Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.
B&C And Acta To Publish Forecast 2020: Start 2020 with the information you need -- Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2020 the first full week of January 2020. In the Forecast, our legal, scientific, and regulatory professionals distill key trends in U.S. and global chemical law and provide their best informed judgment of key developments likely in the coming year. We receive complimentary comments each year from clients and friends who find the Forecast an invaluable resource for setting their compass as they chart their business strategy, and the 2020 edition will be the most comprehensive to date.
B&C Announces Upcoming Events: B&C announces the following events coming in spring 2020:
- B&C will present “Amended TSCA: Priorities, Implementation, and Direction For New and Existing Chemicals” at ChemCon The Americas 2020, March 2, 2020, Philadelphia, Pennsylvania. Contact us to secure discounted registration.
- B&C will present the TSCA Fundamentals workshop at GlobalChem, April 6, 2020, Washington, D.C.
Ninth Circuit Issues Decision In Case Challenging TSCA Prioritization And Risk Evaluation Rules: On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the requirements. Specifically, petitioners claimed that: TSCA requires EPA to evaluate risks associated with a chemical’s uses collectively before determining that the chemical is safe; EPA must consider all of a chemical’s conditions of use in that evaluation; and when considering conditions of use, EPA must evaluate past disposals of all chemicals, as well as the use and subsequent disposal of chemicals not currently or prospectively manufactured or distributed in commerce for that use. Petitioners maintained that various provisions of the risk evaluation rule demonstrate that EPA will not do any of these three things. The court held that it lacks jurisdiction to review petitioners’ first challenge, and that their second challenge fails on the merits. The court granted in part the petition for review with respect to petitioners’ third challenge to EPA’s exclusion of “legacy uses” and “associated disposals” from the definition of “conditions of use,” and those portions of the risk evaluation rule’s preamble are vacated. The court notes that because petitioners’ challenges to EPA’s prioritization rule are “entirely encompassed” within their challenges to the risk evaluation rule, the challenges rise or fall together. The court thus focused only on the risk evaluation rule. More information on the case is available in these blog items: “Court Hears Oral Argument in Case Challenging EPA’s Prioritization and Risk Evaluation Rules” (June 26, 2019); and “EPA, Intervenors File Supplemental Briefs in Case Challenging EPA’s Prioritization and Risk Evaluation Rules” (July 15, 2019).
Ban On Retail Distribution Of Methylene Chloride To Consumers For Paint And Coating Removal Began On November 23: On November 22, 2019, EPA issued a press release reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019. It is now unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for consumer use, including e-commerce sales. EPA states that it “is encouraging all consumers to stop using methylene chloride products that they may have already purchased for paint and coating removal.” EPA also reminds all retailers that sales of these products to consumers are prohibited by EPA regulations under the authority of TSCA Section 6. EPA promulgated the final regulation on methylene chloride for consumer paint and coating removal use on March 27, 2019, and the prohibition related to manufacturing, processing, and distribution of methylene chloride for consumer paint and coating removal use is now in effect. According to EPA, “[a] variety of effective, less harmful substitutes are readily available for paint removal.” EPA notes that it “is continuing to work through the process outlined in TSCA to review the risks associated with other uses of methylene chloride. This process is designed to thoroughly evaluate available science before taking action to manage the risk associated with the other uses of the chemical.” More information on EPA’s actions concerning methylene chloride is available in the following memoranda EPA Publishes Draft Risk Evaluation for Methylene Chloride (October 31, 2019); Communication and Recordkeeping Requirements Related to EPA Ban on Consumer Use Paint Removers Containing Methylene Chloride Go in Effect on August 26, 2019 (July 22, 2019); and EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses (March 20, 2019).
EPA Settles FIFRA Actions Involving Decon 7: On November 18, 2019, EPA Region 9 announced that Decon7 Systems LLC (Decon7) would pay a $200,000 civil penalty in a settlement related to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations. Specifically, EPA found that Decon 7:
- Sold and distributed two products that were not registered with EPA. These products, “D7 Part 1” and “D7 Part 2,” combined to disinfect hard nonporous surfaces. EPA regulations (40 C.F.R. § 152.15) set forth the conditions under which EPA will consider a product to be a pesticide product required to be registered, including but not limited to products containing certain “active” ingredients and/or making claims to kill, repel, or “disinfect” certain pests (e.g., germs, bacteria, viruses).
- Sold and distributed pesticides that were labeled with false and misleading claims regarding safety and efficacy. In addition to misleading efficacy claims to kill all bacteria, viruses, and fungi, EPA states:
The products also had false and misleading safety claims, which created the incorrect impression that the products were noncorrosive and nontoxic. The products’ formulations in fact could have caused skin burns and irreversible eye damage. The products’ labeling also claimed the products were used by various federal government agencies to clean up buildings following anthrax attacks, implying that the federal government recommends or endorses their use.
- Exported unregistered pesticides that did not include necessary notifications and failed to comply with reporting obligations following a Stop Sale, Use or Removal Order (SSURO) issued to the company in 2018.
The Decon7 products are now registered with EPA and the misbranded products were relabeled following the SSURO.
EPA Releases Draft Risk Assessments For Paraquat Dichloride: On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855). Of primary interest in the registration review process under FIFRA are the draft human health and ecological risk assessments. Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical chemistry and residue data; a label use summary; a screening level usage analysis, results of a drinking water jar test; open literature and epidemiology literature reviews; and an incident report summary. Paraquat is currently registered in the United States for use as an herbicide on over 100 crops in agricultural and commercial settings. All paraquat products are restricted use products and may be applied only by certified pesticide applicators. EPA has previously imposed additional restrictions and conditions to ensure the safe use of paraquat consistent with label directions. These actions include a safety awareness campaign, changes to labels and product packaging, and specialized training for certified applicators using paraquat. Evaluation of the effectiveness of these steps will be conducted in the registration review process. Potential risks of concern to workers applying paraquat or entering treated fields are identified in the draft human health risk assessment, as are potential risks to bystanders from spray drift. Prior submissions to EPA suggest a link between proper use of paraquat and Parkinson’s Disease, but EPA’s review of relevant data does not support a causal relationship. This conclusion is not without controversy, as evidenced by an October 15, 2019, press release from the Center for Biological Diversity (CBD) that calls out EPA’s failure to recognize a link between paraquat exposures and Parkinson’s Disease. The ecological risk assessment identifies potential risks to mammals, birds, adult honey bees, terrestrial plants, and algae. EPA is seeking comments on these and other issues raised in the draft risk assessments for paraquat. Comments were due December 16, 2019.
EPA Settles Case With AFCO Asserting FIFRA Violations: On October 31, 2019, EPA Region 3 announced that it reached an agreement with AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged FIFRA violations. AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities. EPA alleges that AFCO sold and distributed ten unregistered pesticide products, a misbranded product, and a product that made claims beyond those permitted by its FIFRA registration. The settlement also addresses violations of a SSURO that EPA issued to AFCO on July 13, 2018. AFCO engaged in sales and distributions that violated this order. AFCO has since discontinued sales of all of the involved products, except for one registered product.
Monsanto Settles With DOJ On Case Asserting FIFRA Violations: On November 21, 2019, the U.S. Department of Justice (DOJ) announced a settlement with Monsanto Company (Monsanto) in which Monsanto agreed to plead guilty to a misdemeanor count of illegally using the pesticide Penncap-M, a methyl parathion product that was cancelled by EPA on July 27, 2010. This settlement of several criminal counts by Monsanto followed an investigation by the EPA Criminal Investigation Division. Under the existing stocks provision in the EPA cancellation order, continued use of Penncap-M became unlawful after December 31, 2013. In the settlement documents, Monsanto admits that its employees knowingly violated this order by using Penncap-M on July 15, 2014, to treat corn seed research crops at Monsanto’s Valley Farm research facility in Maui, Hawaii. Monsanto also admits that Monsanto employees directed other employees to re-enter the treated site seven days after the July 15, 2014, application, although the re-entry period established for this pesticide prior to its cancellation was 31 days. Monsanto further admits that it stored stocks of Penncap-M after December 31, 2013, when unused stocks of this product became an acute hazardous waste under the Resource Conservation and Recovery Act (RCRA) at several locations in Hawaii without obtaining the required permits. As part of the settlement, Monsanto agreed to pay a total of $10.2 million in fines and penalties, which includes a maximum fine of $200,000 for illegal use of a cancelled pesticide, $6 million in fines for the hazardous waste violations, and $4 million in community service payments to Hawaii governmental entities for various environmental remediation programs. Monsanto also agreed to be sentenced to two years of probation. If Monsanto adheres to all of its obligations under this settlement, at the end of the two-year period of probation, the criminal felony counts for the RCRA hazardous waste violations will be dismissed with prejudice. For more information, see our blog.
EPA Proposes Corrections To TRI Reporting: On November 29, 2019, EPA proposed corrections to existing regulatory language for the Toxics Release Inventory (TRI) program. 84 Fed. Reg. 65739. The corrections will update identifiers, formulas, and names for certain listed chemicals and updates to the text that identifies which chemicals the 0.1 percent de minimis concentration applies to remedy a cross reference to an outdated Occupational Safety and Health Administration (OSHA) regulatory citation. Comments are due January 28, 2020.
EPA Releases Consent Agreement And Final Order In Settlement With AFCO C&S, LLC On FIFRA Violations Related To Unregistered And Misbranded Pesticides: EPA recently released the Consent Agreement and Final Order (CAFO) for the October 31, 2019, settlement discussed above. Pursuant to the CAFO, AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities. The CAFO provides more information on the violations Region 3 alleged. The CAFO allegations state that AFCO sold and distributed ten unregistered pesticide products on at least 1,031 separate occasions in violation of FIFRA Section 12(a)(1)(A). The CAFO also alleges that AFCO sold and distributed a product that made claims beyond those permitted by its FIFRA registration on at least five separate occasions. It additionally alleges that AFCO sold or distributed a misbranded pesticide on 41 separate occasions. EPA initially collected the information during an inspection of AFCO’s establishment in Chambersburg, Pennsylvania, on June 20, 2016. The settlement also addresses violations of a SSURO that EPA issued to AFCO on July 13, 2018, requiring AFCO to cease immediately all sales and distributions of the 12 products. The CAFO alleges that AFCO engaged in sales and distributions that violated this order, having sold or distributed the products from at least January 1, 2015, through either August 8 or August 9, 2019. AFCO has since discontinued sales of all of the involved products, except for one registered product, for which EPA issued an Order Modification letter on March 4, 2019, allowing AFCO to recommence sales. AFCO will pay the civil penalty within one year in 12 equal monthly installments, plus interest payment of $7,954.96, totaling $1,496,954.96.
Less Than One Month Remains Before California Online Ingredients Disclosure Requirements Take Effect For Designated Cleaning Products: Time is running out before the effective date of the online requirements set forth in California’s Cleaning Product Right to Know Act of 2017 (S.B. 258). S.B. 258 sets forth new requirements on manufacturers of “designated products” to disclose certain chemical ingredients on the manufacturer’s website and product label. For more information, please read the full memorandum.
EPA Grants First Two Manufacturer Requests For Risk Evaluation: On December 2, 2019, EPA granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production. EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under TSCA. Manufacturer-requested risk evaluations are conducted in the same manner as other risk evaluations conducted under TSCA Section 6(b)(4)(A). EPA received the manufacturer requests from ExxonMobil Chemical Company (for DIDP) and from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex (for DINP), both through the American Chemistry Council’s High Phthalates Panel. Both chemicals were identified in the 2014 Update to the TSCA Work Plan. As reported in our August 17, 2019, blog item, EPA held a public comment period on the requests, as well as additional conditions of use that EPA identified to include in the risk evaluations. More information is available in our August 19, 2019, memorandum, “EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use.”
EPA Issues ANPR On EPCRA Section 313 Listing For PFAS Substances: On December 4, 2019, EPA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comment on whether to add certain per- and polyfluoroalkyl substances (PFAS) to the list of chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 84 Fed. Reg. 66369. EPA is specifically requesting comments on which of the approximately 600 PFAS currently active in commerce have sufficient toxicity information available to meet the EPCRA Section 313(d)(2) listing criteria. EPA is considering whether to add any PFAS currently in commerce for which hazard assessments show that they meet the listing criteria. For any PFAS that meet the listing criteria, EPA also is considering adding those to the list of chemicals of special concern at 40 C.F.R. Section 372.28 and establishing lower reporting thresholds for them. EPA also seeks comment on whether PFAS should be listed as individual chemicals or as a single category or multiple categories. Comments on the appropriate reporting thresholds for PFAS are also requested. The comment period closes on February 3, 2020.
EPA Issues Interim Registration Review Decision For Sodium Cyanide Used In M-44 Predator Control Devices: On December 5, 2019, EPA’s Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device. The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label. Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks. The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states “will reduce the potential for unintended impacts on humans, pets, and other non-target animals.” The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide. The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle. Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual states (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem. More information is available online.
EPA Convened Public Meeting On TSCA New Chemicals Program: On December 10, 2019, EPA convened a public meeting to engage with interested stakeholders on the implementation of EPA’s TSCA New Chemicals program. At the meeting, EPA provided an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” EPA also demonstrated how it has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples; provided an update on confidential business information (CBI) process improvements and clarifications; and discussed its progress on transparency in the TSCA New Chemicals program. By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment. EPA states that feedback from the public meeting and comments received will help inform its ongoing efforts to improve the way EPA reviews new chemicals under TSCA. Later in December 2019, EPA will announce the availability of the updated document after the public meeting and will hold a public comment period. According to the notice, EPA expects the updated document to provide further clarity and detail on EPA’s approach and practices, including: (1) EPA’s general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA Section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations allowable under the statute. The agenda from the December 10 meeting is available here and EPA’s presentation is available here.
EPA Provides TSCA CBI Case List: In advance of the December 10, 2019, public meeting on new chemicals, discussed immediately above, EPA announced the availability of a new web page detailing cases with completed CBI determinations under TSCA. The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g). The table contains information from CBI reviews, including:
- Case Number;
- Submission Type;
- CBI Review Category (specific chemical identity, other information, or both);
- Final Determination;
- Determination Rationale Summary;
- For CBI Claims for Specific Chemical Identity:
- EPA Unique Identifier (UID);
- Accession Number;
- Generic Name; and
- Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.
EPA states that it plans to update this information on a quarterly basis.
EPA Will Host Inaugural Conference On New Approach Methods For Reducing Animal Testing For Chemical Safety: On December 17, 2019, EPA will host its first annual conference in Washington, D.C., to discuss alternative test methods and strategies to reduce animal testing. EPA states that its conference “will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals.” The conference will focus on the New Approach Methods (NAM), which include “any technologies, methodologies, approaches or combinations thereof that can be used to provide information on chemical hazard and potential human exposure that can avoid or significantly reduce the use of testing on animals,” and will have U.S. and international scientific experts present information on advancements in the field. On-site participants attending the conference will have an opportunity to exchange information about scientific advancements in the NAMs field to develop a better understanding of the state of the science, discuss approaches for developing scientific confidence in using alternatives, and summarize existing studies characterizing the uncertainties in results from animal testing. This conference is part of Administrator Wheeler’s “Directive to Prioritize Efforts to Reduce Animal Testing,” issued on September 10, 2019, which outlines EPA’s pursuit to reduce animal testing aggressively. In his directive, Administrator Wheeler calls for EPA to reduce its requests for, and funding of, mammalian studies by 30 percent by 2025 and eliminate all mammalian study requests and funding by 2035. Any mammalian studies requested or funded by EPA after 2035 will require Administrator approval on a case-by-case basis. The directive also supports scientific advancements that allow scientists to predict potential hazards for risk assessments without using traditional animal testing methods. Information on how to register to participate in the conference by webinar is available here.
Deadline For Paying Annual Pesticide Maintenance Fees -- January 15, 2020: The January 15, 2020, deadline for payment of EPA’s annual maintenance fee for pesticide registrations is fast approaching. FIFRA Section 4(i)(5) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental registrations of distributors that are identified by a three-element registration number. The fee for 2020 is $4,000 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and mail the response to EPA by Wednesday, January 15, 2020. Registrations for which the fee is not paid will be canceled, by order and without a hearing. For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:
- The applicant has 500 or fewer employees globally;
- During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10,000,000; and
- The applicant holds a total of five or fewer registrations subject to the maintenance fee.
There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA. More information on the annual maintenance fees is available on EPA’s website.
NAS Will Peer Review EPA’s TSCA Systematic Review Approach: EPA announced on December 13, 2019, that it contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform TSCA risk evaluations. EPA states that “[i]ntegrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.” EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method. NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020. EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process. EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”
EPA Will Host Conference Call On Fee Obligations For EPA-Initiated Risk Evaluations: On December 19, 2019, from 2:00 p.m. to 2:30 p.m. (EST), EPA will host a conference call to review certain provisions of the final rule on fees for the administration of TSCA. EPA states that it will provide a brief overview of the fees associated with an EPA-initiated risk evaluation, the creation of the preliminary list that identifies manufacturers and importers subject to fees, and how it divides fees among the identified businesses. Questions should be submitted in advance to Ryan Schmit. The call-in number is (877) 317-0679, and the conference code is 1480769.
Product Stewardship Society: B&C is a proud supporter of the Product Stewardship Society. Find out more about the benefits of membership, including continuing education, professional development, and active participation in the development and advancement of sustainable product life cycle strategies.
New Recycling Data In The United States Available: EPA has released its most recent Facts and Figures data on national municipal solid waste (MSW) for the years 2016 and 2017. EPA will hold a webinar on the data in early 2020. In 2017 the U.S. generated 267.8 million tons of MSW. The per capita generation rate was 4.51 pounds per person per day. Of the MSW generated, approximately 67 million tons were recycled and 27 million tons composted. In addition, 34 million tons were combusted with energy recovery and more than 139 million tons of MSW were landfilled. Since the passage of RCRA, the recycling rate has more than tripled to the current rate of 35.2 percent. The data are available online.
EPA Revises Guidance On New Source Review: On December 3, 2019, EPA announced several actions that revise its approach to implementing the New Source Review (NSR) permitting requirements under the Clean Air Act (CAA). These actions are part of a suite of measures EPA is taking to modernize and streamline the NSR process, without impeding the Agency’s ongoing efforts to maintain and enhance the nation’s air quality. EPA believes these actions will improve regulatory certainty and remove unnecessary obstacles to projects aiming to improve the reliability, efficiency, and safety of facilities while maintaining air quality standards. EPA is issuing final guidance identifying measures EPA may consider in determining whether a source owner or operator has precluded the general public from having access to its property. Where access is precluded, the portion of the atmosphere above that property is not considered “ambient air” for the purpose of conducting air quality analyses under the CAA. The guidance updates EPA’s policy to recognize that a variety of measures may be considered effective in keeping the public off a source owner/operator’s property. These measures, which account for advances in surveillance and monitoring, depend on site-specific circumstances and continue to include, but are now not solely limited to, fences or other physical barriers. State, local, and tribal permitting authorities have the discretion to apply this guidance on a case-by-case basis. EPA also issued final guidance that revises EPA’s interpretation of when multiple air pollution-emitting activities are located on sufficiently “adjacent” properties to one another that they should be considered a single source for the purposes of permitting.
EPA Declines To Issue CERCLA Financial Responsibility Requirements For Petroleum And Coal Manufacturing Industry Sector: On December 4, 2019, EPA announced that it will not promulgate financial responsibility requirements for the petroleum and coal products manufacturing industry. EPA concluded that the financial risk to the federal government from facilities in this sector is already addressed by various existing federal and state technical and financial requirements and modern material management practices. This proposal is consistent with the analysis EPA undertook in developing its final action for the hard rock mining industry. In that case, EPA’s approach was unanimously upheld by the D.C. Circuit Court of Appeals in July 2019. EPA has evaluated the degree and duration of risk of the possible cost to cover the cleanup of hazardous substance releases associated with the production, transportation, treatment, storage, or disposal of hazardous substances in the petroleum and coal products manufacturing industry. EPA also examined the industry’s economic trends and the financial health of the sector and found the industry to be in a relatively stable financial position with low default risk. EPA’s evaluation showed that existing regulatory programs and voluntary practices reduce the need for federally financed response action at facilities in this industry. By way of background, Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) directs EPA to develop regulations requiring classes of facilities to establish and maintain evidence of financial responsibility to cover the costs associated with releases or threatened releases of hazardous substances from their facilities. In December 2016, EPA described its plan to consider financial requirements under CERCLA for the electric power industry, the petroleum and coal products manufacturing industry, and the chemical manufacturing industry. On July 2, 2019, EPA declined to issue financial responsibility requirements for the electric power industry. EPA is currently working on a proposal for the chemical manufacturing industry.
EPA Rescinds Certain Risk Management Program Requirements: On November 21, 2019, EPA issued a press release announcing a final rule rescinding certain requirements under the CAA Risk Management Program (RMP). The revisions in this rule are intended to drive effective emergency planning and continue to support the long-term trend of fewer significant chemical accidents. According to EPA, the rule reduces unnecessary and ineffective regulatory burdens on facilities and emergency responders; harmonizes rather than conflicts with OSHA’s Process Safety Management standard; and saves Americans roughly $88 million a year. EPA has determined that the RMP’s open-ended information disclosure provisions to allow anonymous access to sensitive chemical facility hazard information “could assist terrorists in selecting targets and/or increase the severity of an attack.” These security concerns were reiterated during the interagency review of the proposed RMP Reconsideration rule last year.
EPA Adds Aerosol Cans To RCRA Universal Waste Program: On December 9, 2019, EPA issued a final rule adding aerosol cans to the RCRA universal waste program. 84 Fed. Reg. 67202. This revision to the RCRA program culls aerosol cans from full hazardous waste regulation under RCRA. Under the rule, a small quantity handler of universal waste must manage universal waste aerosol cans in a way that prevents releases of any universal waste or component of a universal waste to the environment. For example, aerosol cans must be accumulated in a container that is structurally sound, compatible with the contents of the aerosol cans, lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions, and protected from sources of heat. In addition, aerosol cans that show evidence of leakage must be packaged in a separate closed container or overpacked with absorbents, or immediately punctured and drained in accordance with the requirements set forth in the rule. The rule is effective on February 7, 2020.
Chemical Safety Board Issues Proposed Rule On Release Reporting: For the first time in its history, the U.S. Chemical Safety and Hazard Investigation Board (CSB) has issued a proposed rule to clarify when facilities must report accidental chemical releases to CSB. 84 Fed. Reg. 67899. The purpose of the rule is to require the owner or operator of a facility to notify CSB promptly of any accidental release within CSB’s investigatory jurisdiction. The rule defines “accidental release” to mean an unanticipated emission of a regulated substance or other extremely hazardous substance into the ambient air from a stationary source. The rule defines “extremely hazardous substance” broadly, without any reference to threshold planning quantities. The rule would require owners or operators of stationary facilities that have an accidental release to report the release to CSB within four hours. Comments on the rule are due by January 13, 2020.
EPA Issues ANPRM On Ethylene Oxide NESHAP: EPA on December 12, 2019, issued an ANPRM on the National Emission Standards for Hazardous Air Pollutants (NESHAP) for ethylene oxide (EtO) sterilization facilities. 84 Fed. Reg. 67889. EPA is requesting comment on available control technologies for reducing emissions of EtO and developments in practices, measurement, monitoring, processes, and control technologies for the control of EtO from commercial sterilization facilities. EPA is also soliciting comment on a number of other issues. These include:
- Available EtO usage data for individual facilities and additional data contained in the modeling file that EPA intends to use to evaluate the impacts of EtO emissions;
- The use of an emission factor of 0.5 percent of EtO usage for the calculation of fugitive emissions from EtO sterilization facilities;
- The use of permanent total enclosures, pollution prevention, and other operational practices to reduce fugitive emissions;
- Reinstating a chamber exhaust vent control requirement; and
- Other point source control options.
The comment period closes on February 10, 2020.
Waters Of The U.S. (WOTUS) Replacement Rule Under OMB Review: On December 5, 2019, the Office of Management and Budget (OMB) received the final WOTUS rule that is “Step Two” in the EPA and U.S. Army Corps of Engineers (Corps) two-step rulemaking to rescind and replace the 2015 WOTUS rule. The WOTUS definition is the foundation of the Clean Water Act (CWA) as it defines the scope of waters and wetlands that are federally regulated and subjected to CWA regulatory programs, including Section 402 discharge permitting and Section 404 dredge-and-fill permitting. OMB interagency review is a final step before an agency publishes a final rule. Typically, this review period will last around 90 days for major rulemakings, however, there is an expectation that the rule may be released as early as late January 2020/early February 2020. It is anticipated that the final WOTUS rule will not differ substantially from the proposed version. More information on the WOTUS rulemaking is available here.
EPA Proposes Revisions To 2015 Steam Electric ELG Rule: On November 22, 2019, EPA published its much anticipated rule proposal revising the Obama-era 2015 Steam Electric Effluent Limitation Guidelines (ELG). 84 Fed. Reg. 64620. These regulations apply to wastewater discharges from power plants operating as electric utilities and are incorporated into CWA discharge permits for these facilities. There are approximately 1,100 facilities in this ELG category in the U.S. The key proposed changes to the 2015 ELGs are to effluent limits for flue gas desulfurization (FGD) wastewater and bottom ash (BA) transport water. The proposed rule would make the following changes:
- Change the technology-basis for treatment of FGD wastewater and BA transport water to newer pollutant control systems made available since EPA issued the final 2015 ELGs, which will lower costs for utilities and rate payers;
- Revise voluntary incentives program for FGD wastewater to provide a lower cost option;
- Create two sets of best available technology (BAT) limitations for FGD wastewater creating (1) a numeric limit for total suspended solids (TSS) and (2) numeric limits on mercury, arsenic, selenium, and nitrate/nitrite; and
- Create two sets of BAT limitations for BA transport water: (1) TSS numeric limitations; and (2) a not-too-exceed 10 percent volumetric purge limitation.
The proposed rule creates subcategories for high flow facilities, low utilization boilers, and boilers retiring by 2028. The different BAT limit options for FGD wastewater and BA transport water apply based on the subcategory the power plant falls in to. EPA is accepting comments on the proposed rule until January 21, 2020. More information on the rulemaking, including fact sheets and technical support documents, are available here.
FDA Extends Comment Period For New Era Of Smarter Food Safety -- Survey To Assess Allergy To Cosmetics Reporting Burden: On November 21, 2019, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information has been submitted to OMB that estimates reporting burdens for a proposed survey intended to assess allergy to cosmetic products in the United States. 84 Fed. Reg. 64322. FDA proposes conducting a web-based survey to collect data on consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens. Comments on the collection of information must be submitted by December 23, 2019. More information on the New Era of Smarter Food Safety is available here.
FDA Submits To OMB Certification Of Identity Form Reporting Burden: On November 22, 2019, FDA announced that it submitted a proposed collection of information to OMB that estimates reporting burdens associated with Form FDA 3975, which FDA uses to identify individuals that make requests under the Freedom of Information Act (FOIA). 84 Fed. Reg. 64539. FDA estimates that 50 requests are made per year with an average burden per response of ten minutes. Comments on the collection of information must be submitted by January 21, 2020.
FDA Submits To OMB Claim Of Categorical Exclusion Or Environmental Assessment Reporting Burdens: On November 22, 2019, FDA announced a proposed collection of information submitted to OMB that estimates reporting burdens for claiming categorical exclusions or preparing environmental assessments associated with notifications submitted to the Center for Food Safety and Applied Nutrition (CFSAN). 84 Fed. Reg. 64528. FDA estimates that 50 categorical exclusions, with average burden per response of eight hours, and 57 environmental assessments, with average burden per response of 180 hours, are filed per year. Comments on the collection of information must be submitted by December 23, 2019.
ChemSec Adds Carbon Nanotubes To SIN List: On November 14, 2019, the International Chemical Secretariat (ChemSec) announced that it added more chemicals, including carbon nanotubes, to its Substitute It Now! (SIN) List. Dr. Anna Lennquist, Project Manager for the SIN List at ChemSec, states: “Several studies have shown that carbon nanotubes cause lung cancer. The small tubes induce inflammation in a somewhat similar way to asbestos. Reprotoxic properties have also been observed. Up until now, the debate about the safety of nano has focused on the fact that more research is needed. However, here is a perfect example of where there is enough science to say that these materials should not be used.”
EC Publishes Updated Catalog Of Nanomaterials Used In Cosmetics: On November 15, 2019, the European Commission (EC) announced that it published an updated catalog of nanomaterials used in cosmetic products on the European Union (EU) market. The catalog lists 27 nanomaterials used as ultraviolet (UV) filters, colorants, and preservatives. According to the EC, the catalog also indicates the categories of cosmetic products and foreseeable exposure conditions. The EC notes that some substances have more than one function. The EC states that “this catalogue is for information purposes only and is expressly not a list of authorised nanomaterials.”
NNI Announces Launch Of Nanotechnology Entrepreneurship Network: On November 19, 2019, the National Nanotechnology Initiative (NNI) announced the launch of the Nanotechnology Entrepreneurship Network (NEN), “a new community of interest to support entrepreneurs interested in commercializing nanotechnologies.” NNI states that NEN will provide a forum for sharing best practices for advancing nanotechnology commercialization and the lessons learned along the technology development pathway. Activities are likely to include a monthly podcast series, webinars, workshops, and town hall discussions. The inaugural podcast in the series features a conversation between National Nanotechnology Coordination Office (NNCO) Director Lisa Friedersdorf and Joe Sprengard, Chief Executive Officer and founder of Veelo Technologies, who discusses his journey as an entrepreneur and shares the advice he received when he was getting started.
EC Requests Scientific Opinions On Nanoforms Of Platinum And Gold: On November 22, 2019, the EC Directorate-General for Internal Market, Industry, Entrepreneurship, and Small- and Medium-Sized Enterprises (SME) requested two scientific opinions from the Scientific Committee on Consumer Safety (SCCS):
The deadline for each opinion is six months from receipt. SCCS adopted the mandates at its October 30-31, 2019, plenary meeting. More information is available in our November 22, 2019, blog item.
EPA Issues Final SNUR For Carbon Nanomaterial (Generic) (PMN P-10-366): On November 25, 2019, EPA issued final significant new use rules (SNUR) for 22 chemical substances, including carbon nanomaterial (generic) (PMN P-10-366), that are the subject of premanufacture notices (PMN). 84 Fed. Reg. 64754. Persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by the SNURs to notify EPA at least 90 days before commencing that activity. The requirements of the final SNUR for carbon nanomaterial (generic) (PMN P-10-366) do not apply to quantities of the substance after they have been reacted (cured), incorporated, or embedded into a polymer matrix that itself has been completely reacted (cured), embedded in a permanent solid polymer, metal, glass, or ceramic form, or completely embedded in an article as defined at 40 C.F.R. Section 720.3(c). More information the SNUR is available in our November 25, 2019, blog item.
Researchers Find Nanotoxicity Studies May Be Affected By Nanoparticles Staying Behind In Syringes: On November 25, 2019, the EU Observatory for Nanomaterials (EUON) announced the publication of a study published in Frontiers in Pharmacology entitled “Unpredictable Nanoparticle Retention in Commonly Used Plastic Syringes Introduces Dosage Uncertainties That May Compromise the Accuracy of Nanomedicine and Nanotoxicology Studies.” The researchers in the study radiolabeled a variety of different nanoparticles, loaded suspensions of particles into different plastic syringes, and then measured the radioactivity left behind after emptying the nanoparticle suspension from the syringe. According to EUON, in the worst case, up to 79.1 percent of the nanoparticles remained. More information is available in our December 5, 2019, blog item.
White Paper Identifies Challenges Associated With Regulating Nanotechnology-Enabled Health Products In The EU: The EC’s Joint Research Center (JRC) recently published a white paper entitled Anticipation of regulatory needs for nanotechnology-enabled health products. The white paper notes that at this time, “no specific regulatory framework exists for nanotechnology-enabled health products but the current regulatory practice requires additional guidance in order to fully cover the particularities of such products.” The white paper identifies several major challenges associated with regulating nanotechnology-enabled health products. More information is available in our December 2, 2019, blog item.
ECHA Releases New, Updated Guidance Documents For Registering Nanoform Substances: On December 3, 2019, the European Chemicals Agency (ECHA) announced that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification. According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020. ECHA updated the Appendix for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals to reflect the advice of the new guidance document.
NTP Publishes Technical Report On Toxicity Studies Of 1020 Long Multiwalled Carbon Nanotubes: On December 5, 2019, the National Toxicology Program (NTP) announced that the NTP Technical Report on the Toxicity Studies of 1020 Long Multiwalled Carbon Nanotubes Administered by Inhalation to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats and B6C3F1/N Mice is now available. The abstract for the Technical Report states that 0.3 milligrams per cubic meter (mg/m3) is considered the no‑observed‑adverse‑effect level (NOAEL) for 1020 Long Multiwalled Carbon Nanotube (L-MWNT-1020). The abstract includes a detailed chart summarizing the findings considered to be toxicologically relevant in rats and mice exposed to L-MWNT-1020 by inhalation for 30 days. More information is available in our December 7, 2019, blog item.
ISO Standard Specifies Method For Testing Photocatalytic Activity Of Nanoparticles For NADH Oxidation: The International Organization for Standardization (ISO) has published standard ISO 20814:2019, “Nanotechnologies -- Testing the photocatalytic activity of nanoparticles for NADH oxidation.” The standard specifies a method for the measurement of the photocatalytic activity of nanoparticles (NP), suspended in an aqueous environment in physiologically relevant conditions, by measuring the UV-induced nicotine adenine dinucleotide hydrate (NADH) oxidation. According to ISO, the measurement is intended to assess the potential for the photo-toxicity of nanomaterials. The method is also applicable to NP aggregates and agglomerates.
EUON Publishes Nanopinion On Safe By Design Approach To Nanomaterials: On December 11, 2019, EUON published a Nanopinion entitled “The innovator, the regulator and the citizen -- building public trust through transparent, empowered and safe innovation.” Carlos Eduardo Lima da Cunha, the EC, explains how the EU is supporting safe by design approaches to new technologies such as nanomaterials to deliver safer products to the market.
EC’s JRC Publishes Report On Identifying Nanomaterials Through Measurements: The EC’s JRC recently published a JRC Science for Policy Report entitled Identification of nanomaterials through measurements that is intended to support the implementation of the EC’s Recommendation on the definition of nanomaterials (2011/696/EU). The report addresses identification of nanomaterials by measurements and discusses options and points to consider when assessing whether a particulate material is a nanomaterial, according to the definition of nanomaterials. JRC provides examples and practical options for consideration, including a flowchart that can assist users with relevant technical knowledge in the identification of nanomaterials.
9th Nano Conference Will Be Held In October 2020: The Sustainable Nanotechnology Organization (SNO) and Nanotechnology, Occupational and Environmental Health (NanOEH) committees will host the 9th Nano Conference October 4-6, 2020. The Conference will address:
- Green/advanced synthetic materials and manufacturing;
- Nanomedicine, nanodrugs, and pharmaceutical and medical applications;
- Nanotoxicology related to humans;
- Occupational and environmental exposure assessment;
- Global challenges;
- Sustainable water treatment and remediation;
- Fate and transport;
- Sustainable food and agriculture;
- Sustainability and energy;
- Devices and sensors;
- Education panel; and
- Regulation and policy.
The Conference will be held in Denver, Colorado.
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.
Bipartisan Task Force Launched On EtO: On November 20, 2019, Representatives Jody Hice (R-GA) and Brad Schneider (D-IL) announced the formation of a bipartisan congressional task force focused on addressing “the threat of ethylene oxide (EtO) emissions and urging EPA to act” on the chemical. EPA has “yet to issue revised regulations to ensure that the air people are breathing near these facilities is absolutely safe,” Representative Schneider stated. The task force is “calling on the EPA to come up with new regulations, something that should have been done a long time ago,” Representative Hice added. Other members of the task force include Representatives Hank Johnson (D-GA), Barry Loudermilk (R-GA), David Scott (D-GA), Dan Lipinski (D-IL), Sean Casten (D-IL), Bill Foster (D-IL), Lauren Underwood (D-IL), and Susan Wild (D-PA). Many of the task force members are co-sponsors of H.R. 1152, which would require EPA to issue new, strict EtO emissions standards for medical sterilization and chemical facilities and require EPA to notify the public no more than 30 days after it learns that the new standards have been violated.
House Committees Pass Bill Reauthorizing PHMSA: On November 20, 2019, the House Energy and Commerce Committee and Transportation and Infrastructure Committee passed legislation (H.R. 3432) to reauthorize the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA). The Safe, Accountable, Fair and Environmentally Responsible (SAFER) Pipelines Act of 2019 would reauthorize PHMSA through Fiscal Year (FY) 2024. The bill would make significant changes to PHMSA’s operating requirements. Among other things, the legislation would:
- Require operators of gas pipeline facilities to use the best available technology to capture gas released while performing routine operations or maintenance;
- Require automatic shutoff or remote-controlled valves on pipelines;
- Require advanced leak-detection technology on gas pipelines;
- Increase maximum civil penalties from $200,000 to $20 million per violation;
- Strengthen criminal penalties;
- Require PHMSA to promulgate a final rule on gas gathering lines; and
- Require pipeline operators to repair immediately major gas leaks on their pipeline systems.
House Committee Passes Package Of PFAS Bills: On November 20, 2019, the House Energy and Commerce Committee passed several bills addressing PFAS. Chief among these is the PFAS Action Act (H.R. 535). That bill would require EPA to list PFAS as CERCLA hazardous substances. The Committee also passed the following bills:
- H.R. 2377 -- This bill requires EPA to address the level of PFAS in drinking water. Specifically, EPA must publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for total PFAS;
- H.R. 2533 -- The legislation would create a grant program to pay for treatment of water systems contaminated with PFAS;
- H.R. 2566 -- Legislation that would require EPA to revise the Safer Choice Standard to provide for a label for pots, pans, and cooking utensils that do not contain PFAS;
- H.R. 2570 -- A bill that would require polluters to pay for ongoing water treatment costs associated with PFAS contamination;
- H.R. 2577 -- Legislation adding PFAS to the list of chemicals requiring reporting under the TRI;
- H.R. 2591 -- A measure banning the incineration of firefighting foam that contains PFAS as an ingredient;
- H.R. 2596 -- Legislation amending TSCA to require that PFAS manufacturers demonstrate to EPA that their products do not pose an unreasonable risk;
- H.R. 2600 -- This bill would amend TSCA to prohibit the manufacture of PFAS;
- H.R. 2605 -- This bill requires EPA to issue a final rule adding PFAS to the CAA list of hazardous air pollutants; and
- H.R. 2608 -- Legislation requiring health testing under TSCA for PFAS.
Lawmakers Introduce Bill To Get U.S. To Net Zero Emissions By 2050: On November 21, 2019, Representative A. Donald McEachin (D-VA) introduced the 100% Clean Economy Act of 2019,with Representatives Deb Haaland (D-NM), Debbie Dingell (D-MI), Earl Blumenauer (D-OR), Paul Tonko (D-NY), and Chellie Pingree (D-ME). The legislation sets a nationwide goal of achieving a 100 percent clean energy economy by 2050, defined as net-zero climate pollution across all sectors of the United States’ economy. The bill directs federal agencies to use all existing authorities to put the U.S. on a path toward meeting the achievable 100 percent clean economy goal while remaining technology-neutral. The legislation directs EPA to evaluate agency plans, make recommendations to strengthen them as needed, and report each year on progress toward a 100 percent clean economy. The bill also creates an advisory committee, composed of a broad range of stakeholders, to provide recommendations on one or more interim goals.
Senate Bill Seeks To Boost Recycling Programs: On November 22, 2019, Senators Debbie Stabenow (D-MI) and Rob Portman (R-OH) introduced legislation -- S. 2941, the RECYCLE Act-- to create a new federal grant program through EPA to help educate households and consumers about their residential and community recycling programs. This legislation seeks to boost recycling rates and reduce contamination in the recycling stream. According to EPA, the recycling rate in the U.S. is 35.2 percent and $9 billion worth of recyclable materials are thrown away each year. The RECYCLE Act would authorize $15 million a year over five years in grants to states, local governments, Indian tribes, nonprofits, and public private partnerships to educate and inform consumers and households about their residential and community recycling programs. It also would direct EPA to develop a model recycling program toolkit for states, local governments, Indian tribes, and partners to improve recycling rates and decrease contamination in the recycling stream. The legislation also would require EPA to review and revise its Comprehensive Procurement Guidelines, which designate products containing recycled materials and provides recommended practices for federal agencies to purchase such products.
Legislation Would Require Climate Change Be Considered In Transportation Projects: On December 6, 2019, Representative Jared Huffman (D-CA) introduced the Generating Resilient, Environmentally Exceptional National (GREEN) Streets Act (H.R. 5354). The bill attempts to reduce emissions from the U.S. transportation sector by redefining the fundamental goals of the federal transportation program and by increasing accountability for greenhouse gas pollution. Senator Ed Markey (D-MA) introduced companion legislation in the Senate earlier this year. The GREEN Streets Act would direct DOT to work with states to reduce greenhouse gas emissions by cutting down on the amount of driving that is necessary for people to go about their day. Strategies can include increasing the accessibility of schools, workplaces, and transit, as well as improving infrastructure for biking or walking. The bill:
- Directs the Secretary of Transportation to establish minimum standards for states to use to decrease greenhouse gas emissions and per capita vehicle miles traveled (VMT) on the National Highway System.
- Directs the Secretary to establish measures that states can use to assess and reduce carbon dioxide and other greenhouse gas emissions on the National Highway System.
- Requires states that have fallen out of compliance with the per capita vehicle miles traveled standards or carbon dioxide or greenhouse gas emission measures to dedicate federal highway funding to come into compliance.
- Requires states and Metropolitan Planning Organizations (MPO) to consider projects and strategies that reduce per capita vehicle miles traveled and reduce greenhouse gas emissions from the transportation sector.
- Requires states and MPOs to publish an analysis of the impact on per capita vehicle miles traveled and mobile source greenhouse gas emissions for each project that adds new lanes or otherwise increases traffic capacity and costs more than $25 million.
- Establishes national goals for the federal-aid highway program to reduce greenhouse gas emissions and adapt to the adverse effects of climate change.
Bill Would Amend CWA Citizen Suit Provisions: On December 6, 2019, Representative Tom Rice (R-.C) introduced legislation to amend the CWA to streamline the permitting process for infrastructure projects and hold “special interest groups accountable for filing frivolous lawsuits.” H.R. 5341, the Discouraging Frivolous Lawsuits Act, seeks to reduce the delays and costs caused when EPA and “special interest groups” unnecessarily stall infrastructure projects. The bill would remove EPA’s authority to veto wetland permitting projects. It also would create a “loser pays” citizen suit structure to pardon prevailing parties from legal and court fees associated with challenging a permit decision and requires the losing party to pay the costs.
Senate Bill Would Require EPA To Set PFAS Limits Under CWA: On December 4, 2019, Senator Kirsten Gillibrand (D-NY) introduced a bill that would limit the levels of PFAS in water sources. The bill (S. 2980) would require EPA to determine the sources of PFAS contamination in waterbodies and set protective limits on how much of the chemical can be released.
House Passes Sustainable Chemistry Bill: On December 9, 2019, by voice vote, the House passed the Sustainable Chemistry Research and Development Act (H.R. 2051). Introduced on April 3, 2019, by Representative Dan Lipinski (D-IL), the legislation is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems. The bill would seek to support innovations in chemistry that benefit the economy, the environment, and human health. The bill encourages the development of new and innovative chemicals, products, and processes with an improved environmental footprint through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment. A March 2018 Government Accountabilty Office (GAO) report (GAO-18-307) outlined how sustainable chemistry can inspire new products and processes, create jobs, and enhance benefits to human health and the environment. It also identified options for addressing challenges, such as establishment of a national initiative to support sustainable chemistry research and education and the development of tools for assessing sustainable chemistry products and processes. The bill would establish a coordinating entity under the National Science and Technology Council within the White House Office of Science and Technology Policy. The agencies involved in this entity will work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the U.S. and coordinate federal efforts in sustainable chemistry. The agencies would include EPA, the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, the U.S. Department of Agriculture, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, FDA, and others. They would be encouraged to include sustainable chemistry in their existing research, development, technology transfer, commercialization, education, and training programs, including support for partnerships between universities and the private sector. Finally, the legislation encourages the validation of tools for assessment of sustainable chemistry processes or products. This bill does not include any regulatory components or authorize new spending. Senator Chris Coons (D-DE) introduced a companion bill in the Senate (S. 999). The Senate Committee on Commerce, Science, and Transportation approved that bill on November 13, 2019, paving the way for Senate consideration of the bill and, possibly, passage by both houses of the legislation.
ATSDR Issues Draft Toxicological Profiles: On December 9, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the release of draft toxicological profiles for seven substances. 84 Fed. Reg. 66898. The profiles released by ATSDR address:
- Di(2-ethylhexyl)phthalate (DEHP);
- Hexachlorobutadiene; and
The draft profiles are available online. ATSDR will receive comments on the draft profiles until March 5, 2020.
Trump Administration Releases Regulatory Reform Results For FY 2019: The Trump Administration has released a report detailing the results of its regulatory reform efforts. In the report -- Regulatory Reform under Executive Order 13771: Final Accounting for Fiscal Year 2019 -- the Office of Information and Regulatory Affairs (OIRA) compiles the regulatory reform results from FY 2019. President Trump emphasized the importance of reducing regulatory burdens and directed agencies to issue two deregulatory actions for each new regulatory action and to cap their total incremental costs in Executive Order 13771 ("Reducing Regulation and Controlling Regulatory Costs," January 30, 2017). According to the report, the federal government in FY 2019 eliminated 150 regulatory actions and eliminated approximately $13.5 billion in overall regulatory costs across the government. Federal agencies also issued 35 significant regulatory actions. The ratio of deregulatory actions to regulatory actions was 4.3 to 1 for FY 2019 with 61 of the deregulatory actions deemed significant. EPA implemented 18 deregulatory actions in FY 2019 and promulgated six significant regulations. The report also states that in FY 2020, federal agencies anticipate saving a total of $51.6 billion in regulatory costs from final rules.
EPA Seeks Nominations For Environmental Financial Advisory Board: EPA is seeking nominations of candidates for the Environmental Financial Advisory Board (EFAB). 84 Fed. Reg. 63874. Nominations are due no later than January 6, 2020. The EFAB is a chartered federal advisory committee that provides ideas and advice to EPA on innovative ways to lower the costs of, and increase investments in, environmental and public health protection. EPA seeks nominations across all workforce sectors and geographic regions. Nominees should demonstrate experience in environmental finance and/or reducing the cost of financing environmental protection in various environmental media. The type of experience and expertise sought for the board includes, but is not limited to: brownfields, commercial banking, energy efficiency, environmental and financial resiliency, infrastructure financing, insurance markets, local utility management and finance, public-public and public-private partnerships, regulators, resource conservation, sustainable community partnerships, and drinking water and wastewater utility financial management. Additional information is available online.