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June 1, 2019

Monthly Update for June 2019

Bergeson & Campbell, P.C.

TSCA: Three Years Later, Monday, June 24, 2019, 9:00 a.m. – 4:30 p.m. (EDT), Milken Institute School Of Public Health, Washington, D.C.: Join the Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) for a one-day conference providing updates and insights regarding year three of the federal government’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA) on June 22, 2016. Speakers will provide an overview of the current state of TSCA implementation, ongoing and emerging issues, and related developments. Afternoon breakout sessions will invite all participants to discuss current law and policy issues. This conference (in-person and webinar) is free and open to the public, but registration is required by June 21, 2019, at the ELI website.

ELI Summer School Series 2019: Law & Policy Of Products Regulation, July 23, 2019, 12:00 p.m. – 2:00 p.m. (EDT), Washington, D.C. and Via Webinar: The lifecycle of industrial, agricultural, and antimicrobial chemical products, especially those embedded in consumer products, has gained increasing public attention. Regulators are looking at the entire product lifecycle, including post-discard of product at the end of its useful life, as well as toxicity data. Lynn L. Bergeson, Managing Partner, B&C, will present chemical product regulations matters, including risk communication, minimizing legal liability, and evolving policy matters. Register online by July 18, 2019.

WEBINAR — FDA FSMA Food Defense Plan Requirements, July 24, 2019, 1:00 p.m. – 2:00 p.m. (EDT): B&C is pleased to present the complimentary webinar “FDA FSMA Food Defense Plan Requirements.” Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, will present. Register online.


EPA Issues Draft Revised Method For ESA Pesticide Assessments: On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method). 84 Fed. Reg. 22120. EPA also hosted a public meeting on June 10, 2019, in which it presented the Draft Revised Method and provided an opportunity for public comment. The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].” EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.” EPA states the revisions are based on: “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; consideration of National Research Council (NRC) recommendations; and “lessons learned during the development of the first three BEs.” Comments are due by July 1, 2019. More information is available in our blog.

EPA Updates Its New Chemical Statistics Web Page To Increase Transparency: On May 16, 2019, EPA announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the TSCA section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process. The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process. EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.” EPA Assistant Administrator Alexandra Dapolito Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.

EPA Announces Section 5 Notices To Be Posted Without EPA Reviews: On May 20, 2019, EPA announced that on May 30, 2019, it will begin publishing TSCA Section 5 notices, including PMNs, MCANs, and SNUNs, their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView, in the form they are received by EPA, without review by EPA. EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing. EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices. EPA’s announcement states the following as guidance of which submitters should take heed before submitting their TSCA Section 5 notices: verify the asserted CBI claims are correct and consistent; and verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed. More information is available in our blog.

EPA Makes It Easier To Find Information On Pesticide Registration Review Actions: On May 21, 2019, EPA announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year (FY), including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration review action is published. Stakeholders and the public can now quickly locate and sort through the following information for each active ingredient with a recent registration review action: the docket number (with a direct link to the docket); comment period deadline (if applicable); case number; designated division; registration review action type; and contact information for the chemical review manager. The new table also provides direct links to dockets, making it easy to access supporting information and documents related to a pesticide’s registration review.

Annual Green Chemistry And Engineering Conference/International Conference On Green And Sustainable Chemistry: On June 11-13, 2019, the American Chemical Society (ACS) Green Chemistry Institute® (GCI) hosted the 23rd Annual Green Chemistry and Engineering Conference and the 9th International Conference on Green and Sustainable Chemistry. The Conference convened outside of Washington D.C. in Reston, Virginia, and focused on the theme of “Closing the Loop” in the chemical life cycle. More information is available in our blog.

EPA Presents The Green Chemistry Challenge Awards: On June 10, 2019, EPA hosted the Green Chemistry Challenge Awards Ceremony, where four awards were given to academics, scientists, and business innovators across the industry sector. Promoting environmental and economic benefits of developments in green chemistry, EPA, in partnership with the ACS GCI, granted four awards. Congratulated by EPA Assistant Administrator Dunn, the 2019 awardees included:

  • Academic Award — Professor Sanjoy Banerjee, The City University of New York – Energy Institute, Rechargeable Alkaline Zn-MnO2 Batteries for Grid Storage Applications;
  • Small Business Award — Kalion, Inc., Microbially Produced High-Purity Glucaric Acid for Diverse Uses;
  • Greener Synthetic Pathways Award — Merck & Co., Innovating for a Greener Future: Development of a Green & Sustainable Manufacturing Process for ZerbacaTM; and
  • Greener Reaction Conditions Award — WSI, TRUpathTM.

Dunn thanked ACS for its support and highlighted the importance of the awarded technologies in supporting economic growth while reducing energy use, hazardous chemistry, and protecting water. Dunn’s remarks included a note on the need for more people who chose to be in the science field, especially those who support green chemistry. Dunn also pointed out the Office of Chemical Safety and Pollution Prevention’s (OCSPP) work in implementing the TSCA measures, stating that EPA staff is currently working “fast and furiously.”

B&C congratulates all ACS Green Chemistry Challenge Award Winners for their invaluable contributions to a more sustainable and renewable future.

Ninth Circuit Makes Determination On Scope Of Review Of EPA Order On Enlist Duo; Requests Briefing: On May 30, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order in National Family Farm Coalition v. EPA, No. 17-70810 (filed Mar. 21, 2017) regarding the scope of its review of a petition challenging a 2017 EPA Notice of Pesticide Registration. This 2017 order addresses Dow AgroSciences LLC’s Enlist Duo product. The Petitioners include the National Family Farm Coalition and the Natural Resources Defense Council. The May 30, 2019, order addresses whether the court could review two prior EPA orders, one issued in 2014 and one in 2015, regarding the registration of Enlist Duo. Those 2014 and 2015 EPA orders had also been challenged in court, and subsequently remanded to EPA to consider additional information. Following EPA’s consideration of this additional information, EPA increased the allowed use sites for the Enlist Duo registration to include cotton and increased the number of states authorized to use Enlist Duo from 15 to 34 states. The Ninth Circuit’s May 30, 2019, order finds that the 2017 order “reissues the original Enlist Duo registration and amendment addressed in the 2014 and 2015 orders, thus making the full registration of Enlist Duo for GE corn, soybean and cotton for use in 34 states subject to [its] review.” The court based its decision on the language of EPA’s 2017 order and EPA’s Final Registration Decision. The court found persuasive, for example, that EPA’s 2017 order states that it “supercedes” EPA’s 2014 order, which the court stated is “consistent with our determination that the 2014 order previously remanded to EPA has now been finalized.” Since EPA identified its 2017 order as final and had characterized its 2014 and 2015 orders as having an incomplete record, the court stated that it will “review the 2017 order on the combined records of the 2014, 2015 and 2017 orders, all of which is incorporated into the 2017 order’s record.” The court further noted that EPA’s “2017 order also purports to extend the 2014 registration’s (and that of the 2015 amendment) initial 2020 expiration date by two years.” Since the court found that nothing “suggests that this term is specific to the new uses on GE cotton in 34 states or GE corn and soybean in the additional 19 states,” the court stated that the 2017 EPA order could not have been limited to adding only these post-2015 uses as EPA had asserted. More information is available in our blog.


EPA Proposes MCL Options For Perchlorate Under The Safe Drinking Water Act (SDWA): On May 23, 2019, EPA released a pre-publication version of a proposed rule seeking comment on options regarding the regulation of perchlorate in public drinking water systems. EPA is seeking comment on a proposed National Primary Drinking Water Regulation (NPDWR) for perchlorate to establish a Maximum Contaminant Level (MCL) and a health-based Maximum Contaminant Level Goal (MCLG) at 56 micrograms per liter (µg/L). EPA also seeks comment on three alternative regulatory options: an MCL and MCLG for perchlorate set at 18 µg/L; an MCL and MCLG for perchlorate set at 90 µg/L; and withdrawal of EPA’s 2011 determination to regulate perchlorate in drinking water. EPA states that it is especially interested in the perchlorate monitoring and reporting requirements for public water systems and a list of treatment technologies that would enable water systems to comply with the MCL. EPA is also requesting comment on its methodology for deriving the MCLG, the underlying assumptions and analysis of its cost and benefit estimates, and other specific items listed in the proposed rule. The comment period on the proposal will close 60 days after publication in the Federal Register. The pre-publication version of the proposed rule is available here.

PHMSA And OSHA To Hold Public Meetings On International Issues: On June 20, 2019, the Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Occupational Safety and Health Administration (OSHA) will hold public meetings to discuss proposals in preparation of the 55th Session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) and the 37th Session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS), respectively. 84 Fed. Reg. 23585. The PHMSA public meeting will be held from 9:00 a.m. to 12:00 p.m. (EDT), while the OSHA public meeting will be held from 1:00 p.m. to 4:00 p.m. (EDT). Both meetings will be held at DOT Headquarters Conference Center, West Building, Oklahoma City Conference Room, 1200 New Jersey Avenue, SE, Washington, DC 20590. DOT requests that attendees register for these meetings via this link: PHMSA and OSHA have made available supplemental information in advance of the meetings.

EPA Proposes Results Of Residual Risk And Technology Review For Surface Coating NESHAP: On June 4, 2019, EPA proposed amendments to address the results of its residual risk and technology reviews for the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Surface Coating of Metal Cans and Surface Coating of Metal Coils. 84 Fed. Reg. 25904. EPA proposed to find the risks due to emissions of air toxics from these source categories under the current standards to be acceptable and that the standards provide an ample margin of safety to protect public health. EPA thus proposed no revisions to the numerical emission limits based on these analyses. EPA is, however, proposing to amend provisions addressing emissions during periods of startup, shutdown, and malfunction (SSM). EPA is also proposing to amend provisions regarding electronic reporting of performance test results, monitoring requirements, and miscellaneous clarifying and technical corrections. Comments are due by July 19, 2019.

Final Rule Exempts Farm Emissions From EPCRA Reporting: EPA on June 13, 2019, issued a final rule amending the release notification regulations under the Emergency Planning and Community Right-to-Know Act (EPCRA). 84 Fed. Reg. 27533. The rule clarifies that reporting of air emissions from animal waste at farms is not required under EPCRA. On March 23, 2018, President Trump signed into law the Consolidated Appropriations Act of 2018 (Omnibus Bill). Title XI of the Omnibus Bill is entitled the Fair Agricultural Reporting Method Act (FARM Act). The FARM Act expressly exempts reporting of air emissions from animal waste (including decomposing animal waste) at a farm from Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) Section 103. The FARM Act also defines the terms “animal waste” and “farm.” Because these types of releases are exempted under CERCLA, EPA has determined that they also are exempt from reporting under EPCRA Section 304. The rule is effective on July 15, 2019.


FDA Announces Extension Of VQIP Application Period: On May 16, 2019, the U.S. Food and Drug Administration (FDA) announced that it will be extending the application period for importers to submit their notice of intent to participate and their completed application for the FY 2020 benefits period of the Voluntary Qualified Importer Program (VQIP). The application portal will remain open until July 31, 2019, after which it will close to allow time for the agency to review applications before the start of the annual benefits period that will begin on October 1, 2019.

FDA Releases Draft Guidance For Industry On The Use Of An Alternate Name For Potassium Chloride In Food: On May 20, 2019, FDA announced the availability of a draft guidance for industry entitled “The Use of an Alternate Name for Potassium Chloride in Food Labeling.” 84 Fed. Reg. 22749. FDA states that the draft guidance, when issued in final, will explain its “intent to exercise enforcement discretion for the declaration of the name ‘potassium chloride salt,’ as an alternative to ‘potassium chloride,’ in the ingredient statement on the labels of foods that contain potassium chloride as an ingredient.” Comments are requested by July 19, 2019.

FDA Makes Available Menu Labeling Social Media Toolkit: On May 22, 2019, FDA announced it is making available a Menu Labeling Social Media Toolkit for use by organizations and health education professionals to conduct outreach with their audiences. This toolkit is designed to raise awareness of how consumers can use calorie information they may now see on menus and menu boards and features web badges that can be embedded in an organization’s website, a sample newsletter/blog that can be adapted and posted, and social media messages for sharing on Facebook and Twitter.

FDA Announces Series Of Biannual Training Sessions On Emerging Chemical Science Related To Food Safety: On May 28, 2019, FDA announced that it is partnering with the ACS to provide a series of biannual training sessions on chemical science related to food safety. FDA states that this opportunity is open to the public and offers participants a chance to interact with leading technical experts in chemistry but the training sessions are not intended to function as a forum for regulatory issues and recommendations discussions, however. They will focus on aspects of chemistry, including the area of flavor modifiers, manufacturing processes, specifications, and analytical methods. The first ACS/FDA colloquium was held on Tuesday June, 4, 2019, from 9:00 a.m. – 12:00 p.m. (EDT) at the Wiley Building auditorium in College Park, MD. It focused on taste perception in humans and its impact on nutrient intake and on recent advances in food flavors, including the discovery of new flavors. More information on other training sessions is available online.

FDA Announces Availability Of Draft Guidance For Industry Related To Produce Safety Rule: On June 4, 2019, FDA announced the availability of a draft guidance for industry entitled “Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” 84 Fed. Reg. 25814. FDA states that the draft guidance, when issued in final, will “provide recommendations on the factors that covered farms should consider if they are selecting an alternate curriculum training to meet the requirements of the ‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’ (Produce Safety Rule) and for educators when developing or evaluating alternate curricula.” Comments are requested by October 2, 2019.

FDA Announces Availability Of Draft Guidance For Industry Related To Produce Safety Rule: On June 6, 2019, FDA issued an alert to consumers about certain cosmetic products recalled due to the presence of asbestos. On March 5, 2019, FDA issued a Safety Alert warning consumers not to use certain Claire’s products. The June 6 notice updates the March 5 Safety Alert to warn consumers not to use two additional products: Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179; and Claire’s JoJo Siwa Makeup Set, SKU #888711136337, Batch/Lot No. S180109 because they tested positive for asbestos. FDA states that both Beauty Plus and Claire’s recalled their respective products, and urges consumers who have these products to stop using them immediately.


Slides Available From ACS Webinar On Working Safely With Nanomaterials In The Laboratory: The ACS has posted the slides from its May 16, 2019, webinar on working safely with nanomaterials in the laboratory. The panel members discussed the importance of managing products containing nanomaterials by integrating them into an existing lab safety program. They highlighted the importance of a strong safety culture that is created and maintained by bench scientists who champion appropriate safety practices.

SweNanoSafe Launches Free Web Tool To Help Register Nanomaterials Under REACH: On May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.” The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. SweNanoSafe notes that the December 2018 amendments clarifying the information requirements for nanomaterials have not yet been included.

NIOSH Activities At 2019 AIHce EXP Include Presentations On Nanomaterials: On May 17, 2019, the National Institute for Occupational Safety and Health (NIOSH) announced that its presentations at the May 20-22, 2019, American Industrial Hygiene Conference & Expo (AIHce EXP) would include:

  • PDC 601: How to Assess and Manage Nanomaterial Risks;
  • 119 — An Evaluation of Engineered Nanomaterial Safety Data Sheets Post [Globally Harmonized System of Classification and Labeling of Chemicals (GHS)]; and
  • 348 — Comparison of Enhanced Darkfield Microscopy and Hyperspectral Mapping with Electron Microscopy for Analysis of Airborne Nanoparticulate Collected on Filter-based Media.

OECD Publishes New Reports In Series On Safety Of Manufactured Nanomaterials, Including Tour De Table: The Organization for Economic Cooperation and Development (OECD) has posted the following reports in its Series on the Safety of Manufactured Nanomaterials:

More information on the developments reported in the Tour de Table is available in our May 31, 2019, blog item.

Stories From The NNI Podcast Series Includes Conversation With Vince Caprio, NanoBCA Founder And Executive Director: The June 3, 2019, episode of the National Nanotechnology Initiative’s (NNI) podcast series, Stories from the NNI, features Vince Caprio, Founder and Executive Director of the NanoBusiness Commercialization Association (NanoBCA). Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), speaks with Caprio about his memories of the early establishment of NNI, his thoughts on major advances in nanotechnology for the past 15 years, and NanoBCA’s role in advocating for NNI and enabling a better understanding and appreciation of nanotechnology by legislators and federal and state governments.

ISO Guidance Specifies Characteristics And Measurement Methods For Antibacterial Silver Nanoparticles: The International Organization for Standardization (ISO) has published standard ISO/TS 20660:2019, “Nanotechnologies — Antibacterial silver nanoparticles — Specification of characteristics and measurement methods.” The standard provides guidance for the specification of characteristics and relevant measurement methods for silver nanoparticles in powder or colloidal forms that are intended for antibacterial applications in nanotechnology. ISO states that the standard is intended to aid the producer in providing the physicochemical characteristics of silver nanoparticles that have an antibacterial effect to the buyer. ISO notes that the standard does not cover considerations specific to health and safety issues either during manufacturing or use.

EC Calls For Data On Certain Nano Ingredients Used In Cosmetic Products: The European Commission (EC) published on June 11, 2019, a call for data on the following ingredients used in cosmetic products: gold (nano); colloidal gold (nano); platinum (nano); colloidal platinum (nano); copper (nano); and colloidal copper (nano). The EC states that it has concerns about the use of nano forms of gold, colloidal gold, platinum, colloidal platinum, copper, and colloidal copper “because of the potential of nanoparticles to enter cells through dermal absorption or across a mucous membrane.” In addition, according to the EC, the data submitted by the applicants “seem to be insufficient” for the Scientific Committee on Consumer Safety (SCCS) to carry out a full risk assessment. Submissions are due November 10, 2019. More information is available in our June 11, 2019, blog item.

Austrian Academy Of Sciences Publishes NanoTrust Dossier On The Safe-By-Design Concept: The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Safe-by-Design — The Early Integration of Safety Aspects in Innovation Processes.” The Dossier presents an overview of the concepts behind the idea of integrating health or environmental safety considerations in the design of materials, products, or processes, focusing on the nano-specific Safe-by-Design concept. More information is available in our June 12, 2019, blog item.


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


PFAS Release Disclosure Act Introduced In Senate: On May 16, 2019, Senators Shelley Moore Capito (R-WV), Kirsten Gillibrand (D-NY), and Tom Carper (D-DE) introduced the PFAS Release Disclosure Act (S. 1507). The bill is intended to improve the availability of information related to perfluoroalkyl and polyfluoroalkyl substances (PFAS). This is the second PFAS-related bill Senators Capito and Gillibrand have introduced together this week and the second PFAS-related bill Senators Capito and Carper have introduced together in recent months. The bill would:

  • Require that EPA add perfluorooctanoic acid (PFOA) and PFAS to the Toxics Release Inventory (TRI) under EPCRA;
  • Require that any PFAS subject to an existing Significant New Use Rule (SNUR) under TSCA be added to the TRI. The Senators believe that this provision will apply to almost 200 of the 602 PFAS that are currently in commerce.
  • Require any PFAS subject to an ongoing or future SNUR or finalized toxicity value, including the ongoing review of the compound GenX, be added to the TRI after the SNUR or toxicity value is issued in final.
  • Direct EPA to decide whether to add several additional specific PFAS for addition to the TRI within two years.
  • Set the reporting threshold for PFAS by entities subject to TRI reporting at a level of 100 pounds.

House Bill Would Require Testing For PFAS: On May 16, 2019, Representative Elissa Slotkin (D-MI) introduced the PFAS Monitoring Act (H.R. 2800). The bill would amend the SDWA to require public water systems to test for at least 30 PFAS. It also would require the full range of PFAS chemicals to be tested after two years. EPA does not currently require testing for PFAS in drinking water in all public water systems.

House Bill Would Ban Use Of PFAS In Food Containers: On May 17, 2019, Representative Debbie Dingell (D-MI) introduced the Keep Food Containers Safe from PFAS Act (H.R. 2827). The bill would ban the use of PFAS in food containers and cookware. It authorizes FDA to deem PFAS in any food containers or cookware as unsafe under the Federal Food, Drug, and Cosmetic Act (FFDCA). The bill gives FDA until January 1, 2022, to enforce this ban. Ms. Dingell has introduced other legislation this Congress on PFAS, including the PFAS Action Act, which would require EPA to list all PFAS chemicals, including PFOA, perfluorooctane sulfonate (PFOS), GenX, and others, as hazardous substances under CERCLA.

House Appropriations Committee Approves EPA Funding Bill: The House of Representatives Appropriations Committee on May 22, 2019, approved the FY 2020 Interior, Environment, and Related Agencies appropriations bill. The bill now heads to the full House for consideration. The Committee rejected President Trump’s bid to slash EPA’s coffers by more than a third. The bill provides a total of $9.52 billion for EPA — $672 million above the FY 2019 enacted level and $3.42 billion above the President’s budget request. Of this amount, the bill includes:

  • $3.41 billion for EPA’s core science and environmental program work, an increase of $105 million above the 2019 enacted level and $1.03 billion above the President’s budget request;
  • $476 million for Geographic Programs;
  • $511 million for compliance monitoring and enforcement activities, a $40 million increase above the 2019 enacted level and $63 million above the President’s request;
  • $18 million in additional funding for scientific and regulatory work on PFAS, needed to establish a drinking water standard and cleanup standards. This level of funding more than doubles current levels for this work;
  • $4.64 billion for State and Tribal Assistance Grants, a $511 million increase above the 2019 enacted level and $1.87 billion above the President’s budget request;
  • $1.21 billion for Superfund, an increase of $55 million above the 2019 enacted level and $169 million above the President’s request;
  • $10.2 million for Environmental Justice activities, a 47 percent increase above the 2019 enacted level and nearly four times more than the President’s budget request.
  • $274,276,000 for Clean Air Act (CAA) programs, a $1,168,000 increase above the enacted level and $118,462,000 above the President’s budget request;
  • For Resource Conservation and Recovery Act (RCRA) programs, lawmakers recommended $118,377,000, $6,000,000 above the enacted level and $38,362,000 above the budget request; and
  • For Toxics Risk Review and Prevention, the Committee recommends $89,217,000, a decrease of $3,304,000 below the enacted level, and $22,799,000 above the budget request.

Senate Bill Would Revise Definition Of Renewable Biomass Under RFS Program: On May 22, 2019, Senator Ron Wyden (D-OR) introduced a bill (S. 1614) to amend the CAA to modify the definition of “renewable biomass” under the Renewable Fuel Standard (RFS). The CAA currently prohibits the use of biomass from federal lands in the making of renewable fuels as defined by the RFS. The bill would allow the use of biomass from certain federal lands needing ecological restoration in the making of renewable fuels. The bill also is intended to make it financially feasible for private landowners to remove low-value brush that impact wildlife habitats and pose fire risks. Under the bill, all mill residuals — like sawdust and shavings — can be used for biofuels and it requires biomass harvested from federal lands to be done in accordance with all federal laws, regulations, and land-use plans and designations.

Local Water Protection Act Introduced In Senate: On May 22, 2019, Senators Amy Klobuchar (D-MN) and Marco Rubio (R-FL) introduced legislation to reduce water pollution in local communities. The Local Water Protection Act (S. 1604) would reauthorize an EPA grant program to fund states to develop and implement programs for managing nonpoint source water pollution. Currently, states retain the primary role for addressing nonpoint source water pollution caused by snowmelt and rainfall runoff, which they do largely through voluntary means and financial incentives. According to the Government Accountability Office (GAO), however, available incentives have declined recently, leading to increased water pollution. The bill would reauthorize $200 million annually for the voluntary grant fund to give local and state governments flexibility to make conservation improvements aimed at decreasing water pollutants through partnerships within their communities. Companion legislation was introduced in the House by Representatives Brian Mast (R-FL) and Angie Craig (D-MN).

House Ways And Means Subcommittee Holds Hearing On NAFTA Enforcement: The House Ways and Means Trade Subcommittee on May 22, 2019, held a hearing entitled “Enforcement in the New NAFTA.” The hearing examined issues related to how the U.S.-Mexico-Canada Agreement (USMCA), that would replace the North American Free Trade Agreement (NAFTA), would be enforced. Testifying before the Subcommittee were: Beth Baltzan, Principal, American Phoenix Trade Advisory Services PLLC; Owen Herrnstadt, Chief of Staff to the International President, International Association of Machinists and Aerospace Workers; Sandra Polaski, Independent Expert, Former Deputy Director-General for Policy, International Labor Organization; Alexander von Bismarck, Executive Director, Environmental Investigation Agency; and Devry Boughner Vorwerk, Corporate Vice President, Global Corporate Affairs, Cargill, Inc. Witness testimony is available online.

Senate PFAS Hearing: On May 22, 2019, the U.S. Senate Environment and Public Works (EPW) Committee held a legislative hearing entitled, “Examining Legislation to Address the Risks Associated with Per- and Polyfluoroalkyl (PFAS),” as it considers a suite of Senate bill proposals aimed at driving PFAS regulation, site clean-up, and filling data gaps on the presences of PFAS in the environment and industrial releases. Of particular note, the Senate bill package includes companion legislation to House bills that would require designating PFAS as “hazardous substances” under CERCLA (see S. 638), and would direct EPA to develop a MCL and promulgate a national primary drinking water standard for PFAS under the SDWA (see S. 1473). As currently drafted, the legislative proposals do little to differentiate across the broad class of PFAS chemistry. In some cases, such as the CERCLA proposal, the legislation would circumvent established regulatory processes.

During the May 22 hearing, the EPW Committee heard from witnesses representing state drinking water regulators, the Environmental Working Group (EWG), drinking water utilities, and the American Chemistry Council (ACC). The witness representing state drinking water regulators testified that the lack of information about associated risks and presence of PFAS in the environment has hindered states’ ability to make regulatory decisions. The drinking water utilities’ spokesperson, Tracy Mehan, also emphasized the need for more data and cautioned against bypassing established regulatory processes. EWG’s witness, Scott Faber, encouraged legislators to move forward with the CERCLA bill to expedite the clean-up process and to hold the Department of Defense and industry responsible for contamination by “legacy chemicals.” ACC’s witness, Dr. Kimberly White, stressed that PFAS differ greatly in their chemical properties and risk profiles and as such a one-size-fits-all approach to regulation is not supported by science.

More information, including links to the bills proposals and written testimony from the May 22 hearing, is accessible on the hearing page here.

Senate Committee Examines CFATS Program: On June 4, 2019, the Senate Committee on Homeland Security and Government Affairs held a roundtable discussion entitled “Sensibly Reforming the Chemical Facility Anti-Terrorism Standards Program.” The hearing examined whether and how the Chemical Facility Anti-Terrorism Standards Program (CFATS) under the CAA should be revised. Witnesses were:

  • Brian Harrell, Assistant Director for Infrastructure Security, Cybersecurity and Infrastructure Security Agency, U.S. Department of Homeland Security;
  • Nathan Anderson, Acting Director, Homeland Security & Justice Team, U.S. GAO;
  • Matthew Fridley, Safety, Regulatory, and Security Manager, Brenntag North America;
  • Timothy O’Brien, President, Detotec North America;
  • William Erny, Senior Director, ACC;
  • Andrew Wright, Vice President, Legislative Affairs, International Liquid Terminals Association; and
  • John Morawetz, Health and Safety Representative, International Chemical Workers Union Council, United Food & Commercial Workers International Union.

Witness testimony and member statements are available online.

Senate Bill Would Require A Science-Based Method To Determine The Cost Of Carbon Pollution: Senator Michael Bennet (D-CO) on June 5, 2019, re-introduced legislation intended to blunt the Trump Administration’s efforts to weaken climate protections. The Carbon Pollution Transparency Act (S. 1745) is intended to ensure the federal government implements a science-based process to account for the cost of carbon pollution in regulations through a standard metric. The legislation is co-sponsored by the majority of members of the Senate Democrats’ new Special Committee on the Climate Crisis. Senator Bennet first introduced the bill in the last Congress, and the new version makes several updates, including requiring all costs of climate change to be considered, adjusting the values for inflation, broadening the group of agencies involved in determining this metric, and requiring impacts in environmental justice communities to be considered. The bill reinstates a standardized metric and process to quantify the cost of climate pollution across federal agencies, ensuring that federal decisions are transparent, standardized, and grounded in science and economics. The bill would codify the most recent version of the federally determined climate pollution damage metric for carbon dioxide, methane, and nitrous oxide so all federal agencies are utilizing the same cost of carbon pollution in economically significant rulemaking. It also would re-establish a federal interagency working group to revise the cost of carbon pollution every five years, if necessary. The bill would establish a new scientific review committee, comprised of ten members selected by the presidents of the National Academies of Sciences, Engineering, and Medicine. The committee would provide input to the federal government on whether and how the cost of carbon pollution should be revised.

Senate Bill Would Block The Use Of Funds To Withdraw From Paris Climate Agreement: On June 5, 2019, Senator Jeanne Shaheen (D-NH) introduced legislation seeking to ensure the U.S. meets its obligations under the Paris Climate Agreement. The International Climate Accountability Act (S. 1743) would prevent the President from using funds to withdraw from the accord. Instead, the bill directs the Trump Administration to develop a strategic plan for the country to meet its commitment and standards as required under the agreement, which the U.S. joined with nearly 200 other nations.

House Subcommittee Holds Hearing To Address The Future Of The EPA: On June 11, 2019, the House Energy and Commerce Subcommittee on Oversight and Investigation convened a hearing entitled “Critical Mission: Former Administrators Address the Direction of the EPA.” Four past EPA Administrators varying in political affiliation testified and wrote, “[W]e are united that there has never been a more important time for us to put aside our differences and advocate collectively for public health and the environment.” Energy and Commerce Chair Frank Pallone, Jr. (D-NJ) ended his opening statement by stating “more than ever, our communities, families, and planet need a robust EPA that is fully committed to protecting human health and the environment.” Testifying at the hearing were: Gina McCarthy; Christine Todd Whitman; William K. Reilly; and Lee M. Thomas. Member statements, witness testimonies, and an archived webcast of the hearing are available online. Gina McCarthy (2013-2017) stated in her written testimony that, “in my opinion, our beloved EPA is in serious trouble and if I am right, it means that American families are facing increasing risks to their health and wellbeing, especially the very young, the elderly and those living in poverty that are most vulnerable to the impacts of pollution.” Christine Todd Whitman (2001-2003) emphasized the need for environmental policy to be led by science, rather than ideology. Whitman also placed large emphasis on the human related acceleration of climate change, and the damaging effects it will have on oceans. Through a long history with EPA, William K. Reilly (1989-1993) expressed the urgency to address public health and natural resources. To make the strides needed to improve, “EPA needs to re-establish the Agency’s scientific credibility by appointing well qualified scientists from key disciplines to advisory committees and to consider the full range of peer reviewed research and data bases that are relevant to questions at hand.” EPA “needs to be strong and replicable along with broad, bipartisan support,” stated Lee M. Thomas (1985-1989). Thomas concluded by supporting rigorous oversight by the Committee for sound decisions to be made and to provide a clearer direction regarding how to combat climate change.

House Select Committee Holds Hearing On Renewable Energy: On June 13, 2019, the House Select Committee on the Climate Crisis convened a hearing entitled “Solving the Climate Crisis: Ramping Up Renewables.” Committee Chair Kathy Castor (D-FL) in her opening statement stated: “The climate crisis is daunting. But the opportunities we have in front of us for good jobs, clean air and a just future are boundless. So, it is a time for resolve and it is a time for hope. We have the tools and technology we need to succeed. We just need to decide to do it.” Ranking Minority Member Garrett Graves (R-LA) added by stating that the regulatory process makes it difficult to increase renewables and that the science behind renewable energy needs to be balanced and complementary to promote the industry. Testifying before the Committee were:

  • Abigail Ross Hopper, President and CEO, Solar Energy Industries Association;
  • Tom Kiernan, President and CEO, American Wind Energy Association;
  • Christine Tezak, Managing Director of Research, ClearView Energy Partners, LLC; and
  • Katherine Hamilton, Chair, 38 North Solutions.

Hopper stated that solar energy is clean, reliable, and renewable. Solar currently provides 2.3 percent of the nation’s electricity, but that number is to rise to 20 percent by 2030. Hopper recommended that the Committee consider four main options, including extending the Investment Tax Credit, investing in energy storage, maintaining and expanding competition in electricity markets to allow competition for solar, and investing in workforce developments. Hopper and Kiernan both emphasized the need to modernize and invest in the outdated grid. Hamilton proposed flexible technology to retain more valuables from renewable resources. This includes investing in energy storage plants to replace coal and gas grid scale solutions. When questioned regarding the use of rare earth metals, and the diverse issues involved when obtaining these metals from other regions of the world, she suggested using innovative methods and practicing rare earth metal recycling. Tezak suggested designing chemical solutions, which could replace these rare earth metals in the future. The individuals testifying all emphasized ways to practice inclusion and diversity in the renewable energy industry. Hamilton stressed using thoughtfulness, and a holistic outlook to implement renewable energy practices that best match community needs and resources, coupled with tax credits for lower income communities.


California To Commence Proceedings To Cancel Chlorpyrifos Applications: On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos. In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health effects in children and other sensitive populations at lower levels of exposure than previously understood.” DPR’s decision, following years of review in California of chlorpyrifos, is sure to garner significant controversy, comments, and, potentially, litigation. Chlorpyrifos first entered the comprehensive risk assessment process after being designated by DPR with a “high” priority status in 2011, and some of the DPR documents supporting the current action were issued in 2011. In December 2015, DPR released a draft risk assessment for public comment. Since the risk assessment identified potential human exposure to spray drift (via inhalation or deposition) as a concern, DPR entered chlorpyrifos in its formal evaluation process to determine the scientific evidence for listing it as a pesticide Toxic Air Contaminant (TAC) (CA Food & Agric. Code §§ 14021-14027). DPR’s assessments were intended to evaluate chlorpyrifos as a pesticide TAC as defined in California regulations (Title 3, Section 6864). The determination of a pesticide TAC is based on whether the air concentrations, either measured or modeled, exceed the reference concentration (RfC) divided by ten. More information concerning chlorpyrifos is available in our blog.

USDA Issues Proposal To Modernize Regulations For Genetically Modified Organisms: On June 6, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms, in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk posed by them, “thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks.” APHIS notes that the proposed rule “would mark the first comprehensive revision of the regulations since they were established in 1987.” It would provide “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel [GE] organisms that are unlikely to pose plant pest risks.” Comments on the proposed rule are due by August 5, 2019. More information is available online.

In a related action, President Trump on June 11, 2019, issued an “Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products” (EO). The EO directs federal agencies to streamline the agricultural biotechnology regulatory processes. The EO is intended to eliminate delays, reduce developer costs, and provide greater certainty about the review process for farmers. The EO states that it is the policy of the federal government to protect public health and the environment by adopting regulatory approaches for the products of agricultural biotechnology that are proportionate responses to the risks such products pose, and that avoid arbitrary or unjustifiable distinctions across like products developed through different technologies. It directs federal agencies to base regulatory decisions on scientific and technical evidence, and take into account, as appropriate and consistent with applicable law, economic factors. Agencies also must review regulatory applications for products of agricultural biotechnology in a timely and efficient manner. The EO requires agencies to make regulatory determinations based on risks associated with the product and its intended end use and promote trade in products of agricultural biotechnology by urging trading partners to adopt science- and risk-based regulatory approaches. The EO also requires the creation of a web-based platform that contains and provides links to relevant regulatory information.

EPA Administrator Orders Review Of Cost-Benefit Analysis Methodology: On May 13, 2019, EPA Administrator Andrew R. Wheeler issued a memorandum ordering EPA offices to put together regulatory proposals for reviewing and revising the manner in which EPA conducts cost-benefit analyses. The memorandum states that EPA must ensure “that its regulatory decisions are rooted in sound, transparent and consistent approaches to evaluating benefits and costs.” It notes that many EPA statutes require the consideration of benefits and costs as part of regulatory decision-making, but that EPA has historically evaluated these benefits and costs differently depending on the media office (air, water, land) and the underlying authority. This has resulted in various concepts of benefits, costs, and other factors that may be considered, he wrote. Mr. Wheeler stated that “[T]his memorandum will initiate an effort to rectify these inconsistencies through statute-specific actions.” EO 13777, “Enforcing the Regulatory Reform Agenda,” directs agencies to identify regulations that “impose costs that exceed benefits.” Following the issuance of this EO, EPA opened a public docket to solicit feedback in April 2017. Based on the EO and the comments received, EPA in June 2018 issued an Advanced Notice of Proposed Rulemaking (ANPRM) to solicit public input on potential approaches for increasing consistency and transparency in how EPA considers benefits and costs. The memorandum directs the offices to develop regulatory proposals based on the following principles:

  • Ensuring EPA balances benefits and costs in regulatory decision-making. EPA should evaluate and consider both benefits and costs in decision-making.
  • Increasing consistency in the interpretation of statutory terminology. EPA media offices should evaluate benefits and costs in a manner that applies consistent interpretations of key terms and concepts for specific statutes (e.g. “practical,” “appropriate,” “reasonable,” and “feasible’).
  • Providing transparency in the weight assigned to various factors in regulatory decisions. Media offices should identify transparently the factors that they did and did not consider in regulatory analysis and how they weighed these factors to arrive at a particular regulatory outcome.
  • Promoting adherence to best practices in conducting the technical analysis used to inform decisions. EPA’s technical analyses should follow sound economic and scientific principles and adhere to existing guidance and best practices for benefit-cost analysis, including the EPA’s Guidelines for Preparing Economic Analyses and other peer-reviewed standards of practice that are applicable to rulemaking.

Mr. Wheeler tasked the Office of Air and Radiation to be the first office to issue a proposal later this year, followed by the other offices. Mr. Wheeler also directed the Office of Policy to continue to improve and update EPA’s Guidelines for Preparing Economic Analyses.

National Toxicology Program Issues Annual Report: On May 24, 2019, the National Toxicology Program (NTP) issued its annual report. The report addresses published NTP technical reports, literature analysis activities, ongoing toxicology studies, and other issues. The report is available into the online.

California DPR Identifies Top Ten Agricultural Pesticide Use Violations Of 2018: On May 28, 2019, DPR posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here.

Additionally, DPR has created an informative presentation about the 2019 license renewal process to help spread awareness to those renewing this year (last names and business names starting with M-Z). DPR states that it encourages continuing education (CE) sponsors, CAC staff, and others to use the presentation to inform license and certificate holders renewing this year about DPR’s renewal process, CE requirements, important dates, and the benefits of renewing early. The 2019 Renewal Process presentation is available here. More information on the top ten agricultural pesticide use violations of 2018 and the 2019 license renewal process is available in our blog.

California DPR Announces Changes To California-like Conditions For Terrestrial Field Dissipation Studies: On May 29, 2019, DPR released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06). Notice 2018-06, issued in January of 2018, provided to applicants for California registration of new agricultural use pesticides guidance specifically related to the requirement to submit at least one terrestrial field dissipation (TFD) study conducted under “California or similar environmental use conditions.” DPR states it is revising this guidance based on comments from the Western Plant Health Association. Notice 2019-05 also extends the effective date to July 1, 2020; for applications submitted July 1, 2020, or later, DPR states it will consider a TFD study to have been conducted under “California or similar environmental use conditions” if the study was conducted within or outside of California in accordance with EPA study guidelines and under certain criteria. More information is available in our blog.

Health Canada Proposes Cancellation Of All Uses Of Chlorpyrifos: On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment). PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.” PMRA is proposing the cancellation of most uses of chlorpyrifos, including almost all agricultural uses, due to PMRA’s belief that they pose unacceptable risks to the environment. The proposal would allow a small number of uses to continue if certain label changes are made. More specifically, PMRA states that its evaluation of available scientific information “has not found acceptable risks to beneficial arthropods, birds, mammals and all aquatic biota in the environment for most current chlorpyrifos uses” but “[g]reenhouse ornamental, outdoor ornamentals (container stock only) for control of Japanese beetle larvae, indoor and outdoor structural, adult and larval mosquito uses of chlorpyrifos have been shown to be acceptable from the environmental perspective.” The label changes that PMRA states would be required for these uses to continue include the following: (1) standard environmental hazard statements to inform users of the potential toxic effects to non-target species; and (2) standard environmental advisory statements for prevention of contamination of aquatic systems and to reduce volatilization. More information on chlorpyrifos issues, including California’s recent announcement that it would be initiating cancellation proceedings of chlorpyrifos, can be found in our blog.

OECA Issues National Program Guidance For FY 2020 – 2021: EPA’s Office of Enforcement and Compliance Assurance (OECA) on June 7, 2019, released its National Program Guidance for FYs 2020 – 2021. The guidance is available online. The guidance states that OECA’s key strategic initiative is to promote environmental compliance through cooperative federalism, meaning increased collaboration with states, territories, and tribes. The guidance also seeks to reduce the average time from violation identification to correction and to boost the overall environmental law compliance rate. Specific goals highlighted in the guidance include:

  • Reducing the number of CAA non-attainment areas;
  • Reducing the number of community water systems out of compliance with health-based standards;
  • Reducing the number of square miles of watershed with surface water not meeting standards; and
  • Implementinig EPA’s Lead Action Plan.

EPA also identified six new National Compliance Initiatives (NCI). NCIs are high priority areas of focus for OECA. The six new NCIs are:

  • Reducing excess emissions of harmful pollutants from stationary sources;
  • Reducing hazardous air emissions from hazardous waste treatment, storage and disposal facilities (TSDF) and hazardous waste generators;
  • Stopping aftermarket defeat devices for vehicles and engines;
  • Reducing significant noncompliance with National Pollutant Discharge Elimination System (NPDES) permits;
  • Reducing noncompliance with drinking water standards at community water systems; and
  • Reducing risks of accidental releases at facilities subject to the CAA’s Risk Management Program (RMP).

CSB Issues Final Report On Fatal Gas Well Blowout: On June 12, 2019, the U.S. Chemical Safety and Hazard Investigation Board (CSB) released its final investigation report into the blowout that killed five workers at the Pryor Trust gas well in Pittsburgh County, OK. CSB’s report identifies a lack of regulations governing onshore drilling safety and shortcomings in safety management systems and industry standards. The report calls on regulators, industry groups, the state of Oklahoma, and companies to address such gaps. CSB determined that the cause of the blowout and rig fire was the failure of two preventive barriers intended to stop a blowout. Those were the primary barrier — hydrostatic pressure in the well, produced by drilling mud — and the secondary barrier — human detection of gas flowing into or expanding in the well and activation of the rig’s blowout preventer. The report explains that unplanned underbalanced drilling and tripping operations allowed a large quantity of gas to enter the well, and safety-critical operations used to determine if gas is in the well were not performed. The report is available online.

President Trump Nominates Member To CSB: On June 13, 2019, President Trump nominated Katherine Andrea Lemos, Ph.D., to be a member of the CSB. If confirmed by the Senate, Dr. Lemos would serve a five-year term. Dr.Lemos previously served in the Federal Aviation Administration and on the National Transportation Safety Board. She is currently the Director of Programs for Northrop Grumman Corporation’s Aerospace Sector. According to the White House, Dr. Lemos “has a distinguished background in system safety, accident investigation, human factors, and advanced technology research and integration,” and “has broad experience across the product lifecycle in analyzing and promoting product, process, and operational performance.” The CSB is supposed to have five members, but currently only has three. President Trump twice has sought to eliminate the CSB by gutting its funding, but failed in two consecutive attempts. This year, the House appropriated $12 million for the CSB’s FY 2020 funding.

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