Monthly Update for December 2011


Bergeson & Campbell, P.C. extends its best wishes to our many clients and friends and we wish you and your family a happy, healthy, and peaceful New Year.

In the spirit of the Season, in lieu of gifts and cards to clients, Bergeson & Campbell, P.C. has made a substantial contribution to the House of Ruth, serving the needs of women and children who are homeless and victims of domestic violence.

TSCA/FIFRA/IRIS/EPCRA

Jim Jones Designated As Acting Assistant Administrator For OCSPP: On November 22, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson announced that Jim Jones, the current Deputy Assistant Administrator for the Office of Air and Radiation, will be designated to serve as the new Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). Jones started in his role on December 1, 2011. Jones has been with EPA for over two decades and his experience includes serving four years as Principal Deputy Assistant Administrator for OCSPP and six months as acting Assistant Administrator for OCSPP.

EPA Launches IRIS Review Panel: On November 18, 2011, EPA announced that it is launching a standing committee of its Science Advisory Board (SAB) to review EPA's chemical risk assessments. 76 Fed. Reg. 71561. EPA committed to create such a panel as part of a package of reforms intended to address industry and Congressional concerns that its Integrated Risk Information System (IRIS) assessments receive inadequate scientific review. SAB is seeking experts "with knowledge in human health risk assessment and expertise in a range of disciplines including, but not limited to: public health; epidemiology; toxicology; modeling; biostatistics; and risk assessment," according to the Federal Register notice. Nominations for the new SAB panel are due January 6, 2012.

EPA Withdraws Significant New Use Rules For Two Pigments: On December 5, 2011, EPA withdrew two final significant new use rules (SNUR) for pigments to allow interested parties to comment on proposed rules for the same compounds. 76 Fed. Reg. 75794. EPA is withdrawing rules issued on October 5, 2011, covering two pigments: rutile, tin zinc, calcium-doped (CAS No. 389623-01-2) and rutile, tin zinc, sodium-doped (CAS No. 389623-07-8). The Color Pigments Manufacturers Association Inc. notified EPA that it would file adverse or critical comments on the final rule. EPA will propose SNURs for the same two chemicals. In a letter submitted to EPA's docket, J. Lawrence Robinson, President of the Pigments Manufacturers Association Inc., requested a comment period of at least 60 days "to allow for interested parties to review all supporting documentation, collect relevant information and submit meaningful comments."

New Pesticide Chemical Search Tool Launched: EPA released on November 20, 2011, Pesticide Chemical Search, a new web-based application that will allow users access to chemical-specific information from the Office of Pesticide Programs' (OPP) website and several other sources. Pesticide Chemical Search is designed to consolidate information related to pesticide chemicals (active ingredients), making it easier to find related regulatory and scientific information. The new application collects existing web pages on specific chemicals on EPA's OPP website and allows users access to this information through a single portal. Users will also be able to find the current status of a chemical and where it is in the review process. Another feature of the tool is the ability to determine if there are any dockets open for public comment for a given chemical. Other key features of Pesticide Chemical Search include: 20,000+ regulatory documents such as fact sheets and Reregistration Eligibility Decisions (RED); links to over 800 dockets in Regulations.Gov; links to important information, including pesticide tolerances in the eCFR web services that provide a wide variety and depth of information about a particular chemical; and 100,000+ chemical synonyms to power the search engine. Pesticide Chemical Search will be expanded to include pesticide product labels and other relevant information in the near future. Access to the new Pesticide Chemical Search is available online.

EPA Announces Decision To Grant TSCA Petition Regarding Hydraulic Fracking: On November 23, 2011, EPA announced its decision to grant a portion of a petition submitted by 120 public health and environmental organizations asking EPA to use its authority under the Toxic Substances Control Act (TSCA) to require companies to submit health and safety related information on chemicals used in hydraulic fracturing. While EPA has not granted the entire petition, EPA will launch a stakeholder and public engagement process to seek input on the design and scope of TSCA reporting requirements. EPA is exploring an approach that would minimize reporting burden and costs, take advantage of existing information, and avoid duplication of efforts. On August 4, 2011, EPA received a petition requesting that EPA require manufacturers and processors of oil and gas exploration and production chemicals to: (1) require toxicity testing under TSCA Section 4; and (2) maintain and submit records on these chemical substances and mixtures, and any data on environmental or health effects and exposures under TSCA Sections 8(a), 8(c), and 8(d). EPA's response follows a November 2, 2011, interim response which informed the petitioners that EPA is not granting the request to require toxicity testing under TSCA Section 4 because the petition does not satisfy the requirements of TSCA to demonstrate the need for additional testing. EPA notified the petitioners that it is partially granting the TSCA Section 8(a) and 8(d) requests and will initiate a dialogue process to seek public input on the design and scope of TSCA reporting requirements. For more information, visit online.

EPA Releases Formerly Confidential Chemical Information: On November 28, 2011, EPA made available to the public hundreds of studies on chemicals that had been treated as confidential business information (CBI). Releasing the data will, according to EPA, expand the public's access to critical health and safety information on chemicals that are manufactured and processed in the U.S. Newly available information can be found using EPA's Chemical Data Access Tool. Since 2009, 577 formerly confidential chemical identities are no longer confidential and more than 1,000 health and safety studies are now accessible to the public that were previously unavailable or only available in limited circumstances. In 2010, EPA issued new guidance outlining its plans to deny confidentiality claims for chemical identities in health and safety studies under TSCA that are determined to not be entitled to CBI status. EPA has been reviewing CBI claims in new and existing TSCA filings containing health and safety studies. Consistent with the guidance, EPA will request that the submitter voluntarily relinquish the CBI claims and make the newly available studies available to the public. EPA also challenged the chemical industry to make available information that was previously classified as CBI. To date, more than 35 companies have agreed to review previously submitted filings containing health and safety studies and determine if any CBI claims may no longer be necessary. The newly available information can be found under a new "declassified tab" using the Chemical Data Access Tool, launched in December 2010 to assist the public in retrieving chemical health and safety information submitted to EPA under TSCA. For additional information, please visit online.

B&C Posts Q&As From CDR Webinar: On November 15, 2011, Bergeson & Campbell, P.C. (B&C) posted responses to questions raised by stakeholders during the September 15, 2011, Chemical Data Reporting (CDR) rule webinar, hosted by B&C. During the September 15, 2011, webinar, which was attended by more than 300 participants, numerous issues, questions, and requests for clarification were addressed during the Q&A portion of the webinar. Many of the questions submitted, however, could not be addressed during the time allotted. In addition, parties sent in questions after the webinar was completed. B&C compiled all of these questions and developed responses, which have been reviewed by EPA staff. B&C notes that the Q&As "are intended solely as informational guidance and should not be viewed as legal advice. Although EPA staff provided feedback on the responses, the Q&A document is not an official EPA document." The Q&As are available online.

State FIFRA Issues Research & Evaluation Group Meeting: On December 5-6, 2011, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) held its semi-annual full committee meeting in EPA offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and EPA in the development of pesticide policies and regulations. More information about SFIREG is available online. A copy of the meeting handouts is available upon request by sending an e-mail to Chad Howlin. More detailed information is available online.

EPA Releases EDSP Work Plan Summary Overview: EPA released a summary overview of its work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals. The work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics. By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA hopes to prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing. Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to screen and assess these pesticides more quickly and efficiently. Development and validation of these new tools will be a multiyear process. As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to assess more quickly and cost-effectively potential chemical toxicity while minimizing the use of conventional whole animal studies. The work plan summary describes this transition and is available online.

More information on the EDSP and a copy of the full work plan are available online.

GREEN CHEMISTRY DEVELOPMENTS

DTSC GRSP Meets To Review Revised "Informal Draft" Safer Consumer Products Regulations: On November 14-15, 2011, the California Department of Toxic Substances Control's (DTSC) Green Ribbon Science Panel (GRSP) met to review DTSC's "informal draft" Safer Consumer Products Regulations (SCPR) released on October 31, 2011. Memoranda providing background information are available online. Information about the meeting can be found online. More detailed information can be found online. In a related development, the American Bar Association Section of Environmental, Energy, and Resources on December 13, 2011, convened a webinar on the SCPR. Speakers included Jeff Wong, Chief Scientist of the California DTSC, Philip Crowley, Assistant General Counsel of Johnson & Johnson, Joseph H. Guth, Ph.D., Berkeley Center for Green Chemistry, and Philip Moffet, Verdant Law PLLC. For copies of the PowerPoint presentations, please e-mail Chad Howlin at chowlin@lawbc.com.

Guidelines For Selecting Product-Related Environmental Sustainability Standards And/Or Ecolabeling Programs: The American National Standards Institute (ANSI) hosted on November 22, 2011, a webinar delivered by EPA and the General Services Administration (GSA) titled Guidelines for Selecting Product-Related Environmental Sustainability Standards and/or Ecolabeling Programs. The webinar provided an update on ongoing federal efforts to develop guidelines for federal procurement of environmentally friendly and sustainable products. According to the GSA co-chair, Brennan Conaway, and the EPA co-chair, Alison Kinn Bennett, ANSI will post on its website an article concerning this topic that will include a link to the slides from the webinar (see online). More detailed information is available online.

CAA/CWA

EPA Releases Final Integrated Review Plan For The National Ambient Air Quality Standards For Lead: On December 9, 2011, EPA released a final document entitled Integrated Review Plan for the National Ambient Air Quality Standards for Lead. 76 Fed. Reg. 76972. This document outlines EPA's plans for the review of the air quality criteria and National Ambient Air Quality Standards (NAAQS) for lead. The document has been developed as part of the planning phase for the review, which began with a science policy workshop to identify issues and questions to frame the review. Drawing from the workshop discussions, a draft integrated review plan (IRP) was prepared jointly by EPA's National Center for Environmental Assessment. The draft IRP was the subject of a consultation with the Clean Air Scientific Advisory Committee (CASAC) on May 5, 2011. The final IRP has been prepared after consideration of CASAC and public comments and presents EPA's current plans for the schedule for the entire review, the process for conducting the review, and the key policy-relevant science issues that will guide the review.

EPA Extends Greenhouse Gas Reporting Deadline By Six Months: On November 29, 2011, EPA announced its decision to delay 12 industries to report their 2011 greenhouse gas (GHG) emissions. 76 Fed. Reg. 73886. The delay only applies to industries required to begin collecting GHG emissions data in 2011. Extending the reporting deadline from March 31, 2012, to September 28, 2012, will allow those industries additional time to become accustomed to EPA's electronic greenhouse gas reporting tool (e-GGRT), according to EPA. The final rule will amend the reporting deadline at 40 C.F.R. Part 98 for the following industries:

  • Electronics manufacturing (subpart I);
     
  • Fluorinated gas production (subpart L);
     
  • Magnesium production (subpart T);
     
  • Petroleum and natural gas systems (subpart W);
     
  • Use of electric transmission and distribution equipment (subpart DD);
     
  • Underground coal mines (subpart FF);
     
  • Industrial wastewater treatment (subpart II);
     
  • Geologic sequestration of carbon dioxide (subpart RR);
     
  • Manufacture of electric transmission and distribution (subpart SS);
     
  • Industrial waste landfills (subpart TT);
     
  • Underground injection of carbon dioxide (subpart UU); and
     
  • Imports and exports of equipment pre-charged with fluorinated GHGs or containing fluorinated GHGs in closed-cell foams (subpart QQ).

Affected facilities that reported their GHG emissions to EPA for the 2010 reporting year must notify EPA through e-GGRT by March 31, 2012, that they are not required to submit their 2011 report until September 28, 2012. Facilities that are reporting for the first time in 2012 do not need to notify EPA.

EPA Announces Availability Of Data On Analytical Method: On December 14, 2011, EPA announced the availability of new data on an analytical method for the measurement of oil and grease that EPA described in its September 23, 2010, notice but did not propose to approve it for use. EPA proposed new test methods on September 23, 2010, for measuring pollutants under the Clean Water Act (CWA). The test method being considered is ASTM D7575-10 as an alternative to EPA Method 1664A, the current method for measurement of oil and grease. 76 Fed. Reg. 77742. The notice discusses how EPA is considering revising its proposed regulatory requirements for this method. Comments must be received on or before February 13, 2012.

NANOTECHNOLOGY

Congressional Nanotechnology Caucus Hosts Briefing On "Nanotech And Jobs": On November 15, 2011, the Congressional Nanotechnology Caucus hosted a briefing on the impact of nanotechnology on job creation. Topics addressed included the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers included:

  • Hilary Flynn, Lux Research;
     
  • Doug Jamison, Chief Executive Office, Harris & Harris; and
     
  • Robert D. "Skip" Rung, President and Executive Director, Oregon Nanoscience and Microtechnologies Institute.

As noted in Jamison and Flynn's slides, the discussion reinforced the view that nanotechnology is creating jobs and helping grow the economy. The U.S. is in danger of losing ground to the European Union (EU) and emerging economies, however. Rung described how state and regional organizations can be helpful in promoting the commercialization of nanotechnologies.

The presentations are extremely well done and provide some useful metrics on nano commercialization success stories and the positive impact nanotechnology has on the economy. The slides are available online.

ObservatoryNANO Posts Report On Nanotechnology EHS Landscape: ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission (EC), intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade. ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS. ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field. According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time. ObservatoryNANO identified and grouped key organizations and projects into seven major areas:

  • Research;
     
  • Knowledge Transfer and Review;
     
  • Standardization;
     
  • Guidance;
     
  • Regulation;
     
  • Public Engagement; and
     
  • Professional Bodies.

The landscaping document provides a short overview of the organizations working within each area, together with links and references to further information. More information is available online.

EPA Conditionally Registers Pesticide Product Containing Nanosilver As A New Active Ingredient: EPA announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles. In its risk evaluation, EPA used conservative assumptions, overestimating the dose of nanosilver, and maximum values for risk uncertainty factors. Because of EPA's risk concern for occupational exposure to HeiQ AGS-20 powder during mixing and loading operations, HeiQ amended its registration application, and the label now requires workers to wear personal protective equipment (PPE) and use engineering controls when handling HeiQ AGS-20 powder. As a condition of registration, EPA is requiring significant new data development requirements, including route-specific toxicity studies for occupational exposure scenarios and product characterization and stability tests to determine if nanosilver breaks away from HeiQ AGS-20. As members of the nano community know well, this is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy. More detailed information is available online.

NIOSH Science Blog Posts Entry Regarding Respiratory Protection For Workers Handling Engineered Nanoparticles: On December 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) posted an item on its Science Blog entitled "Respiratory Protection for Workers Handling Engineered Nanoparticles." The purpose of the blog item is to provide an update on the science and rationale behind NIOSH's recommendations for the use and selection of respirators against engineered nanoparticles. The article summarizes respirator performance research and respirator selection. Concerning next steps, NIOSH states that, while its research to date has been done in laboratory settings, using filtration test systems and manikins under aggressive test conditions, further research is needed in field settings and using human test subjects. According to NIOSH, "[w]ell-designed studies on face seal leakage of nanoparticles, especially workplace protection factor (WPF) studies that validate assigned protection factor (APF) levels for respirators against nanoparticles will be important," and such studies are already underway. The blog entry is available online.

EC Requests SCENIHR For Scientific Opinion On Nanosilver: The EC requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to humans, data are insufficient to carry out a full risk assessment. The EC states that indirect adverse effects on human health may occur via an increasing resistance of micro-organisms against silver, including nanosilver and silver-based compounds, which could limit the usefulness of nanosilver in medical devices and other medical applications. Furthermore, the EC states, silver can be present in different forms, and it is not clear how these different forms of silver influence its antimicrobial properties, a possible increase of antimicrobial resistance, and the healing process. The EC notes that recent reviews and publications proposed to use a combination of nanosilver and the "usual antibiotics" for the treatment of specific infectious diseases caused by resistant bacteria. The EC requests SCENIHR "to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver," and "to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms." The deadline for SCENIHR's opinion is early 2013. More information is available online.

Japan Establishes Committee On Safety Management For Nanomaterials: Japan's Ministry of Economy, Trade and Industry (METI) established a Committee on Safety Management for Nanomaterials, which was scheduled to hold its first meeting on December 2, 2011. METI states that it established the Committee "on the basis of the results obtained from the project 'Research and Development of Nanoparticle Characterization Methods' commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge." The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. According to Japan's November 30, 2011, press release, the Committee will compile an interim report "around spring to summer in 2012." More information is available online.

Proposed EU Biocidal Products Regulation Addresses Nanomaterials: On November 23, 2011, the EU Council's committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for "problematic" substances. The proposed legislation states that there is "scientific uncertainty" about the safety of nanomaterials, and "to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned." The proposed legislation calls on the EC to "regularly review the provisions on nanomaterials in the light of scientific progress." More detailed information is available online.

NGO Publishes Framework For Food And Food Packaging Products Containing Nanomaterials: As You Sow, a non-governmental organization (NGO), has published a framework providing guidelines intended for food and food packaging companies to assess exposure to and potential risks from food and food packaging products containing nanomaterials. According to As Your Sow, more than a dozen food companies, scientific organizations, and investor groups reviewed the framework, including: Kraft, McDonald's, PepsiCo, Whole Foods, and Yum! Brands; the Center for Food Safety, Consumers Union, Project on Emerging Nanotechnology, International Center for Technology Assessment, Natural Resources Defense Council, and the Technical University of Denmark; As You Sow, Calvert Investments, and the Investor Environmental Health Network. The framework offers tiered recommendations of steps companies should take and information they should obtain from their suppliers regarding the safety testing of nanomaterials and products containing nanomaterials. As You Sow recommends that, until there are "firm regulatory requirements and/or a central repository for safety data on nanomaterials, information requested in this framework should be provided to food and food packaging companies by their suppliers."

The framework:

  • Provides an introduction to key terms and issues;
     
  • Describes the current state of regulations and risks; and
     
  • Makes recommendations regarding the information companies should obtain from suppliers who offer food products and packaging that contain nanomaterials by presenting best practices from existing scientific, industry, and governmental frameworks.

Of note to users, the framework defines nanomaterials as "materials 'intentionally engineered' to take advantage of unique properties at the nanoscale -- from 1-1000 nm." As You Sow states that it is developing a survey for food manufacturers, packagers, distributors, retailers, and fast-food chains regarding their use of, and policies related to, nanomaterials in food products. As You Sow intends to release the results in mid-2012. More information is available online.

LEGISLATIVE DEVELOPMENTS

Senate Committee And Subcommittee Hold Hearing On TSCA Reform Legislation: On November 17, 2011, the Senate Environment and Public Works Committee and the Committee's Superfund, Toxics, and Environmental Health Subcommittee held a hearing on legislation intended to reform TSCA, the Safe Chemicals Act of 2011 (S. 847). Senator Frank Lautenberg (D-NJ), who introduced the legislation on April 14, 2011, and is Chair of the Subcommittee, chaired the hearing. The Safe Chemicals Act is intended to modernize TSCA to require chemical companies to demonstrate the safety of industrial chemicals and EPA to evaluate safety based on the best available science. More information is available in our April 18, 2011, memorandum online. Also, more detailed information is available online.

House Takes On Regulatory Reform: The House of Representatives recently has passed bills that in the words of the Republican majority are intended to reform the process of adopting regulations. Each of the measures seeks in one way or another to lessen the impact or regulations on small business, reduce the cost of compliance on the regulated industry as a whole, or save jobs thought to be lost to excessive government intervention. Several of these measures are considered below.

The Regulatory Flexibility Improvements Act Of 2011 (RFIA): On December 1, 2011, the House passed H.R. 527 by a vote of 263-159. The measure, authored by Representative Lamar Smith (R-TX), amends the Regulatory Flexibility Act of 1980 (RFA) to define "economic impact" with respect to a proposed or final rule as any direct economic effect on small entities from such rule and any indirect economic effect on small entities that is reasonably foreseeable and that results from such rule. The RFIA as passed requires initial and final regulatory flexibility analyses to: describe alternatives to a proposed rule that minimize any adverse significant economic impact or maximize the beneficial significant economic impact on small entities and expands elements of initial and final regulatory flexibility analyses under RFA to include estimates and descriptions of the cumulative economic impact of a proposed rule on a small entity. The RFIA revises requirements for agency notification of the Small Business Administration (SBA) Chief Counsel for Advocacy prior to the publication of any proposed rule and stipulates the agencies provide said Chief Counsel with: (1) all materials prepared or utilized in making the proposed rule; and (2) information on the potential adverse and beneficial economic impacts of the proposed rule on small entities.

Regarding review of agency actions, the RFIA would require each agency to publish in the Federal Register a plan for the periodic review of existing and new rules that have a significant impact on a substantial number of small entities to determine whether such rules should be continued, changed, or rescinded and provides for judicial review of an agency final rule for compliance with RFA requirements after the publication of such rule. Finally, the measure grants federal courts of appeal jurisdiction to review all final rules issued in accordance with RFA.

The Regulatory Accountability Act Of 2011: The Regulatory Accountability Act, H.R. 3010, was also introduced by Representative Lamar Smith. It was taken up and passed in the House by a vote of 263-167, with all Republicans supporting the measure and 19 Democrats following their lead. The measure amends the Administrative Procedure Act (APA) to revise and expand the requirements for federal agency rulemaking by requiring agencies, in making a rule, to base all preliminary and final determinations on evidence and to consider the legal authority under which the rule may be proposed, the specific nature and significance of the problem the agency may address with the rule, any reasonable alternatives for the rule, and the potential costs and benefits associated with such alternatives.

H.R. 3010 requires agencies to publish advance notice of proposed rulemaking for major rules and for high-impact rules, defined as rules having an annual cost on the economy of $100 million or $1 billion or more, respectively, which shall include a written statement identifying the nature and significance of the problem the agency may address with a rule, the legal authority under which the rule may be proposed, and a solicitation for written data and comments from interested persons.

The Accountability Act sets forth criteria for issuing major guidance (agency guidance that is likely to lead to an annual cost on the economy of $100 million or more, a major increase in cost or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or ability to compete) and expands the scope of judicial review of agency rulemaking by allowing immediate review of rulemaking not in compliance with notice requirements and establishing a substantial evidence standard for affirming agency rulemaking decisions.

Regulations From The Executive In Need Of Scrutiny (REINS): REINS was introduced by Representative Geoff Davis (R-KY), and approved by the House on December 7, 2011. The bill rewrites provisions regarding Congressional review of agency rulemaking to require Congressional approval of major rules of the Executive before they may take effect. A "major rule" is defined as any rule, including an interim final rule, that has resulted in or is likely to result in: (1) an annual effect on the economy of $100 million or more; (2) a major increase in costs or prices; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or U.S. competitiveness.

The measure provides that if a joint resolution of approval of a major rule is not enacted by the end of 70 session days or legislative days after the agency proposing the rule submits its report on such rule to Congress, the rule shall be deemed not to be approved and shall not take effect. A major rule may take effect for 90 calendar days without such approval if the President determines such rule is necessary because of an imminent threat to health or safety or other emergency, for the enforcement of criminal laws, for national security, or to implement an international trade agreement.

These three measures join the EPA Regulatory Relief Act of 2011, passed as amended in the House on October 13, 2011.

The EPA Regulatory Relief Act Of 2011: The Relief Act provides that the following rules shall have no force or effect and shall be treated as though they had never taken effect: (1) the National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters; (2) the National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers; (3) the Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units; and (4) Identification of Non-Hazardous Secondary Materials That Are Solid Waste.

A myriad of requirements are imposed on the EPA Administrator attempting to adopt new regulations to take the place of those nullified. For example, the Administrator must establish a date for compliance with standards and requirements under rewritten regulations, which can be no earlier than five years after such a regulation's effective date, after considering compliance costs, non-air quality health and environmental impacts and energy requirements, the feasibility of implementation, the availability of equipment, suppliers, and labor, and potential net employment impacts.

There are a variety of other bills pending or passed in the House that seek to impact EPA operations in one way or another. These include H.R. 1633, the Farm Dust Regulation Prevention Act of 2011, the Protecting Jobs from Government Interference Act, and the Cement Sector Regulatory Relief Act of 2011.

The three measures face the threat of veto by the President if they should pass in the Senate, a significant hurdle in itself since the Democratic majority in the Senate opposes all the bills. At the very least, the bills outlined above will continue to form the framework for the ongoing debate on whether government regulations are overly broad, impose unreasonable costs for compliance, result in lost jobs, hinder economic recovery, and hurt the U.S. trade position worldwide.

MISCELLANEOUS

NTP Holds Listening Session On Proposed Revisions To RoC Review Process: On November 29, 2011, the National Toxicology Program (NTP) held a listening session on its proposed revisions to the review process for the Report on Carcinogens (RoC). According to NTP, its proposed changes are intended to "enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner. The NTP also seeks to maintain critical elements of the existing process including external scientific and public involvement, scientific rigor, and external peer review." NTP received criticism for its 12th RoC, which it published in June 2011. The 12th RoC listed formaldehyde as a known human carcinogen, "based on sufficient evidence of carcinogenicity from studies in humans." Just a few months earlier, the National Academies of Science (NAS), which reviewed EPA's Integrated Risk Information System (IRIS) draft assessment for formaldehyde, concluded in its April 2011 report that EPA failed to justify its conclusion that formaldehyde causes specific types of leukemia. The 12th RoC also listed styrene as a reasonably anticipated human carcinogen. The Styrene Information and Research Center immediately filed suit against the Department of Health and Human Services (HHS), which includes NTP, claiming the listing "is contrary to the weight of scientific evidence and is based primarily on improper and unreviewed information and manipulation of data which further demonstrates that it is arbitrary, capricious, an abuse of discretion, and not in accordance with law." Styrene Information and Research Center v. HHS, D.C. Cir., No. 11-cv-1079. More information on NTP's proposed revisions to the RoC review process is available in our November 1, 2011, memorandum online. More detailed information is available online.

OSHA Issues National Emphasis Program (NEP) Instruction: On November 29, 2011, the U.S. Occupational Safety and Health Administration (OSHA) issued the NEP Instruction for inspecting facilities with highly hazardous chemicals (HHC) in amounts at or greater than the threshold quantities listed in 29 C.F.R. § 1910.119. Programmed inspections will be conducted in facilities that are known to OSHA as having a risk of catastrophic releases. Unprogrammed inspections will take place in Process Safety Management (PSM)-covered facilities as described in this Instruction. Programmed inspections are defined in CPL 02-00-148, Field Operations Manuals as "inspections of worksites which have been scheduled based upon objective or neutral selection criteria." Unprogrammed inspections are defined in CPL 02-00-148, Field Operations Manual as "inspections scheduled in response to alleged hazardous working conditions identified at a specific worksite." The Instruction was effective immediately.

HHS To Begin Screening 10,000 Chemicals; NIH, EPA, And FDA Collaborate To Move Science Forward: On December 7, 2011, the HHS announced it will begin screening 10,000 substances by a high-speed robotic screening system, aimed at protecting human health by improving how chemicals are tested in the United States. The compounds cover a wide variety of classifications, and include consumer products, food additives, chemicals found in industrial processes, and human and veterinary drugs. A complete list of the compounds is publicly available online. Testing these 10,000 compounds is a result of an ongoing collaboration between the National Institutes of Health (NIH), EPA, and the U.S. Food and Drug Administration (FDA), referred to as "Tox21." NIH partners include NTP, administered by the National Institute of Environmental Health Sciences (NIEHS), and the NIH Chemical Genomics Center (NCGC), part of the NIH Center for Translational Therapeutics (NCTT), housed at the National Human Genome Research Institute (NHGRI). A subset of the NTP portion of the 10,000 compound library will focus on pilot testing several formulations or mixtures of compounds, a priority area for NIEHS/NTP. The library constituents were selected after a thorough analysis of existing scientific studies, more than 200 public chemical databases, and chemical nominations received from internal and external partners. Each test compound will undergo a thorough chemical analysis to verify its identity and determine its purity, concentration, and stability. The goal of the testing is to provide results that will be useful for evaluating if these chemicals have the potential to disrupt processes in the human body to an extent that leads to adverse health effects. The development of methods for evaluating chemical toxicity has the potential to revolutionize the assessment of new environmental chemicals and the development of new drugs for therapeutic use. EPA seeks to understand the molecular basis of such chemicals to better protect human health and that of the environment. The FDA, also a partner in Tox21, emphasizes the value of this effort for the public. All testing results will be available to the public through NIH and EPA chemical toxicity databases. In addition, NCTT has created a Tox21 chemical inventory browser freely available online to provide researchers with additional information about the chemicals. For more information about Tox21, visit online. NIEHS supports research to understand the effects of the environment on human health and is part of NIH.

CEQ Issues Draft Guidance For Agencies Outlining Efficiency In Environmental Reviews: On December 13, 2011, the White House Council on Environmental Quality (CEQ) issued for comment draft guidance outlining principles for fostering efficiency and timeliness in the conduct of environmental reviews by federal agencies. 76 Fed. Reg. 77492. The CEQ guidance uses broad statements to encourage concise work and expeditious planning in the fulfillment of agency obligations under the National Environmental Policy Act. Those obligations include the performance of environmental assessments and environmental impact statements, as well as the application of categorical exclusions that allow an agency to avoid an Environmental Assessment (EA) or Environmental Impact Statement (EIS). The draft guidance addresses itself to functional activity by agencies within the existing framework of regulations. It lists nine strategies for agencies to keep in mind:

  • An EA or EIS should be concise, focused on significant issues, with proportionately little time devoted to minor issues;
     
  • An agency should first consider integrating NEPA processes into planning for development of a policy, program, management plan, or project;
     
  • An agency should use well-defined and early scoping -- the determination of what issues need to be addressed in a possible agency action;
     
  • Agencies should explore every reasonable opportunity to collaborate with each other and with state, tribal, and local governments so that environmental reviews can run concurrently rather than consecutively;
     
  • Agencies must integrate their draft EIS work with surveys and studies required by other laws or by executive orders;
     
  • Adoption of one agency's EIS, or a portion of that EIS, by another agency is a useful efficiency to consider to avoid redundancy;
     
  • Incorporation by reference is a similarly useful step to avoid redundancy;
     
  • Agency responses to public comments on a draft EA or draft EIS should be focused on environmental issues and information in comments; and
     
  • Agencies should establish clear time lines for NEPA reviews, with appropriate time limits.

Comment is due by January 27, 2012.

Canada Proposes To Designate HBCD Toxic Under CEPA: On December 9, 2011, Environment Canada and Health Canada issued a draft order designating hexabromocyclododecane (HBCD) as "toxic" under the Canadian Environmental Protection Act (CEPA). HBCD is primarily used as a flame retardant in insulating polystyrene foams, as well as in furniture, transportation seating, wall coverings, and draperies. The toxic designation would require the development, within two years of the order's issuance in final, of regulations or other risk management instruments to control releases of HBCD. A draft risk management approach published November 12, 2011, proposed regulations to prohibit the manufacture, use, sale, offer for sale, or import of the flame retardant and products that contain it, as well as its addition to CEPA's Virtual Elimination List. The draft HBCD order is open to public comment through February 8, 2012. Full text of the Canadian draft order of HBCD is available online.

2012 CDR Notice Regarding CDX Registration And Training: EPA announced on December 12, 2011, that individuals participating in reporting for the 2012 CDR may now register on EPA's Chemical Data Exchange (CDX). To register, follow the instructions from the CDX website to establish your user name and password and to add the program "Submissions for Chemical Safety and Pesticide Programs (CSPP)." If you already have a CDX registration, you may log in to CDX and add the CSPP program. The eCDRweb reporting tool will be available through CDX in early January. For further information, see the CDR website. EPA is also making additional training available to help prepare to report for the 2012 CDR. The first three (of a total of seven) on-line CDR training modules are now available. Those modules explain the basic requirements of the new CDR published in August 2011, who should report, and how to report. The remaining four training modules will be added during the next few weeks. They will cover registering with CDX, using the eCDRweb reporting tool, joint submissions, and byproduct chemical substances.

NTP Issues Draft Technical Reports: On December 14, 2011, NTP announced the availability of seven draft technical reports summarizing carcinogenicity and toxicity tests it has conducted. 76 Fed. Reg. 77832. As of December 13, 2011, draft reports were available for n,n-dimethyl-p-toluidine (CAS No. 99-97-8), ß-picoline (CAS No. 108-99-6); trimethylolpropane triacrylate (CAS No. 15625-89-5); and 3'-azido-3'-deoxythymidine (CAS No. 30516-87-1). All seven draft technical reports are expected to be available online by December 19, 2011. A meeting on the reports is scheduled for February 8-9, 2012. Comment is due by January 25, 2012.

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

 
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