B&C Presents Webinar Regarding Chemical Law And Policy Implications Of The Election, January 28, 2021: Bergeson & Campbell, P.C.’s (B&C®) friends and clients are invited to attend “What To Expect When You’re Electing (a New President),” a webinar focusing on the incoming Biden Administration including what policies and initiatives can be expected in the next four years and how any likely regulatory directions may affect our clients. Register online for this webinar, which will be presented Thursday, January 28, 2021, at 1:00 p.m. (EST).
Lynn L. Bergeson And Lara A. Hall Publish “M&A activity in the analytical services sector: points to consider,” In Financier Worldwide: There has been remarkable consolidation in the analytical services sector in the United States and elsewhere globally over the past few years. Make no mistake; the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialized expertise is also growing exponentially. This article summarizes mergers and acquisitions (M&A) trends and explains why skilled help is essential to avoid liability. A PDF of this article can be downloaded here.
B&C And Acta To Publish Forecast 2021: Start 2021 with the information you need — B&C and The Acta Group (Acta®) will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2021 the first week of January 2021. 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 given the many developments that will shape the agenda for chemicals and chemical products under a new Administration in the coming year, the 2021 edition will be more vital than ever.
EPA Proposes SNURs For Certain Chemical Substances: On November 16, 2020, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for certain chemical substances that are the subject of premanufacture notices (PMN). 85 Fed. Reg. 73007. The proposed SNURs would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The proposed SNURs would further require that persons not commence manufacture or processing for the significant new use until they have submitted a significant new use notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice under the Toxic Substances Control Act (TSCA), and has taken any risk management actions as are required as a result of that determination. Comments are due December 16, 2020.
EPA Announces Implementation Of Electronic Gold Seal Letter For Exporting Pesticides: On November 16, 2020, EPA announced that it will now provide pesticide registrants with electronic Certificates of Registration, commonly known as “Gold Seal” letters. A Gold Seal letter from EPA certifies that a product to be exported is registered with EPA and meets all necessary registration requirements. EPA states that this improved process will allow for the electronic Gold Seal letters to be e-mailed to registrants rather than physically mailed. More information on the new process is available in our blog.
EPA Proposes To Amend Significant New Uses Of Certain Chemical Substances: On November 18, 2020, EPA proposed to amend SNURs for certain chemical substances that were the subject of a PMN and a SNUN. 85 Fed. Reg. 73439. EPA states that it is proposing the amendments following review of SNUNs for the chemical substances and based on review of new and existing data. Specifically, EPA proposes to amend the SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions. Comments are due December 18, 2020.
EPA Seeks Comment On Supplemental Analysis To Draft Risk Evaluation Of 1,4-Dioxane: On November 20, 2020, EPA announced the availability of a supplemental analysis to the draft risk evaluation of 1,4-dioxane under TSCA. 85 Fed. Reg. 74341. EPA states that it developed the supplemental analysis in response to public and peer review comments on the draft risk evaluation. The supplemental analysis includes eight consumer uses, including surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer, where 1,4-dioxane is present as a byproduct. The supplemental analysis also assesses exposure to the general population from 1,4-dioxane in surface water. In the supplemental analysis, EPA preliminarily found no unreasonable risk to consumers from the eight conditions of use assessed. EPA also preliminarily found no unreasonable risks under any of the conditions of use to the general population from exposure to 1,4-dioxane. Comments were due December 10, 2020.
EPA Extends Comment Period For Draft Risk Evaluation For PV29: On November 23, 2020, EPA extended the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 (PV29). 85 Fed. Reg. 74718. As reported in our October 29, 2020, blog item, EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer. EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use. Comments are due December 19, 2020.
EPA Evaluates 54 Conditions Of Use For TCE, Finding That 52 Present An Unreasonable Risk: On November 24, 2020, EPA released the final risk evaluation for trichloroethylene (TCE). 85 Fed. Reg. 75010. Of the 54 conditions of use that EPA reviewed, EPA found that 52 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders. EPA determined that distribution in commerce and consumer use of TCE in pepper spray do not present an unreasonable risk. EPA also found no unreasonable risks to the environment. EPA’s next step in the process required by TSCA is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation. EPA states that it “is moving immediately to risk management for this chemical and will work to propose and finalize actions to protect workers, occupational non-users, consumers, and bystanders.” The potential actions that EPA could take to address these risks include regulating how TCE is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of TCE, as applicable. As with any chemical product, EPA “strongly recommends that users of products containing TCE continue to carefully follow all instructions on the product’s label and safety data sheet.” For more information, please read the full memorandum.
EPA Seeks Comments On Updated Draft Guidance For Pesticide Registrants On Plant Regulators And Claims, Including Plant Biostimulants: On November 24, 2020, EPA announced the availability of, and requested comments on, the updated Draft Guidance for Plant Regulator Products and Claims, Including Plant Biostimulants (Draft Guidance). The original Draft Guidance (2019 Draft Guidance) was made available on March 27, 2019. EPA states that the updated Draft Guidance “incorporates diverse and helpful changes made in response to stakeholder feedback” received during the initial comment period in 2019 and “clarifies which biostimulants, biological substances, and mixtures, in addition to the associated product label claims, EPA considers plant regulators.” EPA is now seeking comments on those changes. Comments on the updated Draft Guidance are due on or before December 30, 2020, in docket EPA-HQ-OPP-2018-0258. 85 Fed. Reg. 76562. EPA states that it anticipates issuing the Draft Guidance in final form in January 2021. More information is available in our blog.
EPA Extends CDR Submission Period To January 29, 2021: On November 25, 2020, EPA amended the Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2020 reports to January 29, 2021. 85 Fed. Reg. 75235. The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory to report data on the manufacturing, processing, and use of the chemical substances. The final rule was effective November 25, 2020.
EPA Releases Updates To List Of Companies Subject To Fees For Risk Evaluations: On November 25, 2020, EPA released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under TSCA Section 6(b). According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the purpose of research and development.” EPA stated it is committed to ensuring this list is accurate and that it planned to use this updated list to begin invoicing for fees in early November. EPA also stated that due to the public health emergency, EPA is exploring options for payment flexibilities. More information is available in our December 7, 2020, blog item.
EPA Releases Draft Scope Documents For Risk Evaluations Of DIDP And DINP For Public Comment: On November 27, 2020, EPA announced the availability of the draft scope documents for the manufacturer-requested risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 85 Fed. Reg. 76077; 85 Fed. Reg. 76072. EPA notes in its November 25, 2020, announcement that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility.” EPA seeks public input on the draft scope documents, which include the conditions of use to be included in the risk evaluations, the next step in the process. Comments on the draft scope documents are due January 11, 2021. EPA will use public comments to inform the final scope documents. More information is available in our full memorandum.
Jeffery Morris, Former OPPT Director, Describes How TSCA Can Be Used To Examine Chemical Exposure Impacts On Tribal And Fenceline Populations: On November 30, 2020, Bloomberg Law Environment & Energy Report published a Practitioner Insight column entitled “The Toxic Substances Control Act Under Biden: Impact on Tribal, Fenceline Populations” by Jeffery Morris, former Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and founder of Jeff Morris Solutions LLC. Morris examines how the Biden Administration could apply TSCA’s requirement to consider impacts on subpopulations in the evaluation of chemical risks. Morris notes that fenceline communities and American Indian and Alaskan Natives (referred to as “tribes” in the article, “recognizing that not all native people are in federally recognized tribes”) have faced significant impacts from chemical exposure and should be priorities.
EPA Seeks Participants For Small Business Review Panel On Carbon Tetrachloride And TCE Risk Management Rulemaking: On November 30, 2020, EPA announced that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels. One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed TSCA risk evaluation for carbon tetrachloride. The second Panel will focus on a risk management rulemaking for trichloroethylene (TCE). Self-nominations were due December 14, 2020. More information is available in our December 11, 2020, blog item.
EPA Issues Final SNURs For Certain Chemical Substances: On December 7, 2020, EPA published final SNURs for certain chemical substances that were the subject of PMNs and are subject to Orders issued by EPA pursuant to TSCA. 85 Fed. Reg. 78743. The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The required notification initiates EPA’s evaluation of the chemical under the conditions of use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required as a result of that determination. The SNURs will be effective on February 5, 2021.
EPA Issues Proposed Interim Registration Review Decision To Require New Risk Mitigation Measures For Chlorpyrifos: On December 7, 2020, EPA issued for comment the Proposed Interim Decision (PID) for chlorpyrifos. 85 Fed. Reg. 78849. EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments. Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021. EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments. Comments can be submitted at EPA-HQ-OPP-2008-0850. More information is available in our December 10, 2020, blog.
EPA Receives Manufacturer Request For Risk Evaluation Of Chemical Category Under TSCA Section 6: On December 8, 2020, EPA announced that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers. International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM). According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan. EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.” Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
TSCA Fees Rule For EPA-Initiated Risk Evaluations: An Opaque And Evolving Story: On December 10, 2020, B&C sent a memorandum to its clients and friends that provides a summary of the several updates and adjustments made to the lists of manufacturers of the 20 high-priority chemical substances undergoing risk evaluation subject to fee obligations. After the summary, our commentary includes information on invoices EPA has transmitted to certain manufacturers, exemptions that have been granted, and recommended actions for EPA to address the issues that have arisen in the early stages of TSCA Fees Rule implementation. For more information, please read the full memorandum.
EPA Publishes Draft Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On December 10, 2020, EPA announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final SNUR that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. The draft guide will be “the official compliance guide for imported articles that may contain long-chain perfluoroalkyl carboxylate chemical substances as part of a surface coating.” According to EPA, the draft guide provides additional clarity on what is meant by a “surface coating”; identifies which entities are regulated; describes the activities that are required or prohibited; and summarizes the notification requirements of the final SNUR. EPA intends to publish a notice in the Federal Register announcing the availability of the draft guidance and beginning a 30-day comment period. More information is available in our full memorandum.
EPA Releases Final Risk Evaluation For Perchloroethylene, Finds Almost All Conditions Of Use Present Unreasonable Risks To Workers, ONUs, Consumers, And Bystanders: On December 14, 2020, EPA released the final risk evaluation for perchloroethylene. The final risk evaluation determined that there are unreasonable risks to workers, ONUs, consumers, and bystanders from 59 out of 61 conditions of uses:
- Consumers and Bystanders: EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene. Common consumer uses include as a dry cleaning solvent; in cleaning and furniture care products; automotive care products like brake cleaners, lubricants, and greases; and adhesives in arts and crafts. The risk to consumers from perchloroethylene’s use in dry cleaning is from short-term skin exposure to items cleaned with perchloroethylene; and
- Workers and ONUs: EPA found unreasonable risks to workers from all but two occupational uses of perchloroethylene. Additionally, EPA found unreasonable risks from most commercial uses of perchloroethylene to workers nearby but not in direct contact with perchloroethylene (known as ONUs). This includes an unreasonable risk to workers and ONUs when domestic manufacturing or importing perchloroethylene; processing as a reactant and intermediate; incorporation into cleaning and degreasing products; uses in a variety of industrial and commercial applications such as degreasing, dry cleaning, in adhesives and sealants, and in paints and coatings; and disposal. The primary health risk identified in the final risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene. The conditions of use in the final risk evaluation that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.
EPA found no unreasonable risks to the environment. The next step in the process required by TSCA is developing a plan to address the unreasonable risks identified in the final risk evaluation. More information will be available in a forthcoming memorandum that will be posted on our website.
EPA Announces Annual Pesticide Maintenance Fee Forms Available To Download From EPA Website — Deadline For Paying Is January 15, 2021: The January 15, 2021, deadline for payment of EPA’s annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) 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, which are identified by a three-element registration number. This year, due to the COVID-19 pandemic, EPA states that most EPA staff continues to telework and is not in the EPA offices; therefore, EPA will not send maintenance fee information by mail this year. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to [email protected]. A paper copy should not be sent to EPA. For more information, please see our blog.
OSHA Updates FAQs To Address Cloth Face Coverings As PPE: On November 18, 2020, the Occupational Safety and Health Administration (OSHA) announced that it has updated its frequently asked questions (FAQ) to address whether OSHA considers cloth face coverings to be personal protective equipment (PPE). OSHA states that it is addressing the topic after the Centers for Disease Control and Prevention (CDC) “recently determined that some cloth face coverings may serve as source control while also providing the wearer with some personal protection.” According to OSHA, the FAQs state that OSHA “does not believe enough information is currently available to determine if a particular cloth face covering provides sufficient protection from the coronavirus hazard to be personal protective equipment under OSHA’s standard.” OSHA states that its determination “is consistent with statements made by the CDC, which has stated it needs more research on cloth facemasks’ protective effects, particularly on the combination of materials that maximize blocking and filtering effectiveness.” OSHA notes that it “continues to encourage workers strongly to wear face coverings when in close contact with others to reduce the risk of spreading the coronavirus, if it is appropriate for the work environment.”
FDA Webinar Series On PPE For Health Care Personnel: On December 8, 2020, the U.S. Food and Drug Administration (FDA) held a webinar, as part of the ongoing series on PPE entitled Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The webinar covered FDA guidance on performance parameters for demonstrating the effectiveness of disinfecting devices and provides recommendations for validation of cleaning and disinfection procedures. The slides are available on the FDA site. In addition, all the previous webinar content from the series is available to review.
Final Rule Allows Reclassification Of Major Sources As Area Sources: On November 19, 2020, EPA published a final rule amending the general provisions that apply to the National Emission Standards for Hazardous Air Pollutants (NESHAP). 85 Fed. Reg. 73854. The amendments implement the plain language reading of the “major source” and “area source” definitions of Section 112 of the Clean Air Act (CAA) and provide that a major source can be reclassified to area source status at any time upon reducing its potential to emit (PTE) hazardous air pollutants (HAP) to below the major source thresholds (MST) of ten tons per year (tpy) of any single HAP and 25 tpy of any combination of HAP. The amendments also clarify the compliance dates, notification, and recordkeeping requirements that apply to sources choosing to reclassify to area source status and to sources that revert back to major source status, including a requirement for electronic notification. The final rule is effective on January 19, 2021.
EPA Announces Interim Strategy To Address PFAS Through Certain EPA-Issued Wastewater Permits: On November 30, 2020, EPA announced two steps intended to address PFAS. First, EPA issued a memorandum detailing an interim National Pollutant Discharge Elimination System (NPDES) permitting strategy for addressing PFAS in EPA-issued wastewater permits. EPA is the permitting authority for three states (Massachusetts, New Hampshire, New Mexico), the District of Columbia, most U.S. territories, and certain federal facilities. The strategy advises EPA permit writers to consider including PFAS monitoring at facilities where PFAS are expected to be present in wastewater discharges, including from municipal separate storm sewer systems and industrial stormwater permits. Second, EPA released information on progress in developing new analytical methods to test for PFAS compounds in wastewater and other environmental media. EPA is developing analytical methods in collaboration with the U.S. Department of Defense to test for PFAS in wastewater and other environmental media, such as soils. EPA states that “[t]ogether, these actions help ensure that federally enforceable wastewater monitoring for PFAS can begin as soon as validated analytical methods are finalized.”
EPA Seeks Nominations For SAB BenMAP Review Panel: On December 1, 2020, EPA requested public nominations of scientific experts to form a Science Advisory Board (SAB) panel to review the Environmental Benefits Mapping and Analysis Program (BenMAP) model, an open-source computer program that calculates estimated air pollution-related deaths and illnesses and their associated economic value. 85 Fed. Reg. 77211. The Panel will review the latest available public release version of the BenMAP software. Nominations are due December 29, 2020.
EPA Issues Final Decisions Not To Impose Financial Responsibility Requirements Under CERCLA For Facilities In Three Industry Sectors: On December 2, 2020, EPA announced that it is issuing final decisions not to impose financial responsibility requirements under Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for facilities in the electric power generation, transmission, and distribution industry; the petroleum and coal products manufacturing industry; and the chemical manufacturing industry. 85 Fed. Reg. 77384. EPA states that the final rulemakings are based on the individual administrative records for each of the three proposed rulemakings, supported by additional analysis conducted in consideration of comments received in the public comment period for each proposed rule. In particular, according to EPA, after examining the existing environmental protections and regulations currently in place and analyzing the Superfund program’s experience cleaning up sites in each industry, EPA concluded that facilities in these three industries operating under a modern regulatory framework do not present a level of risk that warrants financial responsibility requirements under CERCLA Section 108(b). EPA notes that the final rulemakings do not affect its authority to take a response or enforcement action under CERCLA with respect to any particular facility or industry, and do not affect EPA’s authorities that may apply to particular facilities under other environmental statutes. The final actions will be effective on January 4, 2021.
EPA Streamlines Fuel Quality Regulations: On December 4, 2020, EPA issued a final rule that updates many of EPA’s existing gasoline, diesel, and other fuel quality programs to improve overall compliance assurance and maintain environmental performance, while reducing compliance costs for industry and EPA. 85 Fed. Reg. 78412. EPA states that it is streamlining existing fuel quality regulations by removing expired provisions, eliminating redundant compliance provisions (e.g., duplicative registration requirements that are required by every EPA fuels program), removing unnecessary and out-of-date requirements, and replacing them with a single set of provisions and definitions that applies to all gasoline, diesel, and other fuel quality programs. The rule will be effective on January 1, 2021, except for amendatory instructions 48, 51, and 52, which were effective on December 4, 2020, and amendatory instructions 16, 18, and 19, which will be effective on January 1, 2022.
EPA Announces Final Decision To Retain Existing NAAQS For Primary And Secondary PM: On December 7, 2020, EPA announced its final decision to retain the current National Ambient Air Quality Standards (NAAQS) for particulate matter (PM), without revision. The pre-publication version of the Federal Register notice announcing the final action states that EPA has established primary (health-based) and secondary (welfare-based) NAAQS for PM2.5 (particles with diameters generally less than or equal to 2.5 micrometers (µm)) and PM10 (particles with diameters generally less than or equal to 10 µm). This includes two primary PM2.5 standards, an annual average standard with a level of 12.0 micrograms per cubic meter (µg/m3) and a 24-hour standard with a 98th percentile form and a level of 35 µg/m3. It also includes a primary PM10 standard with a 24-hour averaging time, a 1-expected exceedance form, and a level of 150 µg/m3. Secondary PM standards are set equal to the primary standards, except that the level of the secondary annual PM2.5 standard is 15.0 µg/m3. According to EPA, in reaching decisions on these PM standards in the current review, the Administrator considered the available scientific evidence assessed in the Integrated Science Assessment (ISA), analyses in the Policy Assessment (PA), advice from the Clean Air Scientific Advisory Committee (CASAC), and public comments on the proposal. The final action will be effective when published in the Federal Register.
EPA Seeks Information On Beneficial Use And Piles Of Coal Ash: On December 9, 2020, EPA announced that is seeking information and data related to the beneficial use and piles of coal combustion residuals (CCR, commonly known as coal ash). According to EPA, it received new information and data pertaining to its August 14, 2019, proposed rule. EPA seeks public comment on whether this additional information may inform its reconsideration of the beneficial use definition and provisions for CCR accumulations. EPA also is accepting additional information and data from the public that may further help inform its reconsideration of the beneficial use definition and provisions for CCR accumulations, such as information on how coal ash is beneficially used that can help EPA distinguish among the different types of beneficial use applications; information on the management of coal ash at each point in its distribution system; and information on federal, state, and local program provisions and regulations related to beneficial use and CCR accumulations. EPA is requesting comment only on those two issues. Publication of the notice of data availability in the Federal Register will begin a 60-day comment period. A pre-publication of the notice is available online.
EPA Releases Final Rule Intended To Increase Consistency And Transparency In Considering Benefits And Costs In CAA Rulemaking Process: On December 9, 2020, EPA released a pre-publication version of its final rule establishing processes that EPA will be required to undertake in promulgating regulations under the CAA to ensure that information regarding the benefits and costs of regulatory decisions is provided and considered in a consistent and transparent manner. EPA states that it is establishing procedural requirements governing the preparation, development, presentation, and consideration of benefit-cost analyses (BCA), including risk assessments used in the BCA, for significant rulemakings conducted under the CAA. Together, these requirements are intended to help ensure that EPA implements its statutory obligations under the CAA, and describes its work in implementing those obligations, in a way that is consistent and transparent. According to EPA’s fact sheet, the final rule consists of three main requirements:
- EPA will prepare a BCA for all future significant proposed and final regulations under the CAA. EPA anticipates significant regulations will include those with the largest annual impact on the economy; those that would disproportionately affect an industry, group, or area; or those that are novel or relevant for other policy reasons;
- The BCA are developed in accordance with best practices from the economic, engineering, physical, and biological sciences. The rule outlines required elements of BCAs, following established protocols for conducting best cost analyses published by the Office of Management and Budget (OMB) and further elaborated in EPA’s “Guidelines for Preparing Economic Analyses.” These include addressing all key elements of a BCA and — to the extent permitted by law — making underlying data available to the public; and
- EPA must increase transparency in the presentation of the benefits and costs resulting from significant CAA regulations. In addition to a clear reporting of the overall results of the BCA, EPA will require separate reporting of the public health and welfare benefits that are specific to the objective of the CAA provision under which the rule is promulgated.
The final rule will be effective the date it is published in the Federal Register, but EPA notes that it does not apply to final rules for which a proposal was published prior to the effective date.
EPA Issues Draft Guidance Intended To Clarify Wastewater Permit Requirements Under Maui Decision: On December 10, 2020, EPA announced the availability of draft guidance that is intended to clarify how the Supreme Court’s County of Maui v. Hawaii Wildlife Fund decision should be applied under the Clean Water Act (CWA) NPDES permit program. 85 Fed. Reg. 79489. As reported in our April 27, 2020, blog item, the Supreme Court held that an NPDES permit is required for the discharge of pollutants from a point source that reaches “waters of the United States” after traveling through groundwater if that discharge is the “functional equivalent of a direct discharge from the point source into navigable waters.” EPA states in its December 8, 2020, press release that the Maui decision outlines seven non-exclusive factors that the regulated community and permitting authorities should consider when evaluating such a discharge from a point source, depending on the circumstances. EPA’s draft guidance places the “functional equivalent” analysis into context within the NPDES permit program. EPA notes that the draft guidance “reiterates the threshold conditions for triggering the requirement for a NPDES permit — an actual discharge of pollutants from a point source to a water of the United States.” The guidance also proposes that the design and performance of the system or facility from which the pollutant is released is an additional factor that should be considered. Comments are due January 11, 2021.
EPA Launches New Clearinghouse For Environmental Finance: On December 10, 2020, EPA announced the launch of the Clearinghouse for Environmental Finance (Clearinghouse), an online database of land, air, and water information. According to EPA, the new Clearinghouse catalogues available funding, financing, and instructional resources to aid communities in their efforts to improve environmental conditions. The new Clearinghouse expands on the concept of the original Water Finance Clearinghouse and includes over 1,800 funding and financing opportunities and information resources from EPA’s air, water, and land programs. EPA suggests that communities can use this system to access information on funding and financing opportunities for environmental projects as well as financial research, such as case studies, white papers, and webinars.
EPA Expands List Of Acceptable Substitutes In Different SNAP End-Uses: On December 11, 2020, EPA published a determination of acceptability that expands the list of acceptable substitutes pursuant to EPA’s Significant New Alternatives Policy (SNAP) program. 85 Fed. Reg. 79863. The action lists as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, and fire suppression sectors. EPA states that its review of certain substitutes listed in the Federal Register notice is pending for other uses. EPA notes that listing decisions in the end-uses and applications in the notice do not prejudge EPA’s listings of these substitutes for other end-uses. The determination was applicable on December 11, 2020.
OECA Issues Tampering Policy, Requests Information On 1986 Catalyst Policy: On December 14, 2020, EPA announced that its Office of Enforcement and Compliance Assurance has issued EPA Tampering Policy: The EPA Enforcement Policy on Vehicle and Engine Tampering and Aftermarket Defeat Devices under the Clean Air Act (EPA Tampering Policy). 85 Fed. Reg. 80782. According to EPA, the EPA Tampering Policy states how it intends to handle certain potential civil violations of the CAA’s prohibitions on tampering with vehicle and engine emissions controls, as well as the manufacturing, selling, offering to sell, and installation of parts and components that defeat emissions controls. EPA notes that the EPA Tampering Policy “creates no obligations on regulated parties, and it is not a rule. Further, it is principally a restatement of currently applicable enforcement discretion policies.” The EPA Tampering Policy supersedes and replaces former statements of enforcement policy, but “neither supersedes nor replaces a 1986 enforcement policy that is specific to replacement catalytic converters for light-duty gasoline motor vehicles that are beyond their emissions warranty.” EPA requests information relevant to its ongoing evaluation of the 1986 catalyst policy and potential future enforcement policy regarding replacement catalytic converters for light-duty gasoline motor vehicles that are beyond their emissions warranty. Comments are due February 12, 2021.
EPA Extends Comment Period On ANPRM For Legacy CCR Surface Impoundments: On December 14, 2020, EPA extended the comment period on an October 14, 2020, advance notice of proposed rulemaking (ANPRM) seeking comments and data on inactive CCR surface impoundments at inactive facilities to assist in the development of future regulations for these CCR units. 85 Fed. Reg. 80718. The ANPRM also discusses the related research conducted to date, describes EPA’s preliminary analysis of that research, and seeks additional data and public input on issues that may inform a future proposed rule. Comments are due February 12, 2021.
FDA Regulatory Clean Up Amendments: On November 16, 2020, FDA informed the public of non-substantive changes to the U.S Department of Health and Human Services (HHS) regulations to make miscellaneous corrections (e.g., correcting references and misspellings). 85 Fed. Reg. 72899. Non-substantive changes to 21 Code of Federal Regulations (C.F.R.) Parts 170 to 199 include correction of references and the following deletions:
- “In 21 CFR 172.840(c)(13), this rule deletes “and 133.131” as this section was revoked in 1996 (61 FR 58991) after FDA determined that lowfat cottage cheese was more appropriately covered by the general standard in 21 CFR 130.10.”
- “In 21 CFR 178.3730, this rule removes the incorrect reference to 21 CFR 193.60 as this rule was renumbered in 1988 (53 FR 24666) and revoked in 1989 (54 FR 43424).”
This final rule is effective as of December 16, 2020. HHS found good cause to waive notice and the opportunity for public comments as authorized by 5 U.S.C. Section 553(b)(3)(B).
Color Additive Petition For Calcium Carbonate: On November 20, 2020, announced the filing of a color additive petition that would expand the safe use of calcium carbonate to include use in dietary supplement tablets and capsules. 85 Fed. Reg. 74304. The petition, filed by Colorcon, Inc., if approved would permit use of the additive in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice.
Color Additive Petition For Jagua (Genipin-Glycine) Blue: On November 20, 2020, FDA announced the filing of a color additive petition for jagua (genipin-glycine) blue that, if approved, would permit use in a variety of products, including dairy drinks, yogurt, desserts, cereals, snacks, candy, non-alcoholic beverages, and other foods. 85 Fed. Reg. 74304. The petition was filed by Ecoflora SAS.
Food Additive Petition For Tannic Acid: On November 27, 2020, FDA announced the filing of a food additive petition that, if approved, would provide for the safe use of tannic acid as a flavoring agent in animal feed. 85 Fed. Reg. 75971. The petition was submitted on October 5, 2020, by Ag Chem Resources, LLC.
FDA Biennial Registration Renewal Period: On December 1, 2020, FDA issued a reminder to human and animal food facilities that the biennial registration renewal must be complete by December 31, 2020. FDA requires owners, operators, or agents in charge of either a domestic or a foreign facility that is engaged in the manufacturing/processing, packing, or holding food for human or animal consumption, to register the facility. The facility registration process is renewed on a biennial basis, and if a facility fails to renew, FDA considers the registration expired and will cancel the registration. There are several exceptions to the registration requirement, but food additives, for humans or animals, are considered in the FDA definition of “food” and manufacturers of food additives are expected to complete a facility registration.
EUON Publishes Results Of Study On What EU Citizens Think About Nanomaterials: On November 16, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study on how citizens perceive nanomaterials and their potential risks to human health and the environment. According to EUON, the study found that general awareness about the nature, characteristics, and properties of nanomaterials is low. EUON states that the “key recommendation” is “to increase European citizens’ awareness of nanomaterials, including their benefits and risks, to ensure the public can make informed choices.” More information is available in our November 30, 2020, blog item.
Registration Opens For 2021 NNI Strategic Planning Stakeholder Workshop: Registration is now open for the National Nanotechnology Initiative’s (NNI) 2021 NNI Strategic Planning Stakeholder Workshop: Charting the Path Forward, which will be held January 11-13, 2021. As NNI enters its third decade, conversations at the January 2021 workshop will identify effective mechanisms to advance research and development, strategies for communication, and priority topics to shape future directions.
EFSA Publishes Environmental Risk Assessment Of The Application Of Nanoscience And Nanotechnology In The Food And Feed Chain: On November 19, 2020, the European Food Safety Authority (EFSA) published a report entitled “Environmental Risk Assessment (ERA) of the application of nanoscience and nanotechnology in the food and feed chain.” The authors analyzed existing ERA guidance documents for their adequacy to cover issues that are specific for nanomaterials, but note that none of the guidance has a specific focus on the food and feed chain. The report suggests adaptations necessary in exposure assessment and hazard and risk characterization to address nanomaterials. More information is available in our November 24, 2020, blog item.
ANSES Evaluates R-Nano Register, Offers Recommendations To Improve Reliability And Optimize Its Use: On December 1, 2020, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the results of an assessment of R-Nano, France’s national reporting scheme for substances in nanoparticle form. According to ANSES, while the information collected has helped improve the understanding of population exposure levels, “the overall level of information in the reports is unsatisfactory, meaning that the traceability objective has only been partially achieved.” ANSES describes improvements necessary to make the system more reliable and optimize its use. More information is available in our December 9, 2020, blog item.
EUON Conducting Web Satisfaction Survey: EUON is conducting a web satisfaction survey. EUON provides information on the safety, innovation, research, and uses of nanomaterials on the EU market. Information from the survey will be used to make improvements to the existing website and prioritize areas of development in the future. The survey should take only five minutes, and responses are completely anonymous.
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://blog.braginfo.org.
Bill Would Lower GHG Emissions And Encourage Low-Carbon Fuel Production: On November 17, 2020, the Streamlining Advanced Biofuels Registration Act of 2020 (H.R. 8759) was introduced in the House. According to Representative Cheri Bustos’s (D-IL) November 18, 2020, press release, the bipartisan, bicameral legislation would help biofuels plants “cut through red tape” to increase production of cellulosic biomass into renewable fuels. Under the Renewable Fuel Standard, EPA must approve applications to process cellulosic biomass on behalf of biofuels producers. According to the press release, EPA “has refused to act on dozens of applications on behalf of biofuels producers.” The bill “would force the EPA to act on outstanding applications and compel the EPA to accept applications if, after 90 days, the fuel could participate in at least one state’s clean transportation program.”
Senate Bill Would Require EPA To Study Mercury Emissions From Synthetic Flooring: On December 1, 2020, Senator Cory Booker (D-NJ) introduced the Mercury Vapor Study Act of 2020 (S. 4934) that would require EPA to conduct a study on mercury vapor released from synthetic flooring made using phenyl mercuric acetate (PMA). According to Booker’s December 3, 2020, press release, mercury vapor may be released into the air from rubberized flooring made using PMA, which was widely installed in schools, retirement homes, community centers, and other public spaces starting in the 1960s. The bill would require EPA to study the impact on human health of mercury vapor from PMA flooring and develop an official risk assessment model.
Bipartisan Legislation Would Provide Tax Credits For Production Of Renewable Chemicals: On December 4, 2020, Representatives Bill Pascrell, Jr. (D-NJ) and Brian Fitzpatrick (R-PA) introduced the Renewable Chemicals Act of 2020 (H.R. 8879) to create an allocated tax credit for production of qualifying renewable chemicals from biomass or investment in production facilities. According to Pascrell’s December 7, 2020, press release, the bill will accelerate commercialization of renewable chemicals and biobased products and help build a resilient biobased economy. Applicants for the tax credit will be evaluated on job creation, innovation, environmental benefits, commercial viability, and contribution to U.S. energy independence.
House Passes Water Resources Development Act: On December 8, 2020, the House passed the bipartisan Water Resources Develop Act of 2020 (S. 1811). According to the December 8, 2020, press release issued by the House Committee on Transportation and Infrastructure, the legislation, which Congress has developed and passed on a biennial basis since 2014, “is essential to our country’s ports, harbors, and inland waterways, as well as ecosystem restoration and flood mitigation in both rural and urban communities.” The bill includes provisions to invest in ports, harbors, and inland waterways; build more resilient communities; address affordability concerns for communities; unlock the Harbor Maintenance Trust Fund; and ensure that the U.S. Army Corps of Engineers carries out projects in an economically and environmentally responsible manner keeping equity in mind.
House Passes Four Energy Bills: On December 9, 2020, the House passed the following energy bills:
- The Reliable Investment in Vital Energy Reauthorization Act (H.R. 3361P), which would amend the Energy Policy Act of 2005 to reauthorize the hydroelectric production incentives program and the hydroelectric efficiency improvement program;
- The Tribal Power Act (H.R. 5541), which would amend the Energy Policy Act of 1992 to reauthorize programs to assist consenting Indian tribes in meeting energy education, planning, and management needs. The legislation amends the definition of Indian Land to extend eligibility for grant funding to consenting Alaskan Native Tribes;
- The Timely Review of Infrastructure Act (H.R. 1426), which addresses insufficient compensation of employees and other personnel at the Federal Energy Regulatory Commission (FERC); and
- The Ceiling Fan Improvement Act of 2020 (H.R. 5758), which would amend the Energy Policy and Conservation Act to make technical corrections to the energy conservation standard for large-diameter ceiling fans.
Chairs Of The Bipartisan Senate Climate Solutions Caucus Introduce Trillion Trees And Natural Carbon Storage Act: On December 9, 2020, Senators Mike Braun (R-IN) and Chris Coons (D-DE), Co-Chairs of the bipartisan Senate Climate Solutions Caucus, introduced the Trillion Trees and Natural Carbon Storage Act (S. 4985). The bill is intended to support U.S. leadership in reducing carbon in the atmosphere by restoring and conserving forests, grasslands, wetlands, and coastal habitats. According to Coons’s December 9, 2020, press release, the bill would:
- Create the International Forest Foundation, a nonprofit organization, to encourage and accept donations in support of international reforestation, restoration, and deforestation prevention efforts;
- Authorize $10 million for the U.S. Department of Agriculture (USDA) Forest Nursery Revival programs to ensure that the supply of seeds and saplings allows for increased domestic planting;
- Authorize the Secretary of State and the U.S. Agency for International Development (USAID) to increase their forest management cooperation efforts with other nations to promote reforestation and sustainable land use management abroad;
- Amend existing international conservation programs to include explicitly carbon sequestration and forest management among the list of approved technical assistance categories;
- Make it easier for private landowners to participate in carbon credit markets by authorizing USDA to provide loan guarantees for related projects; and
- Require that USDA establish objectives for increasing the net carbon stock of American forests, grasslands, wetlands, and coastal blue carbon habitats.
USPTO Seeks Information On Development Of National Consumer Awareness Campaign On Combating The Trafficking In Counterfeit And Pirated Products: On November 17, 2020, the U.S. Patent and Trademark Office (USPTO) requested comments on the development of a National Consumer Awareness Campaign on Combating the Trafficking in Counterfeit and Pirated Products as a public-private partnership. 85 Fed. Reg. 73264. On January 24, 2020, the Department of Homeland Security (DHS) released its report entitled “Combating Trafficking in Counterfeit and Pirated Goods.” The report included an action item to establish a national consumer awareness campaign. To start implementation of this action item, USPTO seeks information from interested stakeholders, including, but not limited to, intellectual property rights holders affected by the sale of counterfeit goods offered through e-commerce platforms, online third-party marketplaces, third-party intermediaries, other entities with experience in public-private awareness campaigns, and applicable government agencies. USPTO states that it “welcomes all input relevant to the development of the guidelines, action plans, strategies, and best practices for establishing a public-private national consumer awareness campaign designed to educate consumers on the direct and indirect costs and risks of counterfeit and pirated goods.” Comments are due January 4, 2021.
NIOSH Publishes Skin Notation Profiles For Five Chemicals: On November 18, 2020, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of Skin Notation Profiles for Chlorodiphenyl (42% chlorine) (Chemical Abstracts Service (CAS) Number 53469-21-9), Cyclohexanol (CAS Number 108-93-0), Cyclohexanone (CAS Number 108-94-1), Cyclonite (CAS Number 121-82-4), and Diethylenetriamine (CAS Number 111-40-0). 85 Fed. Reg. 73481. Historically, NIOSH has published skin notations in the NIOSH Pocket Guide to Chemical Hazards. Skin Notation Profiles provide information supplemental to the skin notation, including the summary of all relevant data used to aid in determining the hazards associated with skin exposures.
Comments On ORD Staff Handbook For Developing IRIS Assessments Due March 1, 2021: On November 30, 2020, EPA announced a public comment period on the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). 85 Fed. Reg. 76566. EPA states that the IRIS Handbook provides operating procedures for developing Integrated Risk Information System (IRIS) assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values. EPA also released the charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review. Comments are due March 1, 2021.
DOE Issues Notice Of Guidance For Potential Loan Applicants Involving Critical Minerals: On December 1, 2020, the U.S. Department of Energy (DOE) announced that it has issued new guidance for applications to the Loan Programs Office (LPO), stating a preference for projects related to critical minerals. Pursuant to President Trump’s September 2020 Executive Order (EO) Addressing the Threat to the Domestic Supply Chain from Reliance on Critical Minerals from Foreign Adversaries and December 2017 EO on a Federal Strategy to Ensure Secure and Reliable Supplies of Critical Minerals, DOE states that it is the policy of LPO “to interpret the Title XVII Program and the ATVM Program broadly to encourage applications from potential projects involving the production, manufacture, recycling, processing, recovery, or reuse of Critical Minerals and other minerals.” LPO will evaluate all applications on a case-by-case basis. Interested parties are invited to submit applications electronically.