WEBINAR — New TSCA At 3: Key Implementation Issues, Thursday, July 25, 2019, 1:00 p.m. – 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.
WEBINAR — FDA FSMA Food Defense Plan Requirements, Wednesday, 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.” One of the Food Safety Modernization Act (FSMA) foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires non-exempt entities to develop the appropriate preventive measures by July 26, 2019, a date that is fast-approaching. This webinar will cover key aspects of the rule, review strategies for ensuring compliance with major provisions of the rule, including preparation of a Food Defense Plan, and suggest measures to ensure your business is prepared for the July 26, 2019, deadline. Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, will present. Register online now.
B&C’s All Things Chemical™ Podcast: The All Things Chemical™ podcast features B&C’s talented team of lawyers, scientists, and consultants as well as outside experts to keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space. Episodes are available now on iTunes, Spotify, Stitcher, and Google Play Music. Make sure you never miss an episode by subscribing, or follow us on Twitter @lawbc where we always post new episodes.
“TSCA: Three Years Later” Conference Looks To The Past And Into The Future: On June 24, 2019, B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health (GWU) presented “TSCA: Three Years Later,” a day-long conference with leading experts exploring the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. A recording of the full conference is available online. During her luncheon keynote address, Alexandra Dapolito Dunn, EPA’s Assistant Administrator for the OCSPP, shared new information regarding EPA’s findings of unreasonable risks. Bloomberg Environment reported on the keynote in the article Lag Time in EPA Action on Toxic Chemicals May Worry Public. The full conference is available to view on demand. Details regarding the session topics and presenters, including copies of the presentations where available, are below.
TSCA: Three Years Later
Welcome and Overview of Forum
- Lynn R. Goldman, M.D., M.S., M.P.H.,
Michael and Lori Milken Dean and Professor, Environmental and Occupational
Institute School of Public Health, GWU
Morning Keynote Discussion
- LeRoy C. Paddock,
Associate Dean for Environmental Studies and Professorial Lecturer in Law,
Panel 1: TSCA Implementation: Where Are We Now?
Panel 1 focused on how TSCA has been applied over the past three years since the enactment of the 2016 Lautenberg Act Amendments and the impact of TSCA’s implementation on the regulatory, environmental, political, and corporate sectors. This included EPA’s updated Inventory identifying active and inactive chemical substances, the new chemicals’ review process, and the regulation of existing chemicals. Additionally, panelists tackled how to ensure public safety and corporate responsibility, including the treatment and classification of confidential business information (CBI) in accordance with TSCA.
- Steven Bennett, Ph.D., Senior Vice
President, Scientific Affairs, Household and Commercial Products
Association, Moderator (slides)
- Lynn L. Bergeson, Managing Partner,
- Adam M. Finkel, Sc.D., CIH, Clinical
Professor, Environmental Health Sciences, School of Public Health,
University of Michigan (slides)
- Michal Freedhoff, Ph.D., Minority
Director of Oversight, Committee on Environment and Public Works (EPW),
United States Senate
- Alexandra Dapolito Dunn, Assistant
Administrator, EPA OCSPP
Panel 2: Science Policy Issues
Panel 2 focused on the numerous impacts of TSCA on science policy. Panelists explored chemical prioritization and risk evaluation, chemical data reporting and its use in assessments, testing of new and existing chemicals, animal welfare considerations, and more.
- George M. Gray, Ph.D., Professor,
Department of Environmental and Occupational Health and Director of the
Center for Risk Science and Public Health, GWU, Moderator (slides)
- Tala Henry, Ph.D., Deputy Director,
EPA Office of Pollution Prevention and Toxics (OPPT)
- Oscar Hernandez, Ph.D., Senior Regulatory
Chemist, B&C (slides)
- Britt L. McAtee, Ph.D., DABT, Manager,
Toxicology, PPG Industries (slides)
Panel 3: Regulatory and Policy Issues
Panel 3 explored the regulations and policies under TSCA. Panelists examined reporting and labeling requirements, current and potential future compliance standards, enforcement laws and policies, and the role of TSCA in upholding environmental justice.
- James V. Aidala, Senior Government Affairs
Consultant, B&C, Moderator
- Richard E. Engler, Ph.D., Director of
- Eve Gartner, Staff Attorney, Healthy
Communities Program, Earthjustice (slides)
- Jeffery Morris, Director, EPA OPPT
- Scott Fulton, President, ELI
Visit the ELI event website for more details and content from the conference. Subscribe to B&C’s Firm Clients and Friends newsletter for regular chemical regulatory updates and visit TSCAblog™ for the latest developments regarding TSCA implementation.
EPA Receives Manufacturer Requests For Risk Evaluations Of DIDP And DINP: On June 14, 2019, EPA announced that on May 24, 2019, it received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel. More information is available in our June 14, 2019, blog item.
EDF Publishes Report On Trump EPA’s Implementation Of The Lautenberg Act: The Environmental Defense Fund (EDF) announced on June 17, 2019, a report entitled Toxic Consequences: Trump’s attacks on chemical safety put our health at risk. EDF claims that the Trump Administration “is seeking to dismantle the new authorities and mandates under the law with the goal of shifting policies to serve the chemical industry’s agenda.” EDF concludes that “without a drastic change to EPA’s current direction on chemical safety, we will be forced to endure the toxic consequences of its mistakes for decades to come.”
Democratic Senators Call On EPA To “Stop Undermining Key Chemical Safety Law”: On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to EPA Administrator Andrew Wheeler requesting information on EPA’s implementation of the Lautenberg Act. According to the letter, EPA’s implementation of the Lautenberg Act “has deviated dramatically from Congress’ intent and the new law’s requirements.” The Senators’ letter requests EPA’s responses to a number of questions. More information is available in our June 22, 2019, blog item.
EPA Extends Deadline To Submit Comment On Proposed Glyphosate Interim Registration Review Decision: On June 26, 2019, EPA announced it was extending the comment deadline on its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 30112. EPA states that it is extending the comment deadline “after receiving public comments requesting additional time to review the Glyphosate Proposed Interim Registration Review Decision and supporting materials.” The deadline to submit comments was extended from July 5, 2019, to September 3, 2019. The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361. More information on glyphosate issues is available on our blog.
States File Suit To Force EPA To Issue Reporting Rule For Asbestos: On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against EPA for its failure to initiate an asbestos reporting rule under TSCA Section 8(a). The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos. More information is available in our July 3, 2019, blog item.
EPA, Intervenors File Supplemental Briefs In Case Challenging EPA’s Prioritization And Risk Evaluation Rules: On June 28, 2019, EPA filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary remand.” As to the remainder of petitioners’ claims, EPA maintains that their allegations “are based on hypotheticals and other non-final agency actions currently being considered by the agency.” A coalition of industry associations filed a supplemental brief in support of EPA on June 28, 2019. The coalition states: “Although it is theoretically possible that EPA could exclude a use of a particular chemical that could affect the risk evaluation in a way that could cause the agency not to regulate some use of a chemical that could injure Petitioners’ members, that does not create a justiciable controversy now, before the Rules have been applied.” More information is available in our July 15, 2019, blog item.
EPA Seeks Submissions Of Safer Choice Partner Of The Year Awards: On June 28, 2019, EPA announced it was accepting submissions for the 2019 Safer Choice Partner of the Year Awards. 84 Fed. Reg. 31066. The Awards recognize the leadership contributions of Safer Choice partners and stakeholders who have demonstrated outstanding achievement in the design, manufacture, selection, and use of products with safer chemicals. Submissions are due by July 31, 2019.
Appellate Court Rejects Novel Application Of The False Claims Act To TSCA Reporting Requirements: On July 5, 2019, the U.S. Court of Appeals for the District of Columbia Circuit rejected an “invitation” to recognize liability under the False Claims Act (FCA) based on a company’s failure to meet a TSCA reporting requirement and failure to pay an unassessed TSCA penalty. Kasowitz Benson Torres LLP v. BASF Corp. (No. 1:16-cv-02269). The law firm Kasowitz Benson Torres LLP (Kasowitz) filed suit in 2016, claiming that several chemical manufacturers violated TSCA by “repeatedly failing to inform” EPA of “information regarding the dangers of isocyanate chemicals.” Kasowitz argued that the manufacturers’ failure to disclose this information and their subsequent actions deprived the government of property (substantial risk information) and money (TSCA civil penalties and contract damages). The court noted that Kasowitz demanded “billions of dollars in damages, even though the government openly support[ed] the defendants.” The district court dismissed its lawsuit, and Kasowitz appealed, asking the court “to become the first court to recognize FCA liability based on the defendants’ failure to meet a TSCA reporting requirement and on their failure to pay an unassessed TSCA penalty. We decline the invitation and affirm the dismissal.” More information is available in our July 11, 2019, blog item.
EPA Issues Final Rule Revising TSCA Dust-Lead Standards: On July 9, 2019, EPA issued a final rule lowering the dust-lead hazard standards. 84 Fed. Reg. 32632. EPA is lowering the standards from 40 micrograms of lead per square foot (µg/ft2) to 10 µg/ft2 on floors and from 250 µg/ft2 to 100 µg/ft2 on windowsills. The more protective dust-lead hazard standards will apply to inspections, risk assessments, and abatement activities in pre-1978 housing and certain schools, childcare facilities, and hospitals. EPA explained its reasoning behind lowering the standards by referencing new data indicating that health risks exist at lower blood lead levels (BLL) than previously recognized. The Centers for Disease Control and Prevention (CDC) now considers that there is no safe BLL in children and no longer uses the term “level of concern,” and is instead using the blood lead reference value (BLRV) to identify children who have been exposed to lead and who should undergo case management. The BLRV is based on the 97.5th percentile of the U.S. population distribution of BLLs in children ages 1-5 from the 2007-2008 and 2009-2010 National Health and Nutrition Examination Surveys (NHANES). EPA notes that current best available science, “which . . . has evolved considerably since 2001, informs EPA’s understanding of the relationship between exposures to dust-lead loadings, blood lead levels, and risk of adverse human health effects.” Although EPA lowered the risk levels for lead in dust, it did not revise the clearance levels for lead abatements. These levels are used to determine whether a cleanup has actually lowered the lead risk in a home. The clearance level for floors remains unchanged at 40 µg/ft2. EPA states, however, that it has initiated a separate rulemaking to review post-abatement clearance levels for dust-lead. The regulatory agenda notes that rule is slated to be published in 2021. To update the dust-lead clearance levels, EPA explained that it must take a number of steps, including health, exposure, and economic analyses. EPA stated that it will conduct an analysis estimating the health implications of possible revisions of applicable dust-lead clearance levels, taking into account factors such as the locations where clearance samples are collected for each of the various candidate clearance levels under consideration. An economic analysis of candidate dust-lead clearance levels will be conducted for purposes of evaluating the potential costs and benefits of possible revisions to the clearance levels. EPA’s economic analysis will involve establishing a baseline lead hazard profile for facilities affected by the rule based on knowledge of any applicable existing rules and standards and levels of compliance with those rules and standards. EPA will analyze candidate clearance levels with reference to this baseline. Economic modeling will be performed to link each candidate clearance level to the associated scenario of health endpoints and their associated aggregated “benefit” valuations for the whole affected population. EPA had proposed to revise the definition of lead-based paint, but chose not to do so in this final rule. The rule will be effective on January 6, 2020.
EPA Releases Draft Risk Evaluations For HBCD And 1,4-Dioxane, Schedules SACC Peer Review: On July 1, 2019, EPA published a Federal Register noticeannouncing the availability of the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended TSCA. 84 Fed. Reg. 31315. EPA states that the purpose of the risk evaluations is to determine whether a chemical substance presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. EPA is submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review. SACC will hold a five-day in-person meeting on July 29-August 2, 2019, to consider and review these draft risk evaluations. Preceding the in-person meeting, there will be a three-hour preparatory virtual meeting on July 10, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer reviews. Comments on the draft risk evaluations are due August 30, 2019. More information on the risk evaluations is available here.
EPA Proposes MCLs For Perchlorate: On June 26, 2019, EPA proposed a 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). 84 Fed. Reg. 30524. EPA also seeks comment on three alternative regulatory options: an MCL and MCLG set at 18 µg/L; an MCL and MCLG 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. Comments must be received on or before August 26, 2019. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of comments on or before July 26, 2019.
EPA Releases Final Affordable Clean Energy Rule Replacing Obama Era Clean Power Plan: On July 8, 2019, EPAissued a final rule repealing and replacing the Clean Power Plan (CPP), one of President Obama’s landmark environmental protection rules. 84 Fed. Reg. 32520. Unlike the CPP, the Affordable Clean Energy (ACE) rule does not set limits on emission from coal-fired utilities. Instead, EPA gives states latitude in determining how to control emissions of greenhouse gas emissions from coal-fired power plants within their borders. The rule redefines the “best system of emission reduction” (BSER) for carbon dioxide from such plants. Specifically, the rule identifies heat rate improvements as BSER. The ACE rule also establishes emissions guidelines for states to use when developing plans to limit carbon dioxide at their coal-fired power plants and provides states with a list of applicable emissions control technology that power plants can use to ensure compliance with the rule. EPA bars the use of certain options for compliance, including carbon capture and storage, fuel switching, and emissions trading. EPA abandoned an approach that would have eased the New Source Review (NSR) regulations that are triggered if power plants implement significant changes or modifications at their facilities. Also contained within the rule are new implementing regulations for ACE and future existing-source rules under Clean Air Act (CAA) Section 111(d). EPA estimates that by 2030 the ACE rule will reduce emissions of carbon dioxide by 11 million short tons, with reductions in emissions of other pollutants such as mercury, particulate matter, and ground-level ozone. EPA projects that ACE will result in annual net benefits of $120 million to $730 million. The rule is effective September 6, 2019.
EPA Will Not Promulgate CERCLA Financial Assurance Requirements For Electric Utility Industry: EPA on July 2, 2019, announced that it will not issue Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) financial assurance requirements for the electric power generation, transmission, and distribution sector. CERCLA Section 108(b) establishes certain authorities concerning financial responsibility requirements. On January 6, 2010, EPA identified the electric power generation, transmission, and distribution industry as one for which it could develop, as necessary, financial responsibility requirements under CERCLA Section 108(b). On January 11, 2017, EPA made a determination to proceed with rulemakings that will either develop proposed financial responsibility requirements under CERCLA Section 108(b) or determine such requirements are not warranted. In the July 2 notice, EPA stated that the risk from facilities in this sector does not warrant financial responsibility requirements to cover the costs of possible hazardous substance releases. EPA is under a judicial deadline to issue a proposed notice by July 2, 2019, and a final determination by December 2, 2020, on the need for CERCLA financial assurance for this sector. EPA’s evaluation determined that the degree and duration of risk associated with the production, transportation, treatment, storage, or disposal of hazardous substances in the industry do not require financial assurance regulations. A copy of the pre-publication version of the rule is available online.
Court Of Appeals Upholds RCRA Transfer-Based Exclusion: On July 2, 2019, the U.S. Court of Appeals for the D.C. Circuit issued a decision upholding the transfer-based exemption for hazardous waste under the Resource Conservation and Recovery Act’s (RCRA) definition of solid waste (DSW) regulations. California Communities Against Toxics et al., v. EPA (D.C. Cir. Case No. 18-1163). The road to this decision is long and winding, stretching back to 2008, and some background is necessary. Under the Bush Administration, EPA on October 30, 2008, published a final rule conditionally excluding from hazardous waste regulation hazardous secondary material transferred to a third party for recycling, i.e., the transfer-based exclusion. EPA codified that conditional exclusion at 40 C.F.R. Sections 261.4(a)(24) and (25). 73 Fed. Reg. 64668. In January 2015 under the Obama Administration, however, EPA replaced the transfer-based exclusion with the verified recycler exclusion. 80 Fed. Reg. 1694 (Jan. 13, 2015). EPA was sued on that decision. On July 7, 2017, the D.C. Circuit found “unreasonable,” and thus threw out, the verified recycler exclusion. The court reinstated the transfer-based exclusion. American Petroleum Institute v. EPA (D.C. Cir. No. 09-1038). The court then amended its ruling on March 6, 2018, tweaking its 2017 decision. Responding to the court’s July 2017 and March 2018 orders, EPA on May 30, 2018, issued a final rule revising the DSW regulations. 83 Fed. Reg. 24664. That rule removed the verified recycler exclusion and reinstated the transfer-based exclusion. EPA was subsequently sued on that rule, which is the subject of the July 2, 2019, decision. In the decision, the court found that EPA did not act contrary to RCRA in adopting the transfer-based decision. The court concluded that hazardous secondary materials are not “discarded” (and thus not solid waste) each time they are transferred from a generator to a reclaimer along with payment. The court further found that EPA provided a reasoned explanation for applying different standards to materials that are not yet part of the wasted disposal problem RCRA addresses, where they meet conditions EPA has concluded are adequate for safe transfer and legitimate recycling. The immediate impact of the court’s ruling may be minimal. Implementation of the revised rules is a hodgepodge. The immediate effect of the ruling depends upon the authorization status of each state. For the two states that have no final RCRA authorization — Alaska and Iowa — the revised rules are effective immediately. States that have final authorization but that did not adopt the 2015 verified recycler exclusion are not required to adopt or become authorized for the reinstated transfer-based exclusion, as it is less stringent than full hazardous waste regulation. States that have RCRA authorization but have not adopted the 2015 definition of legitimate recycling are, however, required to adopt that definition. For states that have adopted rules similar to the verified recycler exclusion and the 2015 definition of legitimate recycling, but have not yet been authorized for them, the authorization status of the state programs remains unchanged. For states that have previously been authorized for rules similar to the verified recycler exclusion and the 2015 definition of legitimate recycling, and have been authorized for them, the effect is that those previously-authorized state provisions will be considered broader in scope than the federal program (and thus non-enforceable by EPA).
California Senate Urges Basel Ratification: On July 5, 2019, the California Senate voted 28-0 to approve a resolution urging the U.S. to ratify the Basel Convention on the Control of Transboundary Movements of Hazardous Waste and Their Disposal (the Basel Convention). The U.S. signed the Basel Convention in March 1989 and the Senate gave consent to ratification in 1992. But the House of Representatives failed to amend RCRA to incorporate the requirements of the Basel Convention. This prevented the State Department from finalizing the ratification of the convention. California lawmakers voted on the resolution in response to the alarming issue of plastic pollution. In May 2019, the parties to the Basel Convention amended it to include contaminated and mixed plastic waste, therefore requiring consent from receiving countries to accept such wastes.
DOT And EPA To Provide Free Training On The Safe Transportation Of Lithium Batteries: The Department of Transportation (DOT) and EPA are providing free workshops on the safe transportation of lithium batteries. The workshops will focus on the safe transportation of lithium batteries for recycling and the applicable regulations that must be followed by battery recyclers. The workshops are designed for individuals in the battery recycling industry who need a working knowledge of the regulations or who provide training to their employees on the applicable regulations. They will include an overview on the latest regulatory requirements on proper lithium battery packaging, marking, and labeling, as well as a basic understanding of how to apply the Hazardous Materials Regulations. The workshops will be held on July 29, 2019, in Atlanta, July 30, 2019, in Kansas City, August 14, 2019, in Chicago, and September 5, 2019, in San Francisco. Interested parties should register online.
FDA Announces Request For Comments Regarding Substances Generally Recognized As Safe: On June 21, 2019, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information has been submitted to OMB for review and clearance under the PRA. 84 Fed. Reg. 29216. FDA, accounting for an increase in the number of annual Generally Recognized as Safe (GRAS) submissions for human food from 50 to 100, increased the overall estimated burden by 8,500 hours. Comments on the collection of information are requested by July 22, 2019.
FDA Announces Request For Comments Regarding Threshold Of Regulation For Substances Used In Food-Contact Articles: On June 21, 2019, FDA announced an opportunity for public comment as required under the PRA. 84 Fed. Reg. 29209. FDA, accounting for a decrease in the number of annual threshold of regulation submissions from seven to four, decreased the overall estimated burden by 144 hours. Comments on the collection of information are requested by August 20, 2019.
FDA Announces Request For Comments Regarding Claims Of Categorical Exclusion Or Environmental Assessments: On June 25, 2019, FDA announced an opportunity for public comment as required under the PRA. 84 Fed. Reg. 29864. FDA estimates the annual reporting burdens for claims of categorical exclusion and environmental assessments and concludes that it has made no adjustments to the currently approved estimate. Comments on the collection of information are requested by August 26, 2019.
FDA Posts Guidance For Industry Regarding Determining The Number Of Employees For Purposes Of The “Small Business” Definition: On June 21, 2019, FDA announced the availability of guidance titled “Determining The Number Of Employees For Purposes Of The “Small Business” Definition In Parts 117 And 507 (CGMP And Preventive Controls Regulations For Human And Animal Food): Guidance For Industry” to help industry subject to provisions of the FSMA determine the number of employees for purposes of the “small business” definition under Title 21 of the Code of Federal Regulations Parts 117 and 507. 84 Fed. Reg. 29054. The guidance elaborates on relevant definitions, covers counting of full-time equivalent employees (FTE) in detail, and concludes with implications for small businesses under FSMA. The guidance is available online. Comments on the guidance may be submitted at any time.
FDA Extends Comment Period On Draft Guidance Regarding Naming Of Potassium Chloride In Food Labeling: On July 10, 2019, FDA announced a 60-day extension to the comment period on the draft guidance titled “The Use of an Alternate Name for Potassium Chloride in Food Labeling.” 84 Fed. Reg. 32848. FDA proposes an intent to exercise enforcement discretion for declaration of the name “potassium chloride salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride,” which may “lead to increased consumer understanding of the use of potassium chloride as a replacement for sodium chloride (i.e., salt).” The draft guidance is available here. Comments on the draft guidance are requested by September 17, 2019.
EC JRC Contributes To OECD Test Guidelines For Nanomaterials: The European Commission’s (EC) Joint Research Center (JRC) published a press release on June 6, 2019, regarding its contribution to the Organization for Economic Cooperation and Development’s (OECD) development of Test Guidelines for the safety assessment of nanomaterials. According to the press release, scientists from JRC have actively participated in discussions of the OECD’s Working Party on Manufactured Nanomaterials (WPMN) since early on. More information is available in an article in the June 2019 issue of Regulatory Toxicology and Pharmacology, “Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data.”
EC Requests Scientific Opinions On Hydroxyapatite (Nano) And Nano Copper And Colloidal Copper: On June 25, 2019, the EC’s Scientific Committee on Consumer Safety (SCCS) posted two requests for scientific opinions: hydroxyapatite (nano) and copper (nano) and colloidal copper (nano). According to the mandate for hydroxyapatite (nano), the EC has concerns about the use of hydroxyapatite in nano form “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” It requests SCCS carry out a safety assessment of the nano form of hydroxyapatite as reported in the notifications. In the mandate for copper (nano) and colloidal copper (nano), the EC states that it has concerns on the use of copper and colloidal copper in nano form “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” It requests SCCS carry out a safety assessment of the nano form of copper and colloidal copper reported in the notifications.
Council Of The EU Adopts Conclusions On Chemicals To Offer Political Guidance On Sustainable EU Chemicals Policy Strategy: On June 26, 2019, the Council of the European Union (EU) announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.” The June 26, 2019, press release notes that the conclusions address in particular the topics of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, endocrine disruptors, nanomaterials, and pharmaceuticals. According to the press release, the Council requests the EC to extend the European Chemicals Agency’s (ECHA) mandate to collect and make available research data on the characterization, hazard, and potential exposure of “nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of 1 tonne/year.”
Austrian Academy Of Sciences Publishes Nanotrust Dossier On Nano Registries: The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Nano-registries: Country-specific Solutions for Nano-regulation.” While the EU has declined to create an EU-wide nano-registry, several EU Member States have adopted their own nano-registries. The NanoTrust Dossier provides an overview of the registries that includes a helpful summary of who must register and the registration threshold and the information required to be reported. The Dossier suggests that a holistic framework, such as the one proposed in the 2017 article “React now regarding nanomaterial regulation,” “can help gather data on nanomaterials within the European Union, promising increased transparency and benefits for workers, the environment and consumers.”
EUON Search Tool Includes Over 300 Nanomaterials On The EU Market: The EU Observatory for Nanomaterials (EUON) announced on July 3, 2019, that it has added a new search tool for nanomaterials to its website. The search tool combines data submitted by companies in their REACH registration dossiers, data collected about nanomaterials used as ingredients in cosmetic products under the Cosmetics Regulation, and data from the Belgian and French public national nanomaterial inventories. Search results are linked to ECHA’s database of chemicals registered in the EU.
Mid-Term Evaluation Of EUON Includes Recommendations To Increase Its Effectiveness: On July 5, 2019, EUON released an ex-post evaluation report prepared by ECHA with the support of PricewaterhouseCoopers. The ex-post evaluation assessed EUON against the following criteria: effectiveness; coherence; EU added-value; and utility. The recommendations by the external evaluators include:
- Increase the effectiveness and
relevance of the information on EUON by providing additional information
and increasing the frequency of publishing new information;
- Increase the effectiveness of
the EUON by increasing its user-friendliness for non-expert audiences; and
- Increase awareness of EUON
among stakeholders, as a secondary priority to improving and consolidating
the website content.
The internal evaluators recommend developing measurable indicators and targets to track the progress of the project, as well as developing and monitoring indicators relating to cost, speed, and quality of the relevant milestones to facilitate the assessment of both its effectiveness and efficiency.
Registration Opens For Workshop On The Future Of NNI: On August 1-2, 2019, the National Nanotechnology Initiative (NNI) will hold “The Future of the NNI: A Stakeholder Workshop.” The NNI has played a pivotal role in fostering and advancing a dynamic nanotechnology ecosystem in support of the initiative’s four goals: advance world-class research; foster commercialization; develop and sustain research infrastructure; and support the responsible development of nanotechnology. Building on this foundation, experts from the nanotechnology community will share their perspectives on the key elements required for the nanotechnology enterprise to thrive over the next 15 years.
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 Committee Unanimously Passes PFOA/PFOS Amendment Requiring EPA Regulation: On June 19, 2019, the Senate EPW Committee unanimously approved an amendment to a Department of Defense (DOD) spending bill (S. 1790) that would require EPA to regulate per- and polyfluoroalkyl substances (PFAS) under several laws. The legislation would require EPA reporting under Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and their salts, with an initial reporting threshold of 100 pounds. EPA would be required to establish a toxicity value for PFOA and PFOS and add PFOA and PFOS to the list of active chemical substances under the TSCA Inventory. EPA also would be required to issue a TSCA data call for PFOA/PFOS no later than January 1, 2023. In addition, EPA must promulgate in final form the TSCA significant new use rule (SNUR) for long-chain PFOA/PFOS that it proposed on January 21, 2015. 80 Fed. Reg. 2885. Under the bill, EPA would have two years to promulgate a national drinking water standard under the Safe Drinking Water Act (SDWA) for PFOA and PFOS. The United States Geological Survey (USGS) would be required to establish a performance standard for the detection of perfluorinated compounds present in the environment. USGS also would be required to carry out nationwide sampling to determine the concentration of perfluorinated compounds in estuaries, lakes, streams, springs, wells, wetlands, rivers, aquifers, and soil using the performance standard it develops. Within one year of the bill’s enactment, EPA also must publish interim guidance on the destruction and disposal of PFOA/PFOS and materials containing them, including aqueous film-forming foam; soil and biosolids; textiles treated with PFOA and PFOS; and spent filters, membranes, and other waste from water treatment.
House Homeland Security Committee Passes CFATS Reauthorization Bill: On June 19, 2019, the House Homeland Security Committee passed a bill that would amend and reauthorize the Chemical Facility Anti-Terrorism Standards (CFATS) program. The program is the nation’s first regulatory program focused specifically on security at high-risk chemical facilities. The Committee met to mark up the substitute bill, H.R. 3256, which would reform the CFATS program, and reauthorize it for another five years. Committee Chair Bennie Thompson (D-MS) in his opening comments stated, “in just ten months, the only federal program focused on protecting U.S. chemical plants from terrorist attacks will be shuttered unless Congress acts.” Mr. Thompson aims to work with the Energy and Commerce Committee to make improvements on the bill for both operations and communities residing near chemical plants. The House Homeland Security ranking member, Mike Rogers (R-AL), stated that the bill would make several changes to policy that concern him, including lowering the threshold for risk assessment, increasing whistleblower protection, and creating a chemical security advisory committee. Both Messrs. Thompson and Rogers wish to reach a bipartisan agreement to bring the bill to the House floor. Cedric Richmond (R-LA) offered the amendment in the nature of a substitute. Mr. Richmond stated that a lapse in the CFATS program could jeopardize his home state, due to the 20 major chemical facilities within the state. Acting now would enable the program to continue developing over the next five years, stressed Richmond. The measure passed in a largely partisan vote of 14 to 12. The bill must go through at least two other House Committees before reaching the House floor.
Several RFS Bills Introduced: Lawmakers in both houses introduced bills attempting to amend the Renewable Fuel Standard (RFS) under the CAA. On June 14, 2019, Senators Deb Fischer (R-NE) and Tammy Duckworth (D-IL) introduced the Renewable Fuel Standard (RFS) Integrity Act of 2019. The bill is intended to increase transparency and predictability to EPA’s small refinery exemption process under the RFS program. The bill would require small refineries to petition for exemptions by June 1 of each year in the hope that doing so would hold EPA accountable for exempted gallons in the annual Renewable Volume Obligation (RVO) it sets every November. Many complaints have been made regarding President Trump’s EPA liberally providing exemptions to refineries with no back-up information or congressional oversight. This legislation attempts to address this issue by making key information associated with exemptions publicly available. Additionally, the bill would require EPA to report to Congress on the methodology it uses when granting these small refinery exemptions. Representative Steve King (R-IA) on June 21, 2019, introduced two bills intended to halt the “abuse of small refinery exemptions, which undercut the RFS by subtracting from the RFS volume requirements.” The first bill, H.R. 3410, requires that there be no net reduction in RFS volume requirements, which means that if EPA grants a small refinery exemption waiver, other refineries must blend more to make up the difference because waived volumes will be added back to the RFS requirement. The second bill, H.R. 3411, seeks to recapture volumes lost due to waivers from 2006-2018 by adding those previously lost gallons to future year RFS obligations. Also on June 21, 2019, Representative Francis Rooney (R-FL) introduced a bill (H.R. 3427) that would repeal the Renewable Fuel Program entirely.
Utah Senators Introduce Early Action Against Ozone Act: On June 25, 2019,Utah Republican Senators Mike Lee and Mitt Romney introducedthe Early Action Against Ozone Act (S. 1973). The bill would authorize EPA to work with local governments to lower pollution before they violate the National Ambient Air Quality Standard (NAAQS) for ozone under the CAA. Current law authorizes EPA to work with local governments only when they violate ozone NAAQS levels. The bill would allow EPA to engage in partnerships with local communities at risk of ozone NAAQS violations before unhealthy levels have been reached. Senators Lee and Romney modeled the bill after EPA’s Early Action Compact (EAC) Program that gave communities at risk of violating the ozone NAAQS the option of entering into a cooperative early action agreement with EPA before they actually violated the NAAQS. EPA abandoned the EAC program in 2017 due to ligation that argued the program was outside EPA’s authority under the CAA. This bill would authorize and direct EPA to implement a similar program to the EAC.
Legislation Would Set Renewable Electricity Standard: On June 26, 2019, Senators Tom Udall (D-NM), Martin Heinrich (D-NM), Sheldon Whitehouse (D-RI), Tina Smith (D-N), and Angus King (I–ME) introduced a bill (S. 1974) that would set a federal 50 percent standard for renewable electricity generation from utilities in every state. Representative Peter Welch (D-VT) sponsored a companion House version. If enacted, the bill would put the U.S. on a trajectory to decarbonize the power sector by 2050. Starting in 2020, the Renewable Electricity Standard (RES) Act of 2019 would require electricity providers across the country to increase their supply of renewable energy from sources like wind and solar each year. The Senators stated that the bill meets the recommendations of the United Nations Intergovernmental Panel on Climate Change (IPCC) 1.5 C Special Report, which outlines the standards that nations must meet to respond to the threat of climate change.
House Subcommittee Approves PHMSA Funding Bill: On June 26, 2019, the House Energy and Commerce Subcommittee on Energy passed the Safer Pipelines Act of 2019 (H.R.3432). The bill would reauthorize and fund the Pipeline and Hazardous Materials Safety Administration (PHMSA) from Fiscal Year (FY) 2020 through FY 2023. (The Protecting Our Infrastructure of Pipelines and Enhancing Safety (PIPES) Act of 2016 reauthorized the federal pipeline safety program through FY 2019.) The measure would boost PHMSA’s coffers from its current funding level of $164 million to $237 million in FY 2020 and to $256 million in FY 2023. The bill authorizes appropriations for the following PHMSA programs:
- Operational expenses: $24,215,000
in FY 2020;
$24,941,450 in FY 2021;
$26,460,000 in FY 2022;
and $27,254,000 in FY 2023;
- Gas and hazardous liquid
management: $160,800,000 in FY 2020;
$165,624,000 in FY 2021;
$170,600,000 in FY 2022;
and $175,700,000 in FY 2023;
- Hazardous liquid funds from the
Oil Spill Liability Trust Fund: $25 million each year in FY 2020 and FY 2021; and $26 million
each year in FY 2022
and FY 2023;
- Underground natural storage
facility safety: $9 million each year from FY 2020 through FY 2023;
- Emergency response grants:
$12,000,000 each year from FY 2020
through FY 2023;
- Pipeline safety information
grants: $2,000,000 each year from FY 2020 through FY 2023; and
- State damage prevention
programs: $2,000,000 each year from FY 2020 through FY 2023.
The bill requires PHMSA to promulgate a regulation to prioritize more effective technologies over direct assessment for interstate pipelines. For distribution systems, the bill requires PHMSA to study and report on the feasibility of reducing reliance on direct assessment for inspections. H.R. 3432 also makes changes to PHMSA’s enforcement regime. First, it increases PHMSA’s civil penalty authority. Second, the bill removes the limit on total penalties in current law. Finally, it strengthens the criminal penalty standard, moving the standard from “knowingly and willfully” to “knowingly or recklessly.” For pipelines located in high consequence areas, the legislation requires operators, based on a risk assessment, to install automatic or remote shutoff valves for liquid and gas pipelines, as appropriate according to the individual pipeline facility. The language would only take effect if PHMSA fails within two years to promulgate a rule on such valves already required by the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (Public Law 112-90). The bill also restores an individual’s ability to bring civil action against PHMSA to compel it to carry out its statutory obligations. The legislation also requires owners and operators of gas or hazardous liquid pipeline facilities to make critical operational information available on a segment basis to surrounding communities and first responders. House Energy and Commerce Committee Chair Frank Pallone (D-NJ) stated that he hopes the full Committee can approve the bill before the House August recess.
Senate Passes Defense Bill That Includes PFAS Provisions: The Senate on June 27, 2019, passed the National Defense Reauthorization Act (S. 1790). In addition to funding the DOD, the bill contains several provisions related to PFOA and PFAS. Most notably, the bill would require EPA to promulgate within two years national primary drinking water standards for PFOA and PFAS.
Electronic Waste Bill Introduced In House: On June 27, 2019, Representative Adriano Espaillat (R-NY) introduced a bill intended to control the export of electronic waste (e-waste) from the U.S. The Secure E-Waste Export and Recycling Act (H.R. 3559) is not, however, primarily intended to protect countries importing U.S. e-waste from environmental or health harm. Instead, Mr. Espaillat introduced the measure to ensure that foreign entities do not turn e-waste into sources of counterfeit goods that may reenter military and civilian electronics supply chains in the U.S. Representative Espaillat described his bill as “a national security bill to stop the flow of electronic waste (e-waste) to China.” He alleged that China regularly uses e-waste to counterfeit electronics “while returning these dangerous faux products, including critical military equipment, back into the market.” The legislation would stop the flow of e-waste from the U.S. and would require domestic recycling of all untested and nonworking electronics. The bill was referred to the House Committee on Foreign Affairs.
House Bill Would Require PFAS Regulation Under CWA: On July 2, 2019, Representative Chris Pappas (D-NH) and Annie Kuster (D-NH), who both are members of the bipartisan PFAS Task Force, introduced legislation that would regulate the discharge of PFAS within waterways. The Clean Water Standards for PFAS Act (H.R. 3616) is intended to reduce PFAS discharges and hold polluters accountable by adding PFAS to the Clean Water Act’s (CWA) Toxic Pollutants List, allowing EPA to set discharge standards for PFAS.
CRS Issues Report On PFAS And Drinking Water: On July 2, 2019, the Congressional Research Service (CRS) issued a report entitled “PFAS and Drinking Water: Selected EPA and Congressional Actions.” The report addresses the SDWA’s authority to address PFAS in drinking water and summarizes recent EPA action and PFAS legislation introduced in the 116th Congress. The report is available online.
Senate Bill Would Establish A National Climate Bank: On July 8, 2019, Senators Edward J. Markey (D-MA) and Chris Van Hollen (D-MD) introduced the National Climate Bank Act (S. 2057), legislation that would create a federal bank to leverage public and private funds to invest in clean energy technologies and infrastructure. The National Climate Bank would provide financing to eligible regional, state, and local green banks, make investments directly into projects that reduce carbon emission, and provide technical assistance for the start-up of new green banks. The bill would capitalize the National Climate Bank with $10 billion initially, with an additional $5 billion every year for five years. According to a summary of the bill, the purpose of the National Climate Bank is to make the U.S. a world leader in combatting the causes and effects of climate change and to maximize greenhouse gas emissions reduction per public dollar deployed. The National Climate Bank will do this by rapidly deploying mature technologies while commercializing and scaling new technologies. The National Climate Bank would prioritize projects that provide jobs and serve low-income, minority, distressed, and rural communities. It also would prioritize projects that provide access to low-carbon infrastructure at affordable rates, including clean electricity generation, clean water, and reliable and high-quality transportation. The Bank’s methods to accomplish these goals will include investing in low-carbon projects, offering appropriate debt and risk mitigation products, overseeing equity investments in clean energy projects, and overseeing procurements. The National Climate Bank would tap federal investments to remove barriers to private investment in clean energy and low-carbon projects. The bank also would explore the establishment of a “Cash for Carbon” program to remove greenhouse gas emissions from the power sector. The program would use market mechanisms to expedite the retirement of carbon-intensive power generation facilities, acquire carbon assets to reduce emissions, and invest in communities negatively affected by the loss of those facilities. The types of projects the bank will seek to facilitate include renewable energy generation, energy storage, low- and zero-emission vehicle infrastructure, transit-oriented development, transmission for clean energy, climate resiliency measures, energy and water efficiency, reforestation, agricultural projects, and electrification and decarbonization of industrial processes.
Resolutions Introduced In Both Chambers Declaring Climate Change A National Emergency: On July 9, 2019, Senator Bernie Sanders (I-VT) and Representatives Earl Blumenauer (D-OR) and Alexandria Ocasio-Cortez (D-NY) introduced a resolution in both chambers of Congress to declare that climate change demands a “national, social, industrial, and economic mobilization of the resources and labor of the United States” to “restore the climate for future generations.” The resolution is co-sponsored by six Senators and 19 Representatives. It comes in the wake of President Trump’s environmental speech on July 8, 2019, in which he did not mention climate change. The lawmakers note in the resolution that the “United States has a proud history of collaborative, constructive, massive-scale federal mobilizations of resources and labor in order to solve great challenges, such as the Interstate Highway System, the Apollo 11 Moon landing, Reconstruction, the New Deal, and World War II,” and that the United Nations Intergovernmental Panel on Climate Change has warned that the global community has little more than a decade to stop the worst impacts of climate change. The resolution urgently demands a national mobilization to “halt, reverse, mitigate, and prepare for the consequences of the climate emergency and to restore the climate for future generations.”
Legislation Would Lower Drinking Water Standard For Lead: On July 10, 2019, Senator Tammy Duckworth (D-IL) and Representative Dan Kildee (D-MI) introduced in their respective chambers the National Opportunity for Lead Exposure Accountability and Deterrence (NO LEAD) Act. The bill would update the Lead and Copper Rule (LCR), lowering the lead action level from 15 parts per billion (ppb) currently, to 10 ppb by 2020 and 5 ppb by 2026. The bill would also create a lead-service-line inventory to help monitor contaminated service lines and ensure EPA develops a universal testing protocol to make sure the entire lead service line is replaced if water contamination is detected. The NO LEAD Act would also help guide EPA review of the LCR to make lead testing reports more comprehensive and ensure reports are easily available to the public, serving to make clean drinking water more accessible and strengthen education on lead contamination.
Senate EPW Committee Holds Hearing On Transportation: On July 10, 2019, the Senate EPW Committee convened a hearing entitled “Investing in America’s Surface Transportation Infrastructure: The Need for a Multi-Year Reauthorization Bill.” Lawmakers wish to come to a bipartisan agreement addressing infrastructure reform through reauthorizing the Fixing Americas Surface Transportation Act (FAST Act). In his opening statement, Ranking Member Tom Carper (D-DE) stressed the danger to humans and the environment when using forms of transportation, and the urgency to reach a bipartisan agreement and restore the surface transportation programs. Testifying before the Committee were:
- K. Luke Reiner, Director,
Wyoming Department of Transportation;
- Carlos M. Braceras, President,
American Association of State Highway and Transportation Officials;
- Max Kuney, President, Max J.
- Vicki Arroyo, Executive
Director, Georgetown Climate Center; and
- Carolann Wicks, Senior Policy
Fellow, University of Delaware, School of Public Policy &
Mr. Arroyo stated that there are multiple forms of evidence supporting the increase of climate change due to human impacts. He stressed that we need to insure our transportation systems, especially in coastal communities, can withstand climate change, and this will require tools to facilitate resiliency. Ms. Wicks added that not only is our nation’s infrastructure in poor condition, but that climate change adds another level to these issues that already exist. Long-term funding plans to create resiliency, mitigate impacts, and reduce greenhouse gas emissions are essential. Transportation is at the heart of a strong economy, and investing in this infrastructure collaboratively through private and public sectors is the key to prosperity. Mr. Braceras stressed the importance of public investment, and explaining to the public the benefits of transportation programs. Projects need to be advertised and implemented at the right time to meet goals and maintain public trust, he stated. Arroya promoted safer alternatives within communities, including the complete streets program. Money needs to be spent wisely, and keeping toll and tax dollar money locally allows communities to see that these programs are going toward their own safety and benefit, stated Wicks. Braceras emphasized that the federal government needs to develop risk assessments and conduct statistical analysis to determine how to design our transportation systems at a higher level. Wicks addressed this by promoting preventative care, especially in the case of bridges through inspection and technology saving money in the long term. When asked how to pay for the infrastructure needed during the nation’s financial situation, Braceras and Wicks both supported user base, and Mr. Kuney agreed with Braceras regarding gas tax implementation. Wicks also supported mileage based user fees. An archived webcast of the hearing and witness testimony are available online.
House Financial Services Subcommittee Holds Hearing On Climate Related Financial Disclosures: On July 10, 2019, the House Financial Services Subcommittee on Investor Protection, Entrepreneurship and Capital Marketsconvened a hearing entitled “Building a Sustainable and Competitive Economy: An examination of Proposals to improve Environmental, Social, and Governance Disclosures.” The Committee convened to discuss if companies should be required to disclose financial earnings to help investors, companies, shareholders, and enhance accuracy of stock prices with the potential financial impacts of climate change. Committee Chair Carolyn Maloney (D-NY) in her opening statement said, “investors want companies to disclose [Environmental, Social and Governance] ESG information, and evidence shows companies that perform better on ESG metrics also perform better financially.” Testifying before the Committee were:
- Tim Mohin, Chief Executive,
Global Reporting Initiative;
- James Andrus, Investment
Manager-Financial Markets, Sustainable Investment, CalPERS Investment
- Paul S. Atkins, Chief Executive
Officer, Patomak Global Partners;
- Degas A. Wright, CFA, Chief
Executive Officer, Decatur Capitol Management, Inc; and
- Mindy S. Lubber, President and
Chief Executive Officer, Ceres.
Congressman Juan Vargas stated that climate change is real and impacting all of society. This proposal is about protecting investors, and the need to standardize available information, emphasized Vargas. Ms. Lubber stated that climate change is the greatest economic crisis of this decade and beyond. When discussing the ESG disclosure act, Mr. Wright, Mr. Andrus, Mr. Mohin, and Ms. Lubber all welcomed it and felt it would level the playing field for companies and investors. Mr. Atkins stated that although the bill had good intentions, the disclosure mandates have high costs and hinder company goals. When questioned regarding the human induced impacts on climate change, Mr. Atkins stated “there is a lot of data out there that shows various ways, and I haven’t really studied the studies.” Mr. Mohin and Mr. Andrus both stated that climate change and human rights are important issues with which valuable information should be disclosed. Mr. Andrus and Ms. Lubber both stated that disclosures enabled companies to better manage risk factors from climate and water issues. Lubber concluded by stating that as climate change continues, we are experiencing more lawsuits in regard to disclosures. An archived webcast of the hearing and witness testimony are available online.
GOP Forms Environmental Caucus: On July 10, 2019, Representative Fred Upton (R-MI) and Senators Lindsey Graham (R-SC), Cory Gardner (R-CO), Lisa Murkowski (R-AK), Steve Daines (R-MT), Rob Portman (R-OH), and Richard Burr (R-NC), and Representatives Brian Mast (R-FL), Matt Gaetz (R-FL), and Will Hurd (R-TX), announced the formation of the Roosevelt Conservation Caucus. The caucus will “embrace and promote constructive efforts to resolve conservation and environmental problems that align with market-based approaches and promote American ingenuity.”
Senate Confirms Peter Wright As Assistant Administrator For Office Of Land And Environme ntal Management: On July 11, 2019, the Senate approved the nomination of Peter C. Wright to serve as Assistant Administrator for EPA’s Office of Land and Emergency Management (OLEM). The vote was 52 to 38. President Trump announced his intention to nominate Mr. Wright as Assistant Administrator for OLEM in March 2018, but his nomination has languished due to concerns from Senate Democrats over his background. Since 1999, Mr. Wright has worked at The Dow Chemical Company where he served as managing counsel for environmental health and safety. Among other duties, Mr. Wright provided legal support for Superfund and other remediation sites.
Senator Paul Introduces Bills Amending CAA’s NSR Thresholds: Senator Rand Paul (R-KY) on July 11, 2019, introduced a brace of bills aimed at revising the CAA’s thresholds for what changes at a facility constitute a modification and thus trigger NSR. The first, S. 2104, would amend the CAA to exclude energy efficiency projects, pollution control projects, and reliability projects from the definition of a modification. The second, S. 2105, would clarify when a physical change in, or change in the method of operation of, a stationary source constitutes a modification.
House Passes Amendments On PFAS: On July 11, 2019, the House of Representatives passed several amendments to the FY 2020 National Defense Authorization Act legislation (H.R. 2500) that address PFAS contamination. The amendments would:
- Require EPA to list PFAS
as toxic chemicals under the CWA;
- Create an online
clearinghouse to provide information on PFAS health effects;
- Require DOD to share with
local governments information on PFAS monitoring data;
- Fund a $5 million study
by CDC on PFAS;
- Require DOD to dispose of
PFAS wastes using technologies that ensure PFAS is not emitted into the
- Fund a $5 million study
by USGS to monitor PFAS contamination nationwide;
- Require the Government
Accountability Office (GAO) to conduct studies on PFAS contamination in
and around military bases; and
- Require DOD to work with
states in mitigating PFAS contamination.
The White House has threatened to veto the House bill and takes issue with the PFAS provisions. In a Statement of Administration Policy the White House stated:
The Administration strongly objects to this provision, which would provide authority to DOD to treat water sources or provide replacement water for agricultural purposes where the water source is “contaminated” with PFOA and PFOS from military activities. Using the EPA drinking water health advisory (HA) to identify areas subject to this section of the bill would be inconsistent with the scientific basis of the HA — it was not constructed to determine unhealthy levels of PFOA/PFOS in water used for agricultural purposes or human health effects from consumption of foods produced using agricultural water containing PFOA/PFOS. Additionally, at potentially great cost to and significant impact on DOD’s mission, the legislation singles out DOD, only one contributor to the problem.
New York Delays Enforcement Of Household Cleansing Product Information Disclosure Program: On June 12, 2019, the New York State Department of Environmental Conservation (NYSDEC) announced that it will delay enforcement of the Household Cleansing Product Information Disclosure Program (Disclosure Program) from July 1, 2019, to January 1, 2020. NYSDEC states in the June 12, 2019, Environmental Notice Bulletin that it will begin enforcing any violations of the required disclosure as of January 2, 2020. According to the notice, NYSDEC “will continue to work with any manufacturers on the design of their websites, or entertain any questions regarding compliance with website design or safety data sheets.” NYSDEC “remains committed to working with the manufacture[r]s to implement this program in the best manner possible.”
Executive Order Requires Agencies To Terminate One-Third Of Their FACA Committees: A June 14, 2019, Executive Order (EO) issued by President Trump would require all federal agencies and departments to evaluate the need for advisory committees established under Section 9(a)(2) of the Federal Advisory Committee Act (FACA). Entitled “Executive Order on Evaluating and Improving the Utility of Federal Advisory Committees,” the EO also would require each federal agency to terminate at least one-third of its current committees by September 30, 2019.The EO targets committees:
- That have accomplished their
- Where the subject matter or
work of the committee has become obsolete;
- Where the primary functions of
the committee have been assumed by another entity; or
- Where the agency determines
that the cost of the operation of the committee is excessive in relation
to the benefits to the federal government.
The EO allows agencies to count eligible committees terminated since January 20, 2017, toward the one-third goal. EPA has 22 FACA committees and thus must terminate at least seven of them under the terms of the EO. EPA’s FACA committees (and associated EPA offices) are:
- Children’s Health Protection
Advisory Committee (Office of the Administrator/Office of Children’s
- Clean Air Act Advisory
Committee (Office of Air and Radiation);
- Clean Air Scientific Advisory
Committee (Office of the Administrator/Office of Science Advisory Board);
- Environmental Financial
Advisory Board (Office of Water);
- Environmental Laboratory
Advisory Board (Office of Research and Development);
- Board of Scientific Counselors
(Office of Research and Development);
- Science Advisory Board (Office
of the Administrator/Office of the Science Advisor);
- Farm, Ranch, and Rural
Communities Advisory Committee (Office of the Administrator)
- Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) Scientific Advisory Panel (OCSPP);
- Good Neighbor Environmental
Board (Office of Administration and Resources Management);
- Governmental Advisory Committee
to the United States Representative to the North American Commission for
Environmental Cooperation (Office of Administration and Resources
- Great Lakes Advisory Board
(Office of the Regional Administrator, Region 5);
- Hazardous Waste Electronic
Manifest System Advisory Board (OLEM);
- Human Studies Review Board
(Office of Research and Development/Office of the Science Advisory);
- Local Government Advisory
Committee (Office of the Administrator/Office of Congressional and
- National Advisory Committee to
the United States Representative to the North American Commission for
Environmental Cooperation (Office of Administration and Resources
- National Advisory Council for
Environmental Policy and Technology (Office of Administration and
- National Drinking Water
Advisory Council (Office of Water);
- National Environmental
Education Advisory Council (Office of the Administrator/Office of External
Affairs and Environmental Education);
- National Environmental Justice
Advisory Council (Office of Enforcement and Compliance Assurance (OECA));
- Pesticide Program Dialogue
Committee (OCSPP); and
- Science Advisory Committee on
Canada Proposes To Allow Inspection Of Confidential Test Data For Post-Market Reviews: On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.” The purpose of the consultation document is to seek input on a proposal to expand access to confidential test data by inviting interested members of the public to inspect these data at the proposed decision stage for post-market reviews such as re-evaluations and special reviews. PMRA proposes to allow interested parties seeking to understand the scientific basis for a proposed re-evaluation or special review decision to inspect the data used by PMRA earlier in the process. Publication of the consultation document began a 60-day comment period.
EPA Issues Final Rule Revising FOIA: On June 26, 2019, EPA issued final amendments to the regulations under the Freedom of Information Act (FOIA). 84 Fed. Reg. 30028. The revisions implement statutory updates, correct obsolete information, and reflect internal EPA realignment. Importantly, the rule revises the location to which requesters may submit a FOIA request. EPA makes the National FOIA Office in the Office of General Counsel (OGC) the point of entry for all requests. Other revisions were made and interested stakeholders should read the rule to know the scope of the changes. The rule is effective on July 26, 2019.
ATSDR Makes Available Toxicological Profiles For Tetrachloroethylene And Trichloroethylene: On July 1, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the release of the final Toxicological Profiles for Tetrachloroethylene and Trichloroethylene. 84 Fed. Reg. 31321. The Toxicological Profile for Tetrachloroethylene received comments related to the use of specific studies for the profile, potential omission of studies, and derivation of the minimal risk level (MRL). ATSDR addressed these comments by correcting, clarifying, or updating data in the final Toxicological Profile. The Toxicological Profile for Trichloroethylene received comments centered on the methods and data used for deriving the MRLs, as well as suggestions for inclusion of additional studies. ATSDR clarified areas of scientific uncertainty and modeling techniques used to derive the MRLs. ATSDR updated the Profile with several additional studies. For both Profiles, ATSDR also conducted a second peer review of the epidemiological carcinogenicity sections of the Profile by external peer reviewers. A list of peer reviewers and the peer review comments are available at ATSDR’s Peer Review Agenda web page.
EU Parliament Names Environment Committee Members For New Term: On July 4, 2019, the EU Parliament 2019 named 76 members to its Environment Committee. The lawmakers will serve on the Committee through the 2019 – 2024 parliamentary term.
New Executive Director Named For North American Commission For Environmental Cooperation Secretariat: On July 5, 2019, the Council of the Commission for Environmental Cooperation (CEC) announced the appointment of Richard A. Morgan as the new Executive Director of the CEC Secretariat. Mr. Morgan is a former Commissioner for the International Joint Commission. Mr. Morgan succeeds César Rafael Chávez who concludes his three-year term with the CEC on July 15, 2019. The North American Free Trade Agreement (NAFTA) established the CEC. The CEC consists of three bodies: the Council, the Secretariat, and the Joint Public Advisory Committee (JPAC). The Council, composed of the Ministers of Environment from Canada, Mexico, and the United States, is the governing body of the CEC. The Secretariat provides support to the Council, implements the annual operational plan approved by the Council, and implements other activities. The EPA Administrator is the U.S. Council member, representing the United States on the CEC. EPA’s counterparts are Environment and Climate Change Canada (ECCC) and Mexico’s Ministry of Environment and Natural Resources (SEMARNAT).
NIOSH Releases Report On Occupational Exposure Banding For Chemical Risk Management: The National Institute for Occupational Safety and Health (NIOSH) has released a technical report on occupational exposure banding for managing chemical risks. NIOSH states that a vast number of chemical substances in commerce do not have occupational exposure limits (OEL). Consequently, workers may be exposed to these substances at levels that could be harmful. In the absence of OELs, NIOSH states that it is possible to use an approach known as occupational exposure banding. Occupational exposure banding is a process for quickly and accurately assigning chemical substances into categories or “bands” based on their associated health outcomes and on potency considerations. NIOSH’s occupational exposure banding process is not meant to replace OELs; rather, it is a starting point to inform risk management decisions for controlling chemical substances that do not have OELs. The NIOSH process includes: (1) a three-tiered system that allows users of varying expertise to use the process; (2) determination of potential health impacts based on nine health endpoints separately; (3) hazard-based categories linked to quantitative exposure ranges; and (4) assessment of the process via extensive evaluation exercises to determine consistency of the occupational exposure banding process with OELs. The report is available online.
Deputy General Counsels Named For EPA: EPA’s OGC on July 11, 2019, named two individuals to serve as Deputy General Counsels. Elise Packard was named the Deputy General Counsel for Operations and Jim Payne was selected to serve as OGC’s Chief Operating Officer. Ms. Packard since 2014 has served as the Associate General Counsel for Civil Rights and Finance. Mr. Payne has served as Regional Counsel at Region 6 since 2016.
EPA Names New Director Of Children’s Health Office: EPA Administrator Andrew Wheeler on July 11, 2019, named Jeanne Briskin as the new Director of EPA’s Office of Children’s Health Protection (OCHP). Ms. Briskin has been the Director of EPA’s Conflict Prevention and Resolution Center in OGC since 2016.
New EPA Enforcement Policy Calls For Greater Coordination With States: EPA Assistant Administrator for OECA Susan Parker Bodine on July 11, 2019, issued a new policy for greater collaboration between EPA and the states on enforcement of federal environmental laws and regulations. The policy is available online. Entitled Enhancing Effective Partnerships Between the EPA and the States in Civil Enforcement and Compliance Assurance Work,” the policy seeks to craft a more collaborative enforcement process between EPA and states that are authorized, delegated, or approved to implement federal environmental programs. The policy articulates expectations and best practices for periodic joint work planning and effective communication between EPA and states. It also sets forth the primary role of the states in implementing authorized programs, while acknowledging EPA’s responsibilities to take direct action when a state lacks the economic or technical capability or the will to take timely and appropriate action. In addition, the policy sets out the process by which issues that may arise under the policy will be elevated. With respect to periodic work planning, the policy states that “[c]ooperative, periodic, and early joint planning and regular communication between the EPA and states is essential to promote enhanced, shared accountability between federal and state enforcement authorities,” adding that “a no surprises” principle is the foundation of planning. Under the new policy, EPA and states are to conduct strategic planning and work together to identify inspections EPA or a state will perform. The policy states that EPA will generally defer to a state as the primary implementer of inspections and enforcement in authorized programs. EPA will retain, however, concurrent enforcement authority. The policy addresses specific situations where EPA may choose to take direct action. These include:
- Joint work planning or specific
situations where the state requests that EPA take the lead;
- Violations that are part of a
National Compliance Initiative;
- Emergency situations or
situations where there is substantial risk to human health or the
- Situations where a state lacks
adequate equipment, resources, or expertise;
- Situations involving
multi-state or multi-jurisdictional interests or interstate impacts;
- Significant violations that the
state has not timely or appropriately addressed;
- Serious violations for which
EPA’s criminal enforcement authorities may be needed;
- State enforcement program
review inspections; and
Situations that involve enforcement at federal and state owned or operated facilities.
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