federal agencies to review and revise existing regulations that could hinder economic growth. The Executive Order requires federal agencies to review existing regulations to determine which could be eliminated or revised to spur economic growth. The Executive Order requires federal agencies to promote “coordination, simplification, and harmonization” of regulations through better cross-department coordination. It also requires federal agencies to submit to the Office of Information and Regulatory Affairs (OIRA), which is part of the Office of Management and Budget OMB), within 120 days a plan to review periodically existing regulations to determine whether they should be modified, streamlined, expanded, or repealed. Agencies are required to identify rules that may be “outmoded, ineffective, insufficient, or excessively burdensome.” The Executive Order encourages agencies to specify performance objectives, providing industry greater flexibility. It also encourages agencies to consider alternatives to direct regulation, such as economic incentives, whenever feasible. The January 18, 2011, Executive Order largely restates the requirements of Executive Order No. 12,866, signed in 1993 by President Bill Clinton, which required federal agencies to better coordinate regulations and provide more opportunities for public participation in the rulemaking process. A copy of the Executive Order is available online.
FDA Proposal Responds To President Obama Order: The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a “plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.” See FDA News Release, “FDA to improve most common review path for medical devices” (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of medical device reviews by CDRH.
The CDRH Plan, as proposed last August, outlines proposals for more stringent regulation, particularly regarding postmarket clinical trials. The Plan was modified prior to publication and in fact is not yet complete, since CDRH is giving the Institute of Medicine time to comment on seven recommendations prior to a final decision, and CDRH is also planning a public meeting in April to get feedback on two other proposals. The reason for the changes to the Plan, and its publication prior to issuance in final, can be explained in part by an attempt to comply with an Executive Order, issued by the White House on January 18, 2011 (see related item above), and discussed in the Wall Street Journal in an Op Ed piece. The Executive Order is available online and the Wall Street Journal Op Ed piece is available online.
The Executive Order provides in part:
(b) This order is supplemental to and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866 of September 30, 1993. As stated in that Executive Order and to the extent permitted by law, each agency must, among other things: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
The revised CDRH Plan seemingly would do just that. In its News Release, CDRH highlights three of the proposals that should make it easier for industry to get products to market and protect jobs:
- Streamlining the “de novo” review process for certain innovative, lower-risk medical devices;
- Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and
- Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.
The balance of the 25 proposals would clarify further the application of rules and requirements, address internal staffing needs and training, improve knowledge management, and seek to improve other programs, such as the Investigational Device Requirements. As reflected in press reports, industry spokespersons were complimentary regarding the CDRH efforts to comply with the Executive Order, while public advocacy groups were concerned that CDRH was trying to win a popularity contest.
The CDRH Plan of Action for Implementation of 510(k) and Science Recommendations is available online.
EPA Makes Staff Announcements: On January 14, 2011, Administrator Jackson announced that Pete Silva, Assistant Administrator for the Office of Water, will leave EPA on February 12, 2011, and return to California. Nancy Stoner, EPA Deputy Assistant Administrator for the Office of Water, will serve as Acting Assistant Administrator. Administrator Jackson also announced the appointment of Bicky Corman as EPA Deputy Associate Administrator for the Office of Policy. Corman has managed environmental and policy issues at the local and federal levels and previously served at EPA, the Department of Justice, the U.S. Senate, and the District of Columbia Department of the Environment. Additionally, Joel Beauvais joined EPA as Senior Advisor in the Office of General Counsel. Most recently, Beauvais served on the House Committee on Energy and Commerce Subcommittee on Energy and Environment.
EPA Submits Draft Hydraulic Fracturing Study Plan To Independent Scientists For Review: On February 8, 2011, EPA submitted its draft study plan on hydraulic fracturing for review to the Science Advisory Board (SAB), a group of independent scientists. Natural gas plays a key role in our nation’s clean energy future and the process known as hydraulic fracturing is one way of accessing that vital resource. EPA scientists, under this Administration and at the direction of Congress, are undertaking a study of this practice to better understand any potential impacts it may have, including on groundwater. EPA announced its intention to conduct the study in March 2010 and use the best available science, independent sources of information, a transparent, peer-reviewed process, and with consultation from others. Since then, EPA has convened public meetings across the country and has developed a draft plan for moving forward with the study. The scope of the proposed research includes the full lifespan of water in hydraulic fracturing, from acquisition of the water, through the mixing of chemicals and actual fracturing, to the post-fracturing stage, including the management of flowback and produced or used water and its ultimate treatment and disposal. The SAB plans to review the draft plan March 7-8, 2011. A copy of the draft study plan and additional information is available online.
IC2 Developing Priority Chemicals Database: On January 26, 2011, environmental officials from ten state and local governments announced the creation of the Interstate Chemicals Clearinghouse (IC2), which intends to:
- Avoid duplication and enhance efficiency and effectiveness of state, local, and tribal initiatives on chemicals through collaboration and coordination;
- Build agency capacity to identify and promote safer chemicals and products; and
- Ensure that state, local, and tribal agencies, businesses, and the public have ready access to high quality and authoritative chemicals data, information, and assessment methods.
IC2 projects include developing an online, searchable database that will combine the lists of priority chemicals developed by individual IC2 member states. Members as of January 26, 2011, include the California Environmental Protection Agency; Connecticut Department of Environmental Protection; Massachusetts Department of Environmental Protection; Michigan Department of Environmental Quality; Minnesota Pollution Control Agency; New Jersey Department of Environmental Protection; New York Department of Environmental Conservation; Oregon Department of Environmental Quality & Oregon Health Authority; METRO Regional Government (Portland, Oregon); and Washington Department of Ecology. More information on IC2 is available online.