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March 1, 2012

Monthly Update for March 2012

Bergeson & Campbell, P.C.



EPA Updates Science Assessment For Dioxins: On February 17, 2012, the U.S. Environmental Protection Agency (EPA) issued in final its non-cancer science assessment for dioxins under the Integrated Risk Information System (IRIS) program. According to the IRIS assessment, over a person’s lifetime, current exposure to dioxins does not pose a significant health risk. EPA set the reference dose (RfD) at 0.7 picogram of dioxins per kilogram bodyweight per day. That compares to individuals’ estimated intake of dioxins in food and water of about 0.6 picogram per day. Non-cancer effects of exposure to large amounts of dioxin include chloracne, developmental and reproductive effects, damage to the immune system, interference with hormones, skin rashes, skin discoloration, excessive body hair, and possibly mild liver damage. EPA’s assessment and related documents are available online.

EPA Approves HeiQ Conditional FIFRA Nano Pesticide Product Approval: On February 22, 2012, EPA announced approval of the application submitted by HeiQ Materials AG, to conditionally register the pesticide product HeiQ AGS-20 containing a new active ingredient, nanosilver, not included in any previously registered products pursuant to the provisions of Section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. 77 Fed. Reg. 10515. The Natural Resources Defense Council (NRDC) has sued EPA over this approval. See online and online.

EPA Denies Toxic Substances Control Act (TSCA) Fishing Tackle Petition: On February 22, 2012, EPA formally denied a petition to ban/restrict the use of lead in fishing weights, sinkers, lures, and other tackle. 77 Fed. 10451. EPA stated that it denied the rulemaking petition noting that EPA does not believe additional federal regulation is warranted.

NRDC Sues EPA To Force Decision On Petition To Ban 2,4-D: On February 23, 2012, NRDC sued EPA alleging the Agency failed to respond to a 2008 petition to ban use of the herbicide 2,4-D. Natural Resources Defense Council v. EPA, D.D.C., docket number unavailable, 2/23/2012. The petition has been filed in the U.S. Court of Appeals for the District of Columbia Circuit, and seeks a writ of mandamus compelling EPA to act on the petition within 45 days. The petition requested that EPA cancel all registrations to sell products containing 2,4-D and revoke all tolerance limits set for exposure to residues of the pesticide. NRDC alleged EPA was required by the Federal Food, Drug, and Cosmetic Act (FFDCA), FIFRA, and the Administrative Procedure Act (APA) to respond to the petition in a timely manner.

EPA Announces TSCA Work Plan Chemicals: On March 1, 2012, the EPA Office of Pollution Prevention and Toxics (OPPT) announced a work plan of 83 chemicals for further review under TSCA. EPA identified seven chemicals for risk assessment in 2012, and intends to complete some of these assessments this year and initiate new assessments from the work plan in the coming years. EPA stated that, this Spring, it plans to identify specific chemicals for risk assessment in 2013 and 2014. More information on the TSCA Work Plan Chemicals is available online. The announcement also briefly discusses OPPT’s efforts to “build the pipeline of future assessment” and its continuing efforts to increase public access to chemical data and information. The seven chemicals currently being assessed are: antimony and antimony compounds; HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcycl openta[g]-2-benzopyran); long-chain chlorinated paraffins; medium-chain chlorinated paraffins; methylene chloride; N-methylpyrrolidone; and trichloroethylene.

In conducting risk assessments on these chemicals, EPA will use information available through the data sources cited in the TSCA Work Plan Chemicals Methods Document, as well as other sources. EPA states that it “would welcome the submission of additional relevant information on these chemicals, such as unpublished studies not already available through the existing literature.” To meet EPA’s schedule for the completion of risk assessments in 2012, any relevant information should be submitted by March 30, 2012. More information is available online.

OIG Begins IRIS Review: According to a March 2, 2012, memorandum to Lek Kadeli, Acting Assistant Administrator, EPA Office of Research and Development (ORD), EPA’s Office of Inspector General (OIG) is beginning its review of EPA’s use of IRIS. The memorandum states that the review was initiated to answer inquiries from Representative Paul Broun (R-GA). OIG intends to determine how EPA program offices and regions use IRIS in their work and products. OIG’s general project objectives are: determine which EPA offices and regions utilize data derived from IRIS assessments or other similar systems; and determine how EPA offices and regions utilize data derived from IRIS assessments, and the circumstances under which they use IRIS or an alternate system. OIG’s March 2, 2012, memorandum is available online.

EPA Proposes To Require Electronic Reporting Of TRI Data: EPA published a March 5, 2012, proposed rule that, effective January 1, 2013, would require facilities to report non-confidential Toxics Release Inventory (TRI) data to EPA using electronic software. 77 Fed. Reg. 13061. The only exception to the electronic reporting requirement would be for the few facilities that submit trade secret TRI information (including sanitized and unsanitized information), who would continue to submit their trade secret reporting forms and substantiation forms in hard copy. According to EPA, as of Reporting Year 2010, approximately 95 percent of TRI reporting facilities were using the Toxics Release Inventory-Made Easy Internet-based Software Application (TRI-MEweb), making it possible for EPA to process and expedite the release of TRI data to the public. Under the proposed rule, EPA would also require facilities to submit electronically (i.e., not on paper forms or CD-ROMs) any revisions or withdrawals of previously submitted TRI data. For trade secret submissions, EPA would still accept revisions or withdrawals of previously submitted trade secret information on paper forms. Comments are due May 4, 2012.

EPA Issues Results From Inert Ingredient Test Orders Issued Under Its Endocrine Disruptor Screening Program: On March 14, 2012, EPA issued the result of test orders issued in 2010 to companies that manufacture or import any of the following nine chemicals currently used as inert ingredients in pesticide products: acetone, isophorone, di-sec-octyl phthalate, toluene, methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate. 77 Fed. Reg. 15101. The test orders required recipients to submit specific screening data on hormonal effects under EPA’s Endocrine Disruptor Screening Program (EDSP) and the FFDCA. In response to the test orders, companies have agreed to develop data and have asserted data compensation rights for two inert ingredients, acetone and isophorone. According to EPA, no companies are developing data for the remaining seven inert ingredients. For di-sec-octyl phthalate and toluene, EPA plans to issue new test orders as both chemicals meet the selection criteria for endocrine testing under the Safe Drinking Water Act (SDWA). EPA has no plans to issue further test orders for methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate, but plans to no longer approve their use as inert ingredients in pesticide products. EPA is, however, offering an opportunity for interested parties to comment or commit to submitting the required data. Comments must be received on or before May 14, 2012.

EPA Receives $1.2 Million In Private Sector Research Funding From L’Oréal: EPA and L’Oréal cosmetic company announced on March 12, 2012, a research collaboration designed to determine if ToxCast can be used in systemic toxicity tests. EPA is using ToxCast to screen chemicals to understand their potential impact on processes in the human body that lead to adverse health effects. L’Oréal is providing EPA $1.2 million in collaborative research funding, plus robust safety data from a set of representative substances from the cosmetic sector, expanding the types of chemical use groups assessed by ToxCast. EPA will compare the ToxCast results to the L’Oréal data to determine if the reliability and the relevance are appropriate for use in the safety assessment of chemicals in cosmetics. More information on ToxCast is available online.

External Peer Review On Draft Biphenyl Toxicological Review: On April 3, 2012, Versar, Inc., an EPA contractor for external scientific peer review, will convene an independent panel of experts and organize and conduct an external peer review meeting to review the draft human health assessment entitled Toxicological Review of Biphenyl: In Support of Summary Information on the Integrated Risk Information System (IRIS). 77 Fed. Reg. 12836. Versar invites the public to register to attend this meeting as observers. In addition, Versar invites the public to give brief oral comments and/or provide written comments at the meeting regarding the draft assessment under review. Space is limited, and reservations will be accepted on a first-come, first-served basis. In preparing a final report, EPA will consider Versar’s report of the comments and recommendations from the external peer review meeting, as well as any written public comments that EPA received in accordance with the announcements of the public comment period for the biphenyl assessment in a Federal Register notice published September 30, 2011. More information is available online.

EPA Announces Second List Of Chemicals For EDSP Screening And Publication Of Proposed Policies And Procedures For Requiring EDSP Testing Of The Listed Chemicals: According to an EPA official, EPA expects to release a final second list of chemicals (List 2) to be subject to EDSP Tier 1 testing in Spring 2013. Reportedly, EPA is actively working on several EDSP issues and this may be an implicit admission by EPA that these other issues are absorbing EPA’s time.

EPA announced the second list of 134 chemicals and substances for which EPA intends to issue EDSP test orders on November 17, 2010. 75 Fed. Reg. 70248. The 134 chemicals include a significant number of TSCA chemicals that EPA has identified as priorities under SDWA and may be found in sources of drinking water where a substantial number of people may be exposed. The list also includes pesticide active ingredients that EPA is evaluating under its Registration Review Program to ensure they meet current scientific and regulatory standards. A more detailed discussion of this second list is available online.

Since the second list of chemicals was released in November 2010, there have been a number of significant EDSP developments. EPA has been reviewing the Tier 1 data submitted regarding the List 1 substances and is working on validating five assays that will comprise the Tier 2 testing to be required for those substances EPA selects for testing based on the Tier 1 results and the potential of the substances to interact with the endocrine system. EPA also has received two petitions (one from CropLife America (CLA), Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE); the other from the Chemical Producers and Distributors Association (CPDA), Halogenated Solvents Industry Alliance (HSIA), and People for the Ethical Treatment of Animals (PETA)) requesting further information and justifications for EPA’s actions that EPA is now considering.

EPA’s statement that a final EDSP List 2 will not be issued until Spring 2013, at the earliest, perhaps reflects an understanding by EPA that the current program has been under attack from many different directions and EPA needs to address existing problems and determine future pathways before subjecting additional substances to test orders. A decision to postpone issuance of a final List 2 seems a prudent step that will now allow EPA to take related EDSP actions, including consideration and response to the two petitions discussed above, preparation to renew its Information Collection Request (ICR) that expires this year, evaluation of submitted Tier 1 data, and validation of Tier 2 assays.


EPA Issues New Resource Conservation and Recovery Act (RCRA) Guidance Document For TSDF: EPA has released a guidance document entitled Hazardous Waste Treatment, Storage, and Disposal Facilities (TSDF) Regulations: A User-Friendly Reference Document for RCRA Subtitle C Permit Writers and Permittees. EPA issued the guidance to consolidate and streamline the TSDF regulatory requirements into a use-friendly reference tool that features hyperlinked references to the regulations in addition to relevant frequently asked questions, letters, memoranda, and guidance documents. The document can be accessed online.

GAO Report Details Improvements In How EPA Manages Superfund Special Accounts: The General Accountability Office (GAO) on February 17, 2012, issued a report detailing progress in how EPA manages its special accounts under the Superfund program. The report, Status of EPA’s Efforts to Improve Its Management and Oversight of Special Accounts, examines the balances, locations, and recent and planned uses of Superfund special accounts; and the extent to which EPA has implemented processes and policies to improve the monitoring and management of these accounts.

Under the Superfund program, EPA has the authority to enter into agreements with potentially responsible parties (PRP) for them to conduct a cleanup at hazardous waste sites or compel PRPs to do so. EPA can also conduct cleanups itself and then seek reimbursement. EPA is authorized to retain and use funds received from settlements with these parties in interest-earning, site-specific special accounts within the Trust Fund. These accounts provide resources in addition to annual appropriations to clean up sites. The number of accounts grew slowly until 1995 when EPA encouraged their greater use. After 1995, their number and dollar value increased.

The report states that from fiscal year (FY) 1990 through October 2010, EPA collected almost $4 billion in funds that were placed in special accounts. Nearly half of these funds are still available to be obligated for future Superfund cleanup; the remaining funds have already been obligated, but not all of these obligated funds have been disbursed. According to GAO’s analysis of EPA data, EPA has plans to obligate almost all of the available funds in special accounts over the next ten years. GAO also found that EPA has taken steps, including implementing strategies and guidance, in the last few years to better monitor and manage special accounts.

The report is available online.

EPA Adds 19 Sites To Superfund National Priorities List: EPA on March 13, 2012, added 19 sites to the Superfund National Priorities List (NPL). Nine of the sites are final additions, while EPA proposed to add ten additional sites. The final additions are: Continental Cleaners (former dry cleaners) in Miami, FL; Sauer Dump (inactive dump) in Dundalk, MD; Compass Plaza Well TCE (contaminated ground water plume) in Rogersville, MO; Chemfax, Inc. (former manufacturer of synthetic resins and waxes) in Gulfport, MS; Southeastern Wood Preserving (former wood treating operation) in Canton, MS; CTS of Asheville, Inc. (former electronics components manufacturer) in Asheville, NC; Eighteenmile Creek (contaminated creek) in Niagara County, NY; Metro Container Corporation (former drum recycler) in Trainer, PA; and Corozal Well (contaminated ground water plume) in Corozal, PR.

The proposed additions are: Cedar Chemical Corporation (former chemical manufacturer) in West Helena, AR; Fairfax St. Wood Treaters (former wood treating operation) in Jacksonville, FL; Macon Naval Ordnance Plant (former ordnance manufacturer) in Macon, GA; Bautsch-Gray Mine (former lead and zinc mine) in Galena, IL; EVR-Wood Treating/Evangeline Refining Company (former wood treating operation) in Jennings, LA; Holcomb Creosote Co (former wood treating operation) in Yadkinville, NC; Orange Valley Regional Ground Water Contamination (contaminated ground water plume) in Orange/West Orange, NJ; Jackpile-Paguate Uranium Mine (former uranium mine) in Laguna Pueblo, NM; West Troy Contaminated Aquifer (contaminated ground water plume) in Troy, OH; and Circle Court Ground Water Plume (contaminated ground water plume) in Willow Park, TX.

EPA is also withdrawing its earlier proposal to add the Arnold Engineering Development Center site in Coffee and Franklin Counties, Tennessee to the NPL. This site is being addressed under the RCRA program. Cleanup is progressing successfully, the migration of contaminated ground water is under control, and measures have been taken that are protective of human health, EPA said.


Sierra Club, Industry File Petition For Review For Secondary Lead MACT Standards: The Sierra Club on March 5, 2012, filed suit against EPA over the Agency’s January 5, 2012, final rule revising the Maximum Achievable Control Technology (MACT) standards for the secondary lead industry. Also filing suit over the rule on March 5 were the Association of Battery Recyclers Inc., Johnson Controls Battery Group Inc., and the Doe Run Resources Corp. Sierra Club v. EPA, D.C. Cir., No. 12-1135, 3/5/12; Ass’n of Battery Recyclers Inc. v. EPA, D.C. Cir., No. 12-1129, 3/5/12; Johnson Controls Battery Group Inc. v. EPA, D.C. Cir., No. 12-1130, 3/5/12; The Doe Run Resources Corp. v. EPA, D.C. Cir., No. 12-1134, 3/5/12. The final rule lowers the emission limits for lead from secondary lead smelters to 0.2 milligram per dry standard of cubic meter of air. It also requires smelters to implement changes at their operations, such as enclosing sources of fugitive lead emissions.


GSA Launches Website On Improving Supply Chain Sustainability: On March 9, 2012, the General Services Administration (GSA) announced it is developing an online portal for companies to share information about supply chain sustainability. The site, which will be launched at the end of March or beginning of April, will be called the Sustainable Supply Chain Community of Practice. Companies will be able to post their corporate social responsibility reports and other sustainability performance information and will be able to compare their reports against other companies in their industry as well as across sectors. The portal will also feature input from nonprofit organizations, industry associations, and academic institutions that deal with sustainable supply chain topics. GSA is studying how to apply Executive Order No. 13,514, which directs GSA to leverage the federal procurement process to lower the government’s greenhouse gas (GHG) emissions, to the federal purchasing process. The order, which was signed by President Obama in 2009, calls on federal agencies to set and meet specific sustainability related targets in their operations.


FDA Requests Comment On Petition To Amend Food Additive Regulations: On February 17, 2012, the U.S. Food and Drug Administration (FDA) requested comment on a petition filed by the American Chemistry Council (ACC) requesting FDA to amend food additive regulations to provide the use of polycarbonate resins in baby bottles and children’s sippy cups. 77 Fed. Reg. 9608. FDA is requesting comments that address whether the uses of polycarbonate resins have been abandoned and whether the ACC petition adequately defines these uses of polycarbonate resins. Comments are due by April 17, 2012.


Global Agenda Council On Emerging Technologies Identifies Top Technology Trends: During the Summit on the Global Agenda 2011, the World Economic Forum’s Global Agenda Council on Emerging Technologies asked members to identify the technology trends that would have the greatest global impact. The trends, which were presented in order of greatest potential to provide solutions to global challenges, include “nanoscale design of materials” as fourth on the list. According to the Council, “increasing demand on natural resources requires unprecedented gains in efficiency. Nanostructured materials with tailored properties, designed and engineered at the molecular scale, are already showing novel and unique features that will usher in the next clean energy revolution, reduce our dependence on depleting natural resources, and increase atom-efficiency manufacturing and processing.” Nanotechnology was also mentioned in other trends: Number 6, “Utilization of carbon dioxide as a resource” (“[n]ovel catalysts, based on nanostructured materials, can potentially transform carbon dioxide to high value hydrocarbons and other carbon-containing molecules”); Number 8, “High energy density power systems” (“emerging technologies are coming together to lay the foundation for advanced electrical energy storage and use, including the development of nanostructured electrodes, solid electrolysis and rapid-power delivery from novel supercapacitors based on carbon-based nanomaterials”); and Number 9, “Personalized medicine, nutrition and disease prevention” (emerging technologies, including nanotechnology, “are laying the foundation for a revolution in healthcare and well-being that will be less resource intensive and more targeted to individual needs”). More information is available online.

ECHA Announces Plans To Update Guidance For Registration Of Nanoform Substances: On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.” More information is available online.

WHO Background Document On Guidelines On Protecting Workers From Manufactured Nanomaterials Available For Comment: The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments. The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.” Comments are due March 31, 2012. The draft background document is available online.

Wisconsin Bill Would Create Nanotechnology Information Hub And Nanotechnology Council: S.B. 533, which was prepared for the Joint Legislative Council’s Special Committee on Nanotechnology, was introduced in the Wisconsin Senate on February 29, 2012, by the Joint Legislative Council. The bill directs the University of Wisconsin System Board of Regents to maintain a nanotechnology information hub, for at least five years, to promote the development of nanotechnology businesses in Wisconsin, and gather and disseminate information about environmental health and workplace safety related to nanotechnology. The hub is directed to report to the legislature on emerging nanotechnology health and safety information, and at the direction of the nanotechnology council, identify needed legislation relating to nanotechnology safety and development. The nanotechnology council, which would be created by the bill, would set policies and priorities for the nanotechnology information hub and make grants for research and development related to nanotechnology, subject to the availability of funding. The bill does not appropriate any funds for grants but rather directs the nanotechnology hub to seek and compete for federal, state, or other funding to support its activities and to be used by the nanotechnology council to make grants. The bill is available online.

The Special Committee was created to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee was directed to consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements. The Special Committee’s May 10, 2011, Proposed Report to the Legislature, which is available online, includes a draft bill relating to establishing a nanotechnology information hub and a nanotechnology council, as well as a separate draft bill relating to a Wisconsin interagency nanotechnology council. Legislation creating a Wisconsin interagency nanotechnology council has not been introduced at this time. More information regarding the Special Committee is available online.

NIOSH Sponsoring Workshop On Safe Nano Design: The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop. More information regarding the workshop is available online.

Australia Announces New Guidance On The Safe Handling And Use Of Carbon Nanotubes: On March 5, 2012, Safe Work Australia announced the release of an information sheet on the safe handling and use of carbon nanotubes in the workplace and a document entitled Safe Handling and Use of Carbon Nanotubes. The information sheet, which is available online, provides an overview of risk management for carbon nanotubes, while Safe Handling and Use of Carbon Nanotubes, which is available online, describes two approaches to managing the risks: risk management with detailed hazard analysis and exposure assessment, and risk management by using control banding. Either or both of these methods may be used, depending on the circumstances. Safe Work Australia states that the guidance is applicable to other forms of carbon nanofibers, such as carbon nanorods and carbon nanowires. It is also applicable to products containing carbon nanotubes and other forms of carbon nanofibers where these nanomaterials may be released during handling. Safe Work Australia has commissioned a human health hazard assessment and classification of carbon nanotubes, and it expects to publish the findings in mid-2012.


ECHA Adds Eight Chemicals To Authorization List: On February 15, 2012, the EC formally added eight chemicals to the list of chemicals subject to authorization under REACH, increasing the number of chemicals banned under REACH to 14. These eight chemicals were proposed for addition to the Authorization List (or Annex XIV) in December 2010. The full Authorization List is available on ECHA’s website as a chart with information about the 14 banned chemicals online. The eight latest additions and the reasons for adding them are:

Chemical NameCAS NumberReason for Listing
Di-isobutylphthalate (DIBP)84-69-5Toxic for reproduction (category 1B)
Diarsenic trioxide1327-53-3Carcinogenic (category 1A)
Diarsenic pentaoxide1303-28-2Carcinogenic (category 1A)
Lead chromate7758-97-6Carcinogenic (category 1B) Toxic for reproduction (category 1A)
Lead sulfochromate yellow (CI Pigment Yellow 34)1344-37-2Carcinogenic (category 1B) Toxic for reproduction (category 1A)
Lead chromate molybdate sulphate red (CI Pigment Red 104)12656-85-8Carcinogenic (category 1B) Toxic for reproduction (category 1A)
Tris(2-chloroethyl)phosphate (TCEP)115-96-8Toxic for reproduction (category 1B)
2,4-dinitrotoluene (2,4-DNT)121-14-2Carcinogenic (category 1B)

ECHA Launches World Largest C&L Inventory: On February 13, 2012, ECHA launched on its website the public Classification & Labelling (C&L) Inventory. The database contains basic classification and labelling information on 90,000 substances notified and registered in over three million submissions from manufacturers and importers. ECHA claims that it is the largest inventory of its kind in the world. The first version of the inventory contains notifications for substances classified in the hazard classes specified in Article 119(1)(a) of the REACH Regulation, as amended by Article 58(7) of the Classification, Labelling, and Packaging (CLP) Regulation. Some substances not classified or only classified in hazard classes outside of REACH are not included. ECHA states all notifications for European Inventory of Existing Chemical Substances (EINECS) substances will be added in the next version of the inventory, regardless of classification. In addition, due to technical reasons, notifications that classify only in carcinogenic, mutagenic, or reprotoxicity (CMR) and specific target organ toxicity (STOT) hazard classes could not be published in the first version. This will be rectified with the first refresh of the inventory, stated ECHA. Recently and newly submitted notifications will also be added periodically. For more information, see:

  • Public C&L Inventory (online);
  • ECHA press statement (online);
  • ECHA Q&A (online); and
  • EC press statement (online).

ECHA Opens Public Consultation On 13 Substances: On February 27, 2012, ECHA opened a public consultation on the possible addition of 13 substances to the list of candidates for bans under REACH. The consultation is intended to collect comments on the identity and uses of the substances, which will be considered in deciding if they qualify as substances of very high concern (SVHC). The 13 potential SVHCs are 1,2-bis(2-methoxyethoxy)ethane; 1,2-dimethoxyethane; 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H ,3H,5H)-trione; 1,3,5-tris[2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5 H)-trione; 4,4′-bix(dimethylamino)benzophenone; 4,4′-bis(dimethylamino)-4″-(methylamino)trityl alcohol; C.I. Basic Blue 26; C.I. Basic Biolet 3; C.I. Solvent Blue 4; diboron trioxide; formamide; lead(II) bis(methonesulfonate); and N,N,N’,N’-tetramethyl-4,4′-methylenedianiline. Comments on the chemicals will be accepted through April 12, 2012.

ECHA Announces First CoRAP: On February 29, 2012, ECHA announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the REACH substance evaluation process. The substances are scheduled for evaluation in 20122013, and 2014. Following the evaluation, further information may be requested from the registrants of the substances when additional data are considered necessary to clarify the suspected risk. The CoRAP includes the grounds for the initial concerns, and indicates the Member State that is responsible for the evaluation of each substance. In 2012, 36 substances will be evaluated by 17 Member States. The remainder has been listed for 2013 and 2014, but ECHA states that it expects to amend the number and selection of substances listed for those years in the annual updates of the CoRAP. From the publication of the CoRAP, the respective Member States have one year to evaluate substances specified for the year 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the Member State Committee, or by the EC if there is no unanimity at the Member State Committee. For other evaluation decisions, registrants of the substances listed on the CoRAP will have opportunities to comment before any final decision is taken. The 90 substances are:

  • Carbon tetrachloride;
  • Methanol;
  • Chloromethane;
  • Ethylene oxide;
  • 4,4′-isopropylidenediphenol (Bisphenol A);
  • 2-(4-Tert-butylbenzyl)propionalde hyde;
  • N-1-naphthylaniline;
  • Decahydronaphthalene;
  • 1,3-Diphenylguanidine;
  • 4-Methylanisole;
  • Toluene;
  • N-hexane;
  • 2,2′-Iminodiethanol;
  • Decan-1-ol;
  • 2,4,6-Tribromophenol;
  • Hydroquinone;
  • Tributyl phosphate;
  • Ziram;
  • 2-Ethylhexanoic acid;
  • Imidazole;
  • Dimethyl phosphonate;
  • N-(1,4-dimethylpentyl)-N’-phenylbenzene-1,4-diamine;
  • N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine;
  • Tris(2-ethylhexyl) benzene-1,2,4- tricarboxylate;
  • Triclosan;
  • Octocrilene;
  • Hexyl salicylate;
  • Silicon dioxide;
  • M-tolylidene diisocyanate;
  • Isoheptane;
  • Phenol, methylstyrenated;
  • 1,1′-(ethane-1,2-diyl)bis[pentabromoben zene];
  • Alkanes, C14-17, chloro (MCCP, Medium chained chlorinated paraffins);
  • A mixture of: cis- tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4- methylpyran-4-ol;
  • 2- (Phenylmethoxy)naphthalene;
  • Polyhaloalkene;
  • Formaldehyde;
  • Carbon disulphide;
  • 3,5,5-Trimethylcyclohex-;
  • 2-Enone;
  • Biphenyl;
  • 1,2-Dichlorobenzene;
  • Furfuryl alcohol;
  • 4,4′-Methylenediphenyl diisocyanate;
  • Hexamethyldisiloxane;
  • Methylcyclohexane;
  • Tetrahydrofuran;
  • 1,3,5-Trioxane;
  • 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2, 3-dicarboxylic anhydride;
  • Tetrachloroethylene;
  • Diallyl phthalate;
  • 1,3, 5- Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H )-trione;
  • Silver;
  • [1,3(or 1,4)-phenylenebis (1- methylethylidene)]bis[te rt-butyl] peroxide;
  • Diisotridecyl adipate;
  • Phenol, dodecyl-, sulfurized, carbonates, calcium salts, overbased;
  • Mixture of two components: 1. N-(1,3-dimethylbutyl)-N´- phenyl-p- phenylenediamine 2. N1-(1, 3-dimethylbutyl)- N4-(4-(1-methyl-1-phenylethyl)phenyl) benzene-1,4-diamine;
  • Reaction mass of mixed (3,3,4,4,5,5,6,6,7,7,8,8, 8-tridecafluorooctyl) phosphates, ammonium salts;
  • Ammonium salts of mono- and bis[3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl and/or poly (substituted alkene)] phosphate;
  • Mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol;
  • 2-(2-Butoxyethoxy)ethyl 6-propylpiperonyl ether;
  • Dichloro(dimethyl)silane;
  • 4,4′-Sulphonyldiphenol;
  • Diethyl phthalate;
  • 2,4-Di-tert-butylphenol;
  • Methyl 4- hydroxybenzoate;
  • 4-Hydroxybenzoic acid;
  • 2,2′,2″-Nitrilotriethanol;
  • P-cresol;
  • Allyl alcohol;
  • Resorcinol;
  • Triphenyl phosphate;
  • Thiram;
  • 2-Aminoethanol;
  • Diuron;
  • 1,1,1,3,3,3- Hexamethyldisilazane;
  • Gallium arsenide;
  • Tris(methylphenyl) phosphate;
  • Tert-butyl methyl ether;
  • 1-Ethylpyrrolidin-2-one;
  • Diundecyl phthalate;
  • 2-Ethylhexyl 4- methoxycinnamate;
  • Titanium dioxide;
  • Ditolyl ether;
  • Diisodecyl azelate;
  • 2-Ethylhexyl 10-ethyl-4-[[2-[(2- ethylhexyl)oxy]-2- oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate;
  • 1,2-Benzenedicarboxylic acid, benzyl C7-9-branched and linear alkyl esters;
  • 1,2-Benzenedicarboxylic acid, di-C9-11- branched and linear alkyl esters;
  • 1,2-Benzenedicarboxylic acid, di-C11-14- branched alkyl esters, C13-rich;
  • Phenol, 4-nonyl-, branched; and
  • Diundecyl phthalate, branched and linear.

More information is available online.


House Hearing Investigates Costs Of Complying With EPA Regulations: The House Energy and Commerce Subcommittee on Oversight and Investigations (O&I) on February 16, 2012, held a hearing to investigate the potential costs associated with complying with proposed federal regulations. The hearing focused primarily on EPA rules. Subcommittee Chair Cliff Stearns (R-FL) said that a year after Executive Order No. 13,563 was issued, little has changed in the way the federal government issues regulations. The executive order calls upon federal agencies to adopt regulations only when their benefits justify their costs and when they are crafted to impose the least burden on society. President Obama issued the order to quiet the rising din of criticism from Republicans over federal regulations. It has not succeeded. Republicans have held numerous hearings on regulatory reform, with the O&I Subcommittee holding eight hearings on its own. Calls for regulatory reform and a slashing of the cost and scope of EPA’s regulations are likely to continue as a centerpiece of Republicans’ attack on the Obama presidency in the upcoming presidential election cycle.

Senate Resolution Would Revoke EPA’s Utility NESHAP Standards: EPA on February 16, 2012, issued one of its most controversial rules in decades: the national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units. 77 Fed. Reg. 9304. The NESHAP standards seek to limit emissions of mercury and other hazardous air pollutants from utilities and from other steam generating units. EPA received over 900,000 comments on the proposed standards, demonstrating the unparalleled public interest in the rulemaking. Many believe EPA’s rule will have disastrous impacts on the utility industry. To prevent such impacts, Senator James Inhofe (R-OK) on February 16, 2012, introduced a joint resolution to nullify the regulations. Senator Inhofe introduced the resolution under the authority of the Congressional Review Act, a 1996 law passed during the heyday of the “Contract with America” movement in Congress. Under the law, a joint resolution of disapproval that has support from 30 Senators can be discharged from Committee and placed on the Senate calendar for a floor vote.

House Passes Keystone Pipeline And Drilling Bill: By a vote largely along party lines, the House on February 16, 2012, passed legislation intended to expedite the approval of the Keystone XL pipeline and otherwise boost energy production by expanding offshore drilling and oil exploration in the Arctic National Wildlife Refuge (ANWR). The Protecting Investment in Oil Shale the Next Generation of Environmental, Energy, and Resource Security Act or the “PIONEERS Act” likely will be attached to the transportation reauthorization bill.

EPA Quizzed On Budget: A House Appropriations Committee press release dated March 7, 2012, detailed close questioning of EPA on its budget proposals. Idaho Congressman Mike Simpson, Chair of the House Interior and Environment Appropriations Subcommittee, queried EPA Administrator Lisa Jackson regarding EPA’s budget request for FY 2012, and Simpson also grilled Administrator Jackson regarding what many perceive as EPA’s regulatory overreach and the impact that the Agency’s actions are having on the economy. Simpson questioned EPA’s decision to reduce EPA’s budget on the backs of states, which are already struggling to balance their own budgets, as state grants have been reduced by 22% while EPA operations and research budgets are reduced by only 2%-4%. Simpson also defended provisions included in H.R. 1, the continuing resolution (CR) that reduces funding for the EPA by 30% for the remainder of the current FY, which would have limited funding for what he called EPA’s “litany of overreaching regulations.” Simpson pushed for language to be included in the bill to limit EPA’s ability to regulate GHGs, as well as language to prohibit funding for efforts to expand EPA’s jurisdiction over state waters. In addition, during consideration on the House floor, over 20 amendments limiting funding for EPA were accepted by the House. Various press reports outlined EPA’s response to the Congressional challenges. Administrator Jackson reportedly stated that the $8.344 billion request “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.” The request is $105 million below EPA’s enacted budget level for FY 2012 and includes a $50 million savings from eliminating “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.”

House Leaders Urge EPA To Reject NOI Move: Fred Upton (R-MI), Chair of the House Energy and Commerce Committee, and John Shimkus (R-IL), Chair of the Committee’s Subcommittee on Environment and the Economy, wrote Administrator Jackson urging her to defend EPA’s regulatory discretion under RCRA Section 2002(b) and not revise the RCRA regulations regarding the disposal of coal ash as requested in a Notice of Intent (NOI) to Sue filed by EarthJustice. EarthJustice argued in the NOI that EPA had no discretion to decline to revise the rules, and it should do so, especially regarding the toxicity of solid wastes and surface and groundwater issues.

Hearing On Regulatory Reform Held: On February 16, 2012, the Subcommittee on O&I of the House Energy and Commerce Committee held the latest in a series of hearings on the Obama Administration efforts regarding regulatory reform in the Executive Branch, including the impact on jobs. This hearing focused on comments from the private sector, and can be reviewed on the Committee website. Generally, witnesses were critical of the efforts at reform to date.

Amendment To Delay Industrial Boiler And Incinerator MACT Killed In Senate: On March 8, 2012, the Senate rejected an amendment that would have delayed implementation of EPA’s MACT rule for industrial furnaces and incinerators. Senator Susan Collins (R-ME) introduced the amendment, which sought to delay the rules for 15 months and would have extended the compliance period for an additional five years. The measure was offered as an amendment to the transportation reauthorization legislation currently being considered in the Senate. Although the amendment received 52 aye votes, that fell short of the 60 required to pass the amendment under Senate rules. Legislation with similar intent has passed the House, that bill — the EPA Regulatory Relief Act of 2011 (H.R. 2250) — is unlikely to be adopted by the Senate.

221 Representatives Ask OMB To Block Utility GHG Rules: Over 200 House members on February 23, 2012, asked the Office of Management and Budget (OMB) to block forthcoming EPA rules establishing emission limits for GHGs for power plants, arguing the rules would escalate electricity costs and cost American jobs.

Clean Energy Standard Act Of 2012: Senator Jeff Bingaman (D-NM) on March 1, 2012, introduced a bill that seeks to ensure that the majority of the nation’s electricity is generated from clean energy sources. The Clean Energy Standard Act of 2012 (S. 2146) would amend the Public Utility Regulatory Policies Act to implement a federal clean energy standard (CES). The purpose of the CES is to create a “national, market-oriented standard for electric energy generation that stimulates clean energy innovation and promotes a diverse set of low- and zero-carbon generation solutions in the U.S. at the lowest incremental cost to consumers.”

Under the bill, the term “clean energy” is defined to mean: (1) electricity generated at a facility placed in service after 1991 using renewable energy, qualified renewable biomass, natural gas, hydropower, nuclear power, or qualified waste-to-energy; (2) electricity generated at a facility placed in service after enactment that uses qualified combined heat and power, generates electricity with a carbon-intensity lower than 0.82 metric tons per megawatt-hour (the equivalent of new supercritical coal), or as a result of qualified efficiency improvements or capacity additions at existing nuclear or hydropower facilities; and (3) electricity generated at a facility that captures and stores its carbon dioxide emissions.

Under the legislation, beginning in 2015, large utilities must obtain a percentage of the electricity they sell from clean energy sources. The requirement begins at 24% in 2015, and increases by 3% per year through 2035. Utilities may deduct the amount of electricity sold from nuclear and hydropower facilities placed in service before 1992 from their overall sales amount before calculating the percentage of clean energy needed for that year.

Senator Bingaman, who chairs the Senate Energy and Natural Resources Committee, has promised to hold a hearing on the bill. He concedes, however, that getting substantive legislation through Congress will be challenging.

Lead Exposure Reduction Amendments Act Of 2012: Senator James Inhofe (R-OK), Ranking Member of the Senate Committee on Environment and Public Works, on March 2, 2012, introduced the Lead Exposure Reduction Amendments Act of 2012 (S. 2148), legislation that is intended to increase compliance with EPA’s Lead Renovation, Repair and Painting Rule (LRRP). Senators David Vitter (R-LA), Tom Coburn (R-OK), Chuck Grassley (R-IA), Roy Blunt (R-MO), and Mike Enzi (R-WY) are cosponsors of this bill.

EPA’s LRRP has had problems since its 2010 implementation. The rule applies to all pre-1978 homes where renovation work disturbs more than six square feet on the interior of the home. It also applies to all pre-1978 homes where windows and doors are replaced. The regulations require these renovations to follow rigorous work practices supervised by an EPA-certified renovator and performed by an EPA-certified renovation firm. On July 6, 2010, EPA also removed the “Opt-Out Provision” from the rule, which allowed homeowners without children under six or pregnant women residing in the home to allow their contractor to forego the use of lead-safe work practices.

The Lead Exposure Reduction Amendments Act of 2012 restores the “Opt-Out Provision.” It also would suspend the LRRP for homes without small children or pregnant women residing in them, if EPA cannot approve one or more commercially available test kits that meet the regulation’s requirements. The bill would also prohibit EPA from expanding the LRRP to commercial and public buildings until EPA conducts a study demonstrating the need for such an action. It provides a de minimis exemption for first-time paperwork violations and provides for an exemption for renovations after a natural disaster. Finally, the bill eliminates the requirement that recertification training be “hands on,” preventing remodelers having to travel to training facilities out of their region.

Senate Bill Expands Loan Program For Biofuels To Chemicals: On March 5, 2012, Senator Debbie Stabenow (D-MI) introduced legislation that would expand the United States Department of Agriculture’s (USDA) biorefinery loan guarantee program for biofuels to other biobased products, including chemicals and plastics. Senator Stabenow, Chair of the Senate Committee on Agriculture, Nutrition and Forestry, introduced the legislation as part of her new Grow it Here, Make it Here initiative to advance Michigan’s emerging biobased manufacturing industry. The Grow it Here, Make it Here initiative includes several provisions to support Michigan biobased manufacturers and innovators to spur new job growth.


NTP Approaches New Cellular Assay To Determine If Chemicals Mimic Or Block Estrogen: On February 1, 2012, the National Toxicology Program (NTP) advised federal agencies that a cellular test that can identify chemicals with the potential to mimic or block estrogen in the body has been validated through a review process involving scientists from the United States, Europe, and Japan. NTP notified 14 federal agencies that the Lumi-Cell® Estrogen Receptor BG1LUc Estrogen Receptor Transcriptional Activation test has been evaluated by scientist and should be considered for use. According to NTP, the new test has advantages over one EPA now uses for its EDSP. The cells used in the test area are available from two U.S. sources, whereas the cells used in the test EPA currently requires must be purchased from a single company located in Japan. NTP’s views reflect the recommendations of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The Committee’s recommendation is consistent with that of a scientific panel, which also found the new cellular test to have certain advantages. The ICCVAM Authorization Act of 2000, Pub. L. No. 106-545, charged the Committee with promoting “the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness.” Under ICCVAM’s authorizing legislation, federal agencies are to let the Committee know within 180 days of receiving its recommendation whether they plan to adopt a validated test method. Information about ICCVAM’s review of information concerning this cellular assay is available online.

Presidential Memorandum Calls For Increased Federal Procurement Of Biobased Products: President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from USDA, has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products. The memorandum is available online. More information is available online.

CDC Posts Updated Tables For Fourth National Report On Human Exposure To Environmental Chemicals: The Centers for Disease Control and Prevention (CDC) announced the release of the Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables, February 2012 (Updated Tables), which provides all new data since the release of the 2009 Fourth National Report on Human Exposure to Environmental Chemicals (Fourth Report, 2009). The new data include updated tables for 66 chemicals in the Fourth Report, 2009 and tables for 34 new chemicals. The Updated Tables present data from the 2005-2006 and 2007-2008 survey periods and data for a few chemicals from the 2003-2004 survey period. Newly reported chemicals include the anions thiocyanate and nitrate, the sulfonyl urea herbicides (17 chemicals), and the pesticides acephate, methamidophos, dimethoate, omethoate, ethylene thiourea, and propylene thiourea. Datasets that were revised include the following chemicals or chemical groups: the pesticides 2,4- and 2,5-dichlorophenol, ortho-phenylphenol, 2,4,5- and 2,4,6-trichlorophenol; the environmental phenols bisphenol A, triclosan, 4-tert-octylphenol, benzophenone-3, and four parabens; perfluorochemicals (12 chemicals); phthalate metabolites (15 chemicals); and urinary metals, including mercury, and total and speciated arsenic (21 chemicals). The Updated Tables are cumulative and include data reported in earlier updates. More information is available online.

EC Releases Report On Assessment Of Endocrine Disruptors: The EC released a report on its “State of the Art Assessment of Endocrine Disrupters” project. The report summarizes advances in the state of the science assessing endocrine disrupters since 2002 and maps out ways of dealing with endocrine disrupters in important pieces of European Union (EU) chemicals regulation, such as the REACH+ legislation. The report concludes that evidence of endocrine disruptor-related disorders in humans has increased, that the effects of endocrine disrupters are not being adequately captured or addressed in the current testing regimes of EU chemical regulations, and further research and development is needed to close the knowledge gap on these effects. The report recommends:

  • Implementing updated or enhanced validated and internationally recognized test methods into EU chemical regulations;
  • Developing further guidance on interpreting test data;
  • Creating the separate regulatory class “Endocrine Disrupter”;
  • Developing weight-of-evidence procedures that deal with the available evidence by weighing the criteria “adversity” and “mode of action” in parallel, but not by applying these criteria sequentially to exclude substances from the assessment;
  • Considering potency, together with other criteria such as lead toxicity, specificity, severity, and irreversibility in a weight-of-evidence approach; and
  • Creating regulatory categories that stimulate the generation of the necessary data, including test methods that are not validated, beyond the Organization for Economic Co-operation and Development (OECD) Conceptual Framework.

A copy of the EC report is available online.

Chemical Safety Board Issues Policy Expanding Employee Participation In Accident Investigations: The U.S. Chemical Safety Board (CSB) announced on March 7, 2012, that it has developed a new policy on employee participation in investigations that the Board hopes “will enhance the vital role played by plant workers in determining root causes of incidents and promoting facility safety.” The policy, which was approved by a unanimous 3-0 vote of the Board on February 27, 2012, implements a provision of the CSB enabling statute at 42 U.S.C. § 7412(r)(6)(L), which provides that employees and their representatives have similar rights in CSB accident investigations as they do during Occupational Safety and Health Administration (OSHA) inspections under the Occupational Safety and Health Act of 1970.

Under the policy, if the CSB initiates an investigation at a union-represented site, the CSB will promptly identify and notify facility unions of its plans to investigate. At non-union sites, the CSB will seek to identify other employee representatives, such as employee members of any established Health and Safety Committee, or other employee representatives, if possible. The CSB will also seek participation by contract employees and their representatives, similar to facility employees. At the outset of its investigations, the policy calls for the CSB to establish direct, face-to-face communications with employee representatives and to take measures to avoid interference by any party with the proper exercise of employee participation. The policy also provides for private meetings between the CSB and employees. It also provides employees with the opportunity to review and comment on the factual accuracy of CSB reports, recommendations, and interim statements of findings prior to public release.

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.