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May 1, 2016

Monthly Update for May 2016

Bergeson & Campbell, P.C.


Office Of Inspector General Considers Pesticide Imports: In a memorandum dated April 22, 2016, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) informed EPA that it plans “to begin preliminary research to assess the EPA’s inspections of, and enforcement against, illegal pesticide imports.” OIG will review, among other aspects of the program, whether EPA is effectively identifying pesticide imports for inspection and sampling, and “whether the EPA is taking appropriate enforcement action against noncompliant imports.” More information is available in our blog “U.S. EPA OIG to Review EPA’s Inspections and Enforcement Actions Related to Illegal Pesticide Imports.”

EPA Announces Upcoming Webinars On CDR Requirements: On June 1, 2016, EPA is hosting a webinar to familiarize submitters with Chemical Data Reporting (CDR) requirements and explain how to use the 2016 eCDRweb reporting tool used to complete the electronic CDR Form U. Manufacturers, including importers, subject to CDR requirements for 2016 must submit their data between June 1, 2016, and September 30, 2016. EPA uses the data to support its risk screening, assessment, priority setting, and management activities on chemicals. To access the webinar, please click here.

NTP Issues Monograph On Cobalt: On April 22, 2016, the National Toxicology Program (NTP) issued a monograph concluding that cobalt and cobalt compounds that release cobalt ions in vivo are expected to cause human cancer. Specifically, NTP stated that “[t]here is sufficient evidence for the carcinogenicity of cobalt and cobalt compounds that release cobalt ions in vivo (collectively referred to as cobalt) in experimental animals based on increased incidence of malignant and/or a combination of malignant and benign neoplasms at several tissue sites in rats and mice by different routes of exposure.” NTP’s final monograph and related materials are available online.

EPA Issues Fact Sheets On CDR Reporting: In April, EPA released two fact sheets regarding reporting under the CDR rule. The first fact sheet, “TSCA Chemical Data Reporting Fact Sheet: Non-Isolated Intermediates,” relates to information regarding the reporting exemption applicable to non-isolated intermediate chemical substances for purposes of the CDR rule. EPA claims that the primary goal of the document is to help the regulated community comply with the requirements of the CDR rule. The document can be accessed online. The second fact sheet, “TSCA Chemical Data Reporting Fact Sheet: Reporting for Electricity Generating Sites,” is intended to assist electric utilities discharge their CDR rule obligations. The fact sheet is available online.

EPA Issues Direct Final SNUR: On May 16, 2016, EPA issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 55 chemical substances. 81 Fed. Reg. 30452. The rule includes ten premanufacture notification (PMN) substances that are subject to “risk based” consent orders under TSCA Section 5(e)(1)(A)(ii)(I) where EPA determined that the substance may present an unreasonable risk to human health or the environment and 45 PMN substances that are not subject to consent orders under TSCA Section 5(e). The rule will become effective July 15, 2016, unless adverse or critical comments or notice of intent to submit adverse or critical comments are received on or before June 15, 2016, in which case EPA will withdraw the relevant sections of the rule. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

EPA ALJ Denies Bayer’s Motion For Accelerated Decision: On April 25, 2016, EPA Administrative Law Judge (ALJ) Susan L. Biro issued an order denying Petitioners Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI or Petitioners) motion for accelerated decision and deciding that the abbreviated Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) cancellation hearing, rather than the full Section 6(b) process, was appropriate (Order). This decision is significant and, if it stands, could have far-reaching impact on easing EPA’s potential ability to cancel conditionally registered pesticide products. In its Order, the ALJ concludes that FIFRA’s “text, structure, and legislative history and federal court opinions allow for this Section 6(e) proceeding.” Judge Biro states that “Petitioners have cited nothing in the statute or legislative history to suggest that EPA is obliged to use the pre-existing general registration cancellation process under FIFRA Section 6(b) for cancelling general registrations, to cancel conditional registrations.” Judge Biro further notes: “The few cases that Petitioners cite to support their claim that EPA is required to go through a Section 6(b) proceeding to cancel pesticide registrations are all clearly distinguishable from the facts of this case because they involve general registrations, not conditional registrations.” Instead, Judge Biro compared a “conditional registration” to a learner’s permit not entitled to Section 6(b) cancellation proceedings, while unconditional registrations are “entitled to an extended process because EPA previously determined their use, on an indefinite basis, would not cause unreasonable adverse effects on the environment.” More information is available online.

EPA Issues Addendum To National Program Manager Guidance: On April 29, 2016, EPA posted an addendum to its National Program Manager Guidance issued in 2015. The addendum is intended to assist managers as to what chemical and related issues on which they should focus until September 2017. The addendum seems to telegraph a larger role by regional offices in chemical management, perhaps in light of TSCA reform. The addendum and original National Program Manager Guidance for EPA’s chemicals and other agency offices are available online.

EPA Issues Pesticide Tolerance Crop Group Program Amendment IV: On May 3, 2016, EPA issued a final rule amending the current pesticide tolerance crop grouping (Crop Group) regulations. 81 Fed. Reg. 26471. Crop groupings allow petitioners to request a tolerance for multiple related commodities based on research data for one or more representative crops. The final rule is the fourth amendment in a series of planned Crop Group updates begun in December 2007 through collaboration by the U.S. Department of Agriculture’s (USDA) Interregional Research Project Number 4 (IR-4) and the International Crop Groupings Consulting Committee (ICGCC). The rule creates five new Crop Groups, three new and two revised commodity definitions, and revises the regulations on the interaction of Crop Group tolerances with processed food, meat, milk, and egg tolerances. The changes include:

  • Crop Group 22: Stalk, Stem and Leaf Petiole Group: EPA is adding this new Crop Group.
  • Crop Group 23: Tropical and Subtropical Fruit, Edible Peel Group. EPA is adding this new Crop Group.
  • Crop Group 24: Tropical and Subtropical Fruit, Inedible Peel Group. EPA is adding this new Crop Group. EPA has revised several of the subgroup titles from the proposed rule.
  • Crop Group 4-16: Leafy Vegetable Group: EPA is expanding and restructuring this existing Crop Group by both adding and removing commodities. EPA has revised the Crop Group’s name, which was “Crop Group 4-14: Leafy Vegetables (Except Brassica Vegetables)” in the proposed rule.
  • Crop Group 5-16: Head and Stem Brassica Vegetable Group: EPA is revising this existing Crop Group’s name, which was “Crop Group 5-14: Brassica (Cole) Leafy Vegetables” in the proposed rule and has removed commodities and restructured this Crop Group.

EPA’s three prior amendments expanded existing Crop Groups, established new Crop Groups and subgroups, and revised representative crops. These revisions included new oilseeds and edible fungi (mushrooms) Crop Groups and expansions of existing stone fruit and tree nut Crop Groups. EPA’s website provides more information on crop groupings and minor uses. The final rule is effective July 5, 2016.

IRIS Announces Registration To Attend June IRIS Public Science Meeting: EPA’s Integrated Risk Information System (IRIS) Program will host the June IRIS Public Science Meeting on June 29-30, 2016, in Arlington, Virginia. At the meeting, the IRIS Program will provide the public the opportunity to provide input and participate in discussions regarding the draft IRIS Toxicological Review of tert-Butyl Alcohol (TBA) and the potential approaches to estimate the risk of skin cancer following dermal exposure to benzo[a]pyrene. The draft assessment materials for TBA will be released in mid-May. For more information about this assessment and the meeting, visit the June Public Science Meeting website.

EPA Issues Memorandum Regarding Nationally Consistent Approach For Responding To Requests For Certificates Of Establishments And Certificates Of Origins: On May 11, 2016, EPA’s Office of Compliance (OC) and Office of Pesticide Programs (OPP) issued a memorandum to its regional FIFRA Division Directors and Branch Chiefs to establish a joint position of OC and OPP “for how regions should respond to requests for EPA-issued Certificates of Establishment (COEs) and Certificates of Origin (COOs).”

OC and OPP state that the need for a joint position is based on recent requests by exporters to have EPA certify that a specific facility is a registered pesticide producing establishment, or certify that a particular pesticide product was produced at a specific establishment. These certificates are used by exporters to submit to foreign governments that require “?EPA documentation’ prior to allowing registered and unregistered pesticide products into their jurisdictions.”

Under the new national approach, EPA regional offices are to stop issuing COEs or COOs. In the memorandum, OC and OPP state the following three factors in support of this approach:

  • EPA does not believe that FIFRA provides the statutory authority for issuing either a COE or a COO;
  • EPA does not believe that regions have the information necessary to certify the origin of an exported pesticide, registered or unregistered, arriving at a foreign destination; and
  • EPA believes that COE letters, particularly for unregistered pesticides, may be misleading to foreign governments.

More information is available in our blog “EPA Issues Memorandum Regarding Nationally Consistent Approach for Responding to Requests for Certificates of Establishment and Certificates of Origin.”


Environmental Groups Sue To Force Oil And Gas RCRA Regulations: On May 4, 2016, several environmental groups sued EPA to force it to promulgate regulations for oil and gas wastes under the Resource Conservation and Recovery Act (RCRA). The Environmental Integrity Project, the Natural Resources Defense Council, Earthworks, the Center for Health, Environment, and Justice, the West Virginia Citizen Action Group, the Responsible Drilling Alliance, and the San Juan Citizens Alliance filed the suit in the U.S. District Court for the District of Columbia. They claim that EPA has missed nine successive statutory deadlines requiring it to assess whether to craft the regulations for oil and gas wastes under RCRA Subtitle D. The groups contend that RCRA requires EPA to review its regulations for the oil and gas wastes every three years, but EPA has not done so since 1988. In the 1988 regulatory determination EPA concluded that the oil and gas exploration and production (E&P) wastes should be excluded from RCRA hazardous waste regulation. EPA stated, however, that Subtitle D provisions “do not now fully address oil and gas waste concerns.” 53 Fed. Reg. 25456 (July 6, 1988). EPA also determined that it possessed the “authority under Subtitle D to tailor requirements appropriate for the disposal of oil and gas waste.” To rectify these issues, EPA proposed to implement a three-pronged approach toward filling the gaps in existing state and federal programs that regulate the management of wastes from the crude oil and natural gas industries. This approach included (1) working with the states to improve the strength and uniformity of their programs; (2) working with Congress to secure additional statutory authority; and (3) improving federal authorities under the Clean Water Act (CWA), the Safe Drinking Water Act (SDWA), and RCRA Subtitle D for oil and gas wastes. EPA further detailed a plan for how it would revise and tailor RCRA Subtitle D regulations at 40 C.F.R. Part 257 and provide examples of gaps it would address. EPA has not done so, and its failure to take no action in the 28 years since the regulatory determination sparked the suit filed by the environmental groups.


EPA Proposes Amendments To Site Remediation NESHAP: On May 13, 2016, EPA issued a proposed rule to amend the National Emission Standards for Hazardous Air Pollutants (NESHAP) for site remediation activities. 81 Fed. Reg. 29821. EPA is proposing to remove exemptions from the rule for site remediation activities performed under the Comprehensive Environmental, Response, and Compensation Liability Act (CERCLA) and for site remediation activities performed under a RCRA corrective action or other required RCRA order. EPA also proposes to remove the applicability requirement that site remediations be co-located with at least one other stationary source regulated by another NESHAP. EPA is taking comment on the proposed revisions until June 27, 2016.


FDA Announces Public Meeting In Preparation For ICCR Meeting: On April 20, 2016, the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) announced a public meeting would be held on June 15, 2016, to invite public comments on multiple topics related to cosmetics regulations in preparation for the International Cooperation on Cosmetics Regulatory (ICCR) meeting to be held July 12-14, 2016, in Bethesda, Maryland. 81 Fed. Reg. 23308. ICCR is a voluntary international group of regulatory authorities from Brazil, Canada, the European Union (EU), Japan, and the U.S. Registration information, written material, and requests to make an oral presentation to the contact person are due by June 1, 2016.

FDA Extends Comment Period For Request For Scientific Data Related To BSAAO: On April 22, 2016, FDA, as part of ongoing implementation of the Food Safety Modernization Act (FSMA), announced a 60-day extension to the comment period for its risk assessment plan to evaluate the risk of human illness related to the consumption of produce grown in fields treated with raw manure fertilizers or untreated biological soil amendments of animal origin (BSAAO). 81 Fed. Reg. 23733. The risk assessment is being conducted in consultation with USDA. FDA is requesting scientific data and other information, including data on the prevalence and levels of pathogens (i.e., Salmonella, E. coli), and data on the survival and transfer of pathogens to produce, farming and harvesting practices, and storage conditions. The extended comment period ends July 5, 2016.

FDA Recognizes Canada’s Food Safety System: On May 4, 2016, FDA, the Canadian Food Inspection Agency, and the Department of Health Canada signed an agreement, recognizing their food safety systems as being comparable to each other. This agreement allows each partner the ability to work cooperatively on regulatory and scientific issues. FDA indicates that this is the second time a country’s system has been considered comparable, and that other recognition processes are underway.

FDA Schedules Public Meetings On FSMA: On May 9, 2016, FDA announced three one-day public meetings in different regions during the month of June to discuss ongoing FSMA implementation. 81 Fed. Reg. 28035. The three meetings will address the Strategic Implementation of Prevention-Oriented Imported Safety Programs. The intent is to provide importers and other interested parties an opportunity to discuss in detail programs related to improved import safety (i.e., foreign supplier verification programs). The meetings will take place on June 7, 2016, in Costa Mesa, California, June 15, 2016, in Rutherford, New Jersey, and June 21, 2016, in Detroit, Michigan. Registration for the meetings is currently full and the meetings will not be webcast. A recording of the meetings will be made available through the FDA website a few weeks after the meetings have taken place.


SCOEL Discusses Nanomaterials During March Meeting: The European Commission’s (EC) Scientific Committee on Occupational Exposure Limits (SCOEL) met on March 7-9, 2016. The meeting minutes include the following summary regarding SCOEL’s discussion of nanomaterials:

Several chemical agents proposed or envisaged to be addressed by SCOEL do concern or also concern the form as nanomaterial. SCOEL identified a group of scientists to organise a workshop or expert meeting in order to prepare for dealing with the subject in specific and take into account latest state-of-the-art. The lead is with MvT, who will organise the workshop/expert meeting in close collaboration with the Secretariat and the Board.

An update was provided. In view of the enhanced needs for cooperation with [the European Chemicals Agency (ECHA)] and the tight schedule, the nanomaterials and [occupational safety and health] workshop will be planned for 2017.

European Organizations Issue Declaration On Waste Containing Nanomaterials: On April 13, 2016, the Center for International Environmental Law (CIEL), the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institut issued a press release announcing the availability of the Declaration on Waste Containing Nanomaterials. According to the press release, over 80 signatories have endorsed the Declaration, “demonstrating overwhelming support for the demand to categorize waste containing manufactured nanomaterials as hazardous waste.” The Organization for Economic Cooperation and Development’s (OECD) February 2016 report, Nanomaterials in Waste Streams: Current Knowledge on Risks and Impacts, “underpins the Declaration’s call to limit the potential presence of nanotechnology in waste streams.” The Declaration calls for governments, research and innovation funding institutions, and companies to:

  • Implement full producer responsibility to ensure safe management of waste containing manufactured nanomaterials;
  • Restrict transboundary movements of waste containing certain manufactured nanomaterials;
  • Enable transparent quantification and characterization of waste flows containing manufactured nanomaterials through an EU-wide public nano-product registry;
  • Stimulate innovation on waste prevention;
  • Foster the development of safe and effective recycling and disposal technologies for products containing manufactured nanomaterials;
  • Develop and establish verifiable end-of-waste criteria for recyclable materials containing manufactured nanomaterials; and
  • Innovators should explore how advanced properties of manufactured nanomaterials can be employed in support of the circular economy without introducing new environmental risks or aggravating existing ones.

SNWG Submits Comments On NIOSH Draft CIB On Silver Nanomaterials: On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH) draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. According to the draft CIB, “[a]lthough the experimental animal and cellular studies are useful for showing potential risks from exposure to silver nanomaterials, NIOSH considers the currently available data to be too limited to develop a [recommended exposure limit (REL)] for silver that is specific to particle size.” Instead, NIOSH recommends that effective risk management control practices be implemented so that worker exposures to silver nanomaterials do not exceed the NIOSH REL of ten micrograms per cubic meter (μg/m3) (eight-hour time-weighted average) for silver metal dust, fume, and soluble compounds, measured as a total airborne mass concentration. The SNWG states that, in general, it agrees with NIOSH’s recommendation and the evidence upon which the recommendation is based. The SNWG “recognizes the uncertainties that NIOSH has concerning the current data on nanosilver particles, but continues to maintain that the toxicity of nanosilver is not significantly different from bulk or dissolved silver (colloidal silver).” The SNWG states that it “confirms NIOSH’s recommendation that if companies manufacturing and making use of nanosilver particles implement effective risk management control practices so that worker exposures to all forms of silver, including silver nanomaterials,” do not exceed the NIOSH REL for silver metal dust, fume, and soluble compounds measured as a total airborne mass concentration, “their workers will be more than adequately protected from any potential harmful exposures to all forms of silver, including nanosilver.” Regarding the research needs discussed in Section 8 of the draft CIB, the SNWG states that one of its functions is to identify, gather, and consolidate industry data in an anonymous manner to protect confidential business information. If NIOSH needs such a mechanism to obtain any needed data, the SNWG has offered to serve in such a capacity.

EU Nanosafety Cluster Publishes “Closer To The Market” Roadmap: On April 19, 2016, the EU NanoSafety Cluster announced the availability of the “Closer to the Market” Roadmap (CTTM). The NanoSafety Cluster states that the CTTM is a “multi-dimensional, stepwise plan targeting a framework to deliver safe nano-enabled products to the market.” The steps include: (1) building an inclusive collaboration network; (2) bringing together scientific and entrepreneurial experts; (3) strengthening dialog of all stakeholders to raise synergies and exchange safe resources; (4) implementing a novel risk assessment framework supported by regulatory initiatives and implemented by contract research organizations; and (5) building service provider platforms that function as consulting agencies assisting companies to bring their products towards market implementation. According to the CTTM, the first step is underway through a coordination and support action bringing together the nanosafety management platforms and institutes of the EU Member States. The CTTM states that joint calls will be implemented to pool national funding from Member States and third countries (e.g., the U.S.) to finance nanotechnology environmental, health, and safety (nanoEHS) research and market-oriented accompanying measures that are of common interest for the platforms. The timeline is to get the action operational by the end of 2016. The aim is to use this Coordination and Support Action (CSA) to develop further actions. According to the CTTM, the platforms provide services and support for stakeholders (e.g., industry, governments, and researchers) to create in a sustainable way marketable, societal approved products and goods. The CTTM will be part of the NanoSafety Cluster strategic research and innovation agenda that will be launched at the end of 2016.

NGOs Call For Actions, Not Words, From The EC On Nanotechnology: On April 26, 2016, a group of non-governmental organizations (NGO), consumer groups, and research organizations issued a press release expressing “disappointment with the [EC’s] continuing failure to propose adequate measures for the collection and publication of information about nanomaterials on the EU market after a Commission meeting with stakeholders in Brussels on Monday.” The press release criticizes the EC for deciding against an EU-wide nanomaterial registry before completing the impact assessment process. Instead, according to the press release, the EC asked ECHA to develop a nanomaterial observatory as part of its 2015-18 nanomaterials work plan. The press release states that the April 25, 2016, meeting “was supposed to provide more details about this new mechanism, but in reality it provided little hope that the observatory will be able to address the pressing information gaps about nanomaterials on the market.”

Australia Addresses Nanomaterials In Third NICNAS Reforms Consultation Paper: On April 29, 2016, Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial. The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS). Chemicals used in controlled environments, such as contained import/export and research and development (R&D) situations (up to 100 kilograms introduction volume) would be categorized as Exempted. Contained import/export is where a new chemical is imported and then exported without any repackaging or processing (i.e., packaging remains intact). Because the packaging remains unopened and there is negligible exposure to humans or the environment, the consultation paper states that the risk is very low and categorization as an Exempted chemical is appropriate. The proposed definition of R&D excludes commercialization, and according to the consultation paper, these chemicals are used only in controlled environments by trained personnel. R&D facilities are regulated by the Australian State/Territory Work Health and Safety (WHS) regulations. According to the consultation paper, the WHS model adopts a precautionary approach to nanomaterials used in R&D settings, and recommends that safety data sheets (SDS) be provided to workers handling nanomaterials, even if they are not classified as hazardous substances under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Nanomaterials should be labeled as “caution: hazards unknown” or “caution: hazards not fully characterized.” Under the reforms, new chemicals that are nanoforms and do not qualify for the contained import/export or R&D exemption would be categorized within Hazard Bands D or E. Comments are due June 10, 2016. Stakeholder workshops will be held May 16, 2016, and May 18, 2016.

NNCO Holds SME Webinar, Will Hold NanoEHS Webinar: On May 11, 2016, the National Nanotechnology Coordination Office (NNCO) held a webinar for small- and medium-sized enterprises (SME) that will focus on the experiences, successes, and challenges for SMEs working in nanotechnology and on issues of interest to the business community. The National Science Foundation’s Center for High-rate Nanomanufacturing, at Northeastern University’s College of Engineering in Boston, will host the webinar. Speakers include:

  • Marcie Black: Chief Executive Officer (CEO) and co-founder of Advanced Silicon Group (ASG); and
  • Viktor Vejins: President and CEO of Nano-C, Inc.

The speakers began the event by providing an overview of their experiences, successes, and challenges in the nanotechnology small business space.

NNCO will launch its nanoEHS webinar series with a May 18, 2016, webinar, “Applying a Lab Safety Culture to Nanotechnology: Educating the Next Generation of Nanoscientists.” The series is aimed at strategies for safe development and use of nanotechnology along the life cycle of nanomaterials and nanotechnology-enabled products. This first webinar will discuss how an effective culture of safety in the research laboratory facilitates safe and responsible nanomaterial research and supports the National Nanotechnology Initiative (NNI) goal of responsible development. Speakers will include:

  • Charles L. Geraci, Jr.: Associate Director for Nanotechnology and Co-Manager of the Nanotechnology Research Center at NIOSH;
  • Larry Gibbs: Associate Vice Provost for Environmental Health and Safety (EHS) at Stanford University;
  • Craig Merlic: Associate Professor of Chemistry and Executive Director for the University of California, Los Angeles (UCLA) Center for Laboratory Safety; and
  • Lori Seiler: Associate Director for Global Research and Development EHS at Dow Chemical Company.

Questions for the panel can be submitted from now through the end of the webinar at 3:00 p.m. (EDT) on May 18, 2016.

Registration Now Open For 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop: Registration is now open for the June 6-7, 2016, U.S.-EU “Bridging NanoEHS Research Efforts” joint workshop. The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanoEHS research. The goal of the workshop is to publicize progress towards COR goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-COR collaboration. The workshop will also feature a COR-led nanoEHS scrimmage in which the CORs will collectively respond to a hypothetical spill of a nanotechnology-enabled product. The workshop is free and open to the public with registration on a first-come, first-served basis.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to


Senate Passes Energy Policy Bill: The Senate on April 20, 2016, passed broad energy legislation that also includes a number of environmental initiatives. The Energy Policy Modernization Act (S. 2012) passed with overwhelming support by an 85-12 vote. The bill would amend the Energy Conservation and Production Act, the Energy Policy and Conservation Act (EPCA), and the Energy Independence and Security Act of 2007 with respect to energy efficiency in buildings and appliances. It also requires the Department of Energy (DOE) to conduct research, development, engineering, demonstration, and commercial application programs regarding passenger as well as medium- and heavy-duty commercial vehicles and transit vehicles. The bill also would amend the Energy Policy Act of 2005 and other acts regarding hydroelectric power, geothermal energy, marine hydrokinetic renewable energy, biomass, oil and gas, helium, specified critical minerals, coal, nuclear energy, 21st century energy workforce development, and recycled carbon fiber and non-recycled mixed plastics.

House Committee Approves PHMSA Authorization Bill: On April 20, 2016, the House Transportation and Infrastructure Committee unanimously passed a bill reauthorizing the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA). The Protecting our Infrastructure of Pipelines and Enhancing Safety Act of 2016 (H.R. 4937, the PIPES Act) reauthorizes PHMSA for four years, through Fiscal Year 2019. Annual appropriations under the bill for PHMSA average approximately $130 million.

Legislation Seeks To Extend EPA Clean Diesel Grant Program: On April 19, 2016, Senators Jim Inhofe (R-OK), Tom Carper (D-DE), Barbara Boxer (D-CA), and Shelley Moore Capito (R-WV) introduced bipartisan legislation seeking to extend EPA’s Diesel Emissions Reduction Act grant program. The program is currently set to expire in 2016. The Diesel Emission Reduction Act (S. 2816) would extend the program through 2021. EPA administers the grants under the program to provide funding for engine upgrades, installation of pollution controls, and replacement of older, higher emitting diesel vehicles.

House Passes Bill Expanding Liability For Offshore Oil Releases: The House of Representatives on April 26, 2016, passed the Foreign Spill Protection Act (H.R. 1684). The bill amends the Oil Pollution Act of 1990 to make the owner or operator of a foreign offshore unit liable for removal costs and specified damages that result from a discharge, or substantial threat of discharge, of oil that reaches or threatens to reach U.S. navigable waters or adjoining shorelines, or the exclusive economic zone. The bill defines a “foreign offshore unit” as a facility that is located in the territorial sea or on the continental shelf of a foreign country that is used for oil exploration, drilling, production, or related activities. The bill also amends the CWA to prohibit the discharge of oil from a foreign offshore unit that reaches the navigable waters of the United States, adjoining shorelines, or waters of the contiguous zone, and subjects the owner or operator of the unit to penalties under the CWA.

House Passes Great Lakes Restoration Initiative Act: The House on April 26, 2016, passed legislation that reauthorizes EPA’s Great Lakes Restoration Initiative (GLRI). The Great Lakes Restoration Initiative Act (H.R. 223) would authorize the appropriation of $1.5 billion between 2017 and 2021 for the GLRI. The bill provides funding for the remediation of toxic substances and areas of concern; the prevention and control of invasive species and their impacts; the protection and restoration of near-shore health and the prevention and mitigation of nonpoint source pollution; and habitat and wildlife protection and restoration.

House Committee Passes Bipartisan Pipeline Safety Bill: On April 27. 2016, the House Energy and Commerce Committee passed a bill that authorizes DOT’s PHMSA and seeks to strengthen pipeline safety. Culminating months of bipartisan work to identify weaknesses in pipeline safety, the Committee unanimously passed the Pipeline Safety Act of 2016. The legislation contains targeted mandates for PHMSA to increase transparency and accountability, complete overdue regulations, and improve pipeline safety. The bill also tightens provisions allowing PHMSA to issue emergency orders. The bill provides that if PHMSA determines that an issue is causing an imminent hazard, it may issue an emergency order imposing restrictions, prohibitions, and safety measures without prior notice or an opportunity for a hearing.

Senators Boxer, Durbin Introduce Climate Change Bill: Senators Barbara Boxer (D-CA) and Richard Durbin (D-IL) on April 27, 2016, introduced legislation that would authorize up to $200 million in “Climate Change Bonds.” The Climate Change Adapt America Bond Act (S. 2680) would also establish the Climate Change Advisory Commission to develop recommendations, frameworks, and guidelines for projects to respond to the impacts of climate change and to issue the bonds. The legislation is modeled after successful War Bonds programs implemented by the U.S. during World War II. Revenue from the bonds would go into a newly created “Adapt America Fund.” States, municipalities, and other public entities would apply to the fund to finance climate change adaptation and infrastructure resilience projects.

House Bill Would Lower Lead Action Level: A bill introduced in the House on April 28, 2016, would lower the federal drinking water standard for lead in tap water. Introduced by Representative Dan Kildee (D-MI), the Protecting Families from Lead Act of 2016 (H.R. 5110) would amend SDWA Section 1412(b) to require EPA to lower the national primary drinking water for lead to 10 parts per billion (ppb) by the end of 2020, and to 5 ppb by the end of 2026.

Senate Passes Bill Strengthening Standards For Crude Oil Transported By Rail: The Senate on May 9, 2016, passed by unanimous consent legislation that would strengthen emergency response requirements for crude oil transported by rail. Introduced by Senator Heidi Heitkamp (D-ND), the RESPONSE Act of 2015 (S. 546) would amend the Homeland Security Act of 2002 to direct the Federal Emergency Management Agency (FEMA) to establish the Railroad Emergency Services Preparedness, Operational Needs, and Safety Evaluation (RESPONSE) Subcommittee under the National Advisory Council. The RESPONSE Subcommittee will be tasked with developing recommendations for improving emergency responder training and resource allocation for hazardous materials (hazmat) incidents involving railroads. The RESPONSE Subcommittee will evaluate the quality and application of training for local emergency first responders related to rail hazmat incidents, with a particular focus on local emergency responders and small communities near railroads. Also under its purview is the effectiveness of funding levels related to training local emergency responders for rail hazmat incidents, with a particular focus on local emergency responders and small communities. The Subcommittee must also develop a strategy for the integration of commodity flow studies, mapping, and access platforms for local emergency responders and how to increase the rate of access to the individual responder in existing or emerging communications technology. In addition, the bill would require the Subcommittee to consider the need for emergency response plans for rail, similar to existing law related to maritime and stationary facility emergency hazmat response plans, and the need for a rail hazmat incident database.

House Subcommittee Approves Legislation Delaying New Ozone NAAQS: On May 12, 2016, the House Energy and Commerce Subcommittee on Energy and Power approved legislation that would delay implementation of the revised ozone national ambient air quality standard (NAAQS). The Ozone Standards Implementation Act of 2016 (H.R. 4775) would delay for eight years the implementation of the 2015 ozone NAAQS, which EPA set at 70 ppb. The legislation would also extend EPA’s period for reviewing NAAQS from every five years to every ten years.


OSHA Issues Final Rule To Improve Tracking Of Workplace Injuries And Illnesses: On May 12, 2016, the Occupational Safety and Health Administration (OSHA) issued a final rule to revise its Recording and Reporting Occupational Injuries and Illnesses regulation. 81 Fed. Reg. 29624. The final rule requires employers in certain industries to submit electronically to OSHA injury and illness data that employers are already required to keep under existing OSHA regulations. The frequency and content of these establishment-specific submissions is set out in the final rule and is dependent on the size and industry of the employer. OSHA intends to post the data from these submissions on a publicly accessible website. OSHA does not intend to post any information on the website that could be used to identify individual employees. The final rule also amends OSHA’s recordkeeping regulation to update requirements on how employers inform employees to report work-related injuries and illnesses to their employer. The final rule requires employers to inform employees of their right to report work-related injuries and illnesses free from retaliation; clarifies the existing implicit requirement that an employer’s procedure for reporting work-related injuries and illnesses must be reasonable and not deter or discourage employees from reporting; and incorporates the existing statutory prohibition on retaliating against employees for reporting work-related injuries or illnesses. The final rule also amends OSHA’s existing recordkeeping regulation to clarify the rights of employees and their representatives to access the injury and illness records. The final rule will become effective on January 1, 2017, except for 29 C.F.R. §§ 1904.35 and 1904.36, which will become effective on August 10, 2016.

Ninth Circuit Affirms District Court’s Dismissal In Environmental Justice Case Seeking Judicial Review Of EPA’s Decision To Settle CDPR Complaint: On May 11, 2016, the U.S. Court of Appeals for the Ninth Circuit issued an unpublished memorandum decision in an environmental justice case, Garcia v. McCarthy, Case No. 14-15494, that many have been watching closely. The Ninth Circuit affirmed a decision by the U.S. District Court dismissing the Plaintiffs’ Complaint for lack of subject matter jurisdiction. The District Court case involved an effort by the original complainants (parents of Latino school children) to obtain judicial review of a decision by EPA, to enter into a voluntary compliance agreement with the California Department of Pesticide Regulation (CDPR). The original administrative complaint filed in 1999 alleged that CDPR “authorized the use of methyl bromide and other pesticides in a fashion that had a disproportionately harmful effect on Latino school children in violation of Title VI.” Although EPA made an initial finding of a prima facie violation of Title VI, Plaintiffs asserted that EPA did not inform the complainants of the status of their complaint while the matter was being investigated and did not allow them to participate in settlement negotiations. More information is available in our blog “Ninth Circuit Affirms District Court’s Dismissal in Environmental Justice Case Seeking Judicial Review of EPA’s Decision to Settle CDPR Complaint.”

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