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May 1, 2013

Monthly Update for May 2013

Bergeson & Campbell, P.C.

On June 12, 2013, the Biobased Products Advocacy Consortium (B2PAC) and the Society for the Commercial Development of Industrial Biotechnology (SCD-iBIO) will present a webinar entitled Commercializing Renewable Chemicals: What You Need To Know About TSCA. The webinar will be held from 2:00 – 3:30 p.m. (EDT).


EPA Seeks Efficacy Data For Antimicrobial Pesticides For Fogging or Misting: On April 1, 2013, the U.S. Environmental Protection Agency (EPA) sent a letter to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrants intended to ensure that antimicrobial products applied by fogging or misting are effective as claimed and are labeled in a manner that will prevent unreasonable adverse effects on human health or the environment. Several registrants of antimicrobial products that contain fogger/mister label instructions are being asked either to provide existing efficacy data, or to commit to provide new data that address the public health claims for their fogger/misting products. EPA is asking that registrants submit for each product bearing fogging/misting application instructions any efficacy test data from their files regarding this use. If the efficacy data are not available, EPA expects registrants to provide new efficacy data using a protocol approved by the Agency. EPA considers the claims made for disinfection and sanitization products applied by fogging/misting to be “public health” related. The letter requests that registrants respond within 60 days. The letter to registrants can be accessed online.

EPA Updates TRI Pollution Prevention Database: On April 15, 2013, EPA updated its search tool for pollution prevention data reported annually by industrial facilities as part of the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI) reporting. The database tracks industry progress in reducing waste streams and allows users to focus on one or more specific industries, chemicals, states, and/or years. The data can be sorted to find activities corresponding to the largest reductions in releases, total waste managed, or releases specifically to air, water, or land.

EPA Announces FIFRA Scientific Advisory Panel Meeting: On April 17, 2013, EPA announced the scheduling of a four-day meeting of the FIFRA Scientific Advisory Panel (SAP) to consider and review Weight-of-Evidence: Evaluating Results of Endocrine Disruptor Screening Program (EDSP) Tier 1 Screening. 78 Fed. Reg. 22873. The meeting will be held July 30, 2013 – August 2, 2013. Please consult the Federal Register for details.

GAO Finds EPA Could Improve Its Assessment And Control Of Chemicals: On April 29, 2013, the U.S. Government Accountability Office (GAO) released a report entitled Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach, which provides the results of a performance audit conducted by GAO from December 2011 to March 2013. GAO reviewed the extent to which: (1) EPA has made progress implementing its new approach for managing toxic chemicals with the goal of ensuring the safety of chemicals using its existing authorities; and (2) the new approach positions EPA to achieve its goal of ensuring the safety of chemicals. GAO concluded that, although EPA has implemented a new approach to managing existing chemicals, it should take further action, such as promulgating rules under Section 8 of the Toxic Substances Control Act (TSCA) to require chemical companies to report chemical toxicity and exposure-related data submitted to foreign agencies and to require chemical companies to report exposure-related data from processors to EPA. The report is available online. A more detailed memorandum is available online.

District Court Dismisses Complaint In Omnibus Case Alleging That EPA Failed To Consult Under The Endangered Species Act For 382 Registered Pesticides: In a decision with enormous implications for pesticide registrants, on April 22, 2013, the U.S. District Court for the Northern District of California dismissed a complaint in Center for Biological Diversity, et al. v. EPA, a case often referred to as the “Mega-ESA” case. In this suit, the plaintiffs asserted that EPA improperly failed to initiate or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) for 382 separate registered pesticidal active ingredients. Rather than identifying any specific registration action by EPA concerning which there was a failure to consult, the plaintiffs based their complaint on the theory that EPA “retains discretionary control and involvement” over each of the identified pesticides and that such control constitutes ongoing administrative action requiring consultation under the ESA. The court decisively rejected this concept, holding that the plaintiffs “must allege a separate ESA claim corresponding to an affirmative act with respect to each of the 382 pesticides.” More information is available online.

EU Proposes Restriction Of Neonicotinoid Products: The European Union (EU) voted April 29, 2013, on a proposal to restrict the use of three neonicotinoid substances for agricultural uses. The substances are clothianidin, imidacloprid, and thiamethoxam. The proposal failed to gain sufficient support from the 27 EU Member States Appeal Committee and was passed to the European Commission (EC), which has confirmed that the proposal will be adopted in the coming weeks. Restriction upon the agricultural use of the three neonicotinoid substances will apply from December 1, 2013 (see online).

The proposal is supported by several governmental and non-governmental organizations (NGO) that rely upon scientific arguments to support the view that there is a link between use of neonicotinoid substances in agriculture and decline in bee numbers. The European Food Safety Authority (EFSA) has produced risk assessment documents examining the risk with information provided from governments and industry (available online). EFSA concludes that there is a link between neonicotinoid use in agriculture and decline in bee numbers.

Industry may oppose any new restrictions on neonicotinoid use, arguing that pesticides are but one of many factors contributing to bee colony health, and that it is premature to single out any one type of pesticides or any specific ones as the central or main contributor. Ironically, given the proposed suspension of use in the EU, the prohibition on uses may result in a kind of large-scale field experiment in the U.S. Environmental information on bee and pollinator numbers in the EU over the next few seasons may become key to supporting restrictions in other jurisdictions, or may lead to a relaxing of the proposed restriction in the EU. A more detailed memorandum is available online.

NAS Committee Releases Report Recommending Changes In Process Used By EPA And The Services To Assess Risks To Endangered And Threatened Species From Pesticides: In a widely anticipated and potentially influential report released on April 30, 2013, a committee of the National Research Council (NRC) of the National Academy of Sciences (NAS) made detailed recommendations concerning potential revisions to the process by which EPA and the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) assess risk during consultation under ESA Section 7(a)(2) for specific pesticide registration actions taken by EPA under FIFRA. EPA and the Services asked the NAS committee to provide recommendations on specific technical questions, as the agencies have approaches to risk assessment that “differ because their legal mandates, responsibilities, institutional cultures, and expertise differ,” and because the agencies “have been unsuccessful in reaching a consensus regarding their assessment approaches.” Although the NAS committee’s report is only advisory, EPA and the Services are likely to make a significant effort to review the recommendations and to implement those they deem feasible. The report, entitled Assessing Risks to Endangered and Threatened Species from Pesticides, is available online. A more detailed memorandum is available online.

EPA Issues SNUR For Ink Colorant: On May 1, 2013, EPA issued a final significant new use rule (SNUR) for a chemical used to color ink. 78 Fed. Reg. 25388. EPA proposed the SNUR for this chemical December 19, 2012. 77 Fed. Reg. 75085. EPA identified the chemical using a generic name: ethoxylated, propoxylated diamine diaryl substituted phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt. EPA determined the original manufacturer can make the chemical, but only for use “as an ink colorant as described in [its] amended PMN.” The final rule is effective May 31, 2013.

EPA Issues Toxicological Review Of Methanol (Non-Cancer): In Support Of Summary Information On The Integrated Risk Information System (IRIS): On May 3, 2013, EPA announced a 45-day public comment period and peer review on the draft toxicological review titled Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS) (EPA/635/R–11/001Ba). 78 Fed. Reg. 26029. On January 12, 2010, EPA released an external review draft, containing both cancer and non-cancer analyses, for public comment. EPA later placed this external review on hold pending resolution of issues concerning data used in the cancer analysis. On April 18, 2011, EPA released for public comment another external review draft that contained only a non-cancer analysis. On June 22, 2011, EPA released an addendum to the April 18, 2011, non-cancer external review draft to provide the public an opportunity to comment on the incorporation of several new studies into the analysis. The new assessment lowers the non-cancer risk estimate by roughly an order of magnitude. Public comments are due by June 17, 2013.

State FIFRA Issues Research And Evaluation Group Convenes Semi-Annual Full Committee Meetings: On April 22-23, 2013, the Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG) Pesticide Operations Management (POM) Working Committee (WC) held its semi-annual full committee meeting in EPA offices in Crystal City, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and EPA in the development of pesticide policies and regulations. More information about SFIREG and its committees is available online.

Issues of potential interest discussed during the meeting included the following: Bee Inspection Guidance; Insect Repellency Mark Update; Pesticide Use/Misuse in Marijuana Production Activities; EPA’s Spray Drift Reduction Technology Program; National Pesticide Information Center (NPIC) Incident Reporting, Coordination with State Lead Agencies (SLA); Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) Globally Harmonized System (GHS) Implementation and Effect on FIFRA Labeling; SLA Options for Addressing Widespread Use of Unregistered Pesticides; Office of Enforcement and Compliance Assurance (OECA) Update and Distributor Label Enforcement Efforts; and Other Topics. A more detailed memorandum is available online.

EPA Publishes Final Data Requirements For Antimicrobial Pesticides: On May 8, 2013, EPA issued a long-awaited final rule revising the data requirements for antimicrobial pesticide products. 78 Fed. Reg. 26936. EPA states the revisions “reflect current scientific and regulatory practice, and [] provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products.” The final rule revises and updates the data requirements for antimicrobial pesticides that are currently found in 40 C.F.R. Part 161, and relocates them to Subpart W of Part 158. Subpart W sets out data requirements specific to antimicrobial products that are described by the antimicrobial use patterns and use exposure considerations particular to antimicrobials. The final rule is effective July 8, 2013. More information is available online.

EPA Revokes TSCA Section 4 Testing For HPV Chemical: On May 13, 2013, EPA revoked certain testing requirements promulgated under TSCA for the High Production Volume (HPV) chemical substance, benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien- 1-ylidene]methyl]phenyl]amino]- (Chemical Abstracts Service (CAS) Number 1324-76-1), also known as C.I. Pigment Blue 61. 78 Fed. Reg. 27860. After publication in the Federal Register of a final rule requiring testing for C.I. Pigment Blue 61, EPA received adequate, existing studies which eliminated the need for testing. This final rule is effective June 12, 2013.


EPA Approves Fire Suppression And Explosion Protection As Ozone-Depleting Substitute: On April 29, 2013, EPA listed under its Significant New Alternatives Policy (SNAP) program C7 Fluoroketone as an acceptable substitute for ozone-depleting substances used as streaming agents in the fire suppression and explosion protection sector. 78 Fed. Reg. 24997. The program implements Clean Air Act (CAA) Section 612, as amended in 1990, which requires EPA to evaluate substitutes and find them acceptable where they pose comparable or lower overall risk to human health and the environment than other available substitutes. The rule is effective on May 29, 2013.

EPA Announces Notice Of Workshop And Call For Information On Integrated Science Assessment For Oxides Of Sulfur: On May 10, 2013, the Office of Research and Development’s (ORD) National Center for Environmental Assessment (NCEA) announced it is preparing an Integrated Science Assessment (ISA) as part of the review of the primary National Ambient Air Quality Standards (NAAQS) for oxides of sulfur (SOX) (for which the indicator is sulfur dioxide [SO2]). 78 Fed. Reg. 27387. This ISA will update the scientific assessment presented in the Integrated Science Assessment for Sulfur Oxides — Health Criteria (EPA 600/R–08/047F), published in September 2008. Interested parties are invited to submit recent research studies that have been published, accepted for publication, or presented at a public scientific meeting. EPA also announced that a workshop entitled “Kickoff Workshop to Inform EPA’s Review of the Primary SO2 NAAQS” is being organized by NCEA and the EPA Office of Air and Radiation’s Office of Air Quality Planning and Standards. Additionally, in the near future, the EPA Science Advisory Board (SAB) will be forming a Clean Air Scientific Advisory Committee (CASAC) panel for the SO2 NAAQS health review. The workshop will be held on June 12-13, 2013, in Research Triangle Park, North Carolina. All communications and information submitted in response to the call for information should be received by EPA by June 10, 2013.


Conference Participants Discuss Need For EU Register Of Nanomaterials: On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current EU legislation on nanomaterials is insufficient. Participants include representatives from Member States, the EC, European Parliament (EP), industry, and a number of non-governmental organizations. According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create[] more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:

  1. Public concern;
  2. Consumers choice;
  3. Traceability;
  4. Information (for authorities, in the supply chain, for consumers); and
  5. Proportionality, etc.

The Chairman’s Report is available online. The Majority Agreements are available online.

IRSST And Nanoquébec Will Fund Research On Worker Exposure To Engineered Nanoparticles: On April 15, 2013, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) and NanoQuébec announced they will jointly fund three new research projects on worker exposure to engineered nanoparticles. The principal researchers for these projects, their affiliations, and the titles of the projects selected are:

  • Nathalie Tufenkji, McGill University, “Measuring the Effectiveness of Protective Gloves for Working with Nanoparticles in Conditions Simulating their Use in the Workplace”;
  • Maximilian Debia, Université de Montréal, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces”; and
  • Karim Maghni, Université de Montréal, “The Development and Validation of Universal NanoBadge prototypes (u-Nanobadge) for Evaluating Pulmonary and Cutaneous Exposure to Engineered Nanoparticles.”

According to IRSST, the projects will likely take two years to complete and will involve collaborators from various institutions, as well as students. More information is available online.

Swedish Draft Proposal Would Amend REACH To Ensure Safe Handling Of Nanomaterials: The Swedish Chemicals Agency (KemI) published an April draft proposal to amend the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to ensure the safe handling of nanomaterials. The draft proposal would adopt the October 2011 EC recommendation on the definition of nanomaterial. It would require manufacturers and importers of a nanomaterial, either on its own or in one or more mixture(s), in quantities of ten kg or more per year, to register. The obligation to register on-site isolated intermediates or transported intermediates that fulfill the definition of nanomaterials would apply to any manufacturer of the nanomaterial intermediate in quantities of ten kg or more per year. Producers or importers of articles containing nanomaterials would be required to notify the European Chemicals Agency (ECHA) if the nanomaterial is present in those articles in quantities over ten kg per producer or importer per year. The draft proposal is available online.

NRC Identifies Five High Priorities To Improve NNI: The NRC announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:

  • Improve information gathering and communication at the project level;
  • Develop and implement interagency plans for focused areas;
  • Rework the NNI website to serve better the diversity of stakeholder groups;
  • Take advantage of new technologies for data collection and analysis; and
  • Identify, share, and implement best practices, especially relating to technology transfer and commercialization.

In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies. The report is available online.

NIOSH CIB On Carbon Nanotubes And Nanofibers Includes Lower REL: On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m3) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 µg/m3 but that the analytic limit of quantification was 7 µg/m3.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 µg/m3. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed. The CIB is available online.

EPA Posts Application Of Life-Cycle Assessment To Nanoscale Technology: Lithium-ion Batteries For Electric Vehicles On Website: On April 30, 2013, EPA posted a report on the environmental life-cycle assessment (LCA) of lithium-ion batteries used in electric vehicles. The report was developed in partnership with the Department of Energy (DOE), the lithium-ion battery industry, and academics as part of EPA’s Design for the Environment Program. As the demand for electric vehicles increases resulting in reductions in greenhouse gas (GHG) emissions, lithium-ion batteries are expected to play a key role in the electric vehicle industry. This LCA is designed to provide battery manufacturers with information to help select safer materials and processes. The report also reviews the potential impacts of a nanotechnology innovation that could improve battery performance. The report and summary information can be found online.

France Extends Deadline For Reporting Nanomaterials: The Ministry of Ecology, Sustainable Development and Energy recently announced that it has extended the deadline for declaring substances with nanoparticle status to June 30, 2013. According to the Ministry, it received 1,991 declarations from 457 companies by the original deadline of April 30, 2013. The Ministry states that, given the “diversity of actors covered by the declaration requirement, and at the request of several industries,” for the first reporting year, it will grant a two-month extension. More information is available online.


FDA Responds To Concerns About Antimicrobial Resistance: On April 22, 2013, the U.S. Food and Drug Administration (FDA) posted a statement on the Center of Veterinary Medicine (CVM) website discussing comments made by the Environmental Working Group (EWG) concerning data regarding antimicrobial resistance in the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS). FDA stated that while it is always concerned when it encounters antimicrobial resistance, it believes the EWG report oversimplifies the NARMS data and provides misleading conclusions. In the course of addressing its concerns with what EWG said, FDA provides a useful overview of where it believes things stand regarding the effect of possible antimicrobial resistance to treatment options. FDA stated that it does not believe that EWG fully considered important factors that put these results in context, including whether the bacterium discussed is a foodborne pathogen. The report highlights resistance to Enterococcus, but FDA states that Enterococcue is not considered a foodborne pathogen; which drug(s) the bacterium is naturally resistant to; why NARMS includes certain drugs in its testing design; and whether the antibiotics that are commonly used to treat patients are still effective. NARMS data indicate that first-line treatments for all four bacteria that FDA tracks (Salmonella, Enterococcus, Escherichia coli, and Campylobacter) are still effective.

Additionally, FDA stated that it believes that it is inaccurate and alarmist to define bacteria resistant to one, or even a few, antimicrobials as “superbugs” if these same bacteria are still treatable by other commonly used antibiotics. This is especially misleading when speaking of bacteria that do not cause foodborne disease and have natural resistances, such as Enterococcus.


UK Begins Consultation On WEEE Implementation: On April 17, 2013, the United Kingdom’s (UK) Department for Business, Innovation and Skills launched a public consultation on the implementation of the recast Waste Electrical and Electronic Equipment (WEEE) Directive. The consultation focuses on how the government should amend the existing WEEE regulations to ensure compliance with the recast WEEE Directive published on July 24, 2012, and on how to respond to concerns from UK producers of electrical and electronic equipment under the Environmental Theme of the Red Tape Challenge about the cost of meeting their financial obligations under the regulations. Stakeholders and interested parties from all stages of the supply chain are invited to participate, including producers, retailers, distance sellers, and distributors. Comments are due June 21, 2013. More information is available online. A more detailed memorandum is available online.


EPA Proposes SNURs For Eight Renewable Chemical Substances: On April 18, 2013, the EPA proposed SNURs under TSCA for eight chemical substances that were the subject of premanufacture notices (PMN) P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299, the first six of which are renewable, biobased chemical substances manufactured by KiOR, Inc. This memorandum explains why the proposed SNURs for the biobased chemical substances raise novel questions and warrant careful review and comment. More information is available online.


Lautenberg Reintroduces TSCA Reform Legislation: On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act of 2013 (S. 696) (SCA 2013), which would reform TSCA. Senator Lautenberg’s press release noted that the bill is identical to the Safe Chemicals Act of 2011 (S. 847) (SCA 2011), which was reported favorably out of the Senate Environment and Public Works (EPW) Committee on a party-line vote in the 112th Congress on July 25, 2012. Despite the Committee’s passage of SCA 2011, Republicans criticized the scheduled markup, particularly in light of Lautenberg’s earlier agreement to enter into bipartisan negotiations to create a “fresh legislation proposal” to reform TSCA. A summary of SCA 2013 is available online, and the full text of SCA 2013 is available online. Our April 11, 2013, memorandum is available online. More information is available online.

Republicans Boycott Committee Vote On EPA Nominee; Vote Rescheduled: A May 9, 2013, Senate EPW Committee vote on President Obama’s nominee to head EPA was derailed as Republican members of the Committee boycotted the vote. EPW Chair Barbara Boxer (D-CA) was forced to postpone the Committee’s vote on Gina McCarthy, currently the EPA Assistant Administrator for Air and Radiation. Senator Boxer criticized the Committee’s GOP members as being “obstructionists,” adding that Ms. McCarthy is the “most qualified EPA nominee” to ever come before the Committee. Committee Ranking Member David Vitter (R-LA) in a May 9 letter to Senator Boxer said that Ms. McCarthy had failed to respond adequately to the more than 1,100 questions Republican Committee members had asked her and accused EPA of “stonewalling” on its responses. On May 10, 2013, Senator Boxer wrote to Senator Vitter and stated that a vote on Ms. McCarthy is now scheduled for May 16, 2013.

Senator Lautenberg Introduces Legislation Increasing Penalties Against Facilities That Fail To Register Dangerous Chemicals Stored On-Site: Responding to the tragedy of the fatal fertilizer plant in West, Texas, Senator Frank Lautenberg (D-NJ) on April 25, 2013, introduced a bill that would increase penalties for companies that fail to register regulated chemicals under the Chemical Facility Anti-Terrorism Standards (CFATS) with the Department of Homeland Security (DHS). The Protecting Communities from Chemical Explosions Act of 2013 would subject officials of companies that fail to complete a “top screen” under CFATS to up to six years in prison. Reports indicate that the West Fertilizer Co. in West, Texas, should have been registered with DHS’s CFATS. It had not submitted required screening information related to the type of facility, the potential risk to the local population, and the presence of hazardous chemicals. DHS uses this information to prioritize facilities and require additional chemical security measures, if necessary. “The chemical reporting laws on the books today are toothless and do little to help us protect communities from chemical explosions. Facilities that break the reporting rules today essentially get away with just a warning, so my legislation would stiffen penalties and make it a federal crime for plants to intentionally keep their possession of dangerous chemicals a secret,” Senator Lautenberg stated. “We may have been able to save lives in West, Texas if first responders and regulators had knowledge about the chemicals stored on-site,” he added. Current regulations limit DHS’s ability to assess civil penalties by requiring DHS to issue administrative orders before penalties can be levied. Senator Lautenberg’s legislation would eliminate the administrative order requirement and establish the following civil and criminal penalties under the CFATS program: civil penalties of $25,666 per day for any facility that holds a chemical of interest above the screening threshold quantity established by CFATS, but has not reported to DHS through the CFATS program; and Class D Felony penalty for the officers of any company that owns a facility subject to CFATS that intentionally fails to report under CFATS.

Senator Lautenberg has spearheaded legislation to require thousands of chemical and water plants throughout the country to assess and develop plans to address their vulnerabilities, and require the highest-risk facilities to use Inherently Safer Technology (IST) that increases public and environmental safety. Some of the changes that could be implemented at water and chemical plants include reducing the amount of lethal gases stored on-site or minimizing the use of dangerous chlorine gas.

Great Lakes Assurance Program Verification Act: Representative Candice Miller (R-MI) on April 18, 2013, introduced a bill that would amend the Food Security Act of 1985 to require the Secretary of Agriculture to establish a Great Lakes basin initiative for agricultural nonpoint source pollution prevention. The bill (H.R. 1647) would authorize grants to Great Lakes states to fund education and outreach on nonpoint pollution and technical assistance to reduce pollutant runoff to the Great Lakes. The bill provides $30 million in funding over a four-year period for the initiative.

EPA Science Advisory Board Reform Act of 2013 Clears House Committee: By a party line vote of 21-16, the House Science, Space and Technology Committee on April 12, 2013, passed the EPA Science Advisory Board Reform Act of 2013 (H.R. 1422). The bill seeks to amend the process by which EPA selects members of its SAB by addressing criticisms that EPA does not allow industry experts to serve on the SAB and instead “stacks” the SAB with individuals likely to support EPA’s perspective. The bill was introduced by Representative Chris Stewart (R-UT). Stewart stated that the purpose of the bill is to increase the diversity of the SAB, which consists of several committees that review scientific and technical information used for EPA regulations, including advice on chemical risk assessments, drinking water standards, and clean air rules. The bill would limit EPA’s ability to exclude industry representatives and to curtail the inclusion of individuals who have received money from EPA to fund research. It also bars the participation of board members in advisory activities that directly or indirectly involves review of their own work. The bill would require EPA to “make public all reports and relevant scientific information” simultaneously with disclosure to members on the SAB. The bill also requires the SAB, prior to conducting its work, to hold a public information-gathering session to discuss the state of the science and calls for greater consideration of public comments, including the requirement that SAB respond to public comments offered by members of the public.

House Committee Passes Bill To Expedite Approval Of Keystone XL Pipeline: The House Energy and Commerce Committee on April 16, 2103, passed a bill that would bypass President Obama’s authority to decide the fate of the controversial Keystone XL oil sands pipeline. The Northern Route Approval Act (H.R. 3) passed with a 17-9 vote. Fifteen Republicans and two Democrats voted in favor of the bill. The legislation would negate the need for TransCanada Corporation, the builder of the pipeline, to receive a permit from the U.S. Department of State to construct the northern leg of the project. The House Natural Resources Committee on April 24, 2013, followed suit and passed H.R. 3. House Republican leaders have said they wish to schedule a floor vote on H.R. 3 before the Memorial Day recess.

The Sunshine For Regulatory Decrees And Settlements Act: Representative Doug Collins (R-GA) on April 12, 2013, introduced the Sunshine for Regulatory Decrees and Settlements Act, a bill seeking to eliminate so-called “sue and settle” actions attributed to EPA. The bill seeks to curb the sue-and-settle tactic that Republicans say are commonly used by public interest groups, in which a private party will file a lawsuit against an agency that has failed to promulgate a rule by a certain deadline, accusing it of failing to meet its statutory obligation. Rather than fighting the charges, the agency may then choose to settle by advancing the rulemaking sought by the plaintiffs. Collins said that EPA is the primary federal agency that uses this tactic. Collins’ bill would disallow settlements until all the parties affected by the proposed regulations are allowed to participate in the settlement negotiations. The proposed settlement must also be put up for notice and comment under the bill.

The Energy Consumers Relief Act Of 2013: On April 17, 2013, Representative Bill Cassidy (R-LA) proposed the Energy Consumers Relief Act of 2013 (H.R. 1582), a bill seeking to prevent EPA from issuing any energy-related regulation with an impact of $1 billion or higher if it harms the economy and job creation. It would also impose transparency on the issuance of such rules. Stating that “EPA’s power to regulate is also the power to destroy,” Cassidy said he introduced the measure because “it makes no sense for EPA to issue burdensome regulations that will hurt our energy economy and cost American families thousands of jobs.” The bill would mandate that EPA report to Congress on cost, job impacts, and energy price changes before implementing new regulations.

Senate Bill Would Ban CWA Permits For Pesticide Applications Over Waters: Senators Kay Hagan (D-NC) and Mike Crapo (R-ID) introduced legislation on April 23, 2013, that would exempt from Clean Water Act (CWA) permitting requirements legal applications of pesticides near or over waters. The Sensible Environmental Protection Act of 2013 is a companion to H.R. 935, introduced in March 2013.

Republican Senators Ask EPA To Withdraw Guidance On Waters Of The United States: Thirty Republican Senators on April 23, 2013, sent a letter to Acting EPA Administrator Robert Perciasepe asking that EPA withdraw draft guidance under Office of Management and Budget (OMB) review that seeks to define the phrase “waters of the United States” under the CWA. If not withdrawn, the guidance could lead EPA to redefine when isolated wetlands, intermittent streams, and other non-navigable waters should be subject to regulation, said Senator John Barrasso (R-WY), the primary author of the letter. The draft guidance (promulgated in 2011), if issued in final, could expand the scope of the waters to be regulated beyond that intended by Congress, the Senators claim. Moreover, leaving the guidance in place would further frustrate any potential rulemaking process. Given the significance of redefining jurisdictional limits to impose CWA authority, a formal rulemaking process provides a greater opportunity for public input and greater regulatory certainty than a guidance document, they wrote. With regard to the rulemaking, the Senators asked that EPA “stay within the confines of current law and eschew attempts to expand jurisdiction beyond the intent of Congress,” adding that “any rulemaking should identify limits to EPA’s jurisdiction under the statute consistent with those articulated in the [recent] Supreme Court decisions.”

Senate Bill Reduces Permit Requirements For Mining Industry: West Virginia’s Democratic Senator Joe Manchin on April 25, 2013, introduced a bill that would prevent EPA from vetoing certain CWA permits for mines. The EPA Fair Play Act (S. 830) would prevent EPA from vetoing permits issued under CWA Section 404 that allow certain mining debris to be placed in locations that may affect streams. The U.S. Army Corps of Engineers issues the permits in consultation with EPA, which has veto authority under Section 404(c). The bill is identical to legislation Senator Manchin introduced in 2011 that did not advance. Senator Manchin introduced the legislation in response to EPA’s rejection in 2011 of a permit for a mine in West Virginia operated by Arch Coal Inc.

House Bill Would Prohibit Waste Material From Being Used As Fill: Representative Frank Pallone (D-NJ) on May 6, 2013, introduced the Clean Water Protection Act (H.R. 1837). The bill would amend the CWA to clarify that fill material cannot be comprised of waste. It would amend Section 502 by adding the following definition:

FILL MATERIAL- The term ‘fill material’ means any pollutant which replaces portions of the waters of the United States with dry land or which changes the bottom elevation of a water body for any purpose. The term does not include any pollutant discharged into the water primarily to dispose of waste.

The bill has garnered 45 co-sponsors.

Big Bail Out Prevention Legislation Package Introduced In Senate: Following the third anniversary of the Deepwater Horizon explosion and oil spill, Senator Robert Menendez (D-NJ) on April 25, 2013, introduced the Big Oil Bailout Prevention Legislation Package — two bills aimed at holding companies accountable for oil spills and improving the federal government’s ability to help areas affected by an oil disaster. Federal law currently caps oil spill liability at $75 million for economic damages caused by a spill; the legislation removes the $75 million cap for damages such as lost business revenues from fishing or tourism or lost tax revenues of state and local governments. The legislation also seeks to improve the use of Oil Spill Liability Trust Fund monies following a spill. The Oil Spill Liability Trust Fund was established to provide quick relief for victims of an oil spill, to provide immediate funds to respond to a spill and help pay for damages after a company hits its $75 million liability cap, or if the culprit cannot be found or has gone bankrupt. It is funded by an 8 cent tax for every barrel of oil produced or imported into the United States. There is a $1 billion per incident cap on payouts from the fund and Senator Menendez’s bills would eliminate the cap on claims against the Oil Spill Liability Trust Fund. It also allows community responders to access the fund for preparation and mitigation up front, rather than waiting for reimbursement later. If the damage claims exceed the amount in the Oil Spill Liability Trust Fund, the legislation allows the U.S. Treasury to temporarily refill the Fund and be repaid with interest once it is replenished. Finally, the legislation eliminates the $500 million cap on Oil Spill Liability Trust Fund monies used for natural resources damages. Companion legislation (H.R. 1743) was introduced in the House by Representative Rush Holt (D-NJ).

Bill Would Ban Coal Tar Sealants Under TSCA Section 6: Representative Lloyd Doggett (D-TX) on April 18, 2013, introduced a bill that would amend TSCA to ban coal tar sealants. The Coal Tar Sealants Reduction Act of 2013 (H.R. 1625) would amend TSCA Section 6 by adding a new Section (g) that would ban the manufacture, processing, or distribution in commerce of any coal tar sealant, with the ban to go into effect one year after the bill is enacted. The bill defines “coal tar sealant” to mean any product intended for use on a paved surface that contains any substance identified by the CAS Number 65996-93-2, including ingredients listed as coal tar, refined coal tar, refined tar, or refined coal tar pitch.

Grassroots Rural And Community Water Systems Act: Senators Roger Wicker (R-MS) and Heidi Heitkamp (D-ND) on April 25, 2013, introduced a bill that would reauthorize the Safe Drinking Water Act’s technical assistance and training provision for $15 million a year to assist small and rural public water systems comply with federal drinking water regulations. The Senate legislation is a companion bill to H.R. 654, introduced by Representative Gregg Harper (R-MS).

The Water Quality Protection And Job Creation Act Of 2013: Representatives Nick Rahall (D-WV) and Tim Bishop (D-NY) on May 9, 2013, introduced legislation they claim will create jobs by investing $13.8 billion over five years through the CWA’s State Revolving Fund (SRF) and other efforts to improve water quality. The Water Quality Protection and Job Creation Act of 2013 (H.R. 1877) renews the federal commitment to addressing our Nation’s substantial needs for wastewater infrastructure by investing $13.8 billion in the SRF, which, for decades, has been the traditional mechanism for federal wastewater infrastructure assistance. The bill also proposes two complimentary initiatives for the long-term financing of wastewater infrastructure through the establishment of direct loan and loan guarantee programs and a Clean Water Infrastructure Trust Fund. These proposals, when implemented in concert, would leverage billions of additional dollars to meet local wastewater infrastructure needs, the bill’s sponsors claim. The bill would also permanently reinstate the application of Davis-Bacon prevailing wages for the construction of wastewater treatment infrastructure and would codify the application of Buy American provisions within the CWA.

EPA Action Sought On Sulfuryl Flouride: Representative Tom Graves (R-GA) introduced the Pest Free Food Supply Act on April 11, 2013. The bill would require the EPA Administrator to withdraw the proposed order to revoke the previously approved food uses for the pesticide sulfuryl fluoride since supposedly the pesticide has excessively high levels of naturally occurring fluoride. Language in the Act points out that the pesticide is the smallest contributor to total fluoride exposure, and that even EPA admits that “the elimination of sulfuryl fluoride does not solve, or even significantly decrease, the fluoride exposure problems.” The drafters also write that EPA has stated that, if sulfuryl fluoride is “phased-out from use, industry will be left with few viable sanitation alternatives.”

Green Technologies Use Required: On April 12, 2013, Representative John Garamendi (D-CA) introduced the Make it in America: Create Clean Energy Manufacturing Jobs in America Act (H.R. 1524). His bill would authorize federal acquisition of, or the provision of federal funds to states for purchase of, only green technologies that are 85 percent manufactured in the United States from articles, materials, or supplies that are 85 percent grown, produced, or manufactured in the United States. The bill provides that such percentage shall be 50 percent in the first fiscal year (FY) after enactment and 60 percent in the second FY.

The bill defines “green technologies” to mean renewable energy and energy efficiency products and services that: (1) reduce dependence on unreliable sources of energy by encouraging the use of sustainable biomass, wind, small-scale hydroelectric, solar, geothermal, and other renewable energy and energy efficiency products and services; and (2) use hybrid fossil-renewable energy systems.

Move To Axe Credits: Representative Michael Pompeo (R-KS) has put forward H.R. 259, the Energy Freedom and Economic Prosperity Act, which would amend the Internal Revenue Code to repeal: (1) the excise tax credits for alcohol fuel, biodiesel, and alternative fuel mixtures; (2) the tax credits for the purchase of alternative motor vehicles and new qualified plug-in electric drive motor vehicles; (3) the alternative fuel vehicle refueling property tax credit; (4) the income tax credits for alcohol, biodiesel, and renewable diesel used as fuel; (5) the enhanced oil recovery tax credit and the tax credit for producing oil and gas from marginal wells; (6) the tax credits for producing electricity from renewable resources and from advanced nuclear power facilities; (7) the tax credit for carbon dioxide sequestration; (8) the energy tax credit; and (9) the tax credits for investment in qualifying advanced coal projects and qualifying gasification projects. In the place of the credits, the Secretary of the Treasury would be directed to prescribe a flat income tax rate for corporations, in lieu of the existing marginal tax rates, based upon the overall revenue savings from the repeal of energy tax expenditures by this Act.

Genetic Food Labeling: Representative DeFazio (D-OR) has introduced legislation to amend the Federal Food, Drug, and Cosmetic Act to require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly. The bill would establish a consistent and enforceable standard for labeling of foods produced using genetic engineering, including fish, thereby providing consumers with knowledge of how their food is produced. The legislation states that the standard is needed since: the process of genetically engineering food organisms results in material changes to food derived from those organisms; FDA requires the labeling of more than 3,666 ingredients, additives, and processes; individuals in the United States have a right to know if their food was produced with genetic engineering for a variety of reasons, including health, economic, environmental, religious, and ethical; more than 60 countries, including the UK and all other countries of the EU, South Korea, Japan, Brazil, Australia, India, China, and other key United States trading partners have laws or regulations mandating disclosure of genetically engineered food on food labels; in 2011, Codex Alimentarius, the food standards organization of the United Nations, adopted a text that indicates that governments can decide on whether and how to label foods produced with genetic engineering; and mandatory identification of food produced with genetic engineering can be a critical method of preserving the economic value of exports or domestically sensitive markets with labeling requirements for genetically engineered foods.


DOT Revises Maximum And Minimum Civil Penalties For HazMat Transportation Violations: The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Administration (PHMSA) on April 17, 2013, issued a final rule adjusting the maximum and minimum civil penalties for violations of PHMSA’s hazardous materials transportation regulations (HMR). 78 Fed. Reg. 22798. The adjustments are necessary to conform with the Moving Ahead for Progress in the 21st Century Act, which was signed into law on October 1, 2012. The maximum civil penalty for knowingly violating the HMRs is raised from $55,666 to $75,666. The maximum civil penalty for knowingly violating the HMRs in a manner that results in death, serious illness, or severe injury is raised from $110,666 to $175,666. The current minimum civil penalty of $250 is removed, except in the case of a violation related to training, where the minimum civil penalty is raised to $450. The revisions became effective on April 17, 2013.

President Selects Shelanski To Head OMB Regulatory Affairs Office: On April 25, 2013, President Obama nominated Howard Shelanski, a Federal Trade Commission (FTC) economist, to become the next head of the White House OMB’s Office of Information and Regulatory Affairs. Shelanski has been the director of the FTC’s Bureau of Economics since 2012. From 2009 to 2011, Shelanski served as deputy director for antitrust in the FTC’s Bureau of Economics. During the Clinton Administration, he served as chief economist of the Federal Communications Commission and senior economist for the President’s Council of Economic Advisers.

Appellate Court Dismisses Industry Challenge To SEC’s Disclosure Of Payments By Resource Extraction Issuers Rule: On April 26, 2013, the U.S. Court of Appeals for the District of Columbia Circuit dismissed the petition for review for lack of jurisdiction. American Petroleum Institute, et al. v. SEC, No. 12-1398. In its decision, the court notes that “out of an abundance of caution,” petitioners also filed suit in U.S. District Court, and “[t]heir caution proved prescient.” Although the U.S. Securities Exchange Commission (SEC) agreed with petitioners that the court has jurisdiction to hear the petition for review, intervenor Oxfam America did not and argued that petitioners must first sue in the district court. The court states that, absent a grant of original appellate jurisdiction under Section 25 of the Exchange Act, “a party must first proceed by filing suit in district court pursuant to 28 U.S.C. § 1331 and the Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.” The court notes that when Congress enacted Section 13(q) of the Dodd-Frank Act and directed the SEC to issue implementing regulations, it did not add Section 13(q) to the list of provisions contained in Section 25(b) of the Exchange Act. According to the court, given the statutory history, “this suggests quite clearly that Congress, for whatever reason, intended challenges to section 13(q) regulations to be brought first in the district court.” The court acknowledges that Congress’s failure to update Section 25(b) “was far more likely the result of a scrivener’s error,” but states it has “no authority to speculate about congressional intent, especially when our jurisdiction is at stake.”

On May 1, 2013, the parties filed a joint status report in the U.S. District Court for the District of Columbia. American Petroleum Institute, et al. v. SEC, No. 12-cv-01668. The parties separately filed an expedited joint motion to lift the court’s December 5, 2012, order staying proceedings, to expedite consideration of plaintiffs’ motion for summary judgment, and to decide plaintiffs’ motion for summary judgment based on the briefing already presented to the U.S. Court of Appeals for the District of Columbia Circuit. On May 3, 2013, the court issued a scheduling order: (1) the December 5, 2012, stay is lifted; (2) plaintiffs’ motion for summary judgment shall be decided on the briefs submitted by the parties to the U.S. Court of Appeals for the District of Columbia Circuit; (3) the court will schedule oral argument, if any, at a future date; (4) plaintiffs shall file their motion for summary judgment, and plaintiffs and the SEC shall file the same briefs and joint appendix that were filed with the Court of Appeals by not later than May 10, 2013; and (5) any intervenor and all amici who filed briefs with the Court of Appeals may file the same briefs in this action by not later than May 17, 2013. On May 6, 2013, Oxfam America, Inc. filed a motion to intervene as a defendant. On May 10, 2013, the plaintiffs and the SEC filed motions for summary judgment. The court issued a May 10, 2013, order granting Oxfam America’s petition in part, ordering that Oxfam America may intervene in the action. Oxfam America may file a supplemental brief by May 17, 2013. If Oxfam America files a supplemental brief, the plaintiffs and the SEC may each file a responsive supplemental brief by May 24, 2013. The court will hold a motions hearing on June 7, 2013. The court will issue an order dividing argument time at a later date. On May 10, 2013, the SEC filed its opposition to plaintiffs’ motion for summary judgment and memorandum of points and authorities in support of its cross-motion for summary judgment. Plaintiffs filed their reply memorandum in support of their motion for summary judgment on May 12, 2013.

Challenge To SEC’s Final Conflict Minerals Rule Transferred To District Court: On April 29, 2013, the U.S. Court of Appeals for the District of Columbia Circuit issued an order stating that it concluded, on its own motion, that oral argument would not assist the court in this case and that it would dispose of the petition for review without oral argument on the basis of the appendix submitted by the parties and the presentations in the briefs. National Ass’n of Manufacturers v. SEC, No. 12-1422. On April 30, 2013, the petitioners filed a motion requesting the court to transfer the case to the U.S. District Court for the District of Columbia. According to the petitioners’ motion, the SEC advised that it does not oppose the transfer. Amnesty International of the USA, Inc. and Amnesty International Ltd., Respondents-Intervenors, filed a response on April 30, 2013, stating that, although they were not consulted, they do not oppose the transfer. On May 2, 2013, the court ordered that the case be transferred. A status conference on the case will be held in the U.S. District Court for the District of Columbia on May 28, 2013National Ass’n of Manufacturers v. SEC, No. 13-cv-00635.

OMB Issues Annual Report To Congress On Benefits And Costs Of Federal Regulations: The White House OMB has released the draft of its Annual Report to Congress on the Benefits and Costs of Federal Regulations and Agency Compliance With The Unfunded Mandates Reform Act. In the report, OMB states that the estimated annual benefits of major federal regulations reviewed by OMB from FY 2002 through FY 2012 are between $193 billion and $800 billion, while the estimated annual costs are between $57 billion and $84 billion. EPA and DOT accounted for the majority of the major rules during this ten year period, and also were responsible for the majority of total benefits and costs. From FY 2002 through FY 2012 EPA issued 32 major rules with costs of between $30.4 and $36.5 billion, and benefits estimated by OMB to be $112 to $637.6 billion.

Court Requires Removal Of Bisphenol A From Proposition 65 List Pending Lawsuit: On April 19, 2013, the California Superior Court issued an order requiring the state of California to remove Bisphenol A from the list of chemicals linked to reproductive toxicity pending resolution of an industry lawsuit challenging the merits of the listing under the Safe Drinking Water Toxic Enforcement Act of 1987 (Proposition 65) American Chemistry Council v. Office of Environmental Health Hazard Assessment, Cal. Super. Ct., No. 34-2013-00140720, 4/19/13. California Office of Environmental Health Hazard Assessment (OEHHA), the Office that administers Proposition 65, immediately issued a notice removing BPA from the list. OEHHA also issued a notice announcing it was withdrawing a related rulemaking to set a maximum allowable dose level, the exposure level that would trigger the consumer warnings required under Proposition 65. The preliminary injunction requiring the delisting is available online.

EPA Strengthens Conflict Of Interest Review Process For Science Review Panels: On May 3, 2013, EPA announced that it has improved its conflict of interest review process for contractor-managed peer reviews. EPA has put a new oversight process in place to ensure that contractors follow all existing conflicts of interest guidance and requirements. In addition, EPA will now ensure that the public has the opportunity to review and comment on a peer review panel’s composition when influential scientific documents are being considered. “We are committed to scientific integrity at EPA,” said EPA Acting Administrator Bob Perciasepe. “Improving the contract-managed peer review process and increasing transparency will lead to stronger science at the agency.” This revised process will apply to all future technical documents designated as Influential Scientific Information or Highly Influential Scientific Assessments where independent peer reviews will be conducted by panels selected and managed by independent contractors. For future peer review panels, EPA will now publish the names, principal affiliations, and resumes of candidates being considered for the panel. Members of the public will be able to provide comments on the candidates for a period of at least three weeks. After selecting the final peer review panel, the contractor will consult with EPA to review whether the contractor followed existing conflicts of interest guidance and requirements, and identify and provide input on any issues. In addition, the names of the final peer review panel members will be posted publicly before the meeting takes place. This process will ensure that existing conflicts of interest guidance and requirements are applied correctly and where a potential conflict of interest is identified, allow EPA to determine whether the contractor’s plan to address the conflict is acceptable. The new process does not change EPA’s existing standards for determining conflicts of interest. More information about scientific research at EPA is available online.

U.S. Supreme Court Issues Opinion On Bowman v. Monsanto: On May 13, 2013, the U.S. Supreme Court issued a unanimous decision holding that a farmer who buys patented seeds may not reproduce them through planting and harvesting without the patent holder’s permission. Bowman v. Monsanto Co., et al. (No. 11-796). Justice Elena Kagan authored the unanimous decision, which affirmed the lower courts’ holdings that the patent exhaustion doctrine did not protect Bowman because he had created a newly infringing article. The Court emphasized the work involved in all crop production, particularly the actions Bowman took to avoid Monsanto’s licensing fees. “Bowman was not a passive observer of his soybeans’ multiplication…,” according to the decision. The Supreme Court limited the application of the decision to the facts before the Court, but built on past Supreme Court precedent in protecting the intellectual property rights that have fostered the advances of modern agriculture.

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