Monthly Update for March 2013


TSCA/FIFRA/NTP/EPCRA

EPA Schedules FIFRA Scientific Advisory Panel On EDSP: On February 22, 2013, the U.S. Environmental Protection Agency (EPA) scheduled a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Endocrine Disruptor Screening Program (EDSP) Tier 1 Screening Assays and Battery Performance. 78 Fed. Reg. 12311. The meeting will be held on May 21-24, 2013. EPA seeks comments by May 7, 2013, and requests for oral comments by May 14, 2013. EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available by approximately early May 2013. Copies of these documents and other related materials will be available at www.regulations.gov and www.epa.gov/scipoly/sap.

EPA Declares Prion As A Pest Under FIFRA: On February 28, 2013, EPA declared a prion (i.e., proteinaceous infectious particle) to be a "pest" under FIFRA and amended the regulations to include expressly prion within the regulatory definition of pest. 78 Fed. Reg. 13501. A prion is an infectious particle that can cause fatal diseases. The final rule amends existing pesticide product performance data requirements to clarify that efficacy data are required for pesticide products with prion-related claims. In addition, EPA announced the availability of final test guidelines on generating the product performance data for prion-related pesticide products. This rule is effective April 29, 2013.

EPA Releases Annual Pesticide Program Report: On February 27, 2013, EPA released its fiscal year (FY) 2012 report describing EPA's implementation of the Pesticide Registration Improvement Act (PRIA). PRIA authorizes EPA to collect registration service fees and maintenance fees from pesticide registrants and establishes statutory deadlines for completion of some regulatory actions. The annual report includes information on fees collected by EPA in fiscal 2012, decision review times for all completed regulatory actions in fiscal 2012, and a description of pesticide safety education and worker protection activities funded through PRIA. The report also includes information on ongoing process improvements in EPA's Office of Pesticide Programs (OPP). The report is available online.

EPA Convenes Public Meeting Of The Science Advisory Board Chemical Assessment Advisory Committee: On March 5, 2013, the EPA Science Advisory Board (SAB) Staff Office announced a public meeting of the SAB Chemical Assessment Advisory Committee (CAAC) to receive a briefing about the Integrated Risk Information System (IRIS) program and enhancements to the process for developing IRIS toxicological reviews for chemicals. 78 Fed. Reg. 14299. The SAB CAAC meeting dates are April 2-3, 2013, in Washington, D.C.

EPA Denies Petition To Delist Acetonitrile From EPCRA Section 313: On March 5, 2013, EPA denied a petition to remove acetonitrile from the list of chemicals subject to reporting requirements under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and Section 6607 of the Pollution Prevention Act of 1990 (PPA). 78 Fed. Reg. 14241. EPA reviewed the available data on acetonitrile and has determined that it does not meet the deletion criterion of EPCRA Section 313(d)(3). Specifically, EPA denied the petition, submitted by BP Chemicals and GNI Chemicals Corporation, because EPA's review of the petition and available information resulted in the conclusion that acetonitrile meets the listing criterion of EPCRA Section 313(d)(2)(B) due to its potential to cause death or serious or irreversible chronic health effects in humans.

EPA Releases Reference Values For Five Chemicals: On February 28, 2013, EPA released summaries of reference values for five chemicals that U.S. and international agencies, regulators, and private-sector organizations have developed to help analysts understand potential inhalation health risks associated with worker and general public exposures. The final reports are a summary of reference value arrays with critical supporting documentation for: manganese, benzene, toluene, ethylbenzene, and xylene. Each chemical is addressed in a separate document, and each reflects a statement of the status of the available inhalation health effect reference values developed to date. The individual chemical documents include the process used to derive the values, and references to original documentation are provided if more detailed information is needed. The reference values are calculations of exposure levels for different durations of time. If exposed to concentrations of the chemical that are lower than the reference value for a designated duration, workers or the general public are not expected to be harmed. The five final reference value summaries are available online.

EPA's Enforcement Actions Target "Fractions": Rosemarie Kelley, Director, Waste and Chemical Enforcement Division, EPA Office of Enforcement and Compliance Assurance, announced during a recent industry meeting that one of EPA's enforcement priorities will be to look at how manufacturers are naming and listing fractions of existing chemicals for Toxic Substances Control Act (TSCA) Inventory purposes. Kelley stated that fractions or "slices" of existing substances could be new chemical substances for which premanufacture notifications (PMN) should have been filed. In fact, EPA has already begun that process, as several enforcement initiatives are underway derivative of information generated in connection with the action brought against Dover Chemical Company. EPA is investigating alleged violations of TSCA Section 8(a) reporting under the Inventory Update Rule (IUR)/Chemical Data Reporting (CDR) Rule and TSCA Section 5 new chemical notifications against what appears to be a growing number of companies regarding their use of Chemical Identities/Chemical Abstracts Service Registry Numbers (CI/CASRN) for substances that EPA now claims are fractionated and should have been identified with more specificity than what the CI/CASRNs listed on the TSCA Inventory provide.

While there is EPA guidance stating that Inventory entries should be reported "as precisely descriptive as possible for the commercial chemical substance," EPA's recent statements seem to ignore a historical context that developed EPA guidance, and industry understanding, permitting approaches distinct from a strict CAS approach for fractionated products. A more detailed memorandum is available online.

EPA Convenes SFIREG Full Committee Meeting: On March 6, 2013, EPA announced that the Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG), Pesticide Operations and Management (POM) Committee will hold a two-day meeting, beginning on April 22, 2013, and ending April 23, 2013. 78 Fed. Reg. 14537. Topics to be addressed include: bee inspection guidance; EPA's Drift Reduction Technology program; National Pesticide Information Center reporting to State Lead Agencies (SLA) when off label use is evident; status of the implementation of the Globally Harmonized System (GHS) for the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) and potential impacts on FIFRA labeling; and labeling biocide fracking fluid -- the biocide working panel, among others. Please consult the Federal Register for details.

GREEN CHEMISTRY

Prepare For Safer Consumer Products Regulations At 2nd Annual Summit: B&C Consortia Management, L.L.C. is a supporting organization of the 2nd Annual Safer Products Summit, to be held April 2-4, 2013, in San Francisco, California. This event will bring together policy makers, leading consumer brands, and green chemistry experts to lay out the framework entities will need to comply with Safer Consumer Products Regulations in California and beyond.

Some consumer brands and manufacturers are responding, though a great many more remain ill-prepared for what lies ahead and face the strong possibility of losing reputation and market share, finding themselves in violation of regulatory compliance, and even facing tort lawsuits. To mitigate the risks, lagging consumer brands and manufacturers will need to develop a full understanding of the broader policy landscape for safer products and green chemistry. They will need to have a thorough understanding of precisely what is in their raw materials and must be ready to incorporate new components, materials, and ingredients. They must thoroughly understand their current value chain so that they are prepared to realign their existing processes in a way to manufacture safer consumer products.

Kathleen M. Roberts will moderate a panel discussion: "Home and Personal Care Value Chain: Leaning on the Supply Chain for Data Sharing and Innovative New Chemicals and Formulations." Other presentations and panels include: "Green Chemistry and Elements of Safer Chemicals Policy," "Alternatives Assessment: Emergence of a New Best Practice," and "The Debate around Cutting Edge Toxicology." More information is available online.

RCRA

EPA Announces Requirements Gathering Meetings For The e-Manifest System: On February 20, 2013, EPA's Office of Resource Conservation and Recovery (ORCR) announced that it will convene public meetings to discuss and obtain public input from stakeholders on a national electronic manifest (e-Manifest) system to capture information on the shipment of hazardous waste. 78 Fed. Reg. 11877. The purpose of these meetings is to engage the states, industry, communities, non-governmental organizations (NGO), and other stakeholders on what expectations and technical requirements EPA should consider as EPA begins the planning stage of the e-Manifest system development process. EPA will conduct three face-to-face public meetings, one of which was already held in February in Arlington, VA. The dates and locations for the two remaining meeting are: March 14-15, 2013: Chicago, Illinois, EPA Region 5, Ralph Metcalfe Federal Building, 77 West Jackson Blvd., Chicago, IL 60604–3590; and March 21-22, 2013: Denver, Colorado, EPA Region 8, 1595 Wynkoop Street, Denver, CO 80202–1129.

At the February 25, 2013, meeting, EPA stated that it expects to send a final rule authorizing the use of electronic hazardous waste manifests to the Office of Management and Budget (OMB) in May. EPA is using the May 2001 e-Manifest proposed rule as the baseline into which it will graft revisions to incorporate comments from stakeholders and to respond to the requirements of the Hazardous Waste Electronic Manifest Establishment Act (Pub. L. No. 112-195), which President Obama signed into law in October 2012. EPA stated that use of the e-Manifest would be voluntary.

NANOTECHNOLOGY

NGO Issues Results Of Survey On Use Of Nanotechnology In U.S. Food Market: On February 6, 2013, As You Sow, a NGO, announced the release of a report entitled Slipping Through the Cracks: An Issue Brief on Nanomaterials in Foods. As You Sow states that the report is intended to inform companies, investors, and consumers about the emerging use of engineered nanomaterials in food and food related products. The report "highlights the potential risks of nanotechnology for companies who are knowingly or unknowingly using it in their products and for public health." The press release states that the report includes the results of a "survey of 2,500 food companies about their use of nanomaterials in food products, as well as laboratory results showing titanium dioxide (TiO2) nanoparticles in the white powdered sugar that coats Dunkin' Donuts Powdered Cake Donuts and Hostess Donettes." As You Sow sent the survey to 2,500 companies in the food industry, "including the 100 largest food processing companies, the 50 largest food distributors, the 75 largest food retailers, the 25 top packaging companies, the 50 top fast food companies, and 187 supplement companies." According to As You Sow, it received "only 26 responses and a third of those companies admitted they did not know if nanomaterials are present in their products or supply chains." As You Sow notes that "[o]nly two companies had formal policies on the use of this new food additive that has undergone little or no safety testing." The press release states that, to test more common food products, As You Sow has simultaneously launched a crowdfunding campaign "to raise enough money to test M&M's, Pop-Tarts, and Trident gum for nanomaterials." More information is available online.

OECD Publishes Updated Tour De Table: The Organization for Economic Cooperation and Development (OECD) published on February 14, 2013, the updated Current Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table. The purpose of the Tour de Table is to allow each delegation the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. According to OECD, this will facilitate the implementation of the projects of the Working Party on Manufactured. Nanomaterials by allowing delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future co-operation and co-ordination. The Tour de Table is available online.

Switzerland Studies Need For Nano-Specific Regulation: On February 22, 2013, Empa announced the availability of a study prepared on behalf of Switzerland's Federal Office for the Environment (FOEN) entitled Human and Ecotoxicity of Synthetic Nanomaterials: Initial Insights for Major Accident Prevention. The study is intended to address whether new criteria for the determination of the quantity thresholds in the Ordinance on Protection against Major Accidents (OMA) may result from the accident potential or possible new hypothetical accident scenarios related to the human and ecotoxicity of synthetic nanomaterials. According to the study, data available at the present time are very limited and are inadequate to allow general conclusions to be drawn. Nonetheless, the study states, "initial insights for major accident prevention could be won, and a perspective on important pending questions given." FOEN's objective is to encourage research institutions and industry to take up these questions. FOEN "will continue to follow the national and international developments in this field, to put it in a position to introduce the necessary measures when necessary." More information is available online.

EPA Proposes SNURs For 37 Chemical Substances, Including 14 Nanomaterials: On February 25, 2013, EPA published proposed significant new use rules (SNUR) under TSCA for 37 chemical substances that were the subject of PMNs. 78 Fed. Reg. 12684. EPA notes that the proposed SNURs include 14 PMN substances whose reported chemical names include the term "carbon nanotube" (CNT) or "carbon nanofibers." If issued in final, the SNURs would require persons who intend to manufacture, import, or process the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide it with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due April 26, 2013. A more detailed memorandum is available online.

ECHA Announces IUCLID User Manual Updated For Nanomaterials: The European Chemicals Agency (ECHA) announced on February 28, 2013, that the International Uniform Chemical Information Database (IUCLID) user manual for nanomaterials has been updated. According to ECHA, the updated manual allows registrants to select the form of the test material used in all study summaries reported in their dossiers, and "nanomaterial" is one of the available options. The manual provides instructions on how to structure information on different forms of the registered substance in a consistent and coherent manner. ECHA states that the updated manual also includes references and links to recent guidance updates for nanomaterials published on the ECHA website, as well as links to recent reports from projects, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) and the Organization for Economic Cooperation and Development Working Party on Manufactured Nanomaterials. More information is available online.

EU-OSHA Posts Results Of Project On Nano In Furniture: On March 4, 2013, the European Agency for Safety and Health at Work (EU-OSHA) announced the results of a joint project by the European Federation of Building and Woodworkers (EFBWW), the European Furniture Manufacturers Federation (UEA), and the European Furniture Industries Federation (EFIC) on the use of nanomaterials in the European furniture sector. The Dutch institute "IVAM Research and consultancy on Sustainability" (IVAM UvA BV) investigated the current awareness among stakeholders and provided an overview of actual nano-products at the European furniture market. The joint project examined what types of nanomaterials are being used in furniture product manufacturing; the near future perspectives for using nanomaterials in furniture manufacturing; health and safety issues for workers within the workplace; and what a precautionary safe workplace would look like. According to the executive summary, the market for nanomaterial use in furniture products is still in an early phase of development. IVAM UvA BV notes that nanotechnology may have significant implications for the future of furniture manufacturing and on furniture quality and functionalities, as well as on environmental, occupational, and public health performances related to the manufacturing and end-products. More information is available online.

NIOSH Announces New Findings On Lung Tumor Formation In Laboratory Mice Exposed To MWCNT: On March 11, 2013, at the annual meeting of the Society of Toxicology, researchers from the National Institute for Occupational Safety and Health (NIOSH) reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes (MWCNT). According to NIOSH, the study was designed to investigate whether these tiny particles have potential to initiate or promote cancer. One group of laboratory mice was injected with a chemical that is a known cancer initiator, and another group of mice was injected with a saline solution as a control group. The mice then were exposed by inhalation either to air or to a concentration of MWCNT. According to NIOSH, mice receiving both the initiator chemical plus exposure to MWCNT were significantly more likely to develop tumors and have more tumors than mice receiving the initiator chemical alone. Additionally, mice exposed to MWCNT and to MWCNT plus the initiator chemical had larger tumors than the respective control groups. NIOSH concluded that the results indicate that MWCNT can increase the risk of cancer in mice exposed to a known carcinogen. NIOSH notes that the study does not suggest that MWCNTs alone cause cancer in mice. More information regarding the study is available online.

NIOSH states that the study is the first to show that MWCNT is a cancer promoter in a laboratory experiment, and reports the growth of lung tumors in laboratory mice following inhalation exposure to MWCNT rather than injection, instillation, or aspiration. According to NIOSH, inhalation exposure most closely resembles the exposure route of greatest concern in the workplace. NIOSH notes that the research is an important step in understanding the hazard associated with MWCNT, but that it needs more information about actual exposure levels and the types and nature of MWCNT being used in the workplace, and how that compares to the material used in this study, before it can determine whether MWCNT pose an occupational cancer risk. Workplace studies are underway at NIOSH to learn more about actual worker exposure and to develop guidance on how to contain and control MWCNT processes to eliminate exposures, based on advancing knowledge about exposures. NIOSH issued a draft Current Intelligence Bulletin on single-walled and MWCNT in December 2010, which is available online, and expects to issue a final version, incorporating its review of the public comments, "soon." NIOSH will submit the results of the laboratory study on MWCNT to a peer-reviewed journal for publication.

nanoMICEX Publishes First Newsletter: On March 11, 2013, the European Union's (EU) FP7 project on Mitigation of Risk and Control of Exposure in Nanotechnology-based Inks and Pigments (nanoMICEX) announced publication of its first newsletter. According to nanoMICEX, project participants have been working to improve the conditions for workers in the inks and pigments industry, and the newsletter describes the latest news and developments. The newsletter reports on the March 2012 kick-off meeting, where participants discussed which engineered nanoparticles to characterize, how best to carry out hazard and exposure assessments, and ways in which risks will be assessed and managed. The newsletter describes work that has been done to date, while more in-depth articles by nanoMICEX partners provide information on how the partners are ensuring the safety of workers within the industry. The newsletter includes a timeline of upcoming activities in the next six months, including publication of the next newsletter in September 2013. The newsletter is available online.

Lynn L. Bergeson Will Speak At Conference On Scientific Advances Towards Reducing Complexity In Decision Making: Lynn L. Bergeson will speak at a May 8, 2013, conference on recent advances in environmental health and safety (EHS) of engineered nanomaterials. The University of California Center for Environmental Implications of Nanotechnology (UC CEIN) is holding the conference on "Scientific Advances Towards Reducing Complexity in Decision Making." Participants will include industry, regulators, policy makers, nano EHS professionals, and academics from the State of California, nationally, and internationally. The focus of the conference will be on developing alternative testing strategies for engineered nanomaterials and how engineered nanomaterials can be used for decision making in industrial, regulatory, policy, and academic settings. Participants will discuss how the advancement of environmental nanotechnology research impacts daily operations and decision making processes. The National Science Foundation and EPA are funding the conference. The conference is free, but registration is required. More information is available online.

REACH

EU Adopts Changes To REACH Annex: On February 14, 2013, the European Commission (EC) made a number of minor updates to Annex XVII of the REACH chemicals regulation. Annex XVII of REACH lists restrictions on the use of hazardous substances. The regulation, published in the Official Journal of the EU, modifies the Annex in 11 places to clarify terminology, delete extraneous information, correct errors, and add missing information. It also clarifies that EU countries can allow the marketing of paints containing lead carbonates and lead sulfates if the Member State informs the Commission. Another amendment clarifies that a requirement allowing methylene diphenyl diisocyanate (MDI) to be sold only if certain safety precautions are taken also applies to isomers, or compounds, of the substance. MDI is used in the production of polyurethane. The Amendments were effective on March 6, 2103. Commission regulation (EU) No. 126/2013 amending Annex XVII of REACH is available online.

EU Agency Committee Publishes Guidance On Substance Authorization Applications: On March 12, 2013, ECHA's Committee for Socioeconomic Analysis (SEAC) published a guidance on how it understands the concept of "economic feasibility" in applications for authorizations under the EU's REACH regulation. REACH authorizes companies to obtain authorizations to continue to use chemicals to be phased out if they can demonstrate that the substance will be adequately controlled when it is used for a specific application or if they can show that there are socioeconomic reasons for continuing to use the substance for a specific application. If a company applies for continued use on socioeconomic grounds, it must demonstrate that it has considered alternatives, including the cost, or economic feasibility, of those alternatives. For each such application , SEAC will prepare an opinion, which is then forwarded to the EC for a final decision. According to the guidance, in assessing economic feasibility, SEAC will consider the net cost to the applicant of switching to an alternative to the substance for which an authorization request is submitted, and will "pay particular attention to ensuring that applicants have not overestimated the additional or incremental costs of using an alternative substance or technology." The guidance from the Committee for Socioeconomic Analysis on how it will evaluate "economic feasibility" is available online.

BIOBASED PRODUCTS

EPA Proposes Voluntary Quality Assurance Program: On February 21, 2013, EPA issued a proposed rule offering an alternative voluntary quality assurance program (QAP) to help assure compliance and minimize fraudulently procured Renewable Identification Numbers (RIN). 78 Fed. Reg. 12158. Parties subject to the Renewable Fuel Standard (RFS) program demonstrate compliance with the renewable fuel volume standards in one of two ways: by acquiring the required volumes of renewable fuels together with the associated RINs, which are assigned by the renewable fuel producer or importer to each batch of renewable fuel produced or imported, or by acquiring only the RINs without the associated fuel. A validly generated RIN demonstrates that a certain volume of qualifying renewable fuel was produced or imported. The RFS program also includes provisions stipulating the conditions under which RINs are invalid, the potential liability carried by a party that transfers or uses an invalid RIN, and how invalid RINs must be treated. According to EPA, the basis of EPA's treatment of invalid RINs is the concept of "buyer beware," in which all regulated parties are urged to take steps to verify that the RINs they acquire are valid, and that all parties in the value chain are liable for transferring or using invalid RINs. EPA has proposed a new voluntary third-party QAP for verifying RIN validity that regulated parties may exercise as an alternative to the "buyer beware" approach. As was widely reported, last year EPA reached a settlement with approximately 30 companies for allegedly purchasing fraudulent RINs. The settlement required gasoline and fuel refiners and importers to pay millions of dollars in penalties for using RINs that were fraudulently generated. EPA believes that the consequence of such fraudulent RIN purchases is that smaller renewable fuel producers have difficulty selling their RINs. EPA has been seeking ways to prevent this problem, which prompted the new voluntary alternative approaches. EPA has proposed to establish a voluntary third-party QAP to verify the legitimacy of RINs. Under the proposal, if certain conditions are satisfied, the buyer would be able to assert an affirmative defense that would preclude liability for penalties otherwise associated with the purchase or transfer of invalid RINs. Entities may select one of two options for RIN verification through a QAP. These options would provide, according to EPA, flexibility in how parties choose to manage the risk of transferring or using invalid RINs and costs. In this regard, EPA is proposing:

  • Minimum requirements for QAPs, including such things as verification of type of feedstocks, verification that volumes produced are consistent with amount of feedstocks processed, and verification that RINs generated are appropriately categorized and match the volumes produced.
     
  • Qualifications for independent third-party auditors.
     
  • Replacement instruments or other mechanisms that would provide assurance that invalid RINs are replaced with valid RINs.
     
  • Requirements for audits of renewable fuel production facilities, including minimum frequency, site visits, review of records, and reporting.
     
  • Conditions under which a regulated party could assert an affirmative defense to civil liability for transferring or using an invalid RIN.
     
  • Identification of the party or parties who are responsible for replacing invalid RINs with valid RINs and the timing of such replacement.
     
  • Changes to the EPA-Moderated Transaction System (EMTS) that would accommodate the QAP.

EPA proposes that the QAP option would be applicable at the beginning of 2013. EPA also has proposed modifications to the exporter provisions of the RFS program. These modifications would ensure that an appropriate number and type of RINs are retired whenever renewable fuel is exported. Finally, EPA has proposed new provisions to address RINs that become invalid downstream of a renewable fuel producer. A hearing is scheduled for March 19, 2013. Comments are due by April 18, 2013.

USDA Issues BioPreferred Program Notification: The United States Department of Agriculture (USDA) posted a notice on its website concerning the BioPreferred Program. According to USDA, due to the absence of funding in the Farm Bill extension legislation, USDA has suspended the processing of applications for voluntary certification of biobased products. USDA states that it "will continue limited activities related to the Federal procurement preference program, such as adding products to the BioPreferred catalog, as staff resources allow. All existing biobased product label certifications (900 'USDA Certified Biobased Products' as of December 31, 2012) are and will remain valid." Since 2002, USDA has designated some 89 categories representing 9,000 biobased products, all of which qualify for federal sustainable procurement standards. More information is available online.

EPA Issues ICR Concerning Health Effects Research Requirements For Manufacturers Of Fuels And Fuel Additives: EPA published on February 20, 2013, a notice announcing its intent to extend an Information Collection Request (ICR) concerning "Registration of Fuels and Fuel Additives -- Health-Effects Research Requirements for Manufacturers." 78 Fed. Reg. 11869. Manufacturers (including importers) of fuels and additives designated by EPA, including motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels, are required to register their products with EPA before introducing them into commerce. Registrants must submit certain health effects information, and the development of this data is the subject of the ICR. The ICR is currently approved through August 31, 2013. Comments are due April 22, 2013. A more detailed memorandum is available online.

EPA Identifies Additional Qualifying Renewable Fuel Pathways Under The RFS Program: On March 5, 2013, EPA published an important final rule certifying additional fuel pathways that meet the biomass-based diesel, advanced biofuel, or cellulosic biofuel lifecycle greenhouse gas reduction requirements under the RFS program. 78 Fed. Reg. 14190. The final rule describes EPA's evaluation of advanced biofuels produced from camelina (Camelina sativa) oil and energy cane plants, includes an evaluation of renewable gasoline and renewable gasoline blendstocks, and clarifies EPA's definition of "renewable diesel." EPA states that the inclusion of these pathways "creates additional opportunity and flexibility for regulated parties to comply with the advanced and cellulosic [biofuel] requirements of EISA and provides the certainty necessary for investments to bring these biofuels into commercial production from these new feedstocks." According to the notice, EPA is not making final determinations on biofuels produced from giant reed (Arundo donax) or napier grass (Pennisetum purpureum) or biodiesel produced from esterification. EPA "continue[s] to consider the issues concerning these proposals, and will make a final decision on them at a later time." The final rule will be effective May 6, 2013. A fact sheet on the final rule is available online. A more detailed memorandum is available online.

LEGISLATIVE DEVELOPMENTS

House Democrats Form Safe Climate Caucus: Several House Democrats on February 15, 2013, announced that they have formed a Safe Climate Caucus. The caucus will push the need to combat climate change in several House Committees, its members stated. The caucus appears to be led by Henry Waxman (D-CA) and Chris Van Hollen (D-MD). Other caucus members include: Earl Blumenauer (D-OR), Lois Capps (D-CA.); Emanuel Cleaver (D-MO); Steve Cohen (D-TN); Donna Edwards (D-MD); Keith Ellison (D-MN); Tulsi Gabbard (D-HI); John Garamendi (D-CA); Raul Grijalva (D-AZ); Rush Holt (D-NJ); Jared Huffman (D-CA); Hank Johnson (D-GA.); Barbara Lee (D-CA); Ben Ray Lujan (D-NM); Edward Markey (D-MA); Doris Matsui (D-CA); Jerry McNerney (D-CA); Jim Moran (D-VA); Bobby Rush (D-IL); Paul Tonko, (D-NY); and Peter Welch (D-VT).

House Subcommittee Holds Hearing On The Role Of States In Environmental Regulation: The House Energy and Commerce Subcommittee on Environment and the Economy on February 15, 2013, held a hearing on the role of states in environmental regulation. Subcommittee Chair John Shimkus (R-IL) described it as a "kickoff" of the Subcommittee's agenda for the 113th Congress. Mr. Shimkus convened the hearing to highlight the role state officials play in protecting the environment and public health under several of the federal laws in the Subcommittee's jurisdiction, including the Safe Drinking Water Act (SDWA), the Resource Conservation and Recovery Act (RCRA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Testifying before the Subcommittee were:

  • Teresa Marks, Director, Arkansas Department of Environmental Quality, on Behalf of Environmental Council of States;
     
  • Sarah Pillsbury, Administrator, Drinking Water and Groundwater Bureau, on behalf of the Association of State Drinking Water Administrators;
     
  • Jeffrey Steers, Director, Land Protection and Revitalization Division, Virginia Department of Environmental Quality, on behalf of the Association of State and Territorial Solid Waste Management Organizations;
     
  • Matthew J. Lepore, Director, Colorado Oil and Gas Conservation Commission, on behalf of the Ground Water Protection Council;
     
  • Harold R. Fitch, Supervisor of Mineral Wells and Chief, Office of Oil, Gas and Minerals, Michigan Department of Environmental Quality, on behalf of the Interstate Oil and Gas Compact Commission;
     
  • The Honorable Pricey Harrison, North Carolina House of Representatives, on behalf of the National Caucus of Environmental Legislators; and
     
  • The Honorable Michael A. Sesma, Council Vice President, City of Gaithersburg, Maryland, on behalf of the National League of Cities.

The witnesses' written testimony can be accessed online.

Senators Urge EPA To Conduct Risk Assessment Of Flame Retardants: Senator Frank Lautenberg (D-NJ) is leading a group of 23 Senators in calling on EPA to evaluate whether flame retardant chemicals found in everyday household products put Americans' health at risk. In a February 20, 2013, letter, the Senators state that "Studies demonstrate that Americans, and particularly children, continue to be exposed to toxic flame retardant chemicals on a daily basis in their homes. This is a serious public health concern that requires a risk assessment by EPA." The letter cites a study released on February 19, 2013, by the Center for Environmental Health found flame retardant chemicals -- including chlorinated tris, which was banned from children's pajamas in the 1970s -- in children's nap mats. Scientific research has shown that flame retardant chemicals are toxic and are linked to cancer, as well as various neurological and developmental diseases, the letter states. It adds that while these chemicals are purported to make products more flame resistant, the Consumer Product Safety Commission (CPSC) has found that they do not provide any significant protection against the risk of fires in most cases.

In addition to Senator Lautenberg, the letter to EPA Acting Administrator Bob Perciasepe was signed by Senators Richard Durbin (D-IL), Patty Murray (D-WA), Ron Wyden (D-OR), Jeff Merkley (D-OR), Tom Harkin (D-IA), Ben Cardin (D-MD), Charles Schumer (D-NY), Kirsten Gillibrand (D-NY), Jon Tester (D-MT), Bernie Sanders (D-VT), Tom Udall (D-NM), Amy Klobuchar (D-MN), Dianne Feinstein (D-CA), Al Franken (D-MN), Michael Bennet (D-CO), Elizabeth Warren (D-MA), William Cowan (D-MA), Patrick Leahy (D-VT), Richard Blumenthal (D-CT), Max Baucus (D-MT), SheldonWhitehouse (D-RI), and Jeanne Shaheen (D-NH).

House Bill Would Limit EPA's Ability To Set Cellulosic Ethanol Requirements: Legislation introduced on February 15, 2013, by Representative James Sensenbrenner (R-WI) would limit EPA's ability to establish cellulosic ethanol requirements under the renewable fuel standard. Specifically, the bill (H.R. 796) would require EPA to use the commercially available volume of cellulosic biofuel in setting requirements for the renewable fuel program under the Clean Air Act (CAA). It would prevent EPA from raising the annual cellulosic biofuel requirement more than 5 percent or 1 million gallons, whichever is greater, above the total volume of the fuel commercially available the previous calendar year.

Senate Bill Would Ban Gasoline Containing More Than 10 Percent Ethanol: On February 14, 2013, Senators David Vitter (R-LA) and Roger Wicker (R-MS) introduced a bill that would prohibit EPA from allowing into the market gasoline containing more than 10 percent ethanol. The bill (S. 344) is an attempt to overturn EPA's waivers under the CAA that allowed gasoline containing 15 percent ethanol (E15) for model year 2001 and newer passenger vehicles. The Senators believe the E15 waiver will negatively impact businesses and families.

Water Infrastructure Resiliency And Sustainability Act Of 2013: Representative Lois Capps (D-CA) on February 16, 2013, introduced a bill that would authorize EPA with $250 million to assist utilities prepare for adverse impacts related to climate change. The Water Infrastructure Resiliency and Sustainability Act of 2013 (H.R. 765) is intended to help operators of wastewater, drinking water, and storm water utilities prepare for climate-related impacts. It would provide matching federal grants covering up to 50 percent of the cost of a project. The grants would go to utilities that are most at risk from extreme weather conditions due to climate change and would be based on the best available research and data on any ongoing or forecasted changes to the hydrologic conditions in the country. The bill was referred to the House Transportation and Infrastructure Committee and the House Energy and Commerce Committee.

Bill Would Require EPA To Clarify General Duty Clause: Legislation introduced on February 28, 2013, seeks to dispel the uncertainty associated with the General Duty Clause. The General Duty Clarification Act (H.R. 888) is co-sponsored by Representatives Mike Pompeo (R-KS), James Matheson (D-UT), William Long (R-MS), and Robert Latta (R-OH). The bill would require EPA to issue a rulemaking that clearly defines a facility's obligations under CAA Section 112(r), i.e., the General Duty Clause. The General Duty Clause requires owners and operators of certain facilities to take measures to prevent accidental releases of hazardous substances from their facilities. EPA has never defined what steps are necessary to satisfy this statutory obligation. The bill would also ban EPA from mandating that chemical and other facilities install so-called inherently safer technologies (IST) as a means of satisfying the General Duty Clause.

Continuing Resolution Retains EPA Funding At Current Level Through FY 2013: A continuing resolution passed by the House on March 6, 2013, would maintain EPA's funding coffers at their current level through FY 2013, which ends on September 30, 2013. The bill (H.R. 933), introduced on March 4, 2013, by House Appropriations Committee Chair Hal Rogers (R-KY) actually keeps most federal agencies at their FY 2012 levels. EPA's funding would, however, be subject to automatic discretionary spending cuts under sequestration. Funding for federal departments and agencies is currently flowing through a continuing resolution that expires March 27, 2013. President Obama and Congressional leaders have vowed to not allow the government to shut down on March 27 and to pass legislation to keep the government's doors open. The Senate Appropriations Committee, however, took a bigger axe to the EPA budget. The Committee on March 11, 2013, issued a bill that would go beyond the cuts for EPA in the House bill. The bipartisan proposal, to be introduced as a substitute amendment to H.R. 933, would fund the government for the rest of the FY but would slash about $136 million from EPA's budget FY 2012 funding. The House bill would fund EPA at current levels.

Bill Prohibits EPA Grants For Certain International Projects: In a move to rein in EPA's spending on issues outside the U.S., Representative Ed Whitfield (R-KY) introduced legislation on March 5, 2013, that would prohibit EPA from providing grants under the CAA to foreign countries. Section 103 of the CAA authorizes EPA to issue grants to foster research on air pollution and to fund pollution control projects. In the past, EPA has provided such grants to other countries, a practice Whitfield decries as an abuse of discretion. Whitfield's Accountability in Grants Act of 2013 (H.R. 959) would ban grants under Section 103 of the CAA for projects outside the U.S. Recipients of Section 103 grants would further be barred from using any of the grant funds they receive on entities or projects outside the U.S.

Reducing Regulatory Burdens Act Of 2013: A bill introduced by Representative Robert Gibbs (R-OH) would exempt registered pesticides from regulation under the Clean Water Act (CWA). Specifically, the Reducing Regulatory Burdens Act of 2013 provides that pesticides registered under FIFRA are not subject to discharge standards in CWA permits. The bill (H.R. 935) seeks to address the contentious issue of whether pesticide spraying operations that occur near or on bodies of waters trigger any permit requirements under the CWA. The bill would amend the CWA and FIFRA to clarify that such pesticide spraying operations are not subject to CWA permitting. EPA would be banned from requiring National Pollutant Discharge Elimination System (NPDES) permits for pesticides that already are registered for use, sale, and distribution under FIFRA.

Senate Bill Would Amend TSCA For Lead-Based Paint Renovation Activities: Senator James Inhofe (R-OK), senior member of the Environment and Public Works Committee, on March 6, 2013, reintroduced the Lead Exposure Reduction Amendments Act of 2013 (S. 484), which seeks to make it easier for the regulated community to comply with EPA's Lead Renovation, Repair and Painting Rule (LRRP). Senator Inhofe is trying to reduce the regulatory burdens placed on homebuilders and remodelers under the rule while continuing to protect vulnerable populations from the harmful effects of lead exposure. Among other things, the bill would restore the "opt-out provision," which would allow homeowners without small children or pregnant women residing in them to decide whether to require LRRP. 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 also would prohibit EPA from expanding the LRRP to commercial and public buildings until EPA conducts a study demonstrating the need for such an action.

Bill Calls For DOI To Conduct Assessment Of Global Rare Earth Elements: Representative Ed Markey (D-MA) on March 6, 2013, introduced a bill that would require the Department of Interior (DOI) to conduct a global assessment of rare earth elements. The bill (H.R. 981) would call on DOI to identify the quantity of individual rare earth elements in known deposits and to develop models demonstrating the geologic conditions necessary for the formation, and the variability in composition, of the most significant deposits of rare earth elements. The assessment must also provide an assessment of the likelihood of occurrence of undiscovered deposits and an estimate of the quantity of rare earth elements.

Bill Authorizes $250 Million For Brownfields Grants: Senator Frank Lautenberg (D-NJ) on March 7, 2013, introduced legislation that expands the federal brownfields cleanup program and authorizes $250 million annually for cleanup grants. The Brownfields Utilization, Investment, and Local Development (BUILD) Act of 2013 is intended to improve the grant process by increasing the limit for cleanup grants and expanding grant eligibility for certain publicly owned sites and non-profit organizations.

The Nanotechnology Advancement And New Opportunities Act: Legislation introduced by Representative Michael Honda (D-CA) on January 23, 2013, would establish several types of nanotechnology research grants. The Nanotechnology Advancement and New Opportunities Act (H.R. 394) would require the Department of Energy (DOE) to establish grants for nanotechnology research to "address the need for clean, cheap, renewable energy." EPA would be authorized to issue grants for nanotechnologies for the remediation of pollution and other environmental protection technologies. The Department of Homeland Security (DHS) would issue grants for nanotechnology to be used for sensors and other materials related to homeland security needs, and the Department of Health and Human Services (DHHS) would issue grants to address health-related applications of nanotechnology. The bill would also direct the Secretary of Commerce to establish a Nanomanufacturing Investment Partnership, provided the private sector makes $100 million available for use in the project. The partnership would fund direct to advance nanomanufacturing, but it would require a return on investment resulting from the commercialization of developed technologies to the partnership.

Say No To Drug Ads: Representative Jerrold Nadler (D-NY) on February 28, 2013, introduced H.R. 923, the Say No to Drug Ads Act. The bill would amend the Internal Revenue Code of 1986 to deny any deduction for direct-to-consumer advertisements of prescription drugs. The amendments made would apply to amounts paid or incurred after December 31, 2013.

Offshore Wind Power: Senator Thomas Carper (D-DE) introduced S.401, The Incentivizing Offshore Wind Power Act, on February 28, 2013. The legislation would amend the Internal Revenue Code of 1986 to provide for an investment tax credit for any taxable year in an amount equal to 30 percent of the qualified investment for such taxable year related to the production of electricity from offshore wind. S. 401 would apply to any facility located in the inland navigable waters of the United States, including the Great Lakes, or in the coastal waters of the United States, including the territorial seas of the United States, the exclusive economic zone of United States, and the outer Continental Shelf of the United States. The total amount of megawatt capacity for offshore facilities with respect to which credits could be allocated under the program would have to be no more than 3,000 megawatts.

Ensuring Affordable Energy Act: Representative Ted Poe (R-TX) has introduced the Ensuring Affordable Energy Act. The Act would prohibit any funds appropriated or otherwise available for the EPA Administrator from being used to implement or enforce: (1) a cap-and-trade program; or (2) any statutory or regulatory requirement pertaining to emissions of one or more greenhouse gases from stationary sources that is issued or becomes applicable or effective after the date of enactment of this Act. A "cap-and-trade program" is defined as any regulatory program established after the date of enactment of this Act that provides for the sale, auction, or other distribution of a limited amount of allowances that permit the emission of one or more greenhouse gases; "greenhouse gas" is defined as including carbon dioxide, methane, nitrous oxide, sulfur hexafluoride, hydrofluorocarbons, perfluorocarbons, or any other designated anthropogenic gas.

Access To Affordable Generics: Senator Amy Klobuchar (D-MN) introduced S. 214, the Preserve Access to Affordable Generics Act, on February 4. The bill would amend the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. A presumption would apply providing that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. An exception to such presumption would be allowed if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects. A resolution or settlement of a patent infringement claim would be exempt if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent. S. 214 would allow review of FTC enforcement orders under this Act in federal court and it would impose civil penalties for violations of this Act. The measure would also amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. The Chief Executive Officer or the company official responsible for negotiating any such agreement would be required to file a certification that materials filed with respect to such agreement are complete, final, and exclusive. The Federal Food, Drug, and Cosmetic Act (FFDCA) would also be amended to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act. Finally, the FTC would be granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs.

The DATA Act: Representative Henry Waxman (D-CA) introduced H.R 820, the Delivering Antimicrobial Transparency in Animals Act of 2013, or DATA, on February 26, 2013. According to the Congressman, the operation of the Act would increase the knowledge of how antibiotics and other antimicrobials are used in food producing animals by requiring drug manufacturers to obtain and provide better information to the Food and Drug Administration (FDA) on how their drugs are used by determining the amounts of their drugs used in each food-producing animal for which they are approved, and improving the timing and quality of the data that FDA publicly releases. If the bill is enacted into law, large-scale poultry, swine, and livestock producers will be required to report data on the medicated feeds produced for their animals. These producers would need to submit data on the type and amount of antibiotics and other antimicrobials contained in their feed. The Secretaries of DHHS and USDA would coordinate an effort to improve the collection of data on use of the products in food producing animals. FDA would also have to issue guidance on how drug sponsors could comply with recommendations for the judicious use of medically important antibiotics and other antimicrobial drugs in animals.

MISCELLANEOUS

White House Re-nominates Kopocis As Assistant Administrator For Water: On March 13, 2013, President Obama has re-nominated Kenneth J. Kopocis to become EPA's Assistant Administrator for Water. Kopocis, who has more than 25 years of Congressional experience on the CWA, was originally nominated for the position by Obama in June 2011. His nomination was blocked by Republican Senators John Barrasso (R-WY) and David Vitter (R-LA), who objected to proposed EPA guidance that could potentially broaden the jurisdiction of the CWA to intermittent and ephemeral streams as well as geographically isolated wetlands. Kopocis is currently a senior policy adviser at EPA. The Senate Environment and Public Works Committee approved Kopocis to head EPA's Water Office September 21, 2011, but the full Senate did not act on the nomination.

USDA Issues Proposed Rule To Allow Sharing Of Some Confidential Information With States: On February 27, 2013, the Animal and Plant Health Inspection Service (APHIS) proposed to amend its regulations on genetically engineered organisms to allow some confidential business information (CBI) submitted by companies that introduce the organisms into the environment to be shared with state and tribal governments. 78 Fed. Reg. 13286. Currently APHIS removes any CBI from documents that are provided to state and tribal agencies. The new process would apply to permit applications, and notifications for importation, interstate movement, or releases into the environment of genetically engineered organisms regulated by APHIS. APHIS also reported that the proposal would improve disaster response planning because important information , such as the location of a site containing regulated genetically engineered organisms and the identities of the personnel responsible for managing that site, is often designated as CBI. APHIS proposes to establish a new mechanism that would contain requirements for safeguarding shared business information and would also describe what types of CBI could be shared with states and Tribal governments. It proposes that if any of this information is to be retained by the state or Tribal governments, only paper copies would be authorized for retention. Currently, APHIS is examining various electronic options to share certain business information, but a method for doing so has not been selected. Comments are due by April 29, 2013.

President Obama Nominates Gina McCarthy As EPA Administrator: On March 4, 2013, President Barack Obama nominated Gina McCarthy, the current EPA Assistant Administrator for Air and Radiation, to be the new EPA Administrator. If confirmed, McCarthy will replace Lisa P. Jackson, who served as EPA Administrator for President Obama's first term. In announcing the nomination of McCarthy, President Obama said that "nobody can do a better job" at replacing Jackson and that McCarthy has been "focused on practical, cost-effective ways to keep our air clean and economy moving." McCarthy was the Commissioner of the Connecticut Department of Environmental Protection before EPA. McCarthy also served with the Massachusetts government for over 25 years.

USDA Issues New Pest Risk Guidelines For Fruit And Vegetables: On March 6, 2013, USDA's APHIS announced that it has revised its methodology to conduct plant health pest risk assessments for imported fruit and vegetable commodities. 78 Fed. Reg. 14510. The previous guidelines were developed over ten years ago. APHIS concluded the update was necessary to provide a more streamlined and efficient process for developing pest risk assessments (PRAs. "Revising the PRA guidelines allows APHIS to incorporate advancements in PRA methods, provide a clearer, more transparent, and more logical order of progression of the assessment, and more closely align the assessments to... international standards for phytosanitary measures," according to the Department. The new guidelines provide a more technically correct method of assessing risk by recognizing that the likelihood of pest introduction is multiplicative rather than additive. The guidelines are available online.

CPSC Establishes Requirements Pertaining To Third Party Conformity Assessment Bodies: CPSC published a final rule in the March 12, 2013, Federal Register establishing requirements pertaining to the third party conformity assessment bodies (laboratories) whose accreditations are accepted to test children's products in support of the certification required by the Consumer Product Safety Act (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA). 78 Fed. Reg. 15836. The final rule establishes the general requirements concerning third party conformity assessment bodies, such as the requirements and procedures for CPSC acceptance of the accreditation of a third party conformity assessment body, and addresses adverse actions that may be imposed against CPSC-accepted third party conformity assessment bodies. The final rule also amends the audit requirements for third party conformity assessment bodies and amends CPSC's regulation on inspections. The rule will be effective June 10, 2013, and applies to products manufactured on or after that date.

CPSC Proposes To Update Definition Of Strong Sensitizer And Issues Strong Sensitizer Guidance: On March 12, 2013, CPSC published a proposed rule that would update the supplemental definition of "strong sensitizer" under the Federal Hazardous Substances Act (FHSA). 78 Fed. Reg. 15660. According to CPSC, the proposed amendment clarifies or adds language to eliminate redundancy, remove certain subjective factors, incorporate new and anticipated technology, rank the criteria for classification of strong sensitizers in order of importance, define criteria for "severity of reaction," and indicate that a weight-of-evidence approach will be used to determine the strength of the sensitizer. Comments are due May 28, 2013.

CPSC notes that additional action would be needed to designate a substance as a strong sensitizer. CPSC would engage in notice and comment rulemaking, separate from this rulemaking, and make the findings specified in 15 U.S.C. Section 1261(k), i.e., that based upon consideration of the frequency of occurrence and the severity of the reaction, the substance has a significant potential for causing hypersensitivity. If manufacturers of products containing a designated strong sensitizer determine that the strong sensitizer in their products may cause substantial injury or illness as a result of reasonably foreseeable handling or use, that product would be a "hazardous substance" as defined under the FHSA, and therefore would warrant appropriate labeling. CPSC states that alternatively, where there is uncertainty, it has the option under FHSA Section 3(a)(1) to determine through notice and comment rulemaking that a product containing a strong sensitizer is a "hazardous substance." Hazardous substances intended or packaged in a form suitable for use in the household that do not bear the appropriate cautionary labeling would be considered "misbranded" in violation of the FHSA. CPSC notes that cautionary labeling would be insufficient, however, if a toy or other article intended for the use of children is, bears, or contains a hazardous substance, and the hazardous substance is accessible to a child to whom the article is entrusted. Under that scenario, the toy or children's article would be considered a "banned hazardous substance," unless a particular exemption applies.

In a separate March 12, 2013, Federal Register notice, CPSC announced the availability of a document entitled "Strong Sensitizer Guidance." 78 Fed. Reg. 15710. CPSC states that the guidance is intended to clarify the "strong sensitizer" definition, assist manufacturers in understanding how CPSC staff would assess whether a substance and/or product containing that substance should be considered a "strong sensitizer," and how CPSC would make such a determination. The guidance document is available online.

Court Of Appeals Issues Landmark Ruling Vacating Biological Opinion Concerning Effects Of Three Pesticides On Salmon Species: On February 21, 2013, a three judge panel of the Fourth Circuit Court of Appeals issued a unanimous landmark decision in Dow Agrosciences v. National Marine Fisheries Service setting aside a Biological Opinion (BiOp) prepared by the National Marine Fisheries Service (NMFS) that found that use of the pesticides chlorpyrifos, diazinon, and malathion could jeopardize the viability of certain species of salmon and their habitat. The decision will have significant implications for the government and registrants alike. A more detailed memorandum 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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