“Value Chain Communications Required Under TSCA Consent Orders And SNURs: How To Formulate Them And Optimize Their Value” Recording Available Now: If you missed this week’s “Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value” webinar, a complimentary recording is available for our clients and friends. Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules (SNUR). Lynn L. Bergeson, Managing Partner, B&C, discussed the considerable value of formulating these communications with a view toward developing a consistent and positive product narrative that resonates far beyond Toxic Substances Control Act (TSCA) compliance.
EPA Will Provide Minimum 30-Day Public Comment Period On Draft Risk Evaluations: Alexandra Dapolito Dunn, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) stated on October 11, 2019, that EPA will provide more time for public comment on its draft risk evaluations before the TSCA Science Advisory Committee on Chemicals (SACC) meets to peer review the draft documents. According to Dunn, the new schedule will include a comment period of at least 30 days before SACC meets. EPA plans to complete ten chemical risk evaluations by June 22, 2020. To date, EPA has released six draft chemical risk evaluations, and SACC has peer reviewed four of them and is scheduled to peer review two in December 2019. For the remaining four chemicals, EPA intends to release two of the draft risk evaluations for public comment by the end of 2019 and the other two in January 2020. SACC will peer review the four risk evaluations in 2020. Dunn stated that EPA will meet the Lautenberg Act’s deadline to release all ten risk evaluations by June 2020.
EPA Announces Settlement With Company For Chemical Data Reporting Violations: EPA announced on October 23, 2019, that it settled with Miles Chemical Company Inc. for failing to report timely chemical substances it imported. Under the settlement, the Company will pay a $45,000 penalty. According to EPA, between 2012 and 2015, Miles Chemical Company failed to submit timely forms to EPA documenting the import of large quantities of two chemicals. EPA notes that under TSCA, chemical importers and manufacturers are required to submit Chemical Data Reporting (CDR) information to EPA every four years. This reporting allows EPA to track the chemicals being imported, assess potential human health and environmental effects of these chemicals, and make the non-confidential business information (CBI) it receives available to the public. EPA notes that chemical substances listed on the TSCA Inventory that are manufactured or imported at volumes of 25,000 pounds or greater must be reported to EPA, as required by TSCA’s CDR rule.
EPA Publishes Draft Risk Evaluation Of Methylene Chloride: On October 29, 2019, EPA published a Federal Register notice announcing the availability of and soliciting public comment on the TSCA risk evaluation of methylene chloride (MC). 84 Fed. Reg. 57866. EPA is submitting the same document to the TSCA SACC for peer review. The draft risk evaluation states that EPA’s initial determinations of unreasonable risk for the specific conditions of use of MC listed below are based on health risks to workers, occupational non-users (ONU), consumers, or bystanders from consumer use. According to the draft risk evaluation, risks to the general population either were not relevant for these conditions of use or were evaluated and not found to be unreasonable.
- Unreasonable Risk to Workers: EPA determined that the conditions of use that presented unreasonable risks included processing MC into a formulation or mixture; all but two industrial and commercial uses; and disposal.
- Unreasonable Risks to ONUs: For ONUs, EPA determined that the conditions of use that presented unreasonable risks included import of MC, processing MC as a reactant in several industrial sectors, some industrial and commercial uses, and disposal. EPA determined in some cases that a condition of use presented an unreasonable risk not only to workers but also ONUs; in other cases, EPA determined that a condition of use presented an unreasonable risk only to one or the other.
- Unreasonable Risk to Consumers: EPA determined that all but two consumer conditions of use present unreasonable risks.
- Unreasonable Risk to Bystanders (from Consumer Uses): When EPA determined that a condition of use presented risks to consumers, unreasonable risks were, often, but not always, identified for bystanders.
The SACC will convene an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019. Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to the SACC for review and consideration before the December 3-4, 2019, meeting. Requests to present oral comments at the in-person meeting are due December 3, 2019. Comments on the draft risk evaluation are due December30, 2019. For more information, please read the full memorandum.
EPA Publishes Draft Rick Evaluation Of NMP: On November 7, 2019, EPA announced the availability of the draft risk evaluation for N-methylpyrrolidone (NMP), which includes more than 30 uses of NMP in adhesives, sealants, paints and arts and craft paints, paint and coating removers, adhesive removers, and degreasers. 84 Fed. Reg. 60087. EPA’s draft risk evaluation findings include:
- EPA did not find risk to the environment, bystanders, or occupational non-users. For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment, bystanders, or occupational non-users from NMP.
- EPA’s draft risk evaluation preliminarily found unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use. EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use.
EPA notes that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not EPA’s final determinations on whether NMP presents unreasonable risks under the conditions of use. The draft risk evaluation will be peer reviewed by the TSCA SACC on December 5-6, 2019. EPA requests comments on the draft risk evaluation by November 26, 2019, to allow SACC time to review and consider them before the peer review meeting. EPA states that it will use feedback received from the public comment and peer review processes to inform the final risk determinations. Comments on the draft risk evaluation are due January 6, 2020. More information is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”
EPA Announces New Opportunity For Public Comment On CBI Procedures: On November 8, 2019, EPA announced that in response to an April 2019 court decision on the TSCA Inventory Notification (Active-Inactive) Requirements Final Rule, it is proposing a supplement to its proposed rule on CBI procedures. 84 Fed. Reg. 60363. The supplemental notice of proposed rulemakingincludes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making CBI claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by the federal circuit court decision. EPA notes that the supplemental notice is limited in scope and that “[i]t impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Comments are due by December 9, 2019.
EPA Denies TSCA Section 21 Petition On Use Of Hydrofluoric Acid At Oil Refineries: On November 12, 2019, EPA proposed to deny a petition submitted under TSCA Section 21 seeking to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries. 84 Fed. Reg. 60986. Public Employees for Environmental Responsibility (PEER) petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries under TSCA Section 6(a) and under the Administrative Procedure Act (APA) to take the same action pursuant to Section 112 of the Clean Air Act (CAA). PEER claims that a prohibition on use of hydrofluoric acid at refineries is warranted because there are safer alternatives that can be readily substituted. According to EPA, the petition offers “minimal information about these alternatives.” Hydrofluoric acid is a solution of hydrogen fluoride in water and a precursor to fluorine compounds. In oil refineries, hydrofluoric acid is used as a catalyst in a process called alkylation. Due to its hazard properties, hydrofluoric acid is regulated by the federal government under several authorities, including related to preparation for emergency response to accidental and other non-routine releases. EPA denied the petition based on the petition's lack of sufficient facts establishing that it is necessary for the Agency to issue a rule under TSCA Section 6(a). EPA notes that the Federal Register notice specifically addresses only the TSCA Section 21 petition, not the petition submitted under the APA. More information is available in our November 13, 2019, blog item.
EPA Announces New Web Pages Providing New Chemical Notices Receipt Information: EPA announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:
- Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and Test Market Exemption Applications (TMEA);
- Notices of Commencement of Manufacture or Import (NOC); and
- Test information submitted under TSCA Section 5.
The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a CBI claim). EPA states that it will update the web pages monthly.
Ninth Circuit Issues Decision In Case Challenging EPA’s Prioritization And Risk Evaluation Rule: On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging EPA’s prioritization and risk evaluation rule. 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 TSCA’s requirements. Specifically, petitioners claimed that: (1) TSCA requires EPA to evaluate risks associated with a chemical’s uses collectively before determining that the chemical is safe; (2) EPA must consider all of a chemical’s conditions of use in that evaluation; and (3) 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.
EPA Proposes Rule To Update The Worker Protection Standard Pesticide Application Exclusion Zone Requirements: On November 1, 2019, EPA issued a proposed rule proposing narrow updates to the Worker Protection Standard’s (WPS) provision on the Application Exclusion Zone (AEZ) requirements. 84 Fed. Reg. 58666. By narrowing updates to the WPS, EPA states that it will “improve the long-term success of the agency’s Application Exclusion Zone requirements” and “would improve enforceability for state regulators and reduce regulatory burdens for farmers.” EPA believes narrowing updates to the WPS will also continue to protect the health of farm workers and other individuals near agricultural establishments who could be exposed to agricultural pesticide applications. The proposed updates are consistent with the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4). EPA Administrator Andrew Wheeler states that EPA’s proposal “would enhance the agency’s Application Exclusion Zone provisions by making them more effective and easier to implement.” Wheeler states that “our proposal will make targeted updates, maintaining safety requirements to protect the health of those in farm country, while providing greater flexibility for farmers.” Comments are due January 30, 2020. More information is available in our Pesticide Law and Policy Blog®.
EPA Releases Spanish Translation Guide For Pesticide Labeling: On October 17, 2019, EPA released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish. The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish. EPA states that the “guide is written in a universal form of Spanish to reach as many Spanish speakers as possible.” While translating pesticide labels is not a requirement, EPA generally allows pesticide registrants to translate their product labels into any language so long as there is an EPA-accepted English version of the label and the translation is true and accurate. The guide is not intended to substitute for or eliminate the pesticide labels in English. An English version of all required labeling text is needed for all pesticide products in accordance with 40 C.F.R. Section 156.10(a)(3). More information on the guide is available online.
EPA Will Hold Public Meeting On TSCA New Chemicals Program: EPA will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s TSCA New Chemicals program. At the meeting, EPA will:
- Provide 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”;
- Demonstrate how EPA has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples;
- Provide an update on CBI process improvements and clarifications; and
- Discuss 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. Details regarding the meeting are available in the prepublication version of the Federal Register notice announcing the meeting.
EPA Revises RCRA Small Business Handbook: On October 17, 2019, EPA released the updated version of its guide for small businesses that handle hazardous waste. The guide, entitled “Managing Hazardous Waste: A Guide for Small Business,” provides an overview of the federal hazardous waste Resource Conservation and Recovery Act (RCRA) regulations and is intended to give small business owners and operators a basic understanding of their hazardous waste management responsibilities. EPA revised the guide to reflect the changes to the regulations for hazardous waste generators since the previous version of the publication, including the 2016 Generator Improvements Rule, wastes added to the universal waste program, Subpart K for academic laboratories, the Hazardous Waste Pharmaceuticals Rule, and electronic reporting/e-Manifest. The guide is available online.
WOTUS Repeal Rule Published; Environmental Groups File Suit: On October 22, 2019, EPA and the Army Corps of Engineers (Corps) published in the Federal Register the joint rule rescinding the 2015 “Waters of the U.S.” (WOTUS) Rule (2015 Rule) that clarified which waters and wetlands fell within the scope of the federal Clean Water Act (CWA) jurisdiction (Repeal Rule). 84 Fed. Reg. 56626. The Repeal Rule is known as “Step One” in the agencies’ two-part rulemaking effort to repeal-and-replace the 2015 Rule with a WOTUS definition that provides bright lines on which waters are within the scope of the CWA and where federal jurisdiction ends and state jurisdiction begins. Wetlands and ephemeral streams in particular are some of the greatest sources of regulatory uncertainty. This confusion has led to inconsistent regulatory determinations and permitting decisions. Wasting no time, the National Wildlife Federation, Natural Resources Defense Council, and nine other groups filed suit on the rule on October 23, 2019, in the U.S. District Court for the District of South Carolina. The suit claims EPA’s attempt to repeal the WOTUS rule is “arbitrary and unlawful,” and that the Repeal Rule “reinstates an illegal regime” that runs contrary to Supreme Court precedent. The Repeal Rule is effective on December 23, 2019.
DOT Proposes To Allow LNG Be Transported In DOT-113 Tank Cars: On October 24, 2019, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) and Federal Railroad Administration (FRA) issued a proposed rule regarding the transportation of liquefied natural gas (LNG) by rail. 84 Fed. Reg. 56964. The rule proposes to revise the Hazardous Materials Regulations (HMR) to allow rail transportation of LNG in DOT-113 specification tank cars. The proposal is a result of President Trump’s April 2019 “Executive Order on Promoting Energy Infrastructure and Economic Growth.” The Executive Order (EO) recognizesthe leading role the U.S. plays in producing and supplying LNG and the need to continue to transport LNG safely and efficiently. Currently, the HMR do not authorize the use of DOT-113 tank cars for the rail transportation of LNG. Instead, LNG may only be transported by rail in a portable tank with an approval from FRA. The HMR do, however, authorize the use of DOT-113 specification tank cars for other flammable cryogenic liquids and, according to DOT, they are specifically designed for the transportation of refrigerated liquefied gases. This design specification may be similarly suitable for the transport of LNG, the proposal states. DOT also believes that there are many potential benefits of transporting LNG by rail, including the safety benefits inherent to rail transport and the use of approved tank cars, fuel efficiency, fuel accessibility to remote regions, increased U.S. energy competitiveness, and fewer emissions. The comment period on the proposal closes on December 23, 2019.
EPA Proposes Revisions To Organic Liquids Distribution NESHAP: On October 21, 2019, EPA proposed revisions to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the organic liquids distribution (non-gasoline) source category under the CAA. 84 Fed. Reg. 56288. The proposed rule is the result of EPA’s statutorily mandated risk and technology review (RTR) for NESHAP source categories. EPA proposes amendments to the storage tank and equipment leak requirements and also proposes to allow terminals the option to implement a fenceline monitoring program. The comment period closes on December 5, 2019.
EPA Releases Preliminary Effluent Guidelines Program Plan 14; PFAS Issues Addressed: On October 24, 2019, EPA announced the release of its Preliminary Effluent Guidelines Program Plan 14 (Preliminary Plan 14). 84 Fed. Reg. 57019. Section 304(m) of the CWA requires EPA to publish biennially a plan for new and revised effluent limitations guidelines. Preliminary Plan 14 is available online. EPA has concluded that no additional categories warrant new or revised effluent guideline regulations at this time. The plan, does, however discuss the ongoing rulemaking and associated schedule for the Steam Electric Power Generating Category. Preliminary Plan 14 provides updates on ongoing industrial category studies:
- Electrical and Electronic Components Category Detailed Study;
- Oil and Gas Extraction Wastewater Management Study; and
- Petroleum Refining Category Detailed Study.
Preliminary Plan 14 also includes an analysis of available data on industrial sources and discharges of per- and poly-fluoroalkyl substances (PFAS). These efforts aim to identify the extent to which these pollutants are discharged from industrial point sources. EPA introduced three new activities in Preliminary Plan 14:
- A technology review process to help EPA gather information on current industrial wastewater treatment capabilities;
- An economic screening analysis to enable EPA to establish an initial prioritization of industries based on economic factors; and
- A PFAS Multi-Industry Study designed to identify industrial sources of PFAS in surface waters. This study was initially announced as part of EPA’s PFAS Action Plan.
EPA is taking comment on Preliminary Plan 14 until November 25, 2019.
FDA Announces Science Advisory Board Meeting Scheduled For December 3 and 4, 2019: On October 28, 2019, the U.S. Food and Drug Administration (FDA) announced a public advisory committee meeting of the Science Advisory Board to the National Center for Toxicology Research (NCTR). The NCTR Director will provide a Center-wide update on initiatives and accomplishments of the past year and each FDA Center (e.g., Center for Food Safety and Applied Nutrition, Center for Biologics Evaluation and Research) will briefly discuss its specific research strategic needs and potential areas of collaboration. The meeting is open to the public on December 3, 2019, from 8:00 a.m. to 5:55 p.m. and December 4, 2019, from 8:00 a.m. to 11:30 a.m.
FDA Proposes Rule For The Accreditation Of Food Testing Laboratories: On November 4, 2019, FDA proposed a rule that would establish a new program for testing of food by accredited laboratories, as required by Section 422 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Safety Modernization Act (FSMA). 84 Fed. Reg. 59452. Recognized food testing accreditation bodies, accredited food testing laboratories, entities seeking to become either, and owners or consignees required to use accredited food testing laboratories would be subject to the rule. The proposed rule would:
- Include standards accredited laboratories must meet;
- Establish a publicly available list of accreditation bodies and accredited laboratories; and
- Require accredited laboratories to submit certain documentation to FDA.
FDA is seeking comments on all aspects of the proposed rule. Comments should be submitted by March 3, 2020.
FDA Announces Request For Comments Regarding Threshold Of Regulation Burden: On November 6, 2019, FDA announced an opportunity for public comment as required under the Paperwork Reduction Act. 84 Fed. Reg. 59831. FDA estimates that seven threshold of regulation requests will be submitted in 2020 and that the overall estimated burden is 336 hours. Comments on the collection of information are requested by December 6, 2019.
FDA Releases Testing Method For PFAS In Foods And Final Survey Results: FDA made available its validated testing method for 16 types of PFAS in food. Concurrently, FDA released the final results from its limited food sample testing for PFAS derived from three surveys released in June 2019. The surveys included a general sampling of food collected via FDA’s Total Diet Study (TDS), and surveys of produce and dairy products from specific geographic areas of known PFAS environmental contamination.
Using the newly established method detection limit, FDA’s testing for PFAS resulted in a reduction in positive detections in the food samples previously tested. The number of detections in the TDS samples went from 14 down to 2 out of 91 samples tested. Notably, FDA determined that positive detections in chocolate cake, which made national headlines in June, were false positives. To prevent similar false positives, FDA’s analytical method now includes an additional step in the testing procedure. In the produce survey, the number of samples with detectable levels of PFAS went down from 19 to 16 samples. FDA affirmed that the levels were so low that they do not pose a human health concern. The dairy survey results remain unchanged from previous testing.
FDA is analyzing additional TDS samples using its validated testing method and expects to release those results in late 2020. More information is available here.
Agenda And Abstracts Available From 2019 Global Summit On Regulatory Science On Nanotechnology And Nanoplastics: On September 24 - 26, 2019, the European Commission’s (EC) Joint Research Center (JRC) hosted the 2019 Global Summit on Regulatory Science (GSRS19), which focused on nanotechnology and nanoplastics. Co-organized with the Global Coalition for Regulatory Science Research, GSRS19 covered nanotechnology research and its role in enhancing regulatory decision making, including methods, standards, and applications. In addition, GSRS19 also introduced methods and approaches to understand nanoplastics better. JRC has posted the GSRS2019 agenda and abstracts.
EUON Seeks Topics To Address In Upcoming Studies: The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies. EUON states that it is looking for studies that address:
- Questions relating to the health and safety of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
- Specific issues surrounding the uses of nanomaterials; or
- Information about markets for nanomaterials, focusing on EU markets.
Proposals are due by January 15, 2020.
Lynn L. Bergeson Featured In Episode Of Stories From The NNI: The November 4, 2019, episode of the National Nanotechnology Initiative’s (NNI) podcast series, Stories from the NNI, features Lynn L. Bergeson. Ms. Bergeson shares her perspective on the intersection of nanotechnology and the law. Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), speaks with Ms. Bergeson regarding her perspective on the intersection of nanotechnology and the law.
EC Committee Publishes Guidance On Safety Assessment Of Nanomaterials In Cosmetics: On November 4, 2019, the EC’s Scientific Committee on Consumer Safety (SCCS) published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The Guidance updates SCCS’s 2012 Guidance (SCCS/1484/12) on the safety assessment of nanomaterials in cosmetic products. It covers the main elements of safety assessment -- general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6). SCCS notes that due to the evolving nature of nanomaterials safety research, it may revise the Guidance in the future to take account of any new scientific knowledge. More information is available in our November 5, 2019, blog item.
ISO Standard Specifies Characteristics And Measurement Methods For Layered Clay Nanomaterials: The International Organization for Standardization (ISO) has published standard ISO/TS 21236-1:2019, “Nanotechnologies -- Clay nanomaterials -- Part 1: Specification of characteristics and measurement methods for layered clay nanomaterials.” The standard specifies characteristics to be measured of layered clay nanomaterials in powder form and chemically modified ones and describes their relevant measurement methods. ISO notes that the standard does not deal with health, safety, and environmental issues.
EUON Publishes Nanopinion On Nanomaterials In Europe’s Workplaces: On November 12, 2019, EUON published a Nanopinion entitled “Nanomaterials in Europe’s workplaces: what are the risks and how can they be managed?” and written by Elke Schneider, European Agency for Health and Safety at Work (EU-OSHA). Schneider states that at the EU level, the requirements for managing nanomaterials and their potential risks are the same as those for managing other hazardous substances. According to Schneider, a key element of the EU’s occupational safety and health legislation is that employers have to conduct a workplace risk assessment and establish prevention measures that adhere to a hierarchy of prevention measures, according to the STOP principle:
- Substitution (or elimination) of the dangerous substance;
- Technological measures;
- Organizational measures; and
- Personal protective measures.
Schneider notes that many EU Member States “also have their own national legislation that may include additional requirements for managing the risks associated with nanomaterials.” Schneider’s article includes a list of available tools and guidance.
German Environmental Agency Will Hold Conference On Advanced Materials: The German Environment Agency (UBA) will hold a conference on December 5-6, 2019, on “Advanced Materials -- 1st Thematic Conference.” UBA is inviting stakeholders, including representatives of regulatory authorities, science, industry, and non-governmental organizations, to a series of thematic conferences. The aim of the first thematic conference is to present an overview on the multitude of advanced materials and their potential applications. In addition, the relevance of these materials and possibilities to categorize or define them shall be discussed. Additional meetings are scheduled for June 2020 and May 2021.
BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
Senate Rejects Resolution To Repeal ACE Rule: On October 17, 2019, the Senate rejected a resolution that would have repealed the Affordable Clean Energy (ACE) rule, the Trump Administration’s replacement for the Clean Power Plan (CPP). By a vote of 41-53, Senators rejected S.J. Res. 53, introduced on September 9, 2019, by Senator Ben Cardin (D-MD). The resolution sought to block implementation of the ACE rule by using authority under the Congressional Review Act. On July 8, 2019, EPA issued a final rule repealing and replacing the CPP. 84 Fed. Reg. 32520. Unlike the CPP, the ACE rule does not set limits on emissions from coal-fired utilities. Instead, EPA gives states latitude in determining how to control emissions of greenhouse gas (GHG) emissions from coal-fired power plants. The rule redefines the “best system of emission reduction” (BSER) for carbon dioxide from such plants, defining heat rate improvements as BSER. The ACE rule also establishes emissions guidelines for states to use when developing plans to limit carbon dioxide at their coal-fired power plants and provides states with a list of applicable emissions control technology that power plants can use to ensure compliance with the rule. EPA bars the use of certain options for compliance, including carbon capture and storage, fuel switching, and emissions trading. The rule also promulgated new implementing regulations for ACE and future existing-source rules under CAA Section 111(d). EPA estimates that by 2030, the ACE rule will reduce emissions of carbon dioxide by 11 million short tons, with reductions in emissions of other pollutants such as mercury, particulate matter, and ground-level ozone. EPA projects that ACE will result in annual net benefits of $120 million to $730 million. The rule became effective on September 6, 2019.
House Committee Approves Sustainable Chemistry Research And Development Act: On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019. It is co-sponsored by Representative John Moolenaar (R-MI). The bill is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems by establishing a coordinating entity under the National Science and Technology Council within the Office of Science and Technology Policy (OSTP). The legislation would allow the agencies involved in this entity to work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the United States and encourage the validation of tools for assessment of sustainable chemistry processes or products. The agencies would include EPA the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, USDA, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, FDA, and other related federal agencies, as appropriate. The bill also supports improved education and training in sustainable chemistry.
Lawmakers Urge Action On Hexavalent Chromium Standard For Drinking Water: On October 18, 2019, several House lawmakers -- led by Al Green (D-TX) -- sent a letter to EPA Administrator Andrew Wheeler chastising EPA for its inaction to set drinking water standards for hexavalent chromium. The letter criticizes EPA for not acting on the 2010 health assessment of hexavalent chromium, stating that “we find the pace of this assessment unacceptable.” The letter asks for “a timely explanation on why it has taken the EPA nearly a decade to determine what level of chromium-6, a chemical the agency has identified as carcinogenic, is safe for drinking water.” The lawmakers also requested that EPA move expeditiously to complete the assessment.
Senate Bill Would Amend New Source Review Program: On October 22, 2019, Senator John Barrasso (R-WY), Chair of the Environment and Public Works Committee, introduced a bill (S. 2662) that would revise EPA’s new source review (NSR) program under the CAA. The bill targets EPA’s pre-construction permitting requirements. It would exempt from those requirements upgrades to facilities that are intended to improve safety or reliability, along with projects that are intended to reduce air pollution.
House Committee Passes Hardrock Mining Royalty Bill: On October 23, 2019, the House Committee on Natural Resources passed a bill that would require hardrock mining companies to pay royalties for hardrock mines located on federal lands. The Hardrock Leasing and Reclamation Act (H.R. 2579) would update the Mining Law of 1872. The bill would require royalties of between 8 percent to 12.5 percent. Currently, mining companies are not required to pay royalties for mines located on federal land.
U.S. To Start Process To Abandon Paris Climate Accord: On October 23, 2019, speaking at an oil and gas conference in Pittsburgh, President Trump announced that the U.S. will officially begin the process of withdrawing from the Paris Climate Accord. The U.S. was eligible to withdraw on November 4, 2019. The process takes one year, so beginning the paperwork now would set the U.S. up for a chance to break fully from the pact one day after the 2020 presidential election.
Bipartisan Climate Change Caucus Launched In Senate: On October 23, 2019, Senators Chris Coons (D-DE) and Mike Braun (R-IN) launched the bipartisan Climate Solutions Caucus, the first of its kind in the U.S. Senate. According to a statement released by the Senators, the caucus will bring together an equal number of Republicans and Democrats “to find common ground on solutions to address climate change while strengthening American competitiveness and creating opportunities for U.S. workers.” The Senate Climate Solutions Caucus will meet regularly and convene experts from across the political spectrum to craft bipartisan solutions. The caucus will operate by the principle of unanimous consent, acting only when each member agrees.
House Committee Holds Hearing On The Future Of Science In EPA Rulemaking: On November 13, 2019, the House Committee on Science, Space, and Technology held a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The hearing focused on EPA’s April 30, 2018, proposed rule on “Strengthening Transparency in Regulatory Science,” as well as a leaked copy of EPA’s supplemental proposed rule that was published by the New York Times on November 11, 2019. Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, EPA Office of Research and Development (ORD), and EPA Science Advisor, emphasized that the version of the supplemental rule that was leaked to the New York Times was not the most current version and is not the same as the supplemental rule that EPA submitted to the Office of Management and Budget (OMB) for review on November 12, 2019. Because the supplemental proposed rule is currently under OMB review, Dr. Orme-Zavaleta could not comment on it. According to Dr. Orme-Zavaleta, EPA expects to publish the supplemental proposed rule for public comment in early 2020. A summary of the hearing is available in our November 14, 2019, memorandum.
Senate Committee Approves Sustainable Chemistry Bill: The Senate Commerce, Science and Transportation Committee on November 13, 2019, passed legislation intended to spur the development of new and innovative chemicals. Introduced by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV), the Sustainable Chemistry Research and Development Act of 2019 (S. 999) 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. In a statement, Senator Coons said the bill will create a cohesive vision for sustainable chemistry research and development, improve training and retraining of scientists and other professionals, and build new partnerships with the private sector. The bill directs OSTP to convene an interagency entity under the National Science and Technology Council with the responsibility of coordinating federal programs and activities in support of sustainable chemistry. Agencies participating in the entity must carry out specified activities in support of sustainable chemistry, including incorporating sustainable chemistry into existing research, development, demonstration, technology transfer, commercialization, education, and training programs.
Bicameral Bills Seek To Reform The Renewable Fuel Standard: On November 14, 2019, Senators Tom Udall (D-NM) and Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the CAA. The Growing Renewable Energy Through Existing and New Environmentally Responsible Fuels (GREENER) Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the corn ethanol mandate and immediately reduce the amount of ethanol in fuel by as much as 1 billion gallons by capping the amount of ethanol that can be blended into conventional gasoline at 9.7 percent. The legislation also seeks to help farmers return cornfields to pasture and wildlife habitat through a 10 cents per renewable identification number (RIN) fee to fund a new Private Land Protection and Restoration Fund in the U.S. Treasury. The fund will help pay for Department of Interior programs that pay for easements on private lands to keep them out of agricultural production; keep the lands in conservation uses like grass, forest, stream buffers, or pollinator habitat; and help farmers transition land currently in crop production into other uses. The GREENER Act also would extend the cellulosic and advanced next generation biofuel mandate until 2 billion gallons of annual production is achieved or 2037, whichever is soonest, and alters the way the mandate is implemented to produce liquid transportation fuels that dramatically reduce GHG emissions.
USDA Proposes Establishment Of Hemp Regulatory Framework: On October 31, 2019, as required by the 2018 Farm Bill, USDA’s Agricultural Marketing Service published its interim final rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule). 84 Fed. Reg. 58522. The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including:
- Requirements for state/tribal plans for states pursuing regulatory authority over hemp production;
- Recordkeeping requirements;
- Licensing requirements;
- Delta-9 tetrahydrocannabinol (THC) testing;
- Procedures for disposing of non-compliant plants; and
- Compliance provisions and procedures for handling violations.
The Interim Rule does not alter the federal definition distinguishing hemp from marijuana, a distinction hinging on the levels of THC in the plant. Plants containing 0.3 percent or less THC on a dry weight basis are considered hemp, while plants exceeding this level of THC are marijuana. The Interim Rule introduces the term “acceptable hemp THC level” to account for a degree of uncertainty in testing results and explains how to interpret lab results with a measurement of uncertainty. This is a critical clarification given that THC levels dictate whether a grower is engaged in the legal production of hemp or is growing marijuana -- prohibited federally and in the majority of states. USDA is not proposing a single uniform testing method and will accept numerous testing methods and protocols employed by states. The Interim Rule does not include a federal seed certification program. The Interim Rule makes clear that interstate transport of hemp is permissible regardless of whether the states the shipment passes through allow hemp production. The publication of the Interim Rule initiates USDA’s implementation of the hemp program, which includes reviewing state/tribal plans and issuing licenses. USDA will accept public comments on the Interim Rule for 60 days through December 30, 2019. Within two years of publication, USDA will publish a final rule. Also relevant for hemp producers are forthcoming proposals from FDA and EPA addressing the sale of cannabidiol (CBD) and pesticide approvals for application to hemp plants, respectively. More information is available in our blog.
EPA To Eliminate ELAB And NACEPT Advisory Committees: EPA has decided to eliminate two, long-standing advisory committees: the Environmental Laboratory Advisory Committee (ELAB) and the National Advisory Council for Environmental Policy and Technology (NACEPT). EPA took the action in response to a June 14, 2019, EO issued by President Trump that requires all federal agencies and departments to evaluate the need for advisory committees established under Section 9(a)(2) of the Federal Advisory Committee Act (FACA). Entitled “Executive Order on Evaluating and Improving the Utility of Federal Advisory Committees,” the EO also requires each federal agency to terminate at least one-third of its current committees by September 30, 2019. The EO targets committees:
- That have accomplished their stated objectives;
- Where the subject matter or work of the committee has become obsolete;
- Where the primary functions of the committee have been assumed by another entity; or
- Where the agency determines that the cost of the operation of the committee is excessive in relation to the benefits to the federal government.
EPA constituted ELAB under FACA in 1995. Its purpose was “to provide consensus advice, information and recommendations on issues related to enhancing EPA’s measurement programs and facilitating the operation and expansion of a national environmental accreditation program.” NACEPT is even older, established in 1988 “to provide independent advice to the EPA Administrator on a broad range of environmental policy, technology and management issues.” In separate e-mails sent to the members of both committees. EPA explained its decision as such: “After conducting thorough review with senior leadership of its 22 committees, the agency is terminating NACEPT [and ELAB]. The agency identified other more specialized FACs [Federal Advisory Committees] and collaborative groups that provide advice on the agency’s media-specific regulatory actions and policies, thus limiting EPA’s focus for NACEPT [and ELAB] charges.”
OSHA To Hold Meeting Of The National Advisory Committee On Occupational Safety And Health: The Occupational Safety and Health Administration (OSHA) on November 14, 2019, announced that it will hold a meeting of the National Advisory Committee on Occupational Safety and Health (NACOSH) on December 12, 2019, in Washington, D.C. 84 Fed. Reg. 61940. The meeting will include an update on key OSHA initiatives from Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health Loren Sweatt, and remarks from National Institute for Occupational Safety and Health (NIOSH) Director John Howard. Comments and requests to speak may be submitted electronically at http://www.regulations.gov. The deadline for submitting comments and requests to speak is December 5, 2019. NACOSH advises, consults with, and makes recommendations to the Secretaries of Labor and Health and Human Services on matters relating to the Occupational Safety and Health (OSH) Act of 1970.