Monthly Update for January 2013


Predictions For EPAs Office Of Chemical Safety And Pollution Prevention: Bergeson & Campbell, P.C.'s (B&C) thoughts on what may be headed our way in 2013 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) are provided in our memorandum available online. Although the 2012 Presidential Election is over, environmental issues will continue to be used to make distinctions between the two parties (or between the House and Senate). Speculation is currently rife with what directions a re-elected Obama Administration might take: seek a middle-ground approach to maneuver successfully through a divided Congress, or, facing no further election campaigns, play aggressively to the environmentalist base of the coalition that was, in part, responsible for making a second term possible. Beyond the rhetoric one can imagine supporting either position, most day-to-day life at EPA, like most places, will be driven by the immediate demands of the discrete issues that come before program management on a daily basis.

TSCA/FIFRA/IRIS/EPCRA

EPA Steps Up Distributor Label Enforcement: At the most recent Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) meeting on December 10, 2012, Don Lott, Office of Enforcement and Compliance Assurance (OECA), presented an overview of OECA's efforts to assess distributor label compliance with FIFRA. OECA has initiated an enforcement review that focuses on distributor labeling, tracks enforcement cases involving distributor labels, and calls for greater cooperation between EPA and the states. Lott requested that states report all distributor label violations through their respective EPA Regional offices and requested SFIREG to identify potential hurdles to such reporting. OECA is interested in distributor label violations on a national basis so that it may coordinate efforts to tie these violations back to the common registrant. Lott stated that states may take individual action against a registrant but emphasized the need to pass that information to its EPA Regional office as well. Lott stated that OECA would pursue actions against the registrants consistently with the Federal Enforcement Response Policy.

EPA Issues Draft Pesticide Registration Notice On Mold-Related Label Claims: On December 12, 2012, EPA announced in a Federal Register notice the availability of a draft Pesticide Registration (PR) Notice entitled "Guidance for Antimicrobial Pesticide Products with Mold-Related Label Claims" (Draft PR Notice). 77 Fed. Reg. 74003. The Draft PR Notice has some potentially alarming implications regarding the continued use of certain claims under the treated articles exemption that any registrants of active ingredients used in treated articles subject to this Draft PR Notice or companies that rely upon the treated article exemption should be aware of and comment upon.

The Draft PR Notice is available online. Additional supporting documents are available at www.regulations.gov (search for Docket No. EPA-HQ-OPP-2010-0539). A more detailed memorandum is available online. EPA is accepting comments through February 11, 2013.

EPA Proposes Significant New Use Rule On Ethoxylated, Propoxylated Diamine Diaryl Substituted Phenylmethane Ester With Alkenylsuccinate, Dialkylethanolamine Salt: On December 19, 2012, EPA proposed a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt, which was the subject of premanufacture notice (PMN) P-01-384. 77 Fed. Reg. 75085. The rule would require persons who intend to manufacture, import, or process this chemical substance for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. EPA originally issued the SNUR as a direct final rule in April. Since adverse comment was submitted, EPA withdrew the rule and is now proposing it. Comments must be received on or before January 18, 2013.

EPA Removes 16 Chemicals From HPV Orphan Chemicals: On December 19, 2012, EPA's Interagency Testing Committee (ITC) recommended to EPA that 16 High Production Volume (HPV) Challenge Program Orphan Chemicals be removed from the TSCA Section 4(e) Priority Testing List. 77 Fed. Reg. 75350. The orphan chemicals removed from the Priority Testing List are listed below. The ITC determined that the actions have been taken to assess the hazardous potential of these substances. Comments are due January 18, 2013.

CAS No. Chemical Name ITC Report Removal Rationale
62-56-6 Thiourea 55 EPA NPRM
81-16-3 1-Naphthalenesulfonic acid, 2-amino- 55 55 OECD SIDS
84-69-5 1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester 55 EPA NPRM
91-68-9 Phenol, 3-(diethylamino)- 55 Sponsored chemical
110-18-9 1,2-Ethanediamine, N1,N1,N2,N2-tetramethyl- 55 Sponsored chemical
119-33-5 Phenol, 4-methyl-2-nitro- 55 OECD SIDS program
121-69-7 Benzenamine, N,N-dimethyl- 55 Sponsored chemical
131-57-7 Methanone, (2-hydroxy-4-methoxyphenyl)phenyl- 55 EPA NPRM
870-72-4 Methanesulfonic acid, 1-hydroxy-, sodium salt (1:1) 55 EPA NPRM
6473-13-8 2-Naphthalenesulfonicacid, 6-[2-(2,4-diaminophenyl)diazenyl]-3- [2-[4-[[4-[2-[7-[2-(2,4-diaminophenyl)diazenyl]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]phe nyl]amino]-3-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:3) 55 EPA NPRM
28188-24-1 Octadecanoic acid, 1,1'-2- (hydroxymethyl)-2-[[(1- oxooctadecyl)oxy]methyl]- 1,3-propanediyl ester 55 EPA NPRM
61788-44-1 Phenol, styrenated 56 Sponsored chemical
68334-01-0 Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products 55 Sponsored chemical
68457-74-9 Phenol, isobutylenated methylstyrenated 56 Sponsored chemical
68915-39-9 Cyclohexane, oxidized, aq. ext., sodium salt 55 Analog to CAS No. 68915-38-8
90640-80-5 Anthracene oil 55 OECD SIDS program

EPA Withdraws Immediate Final TSCA Section 8(d) Rule: On December 28, 2012, EPA withdrew a final health and safety data reporting rule that it issued pursuant to TSCA Section 8(d) on December 3, 2012. 77 Fed. Reg. 76419. Since the final rule's issuance, EPA noted it had received a number of letters, including requests for withdrawal under 40 C.F.R. Section 716.105(c)-(d), asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty about the final rule in certain industrial sectors subject to the final rule. For example, EPA received comments that the regulatory text did not clearly specify which additional industrial sectors beyond those subject to reporting in Section 716.5(a) must report unpublished health and safety studies, as required by Section 716.5(b). EPA believes that some of the points raised in the letters warrant additional consideration by the Agency. EPA found that there is "good cause" under the Administrative Procedure Act (APA) (5 U.S.C. Section 553(b)(3)(B)) to withdraw this final rule without prior notice and comment. EPA had only a limited time to publish this withdrawal. Related memoranda can be found online and online.

EPA Requests Information, Issues Advance Notice Of Public Meeting On Lead-Based Paint Rule: On December 31, 2012, EPA requested information and announced a public meeting on re-examining the lead-based paint rule. 77 Fed. Reg. 76996. In 2010, EPA issued an advance notice of proposed rulemaking (ANPRM) concerning renovation, repair, and painting activities on and in public and commercial buildings. EPA is determining whether these activities create lead-based paint hazards, and, for those that do, developing certification, training, and work practice requirements as required under TSCA. EPA opened a comment period to allow for additional data and other information to be submitted by the public and interested stakeholders. EPA would like to receive information about: the manufacture, sale, and uses of lead-based paint after 1978; the use of lead-based paint in and on public and commercial buildings; the frequency and extent of renovations on public and commercial buildings; work practices used in renovations; and quantities of dust generated and moved around during repairs and renovations. The notice states EPA would like information "from all sources and regarding all types of potentially affected businesses and other stakeholders, including small businesses." The notice also provides advance notice of EPA's plan to convene a public meeting on June 26, 2013. Comments must be received on or before April 1, 2013.

EPA Proposes Revisions To Minimum Risk Exemption For Pesticides: EPA proposed on December 31, 2012, a new rule intended to address a long-standing enforcement issue that has vexed federal and state inspectors for years. 77 Fed. Reg. 76979. The proposed rule would require that active and inert ingredients permitted in products eligible for the exemption from registration under the FIFRA Section 25(b)(2) for minimum risk pesticides be described more clearly on product labels. EPA proposed to reorganize the lists of eligible active and inert ingredients by adding specific chemical identifiers to make it clearer to manufacturers, the public, and, most importantly, federal and state inspectors which ingredients are permitted in minimum risk pesticide products. EPA also proposed to modify the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. A more detailed memorandum is available online. Comments are due April 1, 2013.

EPA Announces Availability Of Draft Chemical Risk Assessments: EPA announced on January 9, 2013, the availability of the first draft risk assessments developed under the TSCA Work Plan. 78 Fed. Reg. 1856. The draft risk assessments are for particular uses of five chemicals found in household products: methylene chloride or dichloromethane (DCM) and N-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[?]-2 -benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products. In the notice, EPA requests nominations of expert peer reviewers. Comments for nominations of peer reviewers must be received on or before February 8, 2013, and comments on the draft assessments and the charge questions for the external peer reviews must be received on or before March 11, 2013. EPA will forward the nominations to the independent peer review contractor setting up the individual peer review panels. More information on and copies of the draft risk assessments are available online. A more detailed memorandum is available online.

GREEN CHEMISTRY

DTSC Opens Comment Period On Safer Consumer Product Alternatives: On December 20, 2012, the California Department of Toxic Substances Control (DTSC) offered for public comment the revised Initial Statement of Reasons (ISOR) for the Safer Consumer Product Regulations. The Regulations establish the criteria for identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and imposition of regulatory responses. DTSC is revising the ISOR to correct typographical, spelling, cross-referencing, punctuation, and other formatting errors. In addition, DTSC has revised the ISOR to address some substantive drafting issues raised regarding the ISOR. These include, but are not limited to, making more explicit the necessity statement for each provision. The revised ISOR is available online and online. The public comment period for the revised ISOR ends January 22, 2013.

California EPA Convenes Cumulative Impacts And Precautionary Approaches Work Group Meeting: The Office of Environmental Health Hazard Assessment (OEHHA) on behalf of the California Environmental Protection Agency (Cal/EPA) convened a public meeting of the Cal/EPA Cumulative Impacts and Precautionary Approaches (CIPA) Work Group on January 11, 2013. The purpose of the CIPA Work Group meeting was to provide advice on a second public review draft of CalEnviroScreen, a screening methodology to identify California communities that are disproportionately burdened by multiple sources of pollution. The agenda and meeting materials are available online.

CAA

D.C. Circuit Remands EPA Rules Implementing PM2.5 NAAQS: The U.S. Court of Appeals for the District of Columbia Circuit on January 4, 2013, issued a ruling ordering EPA to strengthen two rules seeking to implement the National Ambient Air Quality Standards (NAAQS) for "fine" particulate matter. Fine particulate matter is defined as particulate matter having a diameter of 2.5 micrometers or less (PM2.5). The court's decision in Natural Resources Defense Council v. EPA remanded two EPA rules implementing the PM2.5 NAAQS: the final rule implementing the PM2.5 NAAQS (72 Fed. Reg. 20586; Apr. 25, 2007) and the New Source Review (NSR) implementation rule for the PM2.5 NAAQS (73 Fed. Reg. 28321; May 16. 2008). The court agreed with the petitioners in the case, the Natural Resources Defense Council, Sierra Club, American Lung Association, and Medical Advocates for Health Air, that EPA erred when it issued the rules pursuant to Subpart 1 of Part D of the Clean Air Act (CAA), as opposed to the more specific provisions of Subpart 4 of Part D of Title 1. The latter provisions were added by Congress to the 1990 provisions of the CAA. The decision is likely to result in more stringent standards for PM2.5.

RCRA/CERCLA

EPA Issues Final Rule On Identification Of Non-Hazardous Secondary Materials That Are Solid Wastes: On December 20, 2012, EPA issued in final revisions to CAA standards for boilers and certain solid waste incinerators, originally finalized in March 2011. EPA re-examined the 2011 Identification of Non-Hazardous Secondary Material (NHSM) final rule in 40 C.F.R. Part 241 and amended/clarified certain issues on which EPA has received new information, as well as specific targeted revisions to allow implementation of the rule as EPA originally intended. EPA issued in final revisions to three definitions: "clean cellulosic biomass," "contaminants," and "established tire collection programs." Based on comments received on the proposed rule, EPA also issued in final a revised definition of "resinated wood." EPA issued a revised definition of "clean cellulosic biomass" that: makes clear that the list of biomass materials are examples within the definition and is not intended to be an exhaustive list; and provides a more comprehensive list of clean cellulosic biomass to guide the regulated community. Specifically, the following additional materials are included within the definition of biomass -- agricultural derived biomass, other crop residues (including vines, orchard trees, hulls, and seeds), and other biomass crops used for the production of cellulosic biofuels, hogged fuel, untreated wood pallets, wood pellets, and wood debris from urban areas. EPA also issued a revised definition of "contaminants" to clarify what constituents will be considered contaminants for the purposes of the contaminant legitimacy criterion. Revisions include: the replacement of a reference to "any constituent that will result in emissions" with a specific list of constituents to be considered as contaminants based on their status as a precursor to air emissions; the removal from the definition of specific CAA Sections 112(b) and 129(a)(4) pollutants that are not expected to be found in any NHSM or are adequately covered elsewhere in the definition; and the removal of the phrase "including those constituents that could generate products of incomplete combustion" from the definition. EPA issued a revised definition of "resinated wood" that includes additional materials to be more representative of the universe of resinated wood residuals that are currently used as fuels throughout the wood product manufacturing process. EPA issued a revised contaminant legitimacy criterion for NHSMs used as fuels to provide additional details on how contaminant comparisons between NHSMs and traditional fuels may be made. In preamble text, EPA stated that it received information regarding other NHSMs that are good candidates for a categorical listing in a future rulemaking. These include: paper recycling residuals (including old corrugated cardboard (OCC) rejects); and construction and demolition (C&D) wood processed pursuant to best practices and produced and managed under the oversight of a comprehensive collection system or contractual arrangement. In addition, EPA noted that it had received information related to creosote-treated railroad ties and indicated areas where new information from the regulated community is needed and if such additional information provides support for a categorical listing, that EPA would also address this NHSM in a future rulemaking. A more detailed memorandum is available online.

EPA Revises Institutional Control Guidance For Controlling Contaminants At Cleanup Sites: In December 2012, EPA's Office of Solid Waste and Emergency Response (OSWER) issued revised guidance updating and clarifying past policy on institutional controls (IC) used at Superfund and other contaminated sites. The Guidance, Institutional Controls: A Guide to Planning, Implementing, Maintaining, and Enforcing Institutional Controls at Contaminated Sites (OSWER 9355.0-89, EPA-540-R-09-001, December 2012), identifies parties' responsibilities in implementing, maintaining, and enforcing ICs with a view toward assisting site managers and attorneys when weighing the use of ICs. ICs include non-engineered instruments, such as administrative and legal controls, that minimize exposures to contaminants, according to EPA. The revisions generally update IC guidelines rather than set new policies. The Guidance highlights some of the common issues that may be encountered and identifies EPA's policy regarding the roles and responsibilities of the parties involved in the various life-cycle stages of ICs while recognizing that there are some differences among the cleanup programs. This is the second in a series of guidance documents on the use of ICs. The Guidance is available online.

NANOTECHNOLOGY

Canada Begins Public Consultation On Revised Draft Guidance Document Sunscreen Monograph: On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document -- Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph identifies the permitted ingredients, including nano zinc oxide and nano titanium dioxide; doses; directions and indications for use for these products, which will be required to appear on the product labels; and the recommended supporting test methods. The draft Monograph notes that license holders are expected to continue monitoring and collecting new safety data as they emerge. Applicants are required to keep information for recordkeeping purposes when nano zinc oxide and/or nano titanium dioxide are used in sunscreen products, and this information is required to be made available upon request. Comments are due February 19, 2013. More information is available online.

NIOSH Publishes Information And Comment Request For Silver Nanoparticles: The National Institute for Occupational Safety and Health (NIOSH) published in the December 19, 2012, Federal Register a request for information and comment on silver nanoparticles. 77 Fed. Reg. 75169. According to the notice, NIOSH has initiated an evaluation of the scientific data on silver nanoparticles "to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted." NIOSH has identified a number of "relevant publications" on silver nanoparticles, which is available online. NIOSH requests additional information concerning:

  1. Published and unpublished reports and findings from in vitro and in vivo toxicity studies with silver nanoparticles;
     
  2. Information on possible health effects observed in workers exposed to silver nanoparticles;
     
  3. Information on workplaces and products in which silver nanoparticles can be found;
     
  4. Description of work tasks and scenarios with a potential for exposure;
     
  5. Information on measurement methods and workplace exposure data; and
     
  6. Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to silver nanoparticles occur.

Comments are due February 19, 2013.

EPA Regulatory Agenda Includes Notice Concerning Nanoscale Materials: EPA announced in the January 8, 2013, Federal Register the availability of its 2012 Regulatory Agenda. 78 Fed. Reg. 1624. EPA's Regulatory Agenda includes the following notice concerning nanoscale materials:

Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process nanoscale materials for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. 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 to prevent unreasonable risk to human health or the environment. In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in July 2013. The item is available online.

France Reminds Companies Of Nanomaterials Reporting Requirement: The French Ministry of Ecology and Sustainable Development posted a January 8, 2013, memorandum concerning the annual mandatory reporting of nanomaterials, which took effect January 1, 2013. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a "substance with nanoparticle status" in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. The report will be due by May 1 for information about nanoparticle substances produced/imported/distributed during the prior year. A report containing 2012 data will be due by May 1, 2013. The January 8, 2013, memorandum includes a link to a new website for reporting (in French), which is available online, as well as a link to a frequently asked questions and answers document (in French), which is available online. The January 8, 2013, memorandum (in French) is available online.

REACH

Member State Committee Identifies First Respiratory Sensitizers As SVHCs: On December 17, 2012, the European Chemicals Agency (ECHA) announced that the Member State Committee (MSC) unanimously agreed on the identification of 23 substances of very high concern (SVHC). ECHA added these 23 substances to the Candidate List, along with another 31 substances that did not require MSC involvement. These substances may later become subject to authorization. MSC also indicated their agreement on ECHA's draft recommendation for adding ten new substances to the Authorization List. In its press release, ECHA notes that "[f]or the first time, the MSC identified three respiratory sensitisers, namely diazene-1,2-dicarboxamide (ADCA), hexahydro-2-benzofuran-1,3-dione (HHPA) and hexahydromethylphthalic anhydride (MHHPA) as SVHCs. The MSC considered that these substances are strong respiratory sensitisers and are giving rise to an equivalent level of concern to those of other SVHCs such as carcinogenic, mutagenic or toxic for reproduction (CMRs)." The press release is available online. ECHA held a public consultation, from September 2-October 18, 2012, on whether to list the following 54 substances as SVHCs:

Substance Name Proposed SVHC Property
Bis(pentabromophenyl) ether (DecaBDE) PBT; vPvB
Pentacosafluorotridecanoic acid vPvB
Tricosafluorododecanoic acid vPvB
Henicosafluoroundecanoic acid vPvB
Heptacosafluorotetradecanoic acid vPvB
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated -- Covering well-defined substances and UVCB substances, polymers and homologues Equivalent level of concern - probable serious effects on the environment
4-Nonylphenol, branched and linear -- Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof Equivalent level of concern - probable serious effects on the environment
Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) Equivalent level of concern - probable serious effects on human health
Cyclohexane-1,2-dicarboxylic anhydride (Hexahydrophthalic anhydride - HHPA) Equivalent level of concern - probable serious effects on human health
Hexahydromethylphathalic anhydride, Hexahydro-4-methylphathalic anhydride, Hexahydro-1-methylphathalic anhydride, Hexahydro-3-methylphathalic anhydride Equivalent level of concern - probable serious effects on human health
Methoxy acetic acid Toxic for reproduction; equivalent level of concern -probable serious effects on human health and the environment
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear Toxic for reproduction
Diisopentylphthalate (DIPP) Toxic for reproduction
N-pentyl-isopentylphtalate Toxic for reproduction
1,2-Diethoxyethane Toxic for reproduction
N,N-dimethylformamide; dimethyl formamide Toxic for reproduction
Dibutyltin dichloride (DBT) Toxic for reproduction
Acetic acid, lead salt, basic Toxic for reproduction
Basic lead carbonate (trilead bis(carbonate)dihydroxide) Toxic for reproduction
Lead oxide sulfate (basic lead sulfate) Toxic for reproduction
[Phthalato(2-)]dioxotrilead (dibasic lead phthalate) Toxic for reproduction
Dioxobis(stearato)trilead Toxic for reproduction
Fatty acids, C16-18, lead salts Toxic for reproduction
Lead bis(tetrafluoroborate) Toxic for reproduction
Lead cynamidate Toxic for reproduction
Lead dinitrate Toxic for reproduction
Lead oxide (lead monoxide) Toxic for reproduction
Lead tetroxide (orange lead) Toxic for reproduction
Lead titanium trioxide Toxic for reproduction
Lead titanium zirconium oxide Toxic for reproduction
Pentalead tetraoxide sulphate Toxic for reproduction
Pyrochlore, antimony lead yellow Toxic for reproduction
Silicic acid, barium salt, lead-doped Toxic for reproduction
Silicic acid, lead salt Toxic for reproduction
Sulfurous acid, lead salt, dibasic Toxic for reproduction
Tetraethyllead Toxic for reproduction
Tetralead trioxide sulphate Toxic for reproduction
Trilead dioxide phosphonate Toxic for reproduction
Furan Carcinogenic
Propylene oxide; 1,2-epoxypropane; methyloxirane Carcinogenic; Mutagenic
Diethyl sulphate Carcinogenic; Mutagenic
Dimethyl sulphate Carcinogenic
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine Toxic for reproduction
Dinoseb Toxic for reproduction
4,4'-methylenedi-o-toluidine Carcinogenic
4,4'-oxydianiline and its salts Carcinogenic; Mutagenic
4-Aminoazobenzene; 4-Phenylazoaniline Carcinogenic
4-methyl-m-phenylenediamine (2,4-toluene-diamine) Carcinogenic
6-methoxy-m-toluidine (p-cresidine) Carcinogenic
Biphenyl-4-ylamine Carcinogenic
o-Toluidine; 2-Aminotoluene Carcinogenic
N-methylacetamide Toxic for reproduction
1-bromopropane; n-propyl bromide Toxic for reproduction

ECHA has updated the Candidate List to include the 54 SVHCs. The Candidate List is available online. MSC also agreed by consensus with ECHA's draft recommendation for the inclusion of substances in the Authorization List - Annex XIV of REACH. The draft recommendation contains ten substances proposed by ECHA to be prioritized from the Candidate List to the Authorization List. The substances are the same as provided for public consultation earlier this year:

  • Formaldehyde, oligomeric reaction products with aniline (technical MDA);
     
  • Arsenic acid;
     
  • Dichromium tris(chromate);
     
  • Strontium chromate;
     
  • Potassium hydroxyoctaoxodizincatedichromate;
     
  • Pentazinc chromate octahydroxide;
     
  • Bis(2-methoxyethyl) ether (diglyme);
     
  • N,N-dimethylacetamide (DMAC);
     
  • 1,2-dichloroethane (EDC); and
     
  • 2,2'-dichloro-4,4'-methylenedianiline (MOCA).

ECHA states that it will take the MSC opinion into account when finalizing its recommendation for Annex XIV, which will then be transmitted to the European Commission.

BIOBASED PRODUCTS

EPA Amends Definition Of Clean Cellulosic Biomass: On December 20, 2012, EPA Administrator Lisa Jackson signed a final rule setting forth EPA's final decision on the issues for which it granted reconsideration pertaining to its March 21, 2011, final rule entitled "Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units." (See EPA Issues Final Rule On Identification Of Non-Hazardous Secondary Materials That Are Solid Wastes, above, for more information.) The December 20, 2012, rule makes technical corrections to the March 21, 2011, final rule, including clarifying the definition of clean cellulosic biomass (revisions are in red):

Clean cellulosic biomass means those residuals that are akin to traditional cellulosic biomass, including, but not limited to: agricultural and forest-derived biomass (e.g., green wood, forest thinnings, clean and unadulterated bark, sawdust, trim, tree harvesting residuals from logging and sawmill materials, hogged fuel, wood pellets, untreated wood pallets); urban wood (e.g., tree trimmings, stumps, and related forest-derived biomass from urban settings); corn stover and other biomass crops used specifically for the production of cellulosic biofuels (e.g., energy cane, other fast growing grasses, byproducts of ethanol natural fermentation processes); bagasse and other crop residues (e.g., peanut shells, vines, orchard trees, hulls, seeds, spent grains, cotton byproducts, corn and peanut production residues, rice milling and grain elevator operation residues); wood collected from forest fire clearance activities, trees and clean wood found in disaster debris, clean biomass from land clearing operations, and clean construction and demolition wood. These fuels are not secondary materials or solid wastes unless discarded. Clean biomass is biomass that does not contain contaminants at concentrations not normally associated with virgin biomass materials.

The amended definition will be effective 60 days after publication in the Federal Register.

FDA

FDA Outlines Efforts To Implement FSMA: The Food Safety Modernization Act (FSMA) was signed into law in January 2011 requiring the U.S. Food and Drug Administration (FDA) to develop comprehensive science-based preventive controls across the entirety of the nation's food supply. The legislation included specific deadlines for implementing this massive overhaul of FDA's regulatory structure. Considering the scope of the project -- encompassing virtually all domestic and imported human and animal food -- it is not surprising that FDA has failed to meet most of these deadlines. Consumer groups sued FDA and the Office of Management and Budget (OMB) last summer to compel implementation of key elements of the FSMA. The government agencies' recent response to this suit provides important insight into FDA's plans and timeline for implementing the provisions of the FSMA. FDA points out that the scope of the FSMA is unprecedented and the "aggressive timelines" included in the legislation were essentially "unachievable" even with hundreds of FDA staff working on the issue. To manage the task, the agency split the required rulemakings into two "waves." FDA gave priority to the following four rules it considered "foundational for other rules and offer the most public health benefits:" Preventive Controls for Human Food; Produce Safety Standards; Foreign Supplier Verification Program; and Preventive Controls for Animal Food. According to FDA, each of these rules is under review at OMB. Once that review is completed, the rules will be published for public comment. Rules in the second "wave" are still in review at FDA or OMB. Presumably, the following rules would be expected to issue later: Intentional Adulteration; Sanitary Transport; and Third Party Accreditation.

FDA also explained that consistent with the analysis in Heckler v. Chaney (470 U.S. 821 (1985)), the agency will continue to exercise enforcement discretion of certain self-executing portions of the FSMA, such as preventive controls, until final regulations are implemented.

LEGISLATIVE DEVELOPMENTS

113th Congress Sworn In: Members of the 113th Congress were sworn into office at noon on January 3, 2013, taking over for what many have characterized as the most unproductive Congress in the history of the United States. Almost 100 new members took the oath of office, marshaling in a body of lawmakers that is diverse and, by most accounts, eager to implement change and to distance themselves from their predecessors. The Senate welcomed a dozen newly-elected members, three Republicans, eight Democrats, and one Independent. The Senate added four women for a total of 20, a new record for the upper house. The House added 82 new representatives, 35 Republicans and 47 Democrats. Democrats tightened their grip on the Senate for a 55-45 edge in the new two-year Congress, ensuring that Senator Harry Reid (D-NV) will remain in charge. Republicans maintained their majority in the House, but will have a smaller advantage, 235-199.

President Obama States Climate Change One Of His Top Three Priorities: President Obama has identified climate change as one of his top three priorities in his second term. The President, in an interview for TIME's Person of the Year award, said the economy, immigration, climate change, and energy would be at the top of his agenda for the next four years. He did not provide details in the interview as to how he will seek to reduce emissions of greenhouse gases.

"Fiscal Cliff" Bill Extends Tax Credit For Wind Power And Other Energy Incentives: Legislation signed by President Obama on January 2, 2013, to avert the so-called "fiscal cliff" includes an extension of the wind production tax credit, as well as tax incentives for energy efficiency, biofuels, and alternative power. The American Taxpayer Relief Act (H.R. 8) includes some $18 billion to extend the existing energy tax incentives over ten years. This includes a $12 billion extension of a production tax credit for wind and other forms of renewable energy. The alternative fuels industry will also benefit from the legislation. There is a one-year extension to a biofuels credit, and a 50 percent depreciation allowance for biofuel plants placed in service by the end of 2013. The law also extends through 2013 an alternative fuel infrastructure tax credit for gasoline blended with 85 percent ethanol (E85).

Kucinich Introduces Global Warming Resolution: Representative Dennis Kucinich (D-OH) on December 18, 2012, introduced a resolution (H. Res. 835) expressing the sense of the House that the U.S. should adopt a target of 350 parts per million (ppm) of atmospheric carbon dioxide as a benchmark for evaluating domestic and international climate change policies. The resolution is unlikely to advance.

President Signs American Energy Manufacturing Technical Corrections Act Of 2012: President Obama on December 18, 2012, signed into law a bill intended to promote the development of energy efficient technology. The American Energy Manufacturing Technical Corrections Act of 2012 (H.R. 6582) also weakens the energy efficiency standards for certain appliances. Specifically, the law revises existing energy conservation standards for appliances such as water heaters and commercial refrigerators with glass displays typically used in delicatessens and bakeries. This is intended to provide regulatory relief to manufacturers and small businesses. The law also establishes within the Energy Department a new research and development partnership to promote energy efficient technology. A study on the barriers to industrial energy efficiency, best practices for advanced metering in the federal government, and disclosure of energy and water usage by federal facilities, is also included in the law.

Pro Cap-And-Trade Representative Markey Announces Candidacy For Senate: Representative Edward Markey (D-MA), a champion of imposing cap-and-trade restrictions to reduce emissions of greenhouse gases, on December 27, 2012, said that he will run in this year's special election to fill the Massachusetts Senate seat that would be vacated if Senator John Kerry (D-MA) is confirmed by the Senate as the next Secretary of State. Representative Markey chaired the Energy and Commerce Subcommittee on Energy and Environment and drafted a cap-and-trade bill in 2009. This bill sought to cut U.S. emissions of greenhouse gases by 17 percent by 2020 (with 2005 as the baseline year). In 2007, Markey also led a House Select Committee on Energy Independence and Global Warming, which was tasked with highlighting the challenges of climate change and the need for U.S. and global action.

House Republicans Create Two New Subcommittees For Environmental Regulatory Oversight: House Republicans have created two new Subcommittees for the 113th Congress charged with overseeing EPA rules and federal environmental review requirements. Republican leaders created the new Subcommittees because they believe EPA regulations are harming the economy.

The House Oversight and Government Reform Committee announced on January 3, 2013, that it is creating a new Energy Policy, Health Care and Entitlements Subcommittee, to be chaired by Representative James Lankford (R-OK). The Committee's announcement stated that the new Subcommittee will examine "excessive federal regulations strangling our energy industry and the many businesses that depend on them." The House Natural Resources Committee Chair also announced that it has created a new Public Lands and Environmental Regulation Subcommittee to replace the Subcommittee on National Parks, Forests and Public Lands. The new panel, to be chaired by Representative Rob Bishop (R-UT), will exercise broader oversight and allow it to address how the National Environmental Policy Act (NEPA) is being implemented.

MISCELLANEOUS

EPA Announces Fall 2012 Regulatory Agenda: In a January 8, 2013, Federal Register notice, EPA announced the availability of its Fall 2012 Regulatory Agenda. 78 Fed. Reg. 1624. EPA states that the purpose of the Regulatory Agenda is to update the public about regulations and major policies currently under development; reviews of existing regulations and major policies; and rules and major policy makings completed or canceled since the publication of the last agenda. While EPA includes regulations and certain major policy documents in the Regulatory Agenda, EPA notes there is no legal significance to the omission of an item, and EPA generally does not include the following categories of actions:

  • Administrative actions such as delegations of authority, changes of address, or phone numbers;
     
  • Under the CAA: Revisions to state implementation plans; equivalent methods for ambient air quality monitoring; deletions from the new source performance standards source categories list; delegations of authority to states; area designations for air quality planning purposes;
     
  • Under FIFRA: Registration-related decisions, actions affecting the status of currently registered pesticides, and data call-ins;
     
  • Under the Federal Food, Drug, and Cosmetic Act (FFDCA): Actions regarding pesticide tolerances and food additive regulations;
     
  • Under the Resource Conservation and Recovery Act (RCRA): Authorization of state solid waste management plans; hazardous waste delisting petitions;
     
  • Under the Clean Water Act (CWA): State water quality standards; deletions from the Section 307(a) list of toxic pollutants; suspensions of toxic testing requirements under the National Pollutant Discharge Elimination System (NPDES); delegations of NPDES authority to states;
     
  • Under the Safe Drinking Water Act (SDWA): Actions on state underground injection control programs; and
     
  • Under TSCA: New chemical-related decisions; actions implementing the TSCA ITC decisions; actions affecting extensions for submitting test data.

The Regulatory Agenda is available online.

Negotiations Begin For Global Legally Binding Agreement On Mercury: The fifth session of the Intergovernmental Negotiating Committee (INC5) to prepare a global legally binding instrument on mercury began on January 13, 2013, and will end January 18. More than 130 countries are negotiating an international legal agreement that would reduce the use of mercury and limit emissions. According to participants, differences include the selection of products and processes in which the current use of mercury will be phased out and the deadline for doing so; whether primary mercury mining should be banned completely; and the compliance and financial assistance provisions to include in the agreement. Under the draft agreement from which negotiators are working, the supply and trade of mercury and the use of mercury in products and industrial processes would be regulated. The agreement would outline steps to reduce emissions from power plants and metals production facilities, ensure the safe storage and treatment of waste containing mercury, and develop strategies for identifying and assessing contaminated sites. The European Union, Japan, and Jamaica submitted a joint paper calling for the phase-out of mercury in products such as batteries, switches and relays, fluorescent lamps, pesticides, measuring devices, and soaps and cosmetics by 2018 (or 2020 for batteries and measuring devices), and in processes such as chlor-alkali, polyurethane, and acetaldehyde production by dates ranging from 2018 to 2025. INC5 is scheduled to be the last negotiation. A diplomatic conference is scheduled for October 2013 in Japan to open the text for signature. More information on INC5 is available online.

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

 
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