Federal Development Update for December 2017

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.


Deadline Approaching For Comments On EPA’s Proposed Reporting Requirements For TSCA Mercury Inventory: As reported in our TSCAblog® item, on October 26, 2017, the U.S. Environmental Protection Agency (EPA) proposed triennial electronic reporting requirements pertinent to the supply, use, and trade of mercury in the United States. 82 Fed. Reg. 49564. The 2016 amendments to the Toxic Substances Control Act (TSCA) require EPA to establish periodic mercury reporting requirements for any person that manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process to assist in the development of an inventory of mercury and other recommended actions. These other actions reportedly include potentially revising federal law or regulations to achieve further reductions in mercury use. Under the proposed rule, EPA proposes to require reporting on the manufacture, import, distribution in commerce, storage, and export of mercury. EPA is directed by new TSCA to refrain from requiring reporting related to the generation, handling, or management of mercury-containing waste, unless mercury is recovered in the management of such waste. The proposed rule aims to narrow data gaps and limitations encountered in EPA’s historic reliance on publicly available data on the mercury market in the United States. Additionally, the information provided under the proposed rule would be used by the U.S. government to assist in its implementation of the Minamata Convention, a multilateral environmental agreement that addresses the supply, use, and trade in mercury. Comments on the proposal are due by December 26, 2017.

EPA Issues Determination On Small Manufacturers Under TSCA Section 8: On November 30, 2017, EPA issued a notice of its final determination on whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under TSCA Section 8(a), is warranted. 82 Fed. Reg. 56824. The notice states that EPA has made its final determination that revision is warranted based upon several factors. EPA states in the notice that it preliminarily determined that a revision to the size standards is warranted “[​b]ecause of the magnitude of the increase in the [Producer Price Index (PPI)] since the last revision of the size standards and because the current annual sales standard is comparatively low given current revenue-based size standards developed by [the Small Business Administration (SBA)].” When EPA reviewed the change in the PPI for Chemicals and Allied Products between 1988 and 2015, it found that the PPI has changed by 129 percent, which far exceeds the 20 percent inflation index specified as a level above which EPA may adjust annual sales levels in the current standard if deemed necessary.

EPA also based its determination on a review of the comments on the preliminary determination. EPA states that most commenters agreed with its preliminary determination that an update is warranted and several also provided their opinions on how the standards should be revised. EPA states the actual changes to the standards were out of the scope of this determination, but it will address those issues in the subsequent proposed rulemaking.

Finally, EPA relied upon feedback from consultation with the SBA. SBA’s Office of Advocacy substantively agreed with EPA’s preliminary determination (that a revision to the current size standards is warranted), but it had requested EPA to consider additional factors in reaching that conclusion, which EPA did not. Specifically, the SBA wanted EPA to consider whether the standard is structured appropriately, and wanted EPA to evaluate a broader set of factors related to firm and industry characteristics and percentage of firms impacted by Section 8 rules. More information on these standards is available in our blog item under key phrase size standards.

EPA Extends Comments On Use Information Of PBT Chemicals: EPA issued a memorandum dated December 4, 2017, extending the comment deadline to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals (the memorandum is posted in each docket). EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals. These five chemicals were selected on October 11, 2016, to receive expedited action under TSCA Section 6(h) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals. The five chemicals and their corresponding dockets are:

In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents that provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical. Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed. More information on the PBTs is available on our blog under keyword PBTs. The deadline to submit comments is now January 12, 2018.

EPA Withdraws Direct Final Rule On Formaldehyde Emission Standards For Composite Wood Products: On December 8, 2017, EPA withdrew its direct final rule published on October 25, 2017, to update the voluntary consensus standards that originally were published under the TSCA Title VI formaldehyde emission standards for composite wood products final rule on December 16, 2016. 82 Fed. Reg. 57874. In the direct final rule and proposed rule, EPA amended the testing requirements for panel producers and third-party certifiers establishing correlation between approved quality control test methods and either the ASTM E1333-14 test chamber, or, upon showing equivalence, the ASTM D6007-14 test chamber. As noted in the direct final rule, if EPA received adverse comment on the proposed amendments, EPA would publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the direct action will not take effect. EPA received adverse comment on the proposed rule amendments, and is therefore withdrawing the direct final rule and will instead proceed with a final rule based on the proposed rule after considering all public comments.


“Waters Of The U.S.” (WOTUS) Developments: Two-Step Rulemaking Now Has A “Step Zero”: On November 22, 2017, EPA and the U.S. Army Corps of Engineers (Corps) issued a proposal to add an applicability date to the 2015 Clean Water Rule (CWR) entitled “Definition of ‘Waters of the United States’ – Addition of an Applicability Date to 2015 [CWR]” (Proposed Rule or Step Zero) in the Federal Register. 82 Fed. Reg. 55542. The Proposed Rule complements the EPA/Corps ongoing two-step rulemaking process to rescind and replace the CWR, which re-defined WOTUS for the purposes of clarifying the boundaries of Clean Water Act (CWA) jurisdiction over the nation’s rivers, streams, and wetlands.

The U.S. Court of Appeals for the Sixth Circuit stayed implementation of the CWR nationwide shortly after it went into effect in late 2015, however, the CWR regulatory text currently remains in the Code of Federal Regulations (C.F.R.) pending final action on the proposed rescission and replacement with the pre-existing WOTUS definition language (Step One). With Step Zero, EPA/Corps aim to “maintain the legal status quo and thus provide continuity and certainty for regulated entities, the States and Tribes, agency staff, and the public.” The Proposed Rule would not create any new regulatory obligations; rather it would amend the text of the C.F.R. to add an applicability date two years from the date of final action on this proposal. The brief comment period for the Proposed Rule closed on December 13, 2017.

In pursuing this additional regulatory step, EPA/Corps are aiming to circumvent potential regulatory confusion and legal workload that would ensue if the U.S. Supreme Court invalidates the Sixth Circuit’s jurisdiction in the CWR litigation, which would have the effect of lifting the current nationwide stay. The parties’ venue dispute turns on the Court’s interpretation on CWA Section 509(b), which sets forth the circumstances where CWA challenges should be brought directly to the U.S. Courts of Appeal. The Court heard oral arguments on October 11, 2017, and is expected to issue its ruling in late 2017/early 2018. More background on the CWR and the two-step rulemaking is available in this Bergeson & Campbell, P.C. (B&C®) blog post.

EPA Withdraws CERCLA Hardrock Mining Rule: On December 1, 2017, EPA announced that it will not issue final regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) for certain hardrock mining facilities. “After careful analysis of public comments, the statutory authority, and the record for this rulemaking, EPA is confident that modern industry practices, along with existing state and federal requirements address risks from operating hardrock mining facilities,” stated EPA Administrator Scott Pruitt. “Additional financial assurance requirements are unnecessary and would impose an undue burden on this important sector of the American economy and rural America, where most of these mining jobs are based,” he added. EPA proposed regulations under CERCLA Section 108(b) on January 11, 2017. 82 Fed. Reg. 3388. EPA stated that it has decided not to issue final regulations because the risks associated with these facilities’ operations are addressed by existing federal and state programs and industry practices. EPA was under a court-ordered deadline to take final action on this rulemaking by December 1, 2017.

EPA Releases List Of Superfund Sites Requiring “Immediate And Intense Attention”: EPA on December 8, 2017, released a list of 21 Superfund and other hazardous waste sites that will require "immediate and intense attention." The list includes sites in all ten EPA regions and was created in response to the Superfund Task Force Recommendations, issued this summer. In developing this initial list, EPA considered sites that can benefit from Administrator Pruitt’s direct engagement and have identifiable actions to protect human health and the environment. These are sites requiring timely resolution of specific issues to expedite cleanup and redevelopment efforts. The list is designed to spur action at sites where opportunities exist to act quickly and comprehensively. The list is also intended to be dynamic. Sites will move on and off the list as appropriate. At times, there may be more or fewer sites based on where the Administrator’s attention and focus is most needed. There is no commitment of additional funding associated with a site’s inclusion on the list. The list is available online. EPA also issued a question and answer document accompanying the list.

EPA Issues Final Volume Requirements Under RFS: On December 12, 2017, EPA issued a final rule establishing volume requirements under the Clean Air Act’s (CAA) Renewable Fuel Standard (RFS) program for 2018 for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel, and biomass-based diesel for 2019. 82 Fed. Reg. 58486. The final volume requirements are listed in the table below.

Final Volume Requirementsa




Cellulosic biofuel (million gallons)



Biomass-based diesel (billion gallons)



Advanced biofuel (billion gallons)



Renewable fuel (billion gallons)



a All values are ethanol-equivalent on an energy content basis, except for BBD which is biodiesel-equivalent.

b The 2018 BBD volume requirement was established in the 2017 final rule, (81 FR 89746; December 12, 2016).

The final rule is effective on February 12, 2018.

EPA Releases Science Assessment For Sulfur Oxides NAAQS: EPA on December 13, 2017, announced the availability of a final document titled “Integrated Science Assessment for Sulfur Oxides -- Health Criteria.” 82 fed. Reg. 58600. The document was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur oxides. This Integrated Science Assessment (ISA) provides a comprehensive review, synthesis, and evaluation of the most policy-relevant science to serve as the scientific foundation for EPA's review of the current primary NAAQS for sulfur oxides. The document is available online.

EPA Offers Free Workshop On Hazardous Waste Generator Improvements Rule: EPA’s Office of Resource Conservation and Recovery (ORCR) will hold a full-day workshop on the 2016 Hazardous Waste Generator Improvements Final Rule. The workshop will be held on Wednesday, February 7, 2018, in Arlington, VA, from 8:30 to 3:00 p.m. It is free for all participants. Registration is available online. The workshop will cover all the major provisions of the rule, looking at regulatory text and common implementation questions that have come up since the rule was issued in final. Specifically, the training examines provisions changed by the rule for hazardous waste determinations, counting hazardous waste, marking and labeling, episodic generation, very small quantity generator (VSQG) waste consolidation at large quantity generators (LQG), satellite accumulation areas, emergency planning and preparedness, closure, recordkeeping, and reporting using the updated site identification form. The workshop will be held at EPA's Conference Center in the Potomac Yard building in Arlington, VA. If there is sufficient interest in this training, EPA stated that it will look into offering another in the DC Metro area at a later date.


FDA Releases Draft Guidance On Best Practices For Convening A GRAS Panel: On November 16, 2017, the U.S. Food and Drug Administration (FDA) announced that it was releasing a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel.” 82 Fed. Reg. 53433. FDA states that the draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to evaluate independently whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. To ensure that all comments on this draft guidance are considered before it issues the final version of the guidance, FDA is requesting comments by May 15, 2018; for comments related to the collection of information provisions in the draft guidance, FDA is requesting comments by January 16, 2018.

FDA Releases Small Entity Compliance Guide For FSMA Sanitary Transportation Rule: On November 22, 2017, FDA announced that it was releasing a guidance for industry entitled “Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation -- Small Entity Compliance Guide.” 82 Fed. Reg. 55503. FDA states this Small Entity Compliance Guide (SECG) will assist small businesses understand the requirements of the Final Rule on the Sanitary Transportation of Human and Animal Food (Sanitary Transportation Rule) promulgated under the Food Safety Modernization Act (FSMA). In the guide, shippers, loaders, carriers, and receivers covered by the Sanitary Transportation Rule will find descriptions of the rule requirements in an easy-to-read question and answer format that includes information on topics such as training and recordkeeping. FDA is accepting comments on the guidance. Small businesses have until April 6, 2018, to comply with the Sanitary Transportation Rule.

FDA Working To Address Concerns About Regulation Of Human Food By-products Used For Animal Food: On November 27, 2017, FDA announced its desire to work with industry to address concerns about the regulation of human food by-products used for animal food, and that it is considering approaches that balance practical and public health considerations. FDA’s Frequently Asked Questions on the FSMA web page states this question (PC.20 under the Preventive Controls Rules: Human Food and Animal Food tab): “Do the preventive controls requirements apply to human food by-products for use in animal food that are dried, frozen or slightly modified specifically to facilitate storage and transportation?” In response, FDA states that several sectors of the food industry “have expressed concern about having to meet preventive controls requirements for certain other activities performed on their human food by-product and have asked that FDA consider streamlining the requirements for other activities that are also commonly performed to facilitate the storage and transportation of their by-products, including commingling ingredients, evaporating, chopping, mechanical mixing, pressing, trimming and washing.” Further, FDA “takes these concerns seriously and understands the practical value of these activities in preparing human food by-products for storage and transportation,” “recognize[s] the need to balance how these requirements impact current industry practices and the need to protect human and animal health,” and is “committed to working with industry to address these concerns, and are considering approaches that balance practical and public health considerations.” FDA states that it will not be “conducting routine regulatory inspections of compliance with the animal food preventive controls requirements until the fall of 2018,” and this delay in routine regulatory inspections “includes inspection of human food by-products that are further processed and required to comply with the animal food preventive control requirements.”

FDA Creates Produce Safety Network To Support Implementation Of Produce Safety Rule: On December 6, 2017, FDA announced the establishment of the Produce Safety Network (PSN). The PSN is intended to support the efforts of farmers, state regulators, and other key stakeholders to implement the FSMA final rule on produce safety, which is aimed at preventing foodborne illnesses associated with produce. The PSN establishes regionally-based policy and regulatory experts throughout the country, making them uniquely suited to address the issues specific to the states they are supporting and places these experts, from two very different FDA offices, within one team. The network combines the regulatory expertise from the FDA’s Office of Regulatory Affairs (ORA) with the policy and science expertise from FDA’s Center for Food Safety and Applied Nutrition (CFSAN). More information on the PSN is available on FDA’s website.

IFSAC Issues Paper On Categorization Of Foods Linked To Foodborne Disease Outbreaks: On December 8, 2017, FDA issued a Constituent Update in which it announced that new research from scientists with the Interagency Food Safety Analytics Collaboration (IFSAC) (a collaboration between FDA, the Centers for Disease Control and Prevention (CDC), and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA)) on how to categorize foods linked to foodborne disease outbreaks was recently published in a paper in the journal Foodborne Pathogens and Disease: “An Updated Scheme for Categorizing Foods Implicated in Foodborne Disease Outbreaks: A Tri-Agency Collaboration.” FDA states that this paper updates previous food categories used by CDC and has five levels with subcategories at each level, for a total of 234 food categories. Highlights of the IFSAC food categorization scheme include:

  • Close alignment with the food product definitions used by FDA and FSIS for regulatory purposes;
  • Separation of aquatic animals, land animals, and plant foods into increasingly specific animal or botanical food categories; and
  • Separation of foods based on food processing, preparation, and consumption type.

FDA Releases Draft Guidance On Refusal Of Inspection By A Foreign Food Establishment Or Foreign Government: On December 12, 2017, FDA released a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” 82 Fed. Reg. 58410. FDA states that this draft guidance, when issued in final, will “provide information for foreign food establishments subject to [its] inspection, as well as foreign governments, on when [it] may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by [FDA] as provided in the [FFDCA].” To ensure that all comments on this draft guidance are considered before it issues the final version of the guidance, FDA is requesting comments by February 26, 2018.


EC Posts Comments Received On Draft Regulation To Amend REACH Annexes To Address Nanomaterials: As reported in our October 11, 2017, blog item, on October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances. Comments were due November 6, 2017. The EC has posted the comments online. In all, 36 comments were submitted. The comments received fall into the following categories: business associations; public authorities; non-governmental organizations; company/business organizations; environmental organizations; academic/research institutions; and other.

EC Publishes Report On Ecosystem To Accelerate Uptake Of Innovation In Materials Technology: In October 2017, the EC Directorate-General for Research and Innovation published a report entitled An ecosystem to accelerate the uptake of innovation in materials technology: Report by the High Level Group of EU Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials. The High Level Group of European Union (EU) Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials examined the barriers and obstacles that need to be addressed to accelerate the industrial uptake of nanotechnologies and advanced materials. It agreed on a list of potential actions that the EU Member States and associated countries may carry out in four key areas for upscaling: characterization, modeling translation, pilots, and safety.

Germany Publishes Report On Relationship Of Nanomaterial’s Physical-Chemical Properties And Aquatic Toxicity For The Purpose Of Grouping: Germany’s Federal Environment Agency (UBA) published a November 2017 report entitled Considerations about the relationship of nanomaterial’s physical-chemical properties and aquatic toxicity for the purpose of grouping. The project objective was to correlate physical-chemical data with ecotoxicological effects for selected nanomaterials and to define reference values that can serve as a basis for grouping. The report presents the development of concepts for the grouping of nanomaterials with regard to their ecotoxicological effects, focusing on aquatic ecotoxicity.

INRS 2016/2017 Brochure Includes Studies In Progress Concerning Manufactured Nanomaterials: On November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in 2017. In 2016, INRS completed a study entitled “Impact of sources and of the environment on confinement of nanoparticulate pollutants by collective protective equipment.” The objective of the study was to develop the tools necessary for assessing the effectiveness of collective protection systems, based on ventilation, for protecting people from nanoparticle aerosols. According to INRS, the results made it possible to identify the main nanomaterial aerosol sources present in ventilated enclosures.

ISO Publishes Standard On Aquatic Toxicity Assessment Of Manufactured Nanomaterials In Saltwater Lakes: In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies -- Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii.” ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp. nauplius. ISO states that ISO/TS 20787:2017 is applicable to manufactured nanomaterials that consist of nano-objects such as nanoparticles, nanopowders, nanofibers, nanotubes, and nanowires, as well as aggregates and agglomerates of such manufactured nanomaterials.

NNI Publishes Supplement To President’s 2018 Budget Request: On November 30, 2017, the National Nanotechnology Initiative (NNI) published a supplement to the President’s 2018 budget. The supplement also serves as NNI’s annual report and summarizes the progress made in achieving NNI’s goals, the research and development (R&D) activities and plans of the participating agencies, and the agency investments in each program component area. The President’s 2018 Budget requests $1.2 billion for the NNI, “a continued investment in support of innovation promoting America’s competitiveness, economic growth, and national security.” The NNI investments proposed for 2018 reflect an emphasis on broad, fundamental research in nanoscience to provide a continuing pipeline of new discoveries that will enable future transformative commercial products and services.

RIVM Takes Critical Look At EUON: The Dutch National Institute for Public Health and the Environment (RIVM) published a brochure entitled “The European Union Observatory for Nanomaterials: A step forward?” on November 30, 2017. While the EUON collects the available information in one central location, the quality of the information is also important. RIVM states that one of the sources of information is REACH, but notes that “this risk assessment framework is not yet sufficiently suitable for nanomaterials.” In addition, according to RIVM, the information is limited to broad categories of products and articles, and brand names are not specified. RIVM concludes that “it will remain difficult for consumers, as well as others, to judge whether they are actually using a ‘nanoproduct’ and what the potential health consequences are of such use. Accordingly, even though the EUON maintains a separate web portal for consumers, it appears most relevant for experts, competent authorities, and industry.”

Presentations Available From ECHA Webinar On REACH Guidance For Nanomaterials: On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their REACH registration dossier. The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment. ECHA has posted the presentations from the webinar.

UBA Report Summarizes Work To Develop New OECD Test Guideline On Dispersion Stability Of Nanomaterials: In December 2017, UBA published a report entitled Clarification of methodical questions regarding the investigation of nanomaterials in the environment: Development of a decision support tool for the investigation of nanomaterial’s environmental behaviour based on dispersion behaviour and dissolution in relation to various environmental parameters. The aim of the project was to develop a standardized test method to determine dispersibility and dispersion stability of nanomaterials in simulated environmental media as a new Organization for Economic Cooperation and Development (OECD) Test Guideline. The test method developed was submitted to OECD by UBA and published by OECD in October 2017 as a new “Test Guideline on dispersion stability of nanomaterials in simulated environmental media (OECD No. 318).” The final report describes the considerations, experimental approaches, and obtained results that build the basis for the new OECD Test Guideline.

Sweden Announces Product Registration Requirement For Nanomaterials: On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products. The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will be due in February 2019. As reported in our June 13, 2017, blog item, on June 7, 2017, Sweden notified the draft regulation to the EC. Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the product, regardless of the concentration of the nanomaterials. The definition of nanomaterial will reflect the EC’s recommended definition, except that nanomaterials that are natural or incidental shall not be notified to the product register. Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million.

WHO Publishes Guidelines On Protecting Workers From Potential Risks Of Manufactured Nanomaterials: In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials. The Guideline Development Group (GDG) used a precautionary approach as one of its guiding principles, as well as the hierarchy of controls. The recommendations include:

  • Assess health hazard of manufactured nanomaterials;
  • Assess exposure to manufactured nanomaterials; and
  • Control exposure to manufactured nanomaterials.

The GDG states that it cannot make a recommendation for targeted manufactured nanomaterial-specific health surveillance programs over existing health surveillance programs that are already in use owing to the lack of evidence. According to the Guideline, the GDG considers training workers and worker involvement in health and safety issues to be best practice, but cannot recommend one form of training of workers over another, or one form of worker involvement over another, owing to the lack of studies available. The Guideline states: “It is expected that there will be considerable progress in validated measurement methods and risk assessment. Therefore, the GDG proposes to update these guidelines in five years’ time, in 2022.”


BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), 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 http://www.braginfo.org.


Senate EPW Committee Approves CEQ And EPA Leadership Nominations: On November 29, 2017, the Senate Environment and Public Works (EPW) Committee approved the nomination of Kathleen Hartnett White to serve as Director of the Council on Environmental Quality (CEQ). The Committee also approved the nomination of Andrew Wheeler as Deputy Administrator of EPA. Both votes were along party lines (11-10). White currently serves as Distinguished Senior Fellow for energy and the environment at the Texas Public Policy Foundation (TPPF). From 2001 to 2007, Wheeler was Chairwoman and Commissioner of the Texas Commission on Environmental Quality (TCEQ). White also served as a Director of the Lower Colorado River Authority, the Texas Water Development Board, the Environmental Flows Advisory Group, the Texas Strategic Economic Development Planning Commission, and the Texas Emissions Reduction Advisory Board. Wheeler is a principal and the head of the energy and the environment team at Faegre Baker Daniels Consulting. Wheeler co-chairs the energy and natural resources industry team within the law firm. Prior to joining Faegre Baker Daniels, Wheeler worked at the U.S. Senate EPW Committee for 14 years serving in various roles, including as the Majority and Minority Staff Director and Chief Counsel. Wheeler started his career at EPA as a Special Assistant in the Toxics Office where he received three bronze medals. Wheeler has a B.A. from Case Western Reserve University, a J.D. from Washington University in St. Louis, and an M.B.A. from George Mason University.

House Passes Bill Reauthorizing And Amending Brownfields Program: On November 30, 2017, the House overwhelmingly approved a bill toreauthorize the CERCLA brownfields program. By a vote of 409-8, the House approved the Brownfields Enhancement, Economic Redevelopment, and Reauthorization Act of 2017 (H.R. 3017). This is the first time in 15 years that lawmakers have reauthorized the brownfields program. The bill is an amalgam of H.R. 3017, introduced by Representative David McKinley (R-WV), and H.R. 1758, introduced by Representative Elizabeth Esty (D-CT). The bill provides $200 million in funding for the program for fiscal years (FY) 2017 through 2021 under CERCLA Section 104(k). It also authorizes $50 million for state response grants at current levels for FY 2017 through 2021 under Section 128(a) of CERCLA. The bill amends the definition of “owner or operator” in Section 101(20)(D) of CERCLA by removing the term “involuntarily.” This means that a unit of state or local government that acquires ownership or control involuntarily is not an “owner or operator” under CERCLA. The bill also makes a conforming change in the definition of “contractual relationship” in CERCLA Section 101(35)(D). The bill seeks to enhance redevelopment of petroleum brownfield sites. It seeks to do so by amending the definition of “brownfield site” in CERCLA Section 101(39)(D) to clarify that a petroleum site is eligible to be a brownfield site if there is no viable responsible party and if EPA or the state determine that the site will be assessed and remediated by a person who is not potentially liable to clean up the site. The bill clarifies the existing definition of a “bona fide prospective purchaser” in Section 101(40) of CERCLA with respect to a tenant or person who holds a lease hold interest, but who otherwise meets the requirements to be a bona fide prospective purchaser. Expanded eligibility for nonprofit organizations is also included in the bill. It clarifies that certain non-profit entities 501(c)(3) organizations, limited liability corporations and limited liability partnerships (the members of which are non-profit organizations), and qualified community development entities are “eligible entities” under CERCLA Section 104(k)(1).

House Energy And Commerce Committee Approves Seven Energy And Environmental Bills: The House Energy and Commerce Committee on December 6, 2017, advanced seven environmental and energy bills. The Committee approved: H.R. 1733, which would require the Department of Energy to review and update a report and submit to Congress a coordinated federal strategy to increase the beneficial reuse of use lubricating oil; H.R. 2872, a bill that would promote hydropower development at existing non-powered dams by providing the Federal Energy Regulatory Commission (FERC) with the discretion to grant exemptions from license requirements for qualifying facilities; H.R. 2880, a bill that would promote closed-loop pumped storage hydropower development by limiting FERC’s authority to only impose licensing conditions that are necessary to protect public safety, or are reasonable, economically feasible, and essential to protect fish and wildlife resources; H.R. 350, which would clarify that the anti-tampering provisions applicable to motor vehicles do not apply to vehicles used solely for competition; H.R. 453, a bill to extend the deadlines for the second phase of new source performance standards for new residential wood heaters; H.R. 1119, a bill to provide alternative compliance options with the Cross-State Air Pollution Rule and Mercury and Air Toxic Standards for coal refuse-to-energy plants; and H.R. 1917, which would extend the deadlines for the National Emission Standards for Hazardous Air Pollutants for brick and structural clay products manufacturing or clay ceramics manufacturing. The extension would last until judicial reviews of the rules are completed.

Senate Committee Holds Hearing On Superfund Program: On December 6, 2017, the Senate EPW Subcommittee on Superfund, Waste Management, and Regulatory Oversight concluded a hearing to examine challenges facing Superfund and waste cleanup efforts following natural disasters. The Committee received testimony from Bryan W. Shaw, TCEQ Chairman, Austin; Matthew Rodriquez, California Environmental Protection Agency Secretary, Sacramento; and Tracy Hester, University of Houston Law Center, Houston, Texas. Committee member statements, witness testimony, and a webcast of the hearing are available online.

Senate Approves Susan Bodine As EPA Assistant Administrator For Enforcement: The Senate on December 7, 2017, by voice vote approved Susan Parker Bodine to be the Assistant Administrator of EPA’s Office of Enforcement and Compliance Assurance. Ms. Bodine is Chief Counsel for the Senate Committee on EPW, a position she has held since January 2015. Ms. Bodine’s nearly 29 years of environmental law experience includes both government service and private practice. Ms. Bodine served in the George W. Bush Administration as the Assistant Administrator of EPA’s Office of Solid Waste and Emergency Response. Prior to that, Ms. Bodine was Staff Director and Counsel for the Subcommittee on Water Resources and Environment of the House Committee on Transportation and Infrastructure. She also was an associate at Covington & Burling and a partner at Barnes & Thornburg. Ms. Bodine’s undergraduate degree is from Princeton University and her law degree is from the University of Pennsylvania School of Law.

Senate Committee Approves Nomination Of Scott Mugno To Head OSHA: The Senate Health, Education, Labor, and Pensions Committee on December 13, 2017, approved the nomination of Scott Mugno to be Assistant Secretary of Labor for the Occupational Safety and Health Administration (OSHA).Mr. Mugno is currently the Vice President for Safety, Sustainability and Vehicle Maintenance at FedEx Ground and also served as the Managing Director for FedEx Express Corporate Safety, Health and Fire Protection. Mungo’s responsibilities in both those positions included developing, promoting, and facilitating the safety and health program and culture. Mugno was twice awarded FedEx’s highest honor for his safety leadership at FedEx Express. Prior to FedEx, Mugno was a Division Counsel at Westinghouse Electric Corporation’s Waste Isolation Division and Deputy Staff Judge Advocate for the Eastern Region U.S. Army Military Traffic Management Command. Mungo also held other legal positions in the U.S. Army Judge Advocate General (JAG) Corps at the 24th Infantry Division at Fort Stewart, Georgia, and in small private–practice law firms before joining the U.S. Army JAG Corps.


EPA Semi-Annual Regulatory Agenda Released: On December 14, 2017, EPA released the most recent version of its semi-annual regulatory agenda. The agenda details the status of the regulatory actions currently under development at EPA. The agenda is available online.

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