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April 1, 2012

Monthly Update for April 2012

Bergeson & Campbell, P.C.

Bergeson & Campbell, P.C. (B&C) would like to remind its clients and friends that on April 18, 2012, from 1:30 – 3:30 p.m. (EDT), B&C and The Acta Group, L.L.C. will hold a complimentary webinar on the Occupational Safety and Health Administration’s (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012.


EPA Revokes TSCA Section 4 Testing Requirements For Certain High Production Volume Chemical Substances: On March 16, 2012, the U.S. Environmental Protection Agency (EPA) revoked certain testing requirements for six chemical substances and all testing requirements for four chemical substances. 77 Fed. Reg. 15609. EPA is reportedly basing its decision to take this action on information received since publication of the first test rule for certain high production volume chemical substances (HPV1). HPV1 established testing requirements for ten chemical substances: acetyl chloride; imidodicarbonic diamide; methane, isocyanato-; urea, reaction products with formaldehyde; 9,10-anthracenedione; 1-chlorododecane; phenol,4,4′-methylenebis[2,6-bis(1,1-dimethylethyl )]-; methanesulfinic acid, hydroxyl-, monosodium salt; benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-c yclohexadien-1-ylidene]methyl]phenyl]amino]-; and C.I. solvent black 7. On the effective date of the direct final rule, persons who export or intend to export the four chemical substances for which all the testing requirements are revoked are no longer subject to Section 12(b) of the Toxic Substance Control Act (TSCA) export notification requirements triggered by HPV1. The direct final rule is effective May 15, 2012, without further notice, unless EPA receives adverse comment in writing, or a request to present comment orally, on or before April 16, 2012. If EPA receives adverse comment, or a written request for an opportunity to present oral comments, EPA will publish withdrawal of the direct final rule, and propose a rule designed to achieve the same result.

EPA Schedules Public Meeting On HPV Test Rule: On April 9, 2012, EPA announced that it will hold a public meeting to give the public an opportunity to comment on a proposed test rule for 23 HPV chemical substances and a significant new use rule (SNUR) for another 22 HPV chemical substances under TSCA. 77 Fed. Reg. 21065. The test rule would require manufacturers and processors to develop screening-level health, environmental, and fate data based on the potential for substantial exposures of workers and consumers to the 23 HPV chemical substances. The SNUR component of the rule would require persons to file a significant new use notice (SNUN) with EPA prior to manufacturing, importing, or processing any of the 22 HPV chemical substances for use in a consumer product or for any use, or combination of uses, that would be reasonably likely to expose 1,000 or more workers at a single-corporate entity to the chemical substances. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The opportunity to present oral comment was offered in the proposed rule and, in response to that offer, a request to present oral comments was received. The meeting will be held on Wednesday, May 16, 2012, from 1:30 p.m. to 5 p.m. Requests to participate in the meeting must be received on or before May 15, 2012.

EPA Has New Pesticides And Consumers Resource Directory On EPA.Gov: EPA announced that it has a new resource directory about pesticides for consumers online. The new resource directory extracts information from existing consumer information about pesticides currently online. It includes information about pesticide uses, consumer alerts, illegal pesticides, integrated pest management, safe pesticide use, protecting children and pets, and information for teachers and students. The new resource directory is designed to assist consumers find the information they seek quickly.

EPA Promulgates SNUR For Infused Carbon Nanostructures: On April 4, 2012, EPA promulgated, through a direct final rule, SNURs for 17 chemical substances that were the subject of premanufacture notices (PMN). 77 Fed. Reg. 20296. Two of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.

EPA Releases Proposed SNURs And Test Rule: EPA released in March, proposed SNURs that would require companies to report all new uses of five groups of chemicals, including in domestic and imported products and articles, to give EPA the opportunity, if warranted, to prohibit or limit the activity. The chemicals, which were part of the existing chemical action plans that EPA released in 2009 through 2011, are polybrominated diphenylethers (PBDE) (77 Fed. Reg. 19862, comments due June 1, 2012); hexabromocyclododecane (HBCD) (77 Fed. Reg. 17386, comments due May 25, 2012); benzidine dyes (77 Fed. Reg. 18752, comments due June 26, 2012); short-chain chlorinated paraffins (SCCP) (77 Fed. Reg. 18752, comments due June 26, 2012); and di-n-pentyl phthalate (DnPP) (77 Fed. Reg. 18752, comments due June 26, 2012). EPA is also proposing additional testing on the health and environmental effects of PBDEs. More information on this important set of proposals is available online.

EPA Announces Availability Of Literature Searches For IRIS Assessments: On April 6, 2012, EPA announced the availability of literature searches for acetaldehyde (CAS No. 75-07-0) and 1,2,3-trimethlybenzene (CAS No. 526-73-8). 77 Fed. Reg. 20817. EPA is requesting scientific information on health effects that may result from exposure to these chemical substances. EPA’s Integrated Risk Information System (IRIS) is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to specific chemical substances found in the environment. EPA will accept information related to the specific substances included in the Federal Register notice as well as any other compounds being assessed by the IRIS Program.

Final Rule Revises Manner For Applying TPQs For Certain EHSs: On March 22, 2012, EPA issued a final rule revising the manner for applying threshold planning quantities (TPQ) for extremely hazardous substances (EHS) that are non-reactive solid chemicals in solution. 77 Fed. Reg. 16679. According to EPA, this revision allows facilities subject to the Emergency Planning and Community Right-to-Know (EPCRA) requirements that have a non-reactive solid EHS in solution to first multiply the amount of the solid chemical in solution on-site by 0.2 before determining if this quantity equals or exceeds the lower published TPQ. EPA based this change on data that show less potential for non-reactive solid chemicals in solution to remain airborne and dispersed beyond a facility’s fence line in the event of an accidental release. Previously, EPA assumed that 100 percent of non-reactive solid chemicals in solution could become airborne and dispersed beyond the fenceline in the event of an accidental release. The rule is effective on April 23, 2012.

April 6, 2012, Effective Date For TSCA Section 5 CDX Submissions: Effective April 6, 2012, all chemical manufacturers or importers that submit a TSCA PMN, a Microbial Commercial Activities Notification (MCAN) or other biotechnology notice for genetically modified microorganisms, a Notice of Commencement of Manufacture or Import (NOC), a Significant New Use Notice (SNUN), an exemption application, or related support documents must do so electronically through EPA’s Central Data Exchange (CDX), an Internet portal, using EPA’s electronic PMN (e-PMN) software (which is the same software for all submission types). EPA no longer accepts the historic submission method of a paper copy or the more recent CD-ROM submission. More information is available online.

EPA Rejects (Again) Petition For Ban Under TSCA Of Lead Bullets And Shot: In a letter dated April 9, 2012, EPA has rejected again a petition from the Center for Biological Diversity and other environmental advocacy groups seeking a ban under TSCA on lead bullets and shot. EPA claimed the petition was being rejected because it was a repeat of a 2010 petition, with no significant new information. EPA added that even if the latest petition had contained genuinely new information, it would have been rejected because TSCA Section 3(2)(B)(v) excludes bullets and shot from regulation. That section states that the term “chemical substance” as used in TSCA, excludes any article subject to the sales tax imposed by Section 4181 or 4182 of the Internal Revenue Code. Section 4181 imposes a tax on “pistols, revolvers, firearms, shells, and cartridges.” The EPA letter rejecting the petition for a ban on lead bullets and shot is available online.

EPA Proposed Rule Would Require Electronic Reporting For Chemical Information: On April 13, 2012, EPA announced a proposed rule that would require electronic reporting for certain information submitted under TSCA. EPA states that the proposed rule “is an important milestone in the agency’s effort to increase transparency and public access to chemical information in order to help Americans protect their health and environment.” According to EPA, electronic reporting will increase the speed with which EPA can make information publicly available, increase accuracy, and provide the public with quick and easier access to chemical information. The proposed rule would require electronic reporting for various TSCA actions, including submission of information relating to chemical testing, health and safety studies, and other information. Over the coming months, EPA plans to offer a number of opportunities for potential users to become familiar with the new requirements, including an initial webinar to introduce the web-based electronic reporting tool; follow-up webinars and testing of specific applications; and opportunities for submitters and others to provide feedback on their experiences using the tool before its release. A 60-day comment period will begin once the proposed rule is published in the Federal Register. EPA states that it will post more information concerning the proposed rule online.


EPA Withdraws Guidance On Developing Interim PRGs For Dioxin From OMB Review: On April 6, 2012, EPA withdrew a notice concerning guidance on developing an interim preliminary remediation goal (PRG) for dioxin in residential soil at Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Resource Conservation and Recovery Act (RCRA) sites from review by the Office of Management and Budget (OMB). EPA submitted the notice for review on August 10, 2010. EPA released on January 7, 2010, the draft recommended interim PRG for public comment. EPA’s Office of Solid Waste and Emergency Response (OSWER) developed the draft recommended interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated using existing, peer-reviewed toxicity values and current EPA equations and default exposure assumptions. An EPA spokesperson stated: “EPA will not be issuing a [new] national PRG for dioxin because, with the [Integrated Risk Information System (IRIS) reference dose (RfD)] available, EPA regions will be following the Agency’s toxicity hierarchy approach for determining site-specific PRGs using the IRIS toxicity value. This hierarchy designates IRIS toxicity values as Tier 1, which means IRIS is the first information source to consider when undertaking risk assessments.” The January 2010 proposed PRGs for dioxins in soil were 72 parts per trillion (ppt) at residential sites and 950 ppt at commercial or industrial sites, compared to the 1998 PRGs of 1,000 ppt for residential soil and a range of 5,000 ppt and 20,000 ppt for commercial soil.


EPA Postpones Target Date For Internet Access To Chemical Data: On March 28, 2012, EPA stated that it is postponing indefinitely its July target date to re-establish Internet access for certain categories of data collected through EPA’s Risk Management Plan Program. Representatives of municipals, states, and chemical companies, and some members of Congress, had objected to EPA’s plan to release certain chemical facility risk management data on the Internet, expressing the view that the action could jeopardize facility security. EPA’s plan, announced in December, called for the release of the portion of information known as “non-Off-site Consequence Analysis” (OCA). Non-OCA data in facility Risk Management Plans include facility registration information, information about the history of serious accidental releases at the facility, and the facility’s accident prevention and emergency response programs.


USDA Amends Guidelines For Designating Biobased Products For Federal Procurement: In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. 77 Fed. Reg. 20281. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packaging and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.


GAO Finds FDA Device Reviews Are Taking Longer: The U.S. Government Accountability Office (GAO) released on March 29, 2012, a report entitled “FDA Has Met Most Performance Goals But Device Reviews Are Taking Longer.” According to GAO, even though the Food and Drug Administration (FDA) met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years. GAO was asked to: (1) examine trends in FDA’s 510(k) review performance from fiscal years (FY) 2003-2010; (2) examine trends in FDA’s premarket approval (PMA) review performance from FYs 2003-2010; and (3) describe stakeholder issues with FDA’s review processes and steps FDA is taking that may address these issues. GAO determined that, for each FY since FY 2005 (the first year that 510(k) performance goals were in place), FDA has reviewed over 90 percent of 510(k) submissions within 90 days, thus meeting the first of two 510(k) performance goals. FDA also met the second goal for all three FYs it was in place by reviewing at least 98 percent of 510(k) submissions within 150 days. Although FDA has not yet completed reviewing all of the FY 2011 submissions, GAO states that FDA was exceeding both of these performance goals for those submissions on which it had taken action. Although FDA review time decreased slightly from FY 2003 through FY 2010, the time that elapsed before FDA’s final decision increased substantially. Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days. The GAO report is available online.

FDA Denies Petition Seeking BPA Ban: On March 30, 2012, FDA denied a citizens’ petition requesting FDA to ban bisphenol A (BPA) from food-contact materials. The decision means companies may continue to use the chemical for food packaging. According to FDA, the petition failed to provide sufficient evidence that BPA harms human health to persuade it to launch a rulemaking to ban the chemical.

FDA Issues Guidance On Medical Device Benefit-Risk Determinations: On March 28, 2012, FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) issued a guidance that they described as a first-of-a-kind guidance for medical device manufacturers and Center staff reviewers. The guidance, titled “Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” discusses how the benefits and risks of certain medical devices should be considered during premarket review and the considerations to be addressed when making the benefit to risk determinations needed to demonstrate the safety of devices submitted for approval. The primary purpose of the document is stated to be improvement of the predictability, consistency, and transparency of the review of safety information submitted in PMA applications and De Novo petitions. A critical test in the statutory standard, set forth in Section 513(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), for the review of safety data is whether the applicant demonstrates a reasonable assurance of safety and effectiveness after weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. The guidance separates out the factors that reviewers should observe in considering benefit to risk determinations. The first is the assessment of the benefits to be derived from device use. The extent of benefits is stated to involve the type of benefits (impact on clinical management, patient health, and satisfaction), the magnitude of the benefits, the probability that a given patient will experience one or more of the benefits, and the duration of the effects from device use. The next factors to be considered are the risks from device use, which the guidance first separates into the severity, type, and number and rates of harmful effects, including device-related serious and non-serious adverse events, and procedural complications. The document also discusses the probability and duration of harmful events and, with regard to diagnostics, the risk from false positives or false negative results. The above are the core issues to be addressed in preparing an application and considering it for approval. The guidance goes on from there to mention additional factors in the assessment of the probable benefits and risks for devices. The first is the certainty that perceived benefits will actually occur and the second is whether the disease or condition to be treated is sufficiently characterized so that the device will have its intended effect. Another factor is the patient tolerance for risk and the patient’s perspective on benefits. An important consideration is also the availability of alternative treatment. All of these subjects, and a few others, are discussed at some length in the guidance, and that discussion is followed by the inclusion of a number of hypothetical examples of how the material presented should be applied. A final, important section is a worksheet, where the categories discussed in the guidance are presented in the form of questions that reviewers should answer as a part of their consideration of applications or petitions.

FDA states that sponsors will have a better idea of the reviewer’s thought processes from a review of the completed worksheets in the administrative record and, in certain cases, in the publicly available summary of the agency decisions. The guidance should be of substantial assistance to sponsors preparing the safety and effectiveness data and analysis for submission. Use of the worksheets and application of the principles set forth by reviewers should lead to more consistent results at FDA. It will obviously take some time to see how the guidance is being applied, but it is a start. The guidance, while not made applicable to Premarket Notifications, can be of use in discussing the benefits of the device in a 510(k) submission, if only to lay the groundwork for future marketing claims. Manufacturers can also use the worksheets as a way to monitor the use of devices after they enter the market place.


Dr. Robert Pohanka Appointed As Director Of NNCO: On March 20, 2012, the National Nanotechnology Coordination Office (NNCO) announced the appointment of Dr. Robert Pohanka as the Director of the NNCO. The NNCO provides technical and administrative support to the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee, serves as a central point of contact for federal nanotechnology research and development activities, and provides public outreach on behalf of the National Nanotechnology Initiative (NNI). Dr. Pohanka previously served as the Director of the Defense Venture Catalyst Initiative (DeVenCI), where he led and directed the strategy for finding private sector technologies, developed independently of the Department of Defense (DoD), and transitioned them to DoD Research, Development, and Acquisition. Prior to leading the DeVenCI program, Dr. Pohanka served as the Head of the Materials and Physical Sciences Department at the Office of Naval Research, where he was responsible for leading and directing the strategy for planning and executing a broad range of science and technology investments from basic physics and chemistry at the nanometer scale to engineering solutions for aircraft carriers. During this period, Dr. Pohanka also served as Director for the Materials Science and Technology Division and as Director for the Ship, Hull, Mechanical, and Electrical Division.

EC Requests Scientific Opinion On Health Effects Of Nanomaterials Used In Medical Devices: On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

  • Carbon nanotubes in bone cements;
  • Nanopaste hydroyapatite powder for bone void filling;
  • Polymer setting material with nanoparticles in dental cements;
  • Polycrystalline nanoceramics in dental restorative materials;
  • Nanosilver or other nanomaterials used as coatings on implants and catheters; and
  • Nanosilver used as an antibacterial agent, for example in wound dressings.

Furthermore, according to the request, there are reports on iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field. The EC states that, when assessing nanomaterials for medical applications, the risk assessor should be aware of the specific characteristics of nanomaterials to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology. According to the request, the EC is currently preparing a proposal for a revision of the medical devices directives. The proposal might include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013. The request is available online.

Background Papers Available From The International Symposium On Assessing The Economic Impact Of Nanotechnology: On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with NNI, and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. NNI has posted the following background papers online:

  • Challenges for Governments in Evaluating Return on Investment from Nanotechnology and its Broader Economic Impact;
  • Finance and Investor Models in Nanotechnology;
  • The Economic Contributions of Nanotechnology to Green and Sustainable Growth; and
  • Models, Tools and Metrics Available to Assess the Economic Impact of Nanotechnology.

EC Scientific Committee Requests Information On Nanosilver: On April 10, 2012, the EC SCENIHR invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested 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. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012. More information is available online.


ECHA Publishes Updated Guidance On Substance Identification In 22 Languages: On March 23, 2012, the European Chemicals Agency (ECHA) updated the guidance for identification and naming of substances under Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP), for publication in all 22 European Union (EU) languages. The latest version updates the definition of phase-in substances, and changes in version 1.1 and 1.2 have been consolidated into a single translated version 1.2 for languages other than English. The corrected guidance (English) is available online.


House Subcommittee Holds Hearing On Current State Of Cosmetics Regulation: On March 27, 2012, the House Energy and Commerce Subcommittee on Health held a hearing entitled “Examining the Current State of Cosmetics.” Witnesses included:

  • Michael M. Landa, J.D., Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA;
  • Halyna Breslawec, Ph.D., Chief Scientist and Executive Vice President for Science, The Personal Care Products Council;
  • Peter Barton Hutt, J.D., Senior Counsel, Covington & Burling, LLP;
  • Mr. Curran Dandurand, Co-Founder and Chief Executive Officer, Jack Black Skincare; and
  • Ms. Debbie May, President and Chief Executive Officer, Wholesale Supplies Plus.

During the hearing, Landa testified that the Obama Administration is seeking to strengthen FDA’s regulatory oversight of cosmetics. The Administration’s FY 2013 budget request seeks new legislative authority to allow FDA to require domestic and foreign cosmetics manufacturers to register their products, ingredients, and facilities and to require companies to pay an annual registration fee. Hearing participants discussed whether FDA needs additional funding, and if it should be obtained through registration fees. Discussion also included the Safe Cosmetics Act of 2011 (H.R. 2359), which Representative Janice Schakowsky (D-IL) introduced on June 24, 2011. The bill would amend the FFDCA to require any establishment selling cosmetics in the U.S. to register its products, and would require manufacturers to provide FDA safety data for the ingredients listed on the cosmetic label and in the cosmetic itself. The bill would also require FDA to set a safety standard for ingredients that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic. According to witnesses, some states, such as California, have chosen to regulate cosmetics themselves, instead of waiting for improved FDA oversight. The witness statements and an archived webcast of the hearing are available online.

House Republican Budget Would Significantly Reduce Environmental Spending: With much political fanfare, House Budget Committee Chair Paul Ryan (R-WI) on March 20, 2012, unveiled the Republican House’s $1 trillion budget resolution for FY 2013. A day later, the House Budget Committee approved the budget resolution in a close 19-18 vote. The bill fared far better in the House, where Representatives easily passed the fiscal blueprint on March 29, 2012. The measure passed 228-191, with all Democrats and ten Republicans opposed. The Senate has vowed to adhere to the budget that both chambers agreed to in last summer’s debt limit deal, known as the Budget Control Act. EPA’s regulations have long drawn the ire of House Republicans. This proposal continues Republicans’ efforts to curtail EPA actions that House leaders believe are undermining American business, overreaching, and unnecessary. Dubbed “The Path to Prosperity,” the budget proposal would slash federal spending by $5.3 trillion over ten years. Some $3.5 billion of that would be made up by cuts for environment and natural resources programs. Spending on those programs would fall from $36.8 billion in FY 2012 to $33.3 billion in FY 2013, a reduction of over nine percent. A summary of the budget proposal rebukes President Obama for supporting “the Environmental Protection Agency’s unilateral plan to impose emissions restrictions on American businesses.” The budget resolution calls on Congress to “limit EPA’s discretionary power” to implement a greenhouse gas emissions regulatory program. The plan also criticizes President Obama for pursuing energy and environmental policy “through heavy-handed regulations” that circumvent “accountability to voters and leaves decisions in the hands of a bureaucratic infrastructure.” Unnecessary regulations tie the hands of small businesses and create a hostile and uncertain business environment, discouraging job growth, says the proposal. The budget plan is fearsome in its scope and in the depth of its cuts. To put some perspective on just how far reaching the plan is, consider this: the Congressional Budget Office (CBO) projected Ryan’s plan four decades into the future and concluded that the size of the federal government would shrink to 15 percent of the economy (i.e., the Gross Domestic Product) by 2050. That would make it the smallest government since President Harry S. Truman occupied the Oval Office in 1950. Of course, the resolution has drawn heated fire from Democrats. The White House cautioned that “the budget would give tax cuts to millionaires and billionaires, while paying for it by ending Medicare as we know it and cutting the very investments we need to grow the economy and restore middle class security.” Congressional Democrats warn that the plan would demolish every government program except for the DoD and Social Security. Some ultra-fiscally conservative Republicans are also wary of the plan, claiming that it does not shrink the budget deficit rapidly enough. For example, House Republicans Justin Amash (R-MI) and Tim Huelskamp (R-KS) voted against the Ryan plan, which they believe does not cut the budget fast enough.

Senate Environment And Public Works Committee Holds Hearing On EPA Budget: The Senate Environment and Public Works Committee held a hearing on March 22, 2012, on President Obama’s FY 2013 budget for EPA. EPA Administrator Lisa M. Jackson was the sole witness at the hearing, and defended the budget request. “EPA’s budget request of $8.344 billion focuses on fulfilling EPA’s core mission of protecting public health and the environment, while making the sacrifices and tough decisions that Americans across the country are making every day,” she stated. Administrator Jackson added that “EPA’s budget request fully reflects the President’s commitment to reducing government spending and finding cost savings in a responsible manner while supporting clean air, clean water and the innovative safe guards that are essential to an America that’s built to last. This budget reflects a savings of $50 million through the elimination of several EPA programs and activities that have either met their goals, or can be achieved at the state or local level or by other federal agencies,” she testified. Senator James Inhofe (R-OK), the Committee’s ranking minority member, was unsparing in his criticism of the budget, finding little in it that he liked. He described what he saw as four themes in the request: an escalation in climate change funding; increasing the cost of fuel at the pump; beefing up EPA’s regulatory budget while cutting the states’ ability to deal with new unfunded mandates; and negative impacts on rural America. With respect to the budget’s $240 million programs for climate change, Senator Inhofe stated: “I find this strange, given that you yourself have admitted such activity will do nothing to affect the course of global temperatures.” He stated that it did not make sense to spend a quarter of a billion dollars “in these tough economic times on something that will have no effect.” He also labeled as “calamitous” a host of Clean Air Act (CAA) regulatory programs that are creating “draconian new regulations with the goal of driving up electricity and gasoline prices.” In one of his most pointed arguments, Senator Inhofe accused EPA’s Federal Vehicle and Fuel Standards Certifications Division of “working hard to increase the price at the pump,” adding that “EPA’s policy of increasing the price of fuel certainly seems to be working.” Administrator Jackson defended the request. She stated that it recognizes the importance of EPA’s partners at the state, local and tribal level and that the largest portion — 40 percent of EPA’s funding request — is directed to the state and tribal assistance grants appropriation to support their efforts. Specifically, this budget proposes that $1.2 billion be allocated back to the states and tribes, through categorical grants. Countering Senator Inhofe’s allegations about EPA driving up fuel prices, Administrator Jackson stated that the Administration’s standards for cars and light trucks are projected to result in $1.7 trillion of fuel savings, and 12 billion fewer barrels of oil consumed. Senator Jeff Sessions (R-AL) also grilled Administrator Jackson during the hearing, calling links between air pollution and human health “figments of EPA’s statistical imagination.” He also criticized the President’s budget request for EPA, which he said has received “extraordinary increases” in funding since the President took office. Administrator Jackson in response promised to provide Senator Sessions with the studies EPA has relied upon that demonstrate a link between poor health and poor air quality.

Senate Subcommittee Holds Hearing On EPA’s Mercury And Air Toxics Standards For Power Plants: The Senate Environment and Public Works Subcommittee on Clean Air and Nuclear Safety on March 20, 2012, held a hearing to examine the oversight of EPA’s recently promulgated rule establishing Maximum Achievable Control Technology (MACT) standards to reduce mercury emissions from power plants. The focus of the hearing was the impact the rule appears to be having on the closure of power plants. Senator John Barrasso (R-WY) during the hearing predicted that the new rules will force the closure of many power plants and will have devastating consequences for local communities. Gina McCarthy, EPA’s Assistant Administrator for Air and Radiation, countered this claim, stating that the rules likely will result in the closure of relatively few power plants. Others testifying at the hearing, including state and local officials, supported the argument that the rules will have a positive net impact on the environment and public health. The testimony can be viewed here.

House Committee Approves Bill To Place Moratorium On Rules Until Jobless Rate Falls: The House Judiciary Committee on March 20, 2012, approved the Regulatory Freeze for Jobs Act of 2012 (H.R. 4078), legislation that would suspend major environmental regulations (and other federal rules) until the unemployment rate is brought down to six percent. Passing along a party line vote, the bill is applicable to regulations that would have an annual cost of $100 million or more. An amendment to the legislation — intended to blunt Democrats’ concerns — would provide a mechanism for rules that are vital to public health, safety, and the environment be exempt from the moratorium. Specifically, the legislation would allow the President to seek a waiver from Congress for any significant rule the executive branch considers “necessary to protect the public health, safety or welfare.” This would not be an automatic waiver, however, although the bill states that Congress would “give expeditious consideration” to the President’s requests.

Gasoline Regulations Act Of 2012 Would Require EPA To Analyze Whether Air Rules Increase Gasoline Prices: Representative Ed Whitfield (R-KY) on March 22, 2012, introduced legislation that would require EPA to analyze whether its regulations under the CAA increase gasoline prices at the pump. The Gasoline Regulations Act of 2012 would also call upon EPA to consider the costs and feasibility of industry compliance in any revision of the ozone National Ambient Air Quality Standards (NAAQS). Rules specifically targeted by the bill are EPA’s so-called Tier 3 standards for sulfur content in gasoline, the new source performance standards limiting emissions of greenhouse gases from petroleum refineries, and the revisions to the NAAQS for ozone. The bill would prohibit EPA from issuing these rules until the analysis is complete, and it gives EPA 90 days to conduct the assessment.

Bill Would Prohibit Use Of “Compound 1080”: Sodium fluoroacetate, commonly known as “Compound 1080,” would be banned from use as a predator control under legislation introduced on March 20, 2012, by Representative John Campbell (R-CA). The Compound 1080 and Sodium Cyanide Elimination Act (H.R. 4214) would amend TSCA Section 6 by adding a new Section 6(g) that would ban the use, production, sale, importation, or exportation of sodium fluoroacetate and providing for imprisonment of up to two years for anyone violating the prohibition. The bill would also ban the use of sodium cyanide in any predator control device. Congressman Campbell is a staunch advocate of animal rights and a member of the Congressional Animal Protection Caucus. The Humane Society of the United States and the Humane Society Legislative Fund have distinguished Representative Campbell for his leadership on animal protection legislation.

Bill Would Block EPA From Implementing Clean Water Act Guidance Clarifying Jurisdiction: Twenty-nine Republican Senators introduced a bill on March 28, 2012, that would prevent EPA and the U.S. Army Corps of Engineers from implementing joint guidance clarifying what waters are subject to federal jurisdiction under the Clean Water Act (CWA). The Preserve the Waters of the U.S. Act (S. 2245) is intended to blunt what Republican lawmakers believe is an over-reach of federal authority by EPA. OMB is reviewing the guidance, which is intended to clarify the term “waters of the United States” and thus provide clarity on the types of waters and wetlands that fall under the jurisdiction of the CWA.

House Bill Seeks MCLG/MCL For Hexavalent Chromium: Representative Adam Schiff (D-CA) on March 27, 2012, introduced legislation that would amend the Safe Drinking Water Act (SDWA) with the intent of protecting pregnant women, infants, and children against hazards posed by ingesting hexavalent chromium (CrVI) in drinking water. The Protecting Pregnant Women and Children From Hexavalent Chromium Act of 2012 (H.R. 4266) would amend SDWA Section 1412(b)(12) by requiring EPA to establish a health advisory for CrVI that is fully protective, with an adequate margin of safety, of the health of vulnerable individuals (including pregnant women, infants, and children), taking into consideration body weight, exposure patterns, and all routes of exposure. This essentially would establish an unenforceable Maximum Contaminant Level Goal (MCLG) for CrVI. EPA is to issue the MCLG within 90 days of the bill’s enactment. Within one year of the bill’s enactment, the legislation would then require EPA to issue a national primary drinking water regulation, i.e., a Maximum Contaminant Level (MCL), for CrVI. EPA will soon issue a final rule — the Unregulated Contaminated Monitoring Rule — under the SDWA that will require utilities to monitor for CrVI and other unregulated compounds. EPA delayed, however, its risk assessment under the IRIS for CrVI. Congressman Schiff has criticized EPA for delaying the IRIS assessment and for the manner in which EPA is reviewing the hazards posed by CrVI in drinking water. His bill would force EPA to take regulatory action for CrVI in drinking water.

Fracturing Regulations Are Effective In State Hands Act Introduced In Senate: Authority to regulate hydraulic fracturing or “fracking” operations would be stripped from EPA and other federal agencies and delegated to the states under legislation introduced on March 28, 2012, by Senator James Inhofe (R-OK). The Fracturing Regulations are Effective in State Hands Act (S. 2248) would vest states with the sole authority to regulate hydraulic fracturing operations within their borders. The bill would further prohibit EPA from even issuing guidance on regulating hydraulic fracturing, even when diesel fuels are used as a fracking agent. EPA currently regulates the use of diesel fuel as fracking agents under the SDWA’s Underground Injection Control program.

Resolving Environmental And Grid Reliability Conflicts Act: The Department of Energy (DOE) at times orders utilities to increase power generation, and this sometimes results in violations by the utilities of federal, state, or local air pollution regulations. Legislation introduced in the House on March 28, 2012, would shield utilities from enforcement and exempt them from complying with these regulations when they are ordered by DOE to increase power generation. The Resolving Environmental and Grid Reliability Conflicts Act (H.R. 4273) was sponsored by Representative Peter Olson (R-TX) and is intended to ensure that utilities finding themselves in this situation are protected from enforcement actions and citizen suits.

House Committee Issues Subpoenas To Interior Department: As described in a press release, House Natural Resources Committee Chair Doc Hastings (R-WA) issued a subpoena to the Department of the Interior for documents related to the Committee’s more than year-long investigation into the Obama Administration’s rewrite of a coal production regulation. The Chair contends that the documents included in the subpoena will provide further information on why the Interior Department decided to rewrite this regulation and how the process to rewrite the rule is being managed. The documents sought in the subpoena include: recordings and transcripts of recordings of meetings between the Department and contractors regarding the rewrite of the rule. This includes, but is not limited to, the known 43 digital audio recordings totaling approximately 30 hours. Also included are unredacted versions of e-mail communications previously provided to the Committee, documents related to the development of the Advanced Notice of Proposed Rulemaking and Notice of Intent to prepare a Supplemental Environmental Impact Statement for the coal production regulation, and drafts of the Impact statement, and impact analysis for the Administration’s rewrite of the coal production regulation. Describing the purpose for the subpoena, Representative Hastings stated: “The Obama Administration’s many attacks on coal as a low-cost American energy source are very clear, but they’ve refused to disclose information detailing their decisions and actions to rewrite this rule governing coal production. After more than a year of patiently requesting cooperation and documents from the Department of the Interior, a subpoena is now needed to force them to live up to the President’s own transparency promises.” The Chair also directed a second subpoena to the Department for documents related to a more than year-long investigation into why an Obama Administration report that recommended a six-month drilling moratorium in the Gulf of Mexico was edited to make it appear as though the moratorium was supported by a panel of engineering experts when, it is alleged, it was not. Speaking of the need for this subpoena, Representative Hastings said that the President “pledged unprecedented transparency and it’s regrettable that a Congressional subpoena is necessary to obtain documents pertaining to the Administration’s report.” The Chair went on to allege that the report “falsely stated the professional views of independent engineers and the moratorium directly caused thousands of lost jobs, economic pain throughout the Gulf region, and a decline in American energy production. It’s important to clearly understand exactly how this happened.”

Representative Moves To Reign In EPA Settlement Authority: Representative Ben Quayle (R-AZ.) has introduced legislation intended to curb the use of settlements by EPA to allegedly make new policy. The practice has incurred the wrath of conservatives and some state officials, and is exemplified by remarks made by Dr. Rich Sweir on Teabook. “In a dangerous move, the EPA settled its lawsuit with environmental interests before any court had the opportunity to rule on the merits of the case. Sound strange? Unfortunately, this is how things are done in Washington. For example, want to regulate livestock farmers? Get sued. Want to regulate greenhouse gases? Get sued. Want to expand onerous regulation to new industries? Get sued. Then agree to a settlement that requires you to do what you wanted to do in the first place — write new regulations, regardless of the science and free from public scrutiny…. It’s a tidy arrangement. The problem for the rest of us is that the settlement terms trigger new, onerous and costly regulations.” Representative Quayle stated that the purpose of H.R. 3892, the Sunshine for Regulatory Decrees and Settlements Act of 2012, is to impose certain limitations on consent decrees and settlement agreements by agencies that require the agencies to take regulatory action in accordance with the terms thereof, and for other purposes. If enacted, the law would require that the complaint in the action, the consent decree or settlement agreement, and any award of attorneys’ fees or costs shall be published, including electronically, in a readily accessible manner. Until the conclusion of an opportunity for affected parties to intervene in the action, a party may not file with the court a motion for a consent decree or to dismiss the case pursuant to a settlement agreement. If the court grants a motion to intervene in the action, the court shall refer the action to its mediation program or a magistrate judge to facilitate settlement discussions, which shall include the plaintiff, the defendant agency, and the intervenors. EPA thereafter is required to publish any proposed consent decree or settlement agreement for public comment before filing it with the court, allowing comment on any issue related to the matters alleged in the complaint or addressed or affected by the consent decree or settlement agreement. Other requirements are imposed if the settlement includes an agency action.

Congressman Acts To Restrain EPA And The Corps Of Engineers: Representative Thomas Rooney (R-FL) has introduced H.R. 4304, a measure styled to clarify the definition of navigable waters, to mean the waters of the United States, including the territorial seas, that are navigable-in-fact, or permanent, standing, or continuously flowing bodies of water that form geographical features commonly known as streams, oceans, rivers, and lakes that are connected to waters that are navigable-in-fact; there are a number of exclusions from the definition. The bill also provides language intended to overturn activities by EPA and the Corps of Engineers (Corps) based on the interpretation of navigable water, and prohibit them from impinging upon the traditional and primary power of States over land and water use without explicit State authorization. The previous actions by EPA or the Corps that would have no effect if the legislation is enacted would be the final rule of the Corps entitled “Final Rule for Regulatory Programs of the Corps of Engineers” (51 Fed. Reg. 41206, Nov. 13, 1986); the proposed EPA rule entitled “Advance Notice of Proposed Rulemaking on the Clean Water Act Regulatory Definition of ‘Waters of the United States'” (68 Fed. Reg. 1991, Jan. 15, 2003); the guidance document entitled “Clean Water Act Jurisdiction Following the U.S. Supreme Court’s Decision in Rapanos v. United States and Carabell v. United States” (Dec. 2, 2008) (relating to the definition of waters under the jurisdiction of the Federal Water Pollution Control Act (33 U.S.C. 1251 et seq.), and generically, any subsequent regulation of or guidance issued by any Federal agency that defines or interprets the term “navigable waters.” The Secretary of the Army, acting through the Chief of Engineers, and EPA are further prohibited from promulgating any rules or issue any guidance that expands or interprets the definition of navigable waters unless expressly authorized by Congress. There is a similar bill, S. 2122, pending in the Senate.

Bill Introduced To Merge Key Departments: Representative Marsha Blackburn (R-TN) has introduced H.R. 4295, the “Consolidate Heavy-handed and Outdated Programs Act of 2012.” The measure would consolidate the DOE and EPA into a Department to be known as the Department of Energy and the Environment (DOEE). The bill would consolidate duplicative functions, while leaving in place the core activities of each entity, and improving administration. Representative Blackburn said in a press release that her bill would save taxpayers $5.3 billion per year.

The School Environment Protection Act: Representative Rush Holt (D-NJ) has introduced H.R. 4225, a measure that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to require each local educational agency (agency) of a school district to implement an integrated pest management (IPM) program that: (1) applies to school buildings and school grounds; (2) establishes an IPM coordinator within the agency; and (3) follows an IPM plan for addressing school pest problems. H.R. 4225 would prohibit agencies or schools from using pesticides other than nontoxic or least toxic (as defined in this Act) pesticides, or synthetic fertilizers, but would permit an agency or school to use: (1) a least toxic pesticide as part of the IPM program only as a last resort and only if the area or room treated is unoccupied or not in use; and (2) only natural organic fertilizers. Other conditions are imposed on the use of a pesticide. The bill requires the Administrator of EPA to establish a National School Integrated Pest Management Advisory Board to: (1) establish uniform standards and criteria for developing IPM; and (2) develop standards for the use of least toxic pesticides in schools, and .appoint an official for school pest management within EPA’s Office of Pesticide Programs to coordinate the implementation of IPM programs in schools, and publish an IPM plan and a list of products containing the least toxic pesticides and restrictions on their use.


OECD Announces Availability Of Modified Environmental Risk Assessment Toolkit: The OECD Environmental Risk Assessment Toolkit describes the work flow for environmental risk assessment and management of chemicals with links to available OECD material relevant for the different steps in risk assessment and management. OECD announced on March 19, 2012, that it has revised the Toolkit to include resources other than OECD products, and to incorporate three examples (i.e., textile dye, pesticide, and environmental quality standard setting) that show the risk assessment steps involved in each case. More information is available online.

OMB Calls On Agencies To Consider Cumulative Impacts Of Regulations: Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs, on March 20, 2012, issued a memorandum to the heads of executive departments and agencies calling on them to “take active steps to take account of the cumulative effects of new and existing rules and to identify opportunities to harmonize and streamline multiple rules.” The goal of the guidance, which is effective immediately, is “to simplify requirements on the public and private sectors; to ensure against unjustified, redundant, or excessive requirements; and ultimately to increase the net benefits of regulations.” The memorandum directs agencies to take the following steps:

  • Early consultation with, advance notice to, and close engagement with affected stakeholders to discuss potential interactions between rulemakings under consideration and existing regulations as well as other anticipated regulatory requirements;
  • Early engagement with state, tribal, and local regulatory agencies to identify opportunities for harmonizing regulatory requirements, reducing administrative costs, avoiding unnecessary or inconsistent requirements, and otherwise improving regulatory outcomes;
  • Use of Requests for Information and Advance Notices of Proposed Rulemaking to obtain public input on potentially overlapping rulemakings and on rulemakings that may have significant cumulative effects;
  • Specific consideration of the cumulative effects of regulations on small businesses and start-ups;
  • Identification of opportunities to increase the net benefits of regulations and to reduce administrative and other costs, while meeting policy goals and legal requirements;
  • Careful consideration, in the analysis of costs and benefits, of the relationship between new regulations and regulations that are already in effect;
  • Identification of opportunities to integrate and simplify the requirements of new and existing rules, so as to eliminate inconsistency and redundancy;
  • Coordination of timing, content, and requirements of multiple rulemakings that are contemplated for a particular industry or sector, so as to increase net benefits; and
  • Consideration of the interactive and cumulative effects of multiple regulations affecting individual sectors as part of agencies’ retrospective analysis of existing rules, consistent with Executive Order 13563.

The memorandum on the cumulative effects of regulations is available online.

OSHA Releases Final HCS Rule: On March 26, 2012, OSHA issued a final rule that revises the HCS, aligning it with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). 77 Fed. Reg. 17574. The final HCS rule will be implemented in various phases with full implementation by 2016 and, according to OSHA, will benefit workers by reducing confusion about chemical hazards in the workplace, facilitating safety training, and improving understanding of hazards, especially for low literacy workers. OSHA states that the revised HCS will “classify chemicals according to their health and physical hazards, and establish consistent labels and safety data sheets for all chemicals made in the United States and imported from abroad.” During the transition period to the effective completion dates noted in the revised HCS, chemical manufacturers, importers, distributors, and employers may comply with either 29 C.F.R. Part 1910.1200 (the final standard), the current standard, or both. The rule will be effective on May 25, 2012. More information is available online.

Supreme Court Unanimously Rules That CWA Administrative Orders Are Subject To Judicial Review: The Supreme Court unanimously ruled on March 21, 2012, that CWA administrative orders are final agency actions and thus subject to judicial review under the Administrative Procedure Act (APA). Sackett v. EPA, U.S., No. 10-1062. The petitioners received a compliance order from EPA, stating that their residential lot contained navigable waters and that their construction project violated the CWA. The petitioners filed suit in the U.S. District Court, seeking declarative and injunctive relief. The petitioners argued that the compliance order was “arbitrary [and] capricious” under the APA and that it deprived them of due process in violation of the Fifth Amendment. The District Court dismissed the claims for want of subject-matter jurisdiction. The Ninth Circuit affirmed, concluding that the CWA precluded pre-enforcement judicial review of compliance orders and that such preclusion did not violate due process. The Supreme Court ruled that the petitioners could bring a civil action under the APA to challenge EPA’s order. The APA provides for judicial review of “final agency action for which there is no other adequate remedy in a court,” and, according to the Supreme Court, EPA’s compliance order has all the hallmarks of APA finality. The Supreme Court also held that the CWA is not a statute that “preclude[s] judicial review” under the APA. The Supreme Court reversed the judgment of the Court of Appeals and remanded the case. The Supreme Court’s opinion is available online.

Governor Brown Appoints Deputy Secretary For Science And Health At CalEPA: On April 11, 2012, Governor Edmund G. Brown, Jr. (D) announced the appointment of Dr. Gina Solomon, 47, as Deputy Secretary for Science and Health at the California Environmental Protection Agency (CalEPA). Solomon has been a Senior Scientist for the Natural Resources Defense Council since 1996, and a Clinical Professor of Health Sciences at the University of California, San Francisco (UCSF) since 2011. She served as an Associate Clinical Professor of Medicine at UCSF since 2006, and as an Assistant Clinical Professor of Medicine from 1998 to 2006. Solomon has also served as the Director of the Occupational and Environmental Medicine Residency Program at UCSF since 2008 and as the Associate Director of the University of California Pediatric Environmental Health Specialty Unit since 2003. Solomon has served on the Scientific Guidance Panel for the California Environmental Contaminant Biomonitoring Program since 2007, and EPA’s Science Advisory Board (SAB) since 2011.

OEHHA Appoints Director: Dr. George Alexeeff has been appointed the Director of the Office of Environmental Health Hazard Assessment (OEHHA), the CalEPA Department that administers the Prop 65 and biomonitoring programs. Dr. John Dexter had been Director, but stepped down. Dr. Alexeeff has been serving as the Acting Director since early in Governor Brown’s administration and, prior to that, was the Chief Scientist/Deputy Director.

EPA Launches Effort To Seek SAB Review Of Science Behind Key Rules: On March 26, 2012, EPA created a formal process to seek the advice of its SAB on the scientific underpinnings of its rules and policies, a move intended to address criticisms from lawmakers and industry on the science EPA has used in controversial air, greenhouse gas, and other rules. Discussed at a March 23, 2012, SAB meeting in Washington, D.C., the initiative would provide the board with “a meaningful opportunity to provide advice and comment, where appropriate, on the science supporting proposed agency actions,” according to briefing material distributed at the meeting. The new process, which will be overseen by EPA’s Office of Policy (OP), will allow EPA to coordinate with SAB “on the science and technical information underlying the EPA’s proposed criteria documents, standards, limitations and regulations,” specifically focusing on those proposed rules and documents that undergo interagency review. Under the process being developed, OP will provide SAB a list of rules every six months “that are expected to undergo interagency review,” including those from EPA’s semiannual regulatory agenda and those that program and regional offices expect to be submitted that are not listed on the agenda. In turn, program and regional offices “will notify the SAB staff office when proposed Agency actions that undergo interagency review become formally available for public review and comment. EPA programs are also expected to provide additional information as requested by the SAB Staff Office to facilitate the SAB’s consideration of this information.” An intra-agency working group is currently developing criteria and other screening tools to determine which rules SAB should review going forward and how best to provide information to SAB in the effort. SAB members with assistance from EPA also completed a pilot project ahead of the March 23 meeting in an effort to assess what an SAB review may look like or whether SAB needed to review the science behind the rules. The pilot project focused on the science behind EPA’s boiler and incinerator air rules, as well as the vehicle greenhouse gas rules that are slated to take effect in model year 2017. The board is also working to create a standing committee to review the science behind EPA’s chemical risk assessments.

Canada Adds Four Substances To CEPA Schedule: Under an order in the March 28, 2012, Canada Gazette, four substances have been added to Schedule 1 of the Canadian Environmental Protection Act (CEPA): propane, 2-nitro (2-nitropropane); benzene, 1-methyl-2-nitro- (2-nitrotoluene); phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (DTBSBP); and methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)3-methy lphenyl]-, acetate (MAPBAP acetate). By adding these substances to Schedule 1, the Minister of the Environment and the Minister of Health (the Ministers) can develop proposed regulations or instruments to manage human health and environmental risks posed by these substances under CEPA. The Ministers may, however, choose to develop instruments outside of the purview of CEPA to manage these risks. These substances were included in Batch 8 of Canada’s Challenge under its Chemicals Management Plan. Environment Canada and Health Canada proposed development of regulatory controls intended to eliminate virtually all releases of DTBSBP to the environment and regulations to limit conditions under which it may be imported, manufactured, or used. Canada intends to publish proposed regulations by July 31, 2012, and promulgate final regulations by January 31, 2013. Environment Canada and Health Canada proposed development of a new environmental release guideline for MAPBAP acetate and products containing it, and to apply CEPA’s significant new activity notice provisions to 2-nitropropane, 2-nitrotoluene, and MAPBAP acetate. More information is available online.

ATSDR Requests Comments On Proposed Substances: On April 3, 2012, the Agency for Toxic Substances and Disease Registry (ATSDR) announced a list of substances that will be evaluated for CERCLA Set 26 toxicological profile development. 77 Fed. Reg. 20022. CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires ATSDR, located within the Department of Health and Human Services (HHS), to prepare and to revise periodically toxicological profiles on hazardous substances. ATSDR’s Division of Toxicology and Human Health Sciences is soliciting public nominations from the list of substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional substances that are not included on this list that may have public health implications, on the basis of ATSDR’s authority to prepare toxicological profiles for substances not found at sites on the National Priorities List. Nominations from the substance priority list and/or additional substances must be submitted by May 3, 2012.

EPA Shifts Enforcement Resources In Light Of Reduced Funding: Facing substantially reduced financial resources in FY 2013 and beyond, EPA’s Office of Enforcement and Compliance Assurance (OECA) is radically revising how it enforces the nation’s environmental regulations. On February 20, 2102, EPA released the OECA Draft National Program Manager (NPM) Guidance. The NPM guidance is available online. After issuing the NPM guidance, Larry Starfield, OECA’s Principal Deputy Assistant Administrator, on March 12, 2012, sent a memorandum to compliance and enforcement staff at Agency headquarters and EPA regions providing further details on the areas in which EPA intends to “divest” or significantly reduce resources. The Starfield memorandum states that EPA is “ramping up work in top-priority areas like air toxics and drinking water. We are also investing in next generation compliance, electronic reporting, and new monitoring technologies, which will position EPA’s enforcement program to more efficiently and effectively address the biggest pollution threats while reducing costs for sources and states.” But it then goes on to list the areas where EPA is compelled to reduce its enforcement efforts and reallocate its resources. Acid rain is one area where EPA will almost completely divest its enforcement efforts. Citing that most sources emitting sulphur dioxide use continuous emissions monitoring (CEM) systems and that sulphur dioxide allowances are tracked in a national database, EPA says that it sees little need to focus on acid rain compliance as an area of enforcement. The memorandum then lists several areas where EPA will reduce its enforcement activities to a “minimal national presence.” Perhaps the most significant area in this category is EPA’s Audit Policy and Self-Disclosures. Since implementation of the Audit Policy began in 1995, EPA states that it has increased its understanding of environmental compliance auditing, and believes that auditing has become more widely adopted by the regulated community. EPA has found that most violations disclosed under the Policy are not in high priority enforcement areas for protecting human health and the environment. In addition, “the outcome benefits measured for voluntary disclosures do not justify the current resource commitment for implementing the current Audit Policy,” the memorandum states. Therefore, OECA plans to reduce substantially the enforcement resources dedicated to implementation of the Audit Policy. Of significant interest is that the memorandum discloses that EPA is considering implementing a self-implementing audit policy program and will also consider providing penalty mitigation to a company involved in an EPA enforcement action, if it can show conformance with the Audit Policy. If EPA implements these changes, it will alter significant the manner in which companies self-report violations. Other areas shunted to EPA’s “minimal national presence” enforcement category include: EPCRA Sections 311/312, Biosolids, the wood heater program, the asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP), polychlorinated biphenyl (PCB) standards, FIFRA imports, brownfields, good lab practices, and stratospheric ozone protection. Areas slated by OECA for “significant reduction” include the Underground Injection Control (UIC) program under the SDWA, underground storage tanks regulated under RCRA, compliance assistance centers, Superfund enforcement, and, amazingly, criminal enforcement.

Chemical Safety Board Seeks Comments On Its 2012-2016 Draft Strategic Plan: The U.S. Chemical Safety Board (CSB) on March 29, 2012, announced that it is seeking public comments on its draft 2012-2016 CSB Strategic Plan. The draft plan includes the CSB’s strategic goals, strategic objectives, and associated measures for managing and evaluating agency operations. Comments were requested by April 12, 2012, via e-mail to

ECOS Resolutions Adopted At Spring Meeting: The Environmental Council of the States (ECOS) at its Spring meeting in March adopted or revised several resolutions. Chief among these is ECOS’ resolution on environmental federalism, which ECOS revised in an effort to establish a broader role for states in environmental regulation. The revised federalism resolution calls on EPA to allow states flexibility in implementing programs, specifically in the use of risk-based inspections or multi-media environmental programs. It also recommends that EPA refrain from intervening in state environmental regulatory programs except in “rare and egregious” cases. Also adopted was a resolution calling on the administration to modify CERCLA immunity for federal facilities by clarifying “federal facilities are subject to appropriate state regulations and are not unduly shielded by sovereign immunity and lead agency authority.” ECOS also adopted or revised resolutions on environmental enforcement training for state and local environmental regulators, innovative approaches to protecting human health and the environment, the National Environmental Information Exchange Network, greater coordination with the National Governors’ Association, mercury recovery, greenhouse gas emissions, product stewardship, and emerging contaminants and related risk communication. The ECOS resolutions are available online.

India Proposes Draft National Chemical Policy: On March 29, 2012, India’s Department of Chemicals and Petrochemicals (DCPC), located within the Ministry of Chemicals and Fertilizers, announced the availability of a draft National Chemical Policy, 2012. The draft Policy is intended to facilitate the growth and development of the chemical sector in India. DCPC states that the policy “accords high importance” to research and development (R&D), technology up-gradation, safety and sustainability, pollution and environmental aspects, effluent/waste disposal and treatment, and green chemicals. DCPC requests comments from all concerned Ministries, government departments, industry associations and industries, and citizens. Comments are due April 30, 2012. The draft Policy is available online. DCPC notes that in 2008, the EU’s REACH legislation replaced around 40 different environment-related legislations. Other countries, including Australia, Canada, Japan, and China, are adopting similar policies to retain their position in the global market, and “India may also have to pursue similar measures.” DCPC states that, apart from multiplicity of regulations, there are no specific Indian laws pertaining to:

  • Registration of substances;
  • Preparation of a national inventory;
  • Restrictions on hazardous substances;
  • Banning of certain substances;
  • Detailed classification and labeling criteria; and
  • Transport classification.

Though some of these issues have been briefly considered under certain legislations, according to DCPC, “they are yet to be addressed adequately in a comprehensive scientific and coherent manner.” DCPC concludes that there “is a need to create REACH like legislation in India for safe use of chemicals for protection of human health & environment.” More information is available in The Acta Group, L.L.C.’s April 12, 2012, memorandum, which is available online.

OSHA Will Hold Public Meeting In Preparation Of UN GHS Subcommittee Meeting: On May 11, 2012, OSHA will host a public meeting of the U.S. Interagency GHS Coordinating Group to provide interested groups and individuals with an update on GHS-related issues and an opportunity to express their views for consideration in developing U.S. government positions for the upcoming United Nations Sub-committee of Experts on the GHS (UNSCEGHS) meeting. 77 Fed. Reg. 22358. Interested stakeholders may also provide input on issues related to the Regulatory Coordination Council (RCC) at the meeting. The public is invited to attend without prior notification. The meeting agenda, in general, is as follows:

  • Discussion of working papers for the 23rd Session of the UNSCEGHS;
  • Update on UNSCEGHS correspondence group activity; and
  • Update of RCC activity and discussion of issues.

OSHA states that it does not seek stakeholder consensus in the meeting, but rather to learn stakeholders’ individual views on these issues and receive any relevant information they may have. The May 11, 2012, meeting will be held in Washington, D.C. The UNSCEGHS meeting will be held July 4-6, 2012, in Geneva, Switzerland.

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.