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September 1, 2011

Monthly Update for September 2011

Bergeson & Campbell, P.C.


EPA Publishes Chemical Data Reporting Rule: On August 16, 2011, the U.S. Environmental Protection Agency (EPA) published a final rule entitled Chemical Data Reporting (CDR) Rule, formerly known as the Inventory Update Reporting (IUR) Rule, under the Toxic Substances Control Act (TSCA). 76 Fed. Reg. 50816. The revisions, which were first announced August 2, 2011, expand the requirements for reporting data on production volume, use, and exposure for many chemicals widely used in commerce, and they make electronic reporting mandatory. The first reporting period under the new rule will be from February 1, 2012, to June 30, 2012. The final rule is available online. Two memoranda on the rule are available online here and here.

In a separate, more recent action, EPA issued on September 6, 2011, a revised regulatory text of the new rule, which was corrected to address several technical errors. 76 Fed. Reg. 54932.

EPA Extends Comment Period On Glymes SNUR: On September 8, 2011, EPA extended the comment period on the glymes significant new use rule (SNUR). 76 Fed. Reg. 55622. Comments are now due on October 12, 2011.

EPA Releases Background Paper On Identifying Priority Chemicals: On August 18, 2011, EPA issued a document entitled Discussion Guide: Background and Discussion Question Identifying Priority Chemicals for Review and Assessment, which is available online. The guide is intended to identify priority chemicals for review and possible risk management actions under TSCA. Identification of a chemical as a priority chemical for review would not itself constitute a finding by EPA that the chemical presents a risk to human health or the environment. Rather, identification of a chemical as a priority chemical would indicate only that EPA intends to review it on a priority basis. EPA believes that identifying these chemicals early in the review process would afford all interested parties the opportunity to bring additional relevant information on those chemicals to EPA’s attention to further inform the review. More detailed information is available online.

On September 7, 2011, EPA held a webinar regarding its plans to use a two-step process to identify priority chemical substances for review and assessment under TSCA. EPA states that its goal is “to identify priority chemicals for near-term evaluation, not to screen and prioritize the entire TSCA Inventory of approximately 84,000 chemicals.” EPA held the webinar to obtain public input on the prioritization factors and data sources it plans to use. A more detailed memorandum is available online.

EPA Announces Schedule For Dioxin Assessment: On August 29, 2011, EPA announced that it intends to complete the non-cancer portion of its Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments (Reanalysis), and post the final non-cancer assessment to the Integrated Risk Information System (IRIS) by the end of January 2012. After completing the non-cancer portion, EPA will then prepare in final the cancer portion of the dioxin reanalysis as quickly as possible. The decision to split the dioxin assessment into two portions, one being the cancer assessment and the other being the non-cancer assessment, follows the release by the Science Advisory Board (SAB) of its final review report of EPA’s Reanalysis on August 26, 2011. The Reanalysis responded to the recommendations and comments included in the National Academy of Sciences’ (NAS) 2006 review of EPA’s 2003 draft dioxin assessment. More information on dioxin is available online.

EPA Schedules Public Comment Period And Listening Session On 1,4-Dioxane: On August 31, 2011, EPA announced a 60-day public comment period and a public listening session for the external review draft human health assessment titled, Toxicological Review of 1,4-Dioxane: In Support of Summary Information on the Integrated Risk Information System (IRIS). 76 Fed. Reg. 54225. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA). According to EPA, new studies regarding the toxicity of 1,4-dioxane through the inhalation route of exposure are available that were not included in the 1,4-dioxane assessment that was posted on the IRIS database in 2010. The listening session for 1,4-dioxane will be held on October 18, 2011. The public comment period on 1,4-dioxane ends October 31, 2011.

EPA Issues Draft Toxicological Review On n-Butanol Under IRIS Program: On September 15, 2011, EPA announced the release of a 60-day external review draft human health assessment titled, Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk Information System (IRIS) (EPA/635/R-11/081A). 76 Fed. Reg. 57033. The draft assessment was prepared by NCEA within EPA’s Office of Research and Development (ORD). EPA will convene a listening session on October 26, 2011, during the public comment period for the draft assessment. The purpose of the listening session is to allow all interested parties to present scientific and technical comments on draft IRIS health assessments to EPA and other interested parties attending the listening session. The public comment period will end on November 7, 2011.

EPA Schedules SAP Meeting To Consider Rodenticide Cancellations: On September 7, 2011, EPA announced the scheduling of a three-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) to consider and review scientific conclusions supporting EPA’s FIFRA Section 6(b) Notice of Intent to Cancel Twenty Homeowner Rodenticide Bait Products. 76 Fed. Reg. 55381. According to the notice, EPA intends to propose a Notice of Intent to Cancel (NOIC) for 20 consumer/homeowner rodenticide products. EPA intends to seek advice and recommendations from the SAP on the following scientific issues: EPA’s evaluation of human and pet incidents of accidental exposure to rodenticides; EPA’s evaluation of ecological incidents of accidental exposure to rodenticides; the differences in uptake and clearance of first-generation anticoagulant rodenticides, non-anticoagulant rodenticides, and second-generation anticoagulant rodenticides, in target and non-target wildlife; EPA’s ecological risk assessments for rodenticides, including ecological risks of first-generation anticoagulant rodenticides, non-anticoagulant rodenticides, and second-generation anticoagulant rodenticides; and the differences in secondary ecological exposure between first-generation anticoagulant rodenticides, non-anticoagulant rodenticides, and second-generation anticoagulant rodenticides. The meeting will be held on November 29, 2011, through December 1, 2011. Comments must be submitted by November 15, 2011, and requests for oral comments be submitted by November 22, 2011.


DTSC Schedules Symposium On Alternatives Analysis: On September 2, 2011, the California Department of Toxic Substances Control (DTSC) scheduled a symposium on September 15, 2011, to discuss alternatives analysis. Alternatives analysis is a core component of developing safer consumer products. According to DTSC, the fundamentals of the process are routinely executed as part of industry’s ongoing research and development and product improvement. Representatives of consumer product manufacturers convened in Sacramento on September 15, 2011, to give presentations on a variety of existing decision making tools and approaches for developing products. More information is available online.


FDA Regulatory Science Plan Addresses Nanomaterials And Nanotechnology: The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities. FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use these new scientific advances, FDA developed the Strategic Plan. According to the Strategic Plan, one of the ways FDA intends to support new approaches to improve product manufacturing and quality is by developing new analytical methods, including improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials in FDA-regulated products. The priority area entitled “Ensure FDA Readiness to Evaluate Innovative Emerging Technologies” includes the following statement regarding nanotechnology:

As medical products are being revolutionized by cutting-edge technologies like nanotechnology, it is more critical than ever for FDA to fully understand how nanomaterials are being used in these products. FDA has established Nanotechnology Core Centers to provide critically needed equipment and technical staff to conduct product assessment and safety research in support of regulatory decision making. These centers will facilitate investigations on the safety of products that use nanomaterials, establish methods to assess quality and effectiveness of products that use nanomaterials, and identify standards to be incorporated in the preclinical safety assessment of products that contain nanomaterials.

The Strategic Plan is available online.

Denmark Publishes Literature Review For Seven Nanomaterials: In August 2011, the Danish Environmental Protection Agency (DEPA) published a document entitled Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, which is intended to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials, and the possibility of exposure of humans and the environment. DEPA selected fullerenes, iron, silver, nanoclay, and titanium, cerium, and silicon dioxides for the project. Based on current uses, DEPA concluded that current applications of nano-iron and nano-clay cannot cause unexpected “nano-associated” health or environmental problems. Although DEPA identified no specific risk associated with current uses of any of the identified nanomaterials, it concluded “there are areas where there may be reason for attention and thus need for more knowledge.” More information is available online.

JRC-IHCP Argues For Definition Of Engineered Nanomaterials: The August 25, 2011, issue of Nature includes a letter from Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP). In response to Andrew Maynard’s article entitled “Don’t define nanomaterials,” in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is “urgently needed.” Maynard proposes that a “‘one size fits all’ definition of nanomaterials will fail to capture what is important for addressing risk,” and suggests that regulators use “a list of nine or ten attributes (including size and surface area) for which certain values trigger action.” Stamm, however, maintains that size is “the most appropriate parameter on which to base a broad definition.” Maynard concludes that adaptive regulations are necessary to respond to scientific evidence, while Stamm acknowledges that a definition “would need revision in line with fresh scientific evidence.” Stamm’s letter is available online, and Maynard’s article is available online.

German Advisory Council Releases Report Concerning Precautionary Strategies For Managing Nanomaterials: The German Advisory Council on the Environment (SRU) released on September 1, 2011, a report entitled Precautionary Strategies for Managing Nanomaterials, which makes recommendations for a “responsible and precautionary development” of nanotechnology. According to SRU, its objective is to allow for innovation while also identifying and reducing risks at an early stage. SRU concludes that while chemical, product, and environmental regulations are “generally applicable” to nanomaterials, the specific characteristics of nanomaterials could impede the application of the regulations. Closing the regulatory gaps “would require a uniform definition for nanomaterials, their treatment as separate substances in chemicals risk assessments and the obligation for manufacturers to submit data sets specifically adapted to nanomaterials.” SRU states that activities that it believes pose “a certain cause of concern are, in particular, the use of nanomaterials in consumer sprays, the growing sales of consumer products containing silver nanoparticles and the production and processing of carbon nanotubes, which are suspected to be carcinogenic — especially those with a high aspect ratio.” To increase transparency regarding the presence of nanomaterials in consumer products, SRU recommends a register for products containing nanomaterials and an extension of existing labeling requirements. The SRU was founded in 1971 to advise the German government and consists of seven university professors from a range of different environment-related disciplines. SRU’s advice is independent from external instructions. More information is available online.


EPA Accepts First GHG Reporting Data: On August 22, 2011, EPA announced the launching of a new tool to allow 28 industrial sectors to submit their 2010 greenhouse gas (GHG) emission data electronically. Prior to being issued in final, more than 1,000 stakeholders, including industry associations, states, and non-governmental organizations (NGO), tested the electronic GHG Reporting Tool (e-GGRT) to ensure clarity and user-friendliness. The data collected with e-GGRT will provide the public with information about the largest domestic stationary sources of GHG. EPA expects to receive 2010 GHG data from approximately 7,000 large industrial GHG emitters and suppliers, including power plants, petroleum refineries, and landfills. EPA’s GHG Reporting Program (GHGRP), launched in October 2009, requires the reporting of GHG data from large emission sources across a range of industry sectors. Suppliers of products that would emit GHGs if released, combusted, or oxidized are also required to report GHG data. Under the program, covered entities are required to submit GHG data to EPA annually and the first round of data will be submitted electronically by September 30, 2011. EPA plans to publish non-confidential GHG data collected through the GHGRP by the end of 2011. More information on the GHGRP is available online.

EPA Defers Deadline To Report Factors Used To Calculate GHG Emissions: On August 25, 2011, EPA deferred the reporting deadline for data elements that are used by direct emitter reporters as inputs to emission equations under the Mandatory Greenhouse Gas Reporting Rule. 76 Fed. Reg. 53057. The deadline for reporting some of these data elements is deferred to March 31, 2013, and the deadline for reporting others is deferred to March 31, 2015. This final rule does not change any other requirements of the Mandatory Greenhouse Gas Reporting Rule. According to EPA, more time is needed to calculate inputs as the data elements requiring evaluation are much larger than EPA anticipated. The final rule was effective on September 9, 2011.

EPA Proposes Technical Corrections To GHG Rule For The Electronics Manufacturing And Petroleum And Natural Gas Systems Categories: On September 9, 2011, EPA proposed technical revisions to the electronics manufacturing and the petroleum and natural gas systems source categories of the GHG reporting rule. Proposed changes include providing clarification on existing requirements, increasing flexibility for certain calculation methods, amending data reporting requirements clarifying terms and definitions, and technical corrections. 76 Fed. Reg. 56010. In addition, EPA proposed to amend the definition of heat transfer fluids in subpart I to include more fluorocarbons used as heat transfer fluids in the electronics manufacturing industry. Comments must be received on or before October 11, 2011.


NIOSH Announces Carcinogen And REL Policy Assessment: On August 23, 2011, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced its intent to review its approach to classifying carcinogens and establishing recommended exposure limits (REL) for occupational exposures to hazards associated with cancer. 76 Fed. Reg. 52664. As part of this effort, NIOSH is requesting initial input on five questions. The five questions are: (1) Should there explicitly be a carcinogen policy as opposed to a broader policy on toxicant identification and classification (e.g., carcinogens, reproductive hazards, neurotoxic agents)? (2) What evidence should form the basis for determining that substances are carcinogens? How should these criteria correspond to nomenclature and categorizations (e.g., known, reasonably anticipated, etc.)? (3) Should 1 in 1,000 working lifetime risk (for persons occupationally exposed) be the target level for a REL for carcinogens or should lower targets be considered? (4) In establishing NIOSH RELs, how should the phrase “to the extent feasible” (defined in the 1995 NIOSH Recommended Exposure Limit Policy) be interpreted and applied? (5) In the absence of data, what uncertainties or assumptions are appropriate for use in the development of RELs? What is the utility of a standard “action level” (i.e., an exposure limit set below the REL typically used to trigger risk management actions) and how should it be set? How should NIOSH address worker exposure to complex mixtures? This information will be taken under consideration and used to inform NIOSH’s efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer. NIOSH has also created a new NIOSH Cancer and REL Policy Web Topic Page, available online. The page is intended to provide additional details about this effort and progress updates. Comments are due September 22, 2011.


Congress Amends CPSIA: President Obama signed into law on August 14, 2011, H.R. 2715, an amendment to the Consumer Product Safety Improvement Act (CPSIA). The amendment provides the Consumer Product Safety Commission (CPSC) with additional authority and discretion in enforcing consumer product safety laws. Among the product related provisions is the proviso that any lead limit in a children’s product must apply only to a product manufactured after the effective date of any such limit. Products manufactured before August 14, 2011, must comply with the preexisting 300 ppm lead limit, but not the 100 ppm limit that would have gone into effect August 14, 2011, pursuant to a provision in the CPSIA. The amendment also revises Section 7 regarding reports of harm relating to the use of consumer products to require a stay of five days before posting information on the Safer database if CPSC received notice that information in a report is materially inaccurate, and establish procedures for when CPSC receives a report missing a model or serial number for the product. Finally, CPSC under the amendment is given the authority to issue subpoenas to federal, state, or local government agencies.


ECHA Lists 20 Substances For Possible EU Ban: On August 29, 2011, the European Chemicals Agency (ECHA) proposed to list 20 chemicals as “substances of very high concern” (SVHC) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The substances were nominated for SVHC status by ECHA and by regulatory authorities in Austria, France, Germany, Norway, and Slovakia. The 19 carcinogenic, mutagenic, and reprotoxic (CMR) substances are: 1,2-dichloroethane; 2,2′-dichloro-4,4′-methylenedianiline (MOCA); aluminosilicate refractory ceramic fibers (RCF); arsenic acid; bis(2-methoxyethyl) ether; bis(2-methoxyethyl) phthalate; calcium arsenate; dichromium tris(chromate); formaldehyde, oligomeric reaction products with aniline; o-anisidine; lead diazide; lead dipicrate; lead styphnate; N,N-dimethylacetamide (DMAC); pentazinc chromate octahydroxide; phenolphthalein; potassium hydroxyoctaoxodizincatedichromate; trilead diarsenate; and zirconia aluminosilicate refractory ceramic fibers. The substance with endocrine disrupting properties is 4-tert-octylphenol. Comments on the proposed listing are due by October 13, 2011. More information on the ECHA consultations on proposals to identify SVHCs is available online.

Canada Seeks To Modify CEPA Schedule 3: In early August 2011, Canada submitted a notification to the World Trade Organization that it is modifying Schedule 3 of the Canadian Environmental Protection Act (CEPA). The proposed Order would make several additions and modifications to the Export Control List (ECL). It would add the following five substances to Part 1 of the ECL. These substances are prohibited in Canada and are therefore proposed for inclusion in Part 1 of the ECL:

  • Chlordecone (Chemical Abstracts Service (CAS) registry number 143-50-0);
  • Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy-1,4,4a,5,6,7, 8, 8a-octahydro-exo-1,4-exo-5,8-dimethanonaphthalene) (CAS 72-20-8);
  • Toxaphene (CAS 8001-35-2);
  • Alpha-HCH (CAS 319-84-6); and
  • Beta-HCH (CAS 319-85-7).

The current listings for endrin (Part 3, item 7), toxaphene (Part 2, item 25), and the HCH isomers (Part 2, item 12) would be removed upon their addition to Part 1 of the ECL. All of these substances are listed in Annex A of the Stockholm Convention.

The proposed Order would also add the following three groups of substances, all of which have been added to Annex III to the Rotterdam Convention, to Part 2 of the ECL:

  • Dinitro-ortho-cresol (DNOC) and its salts (CAS 534-52-1; CAS 2980-64-5; CAS 5787-96-2; CAS 2312-76-7);
  • Dustable powder formulations containing a combination of benomyl at or above 7% (CAS 17804-35-2), carbofuran at or above 10% (CAS 1563-66-2) and thiram at or above 15% (CAS 137-26-8); and
  • All tributyltin compounds, including
    • Tributyltin oxide (CAS 56-35-9);
    • Tributyltin fluoride (CAS 1983-10-4);
    • Tributyltin methacrylate (CAS 2155-70-6);
    • Tributyltin benzoate (CAS 4342-36-3);
    • Tributyltin chloride (CAS 1461-22-9);
    • Tributyltin linoleate (CAS 24124-25-2); and
    • Tributyltin naphthenate (CAS 85409-17-2).

Recent amendment to Annex III to the Rotterdam Convention added two substances that are currently in Part 3 of the ECL. These substances would be deleted from Part 3 of the ECL and added to Part 2:

  • Tetraethyl lead (CAS 78-00-2); and
  • Tetramethyl lead (CAS 75-74-1).

The proposed Order would add nine substances or groups of substances to Part 3 of the ECL. These additions are proposed because there are controls placed on these substances in Canada which restrict their use:

  • Benzidine and benzidine dihydrochloride, which have the molecular formulas C12H12N2 and C12H12N2×2HCl, respectively (CAS 92-87-5; CAS 531-85-1);
  • 2-Methoxyethanol, which has the molecular formula C3H8O2 (CAS 109-86-4);
  • Pentachlorobenzene, which has the molecular formula C6HCl5 (CAS 608-93-5);
  • Tetrachlorobenzenes, which have the molecular formula C6H2Cl4 (CAS 12408-10-5; CAS 84713-12-2; CAS 634-90-2; CAS 634-66-2; CAS 95-94-3);
  • Perfluorooctane sulfonate (PFOS) and its salts;
  • Compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N;
  • Azinphos-methyl (CAS 86-50-0);
  • Phorate (CAS 298-02-2); and
  • Terbufos (CAS 13071-79-9).

Pentachlorobenzene is listed in Annex A of the Stockholm Convention. Perfluorooctane sulfonate, its salts and perfluorooctane sulfonyl fluoride (contains the group C8F17SO2) are listed in Annex B of the Stockholm Convention.

CPSC Announces Development Of A Toy Safety Standard Strategic Outreach And Education Plan: CPSC announced on September 6, 2011, the development of a strategic outreach and education plan to help the business community and other stakeholders learn about testing and certification requirements for children’s toys and toy chests and their compliance with ASTM International’s Standard Consumer Safety Specification for Toy Safety. 76 Fed. Reg. 55056. The notice specified that written comments must be submitted no later than October 21, 2011.

CPSC Votes To Regulate Cadmium Unless ASTM Publishes Standards: On September 6, 2011, CPSC directed staff to begin drafting a rule declaring cadmium a hazardous product if the substance occurs in children’s toy metal jewelry unless ASTM International publishes a voluntary standard in three months. The commissioners also agreed to grant a petition seeking the initiation of the rulemaking submitted by the Empire State Consumer Project, the Sierra Club, the Center for Environmental Health, and the Rochesterians Against the Misuse of Pesticides. These petitioners requested that CPSC adopt regulations declaring children’s jewelry containing cadmium in greater than trace amounts to be a banned hazardous substance within the meaning of the Federal Hazardous Substance Act. The vote is a reversal of an agency staff recommendation to defer for the second time a decision to adopt regulations. CPSC staff in its briefing package said ASTM subcommittees are nearing completion of voluntary standards that address accessible cadmium from children’s metal jewelry and toy jewelry. Staff members recommended deferring a decision until the subcommittees finish their work and staff has a chance to review the voluntary standards to determine their adequacy. ASTM International is the former American Society for Testing and Materials, and its purpose is development of voluntary consensus standards for products.

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