Recent Federal Developments – June 2018
Lynn L. Bergeson, Richard E. Engler, Ph.D., And Susan M. Kirsch Contribute To ABA SEER’s The Year In Review 2017: Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2017: Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER). The Year in Review 2017 provides an annual summary of developments in environmental, energy, and resources law. B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., co-authored the Pesticides, Chemical Regulation, and Right-to-Know 2017 Annual Report, and B&C Government Affairs Advisor Susan M. Kirsch co-authored the Water Quality and Wetlands 2017 Annual Report.
The Year in Review 2017 provides a detailed catalogue of the impacts and trends of the Trump Administration’s deregulatory effects and reversal of actions taken by prior Administrations. These include citizen groups and non-governmental organizations (NGO) challenging regulatory and executive actions in court, states responding to federal deregulation with increased regulatory activity, and the international community remaining committed to pledges made in climate and other environmental agreements. The Year in Review 2017 is an electronic-only publication that provides convenient links to key cases and recent statutory material. Chapters can be accessed individually in PDF format and the full publication is also available as a single PDF. We are pleased to share this useful document with our clients and friends.
EPA’s Spring 2018 Unified Agenda And Regulatory Plan Released: On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to pesticides or the Toxic Substances Control Act (TSCA) are available in our blog items, “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes Pesticide Rulemakings” and “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes TSCA Rulemakings.”
EPA Releases Problem Formulation And Systematic Review Documents: On June 11, 2018, EPA took steps intended to ensure chemical safety under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA. Specifically, EPA released the following for public comment: the first ten problem formulation documents (83 Fed. Reg. 26998); EPA’s systematic review approach document (83 Fed. Reg. 26998); and (3) a significant new use rule (SNUR) proposal enabling EPA to prevent new uses of asbestos, “the first such action on asbestos ever proposed” (see related item below). More information is available at /regulatory-developments/entry/epa-takes-three-important-steps-intended-to-ensure-chemical-safety. Comments on the public formulation documents are due July 26, 2018. Comments on the systematic review document are due July 26, 2018, however, because this document is a “living document which may be revised periodically, EPA welcomes public input on this document at any time.”
EPA Proposes SNUR For Asbestos Uses: On June 11, 2018, EPA proposed a SNUR for asbestos as defined under the Asbestos Hazard Emergency Response Act. 83 Fed. Reg. 26922. The proposed significant new use of asbestos (including as part of an article) is manufacturing (including importing) or processing for certain uses identified by EPA as no longer ongoing. EPA has found no information indicating that the following uses are ongoing, and therefore, the following uses would be subject to a proposed SNUR issued in final: adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement). Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing (including importing) or processing of asbestos (including as part of an article) for a significant new use. The required notification initiates EPA’s evaluation of the conditions of use associated with the intended use within the applicable review period. Manufacturing (including importing) and processing (including as part of an article) for the significant new use may not commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. Comments must be received on or before August 10, 2018.
EPA Adds 13 Specific Nonylphenol Ethoxylates To EPCRA Toxics Release Inventory: On June 12, 2018, EPA issued a final rule adding a category of 13 specific nonylphenol ethoxylates (NPE) to the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). 83 Fed. Reg. 27291. EPA states that this addition “ensures the most up-to-date information is easily accessible to the public.” On its web page regarding the final rule, EPA states that it is issuing the final rule “because we have determined that longer-chain NPEs can break down in the environment to short-chain NPEs and nonylphenol, both of which are highly toxic to aquatic organisms. For this reason, EPA has determined that NPEs meet [EPCRA] section 313(d)(2)(C) toxicity listing criteria.” The final rule will apply for the reporting year beginning January 1, 2019, with the first reporting forms due July 1, 2020. The final rule is effective November 30, 2018. More information is available at /regulatory-developments/entry/epa-will-add-13-specific-nonylphenol-ethoxylates-to-epcra-toxics-release-in.
EPA Holds Environmental Modeling Public Meeting On The Quantitative Use Of Surface Water Monitoring Data In Pesticide Risk Assessment: On May 23, 2018, EPA held an “Environmental Modeling Public Meeting” (EMPM). As stated in the April 12, 2018, Federal Register notice announcing the meeting, the “EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.” The overall theme of the EMPM was the quantitative use of surface water monitoring data. The morning session featured a series of presentations by representatives from EPA, the U.S. Geological Survey (USGS) and the Washington State Department of Agriculture concerning the development of a framework to use surface water monitoring data quantitatively in pesticide risk assessments. A major focus of the presentations was the exploration and evaluation of the capabilities of the USGS recently-developed model SEAWAVE-QEX to improve the robustness of surface water monitoring datasets so that they might be used in pesticide risk assessments. Further public presentations on the evaluation and development of the framework are scheduled at the American Chemical Society meeting to be held on August 19-23, 2018, in Boston, Massachusetts. There are plans to hold a Scientific Advisory Panel meeting on the framework in 2019, but no exact date has been set. More information is available at http://pesticideblog.lawbc.com/entry/epa-holds-environmental-modeling-public-meeting-on-the-quantitative-use-of.
EPA Schedules Public Meeting On Formaldehyde Emission Standards For Composite Wood Products Final Rule Technical Issues: On May 24, 2018, EPA announced it would be hosting a public meeting on June 28, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) in Washington, D.C. regarding technical issues in the Formaldehyde Emission Standards for Composite Wood Products Final Rule published on December 12, 2016. 83 Fed. Reg. 24104. The Federal Register notice states that the meeting will “inform EPA’s potential development of a proposed rule to address … technical issues and to further align the rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program.” EPA states that this meeting is open to the public but that the primary audience for this public meeting is Third Party Certifiers (TPC) and panel producers who contract with TPCs to certify composite wood products under the December 12, 2016, final rule. EPA is most interested in receiving comments or questions on the specific technical issues that will be outlined on the meeting agenda, including timing and ways to implement any changes should the Agency decide to propose additional technical amendments; and other technical rule provisions that can help improve consistency with CARB’s regulation, improve clarity in the rule, and help improve overall implementation of the rule. The meeting agenda is available on EPA’s website. Registration is requested by June 22, 2018, and is available online. More information on composite wood products under TSCA is available on our blog.
EPA Schedules Letter Peer Reviews For Exposure And Use Assessment, Human Health And Environmental Hazard Summary For Five PBT Chemicals: On May 25, 2018, EPA announced that there will be a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five PBT chemicals. 83 Fed. Reg. 24305. The preparatory meeting will be held via teleconference and webcast only. Registration is required to attend. Requests to present oral comments during the preparatory meeting should be submitted on or before June 21, 2018. Written comments to be considered by the peer reviewers may be submitted until July 23, 2018. Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018. The preparatory meeting will be held on June 25, 2018, from approximately 1:00 p.m. to 5:00 p.m. (EDT).
EPA To Publish NOA For WPS Training Materials; Employers Required to Provide Expanded Training Within 180 Days: On June 14, 2018, EPA announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use. The pre-publication version of the NOA is available on EPA’s website. The NOA confirms that the publication “triggers the WPS requirement that training programs must include all of the topics specified in the 2015 revisions to the WPS.” Because the 2015 WPS rule is already in effect, employers must provide expanded training addressing these topics within 180 days of publication. The expanded training materials that are the subject of the NOA were developed through a cooperative agreement with the Pesticide Education Resources Collaborative (PERC), and are available on PERC’s website.
EPA previously issued a Federal Register notice on December 21, 2017, stating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zone.” In this 2017 notice, EPA stated that it did not expect to issue the NOA for training materials addressing the 2015 WPS rule until after completing a rulemaking concerning these proposed revisions. This deferral of the NOA would have significantly delayed the expanded training for handlers and agricultural workers contemplated by the 2015 rule. In the NOA, EPA states that it is still reconsidering the same three requirements, and that “[i]f those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.”
On May 30, 2018, two complaints were filed against EPA in the United States District Court for the Southern District of New York challenging EPA’s decision to defer publication of the NOA. More information on these lawsuits is available in our blog item “Lawsuits Filed in Federal District Court Regarding WPS Training Delay.” Because publication of the new NOA will afford the plaintiffs in these cases all of the substantive relief they were seeking, it appears that these actions will now be moot other than any request for attorney’s fees and costs incurred by the plaintiffs.
Hazardous Waste Electronic Manifest System Launches On June 30: For several years, EPA has been working on establishing a national system for tracking hazardous waste manifests electronically under the Resource Conservation and Recovery Act (RCRA). This system, known as “e-Manifest,” launches on June 30, 2018. EPA is establishing the e-Manifest system according to the Hazardous Waste Electronic Manifest Establishment Act (e-Manifest Act), enacted into law on October 5, 2012. The e-Manifest Act authorizes EPA to implement a national electronic manifest system and requires that the costs of developing and operating the new e-Manifest system be recovered from user fees charged to those who use hazardous waste manifests to track off-site shipments of their wastes. In January 2018, EPA published its final methodology for setting user fees based on the costs of processing manifests.
EPA Launches New Owner CAA Audit Program For Oil And Natural Gas Exploration And Production Facilities: EPA has initiated a “New Owner Audit Program”tailored for the oil and natural gas sector. EPA states that this program will provide environmentally protective efficiencies and certainty in the oil and natural gas sector based on EPA’s analysis of the sector’s unique operations. EPA states that it views the audit program as an opportunity for timely and cost-effective Clean Air Act (CAA) compliance. EPA will initially make the program available to upstream exploration and production sites where EPA and states have seen significant noncompliance. Under the policy, EPA will offer additional flexibilities under a specific and tailored new owner audit program that it believes will make it easier for the regulated community to self-disclose and correct violations, thereby providing additional protection for public health and the environment. A key program component will require that companies assess storage tank battery vapor control system design as part of the audit process. EPA has developed a draft standard audit program agreement template. The template is available online. EPA will accept comments on the draft standard audit program agreement until Monday, July 2, 2018.
EPA Issues Immediately Effective Rule Amending RCRA Solid Waste Definition: Responding to July 2017 and March 2018 orders issued by the U.S. Court of Appeals for the District of Columbia Circuit, EPA on May 30, 2018, issued a final rule revising the Definition of Solid Waste under RCRA. 83 Fed. Reg. 24664. More information is available in our memorandum.
EPA Proposes RMP Reconsideration Rule:On May 30, 2018, EPA issued a rule proposing changes to the Risk Management Program (RMP) Amendments Rule (82 Fed. Reg. 4594; Jan. 13, 2017). 83 Fed. Reg. 24850. The proposed changes are intended to promote better emergency planning and public information about accidents and maintain the trend of fewer significant accidents involving chemicals regulated under the RMP rule. EPA is reconsidering the final RMP Amendments Rule to respond to objections raised in three petitions submitted to EPA under CAA Section 307(d)(7)(B) and based on its own review of the rule. The proposal addresses potential security risks associated with new information disclosure requirements introduced in the final rule; a finding that the fire and explosion in West, Texas, was caused by a criminal act (arson) rather than being the result of an accident; concerns with EPA’s economic analysis; and concerns that EPA did not coordinate its rulemaking with the Occupational Safety and Health Administration (OSHA). EPA is proposing changes to the Amendments final rule to maintain consistency of RMP accident prevention requirements with the OSHA Process Safety Management (PSM) standard. The rule also seeks to address security concerns, reduce unnecessary regulations and regulatory costs, and revise compliance dates to provide necessary time for program changes. EPA estimates that these revisions would result in total annual cost savings of about $88 million a year. EPA will accept comments on the rule until July 30, 2018.
EPA Proposes To Retain Current SOx NAAQS: EPA on June 8, 2018, issued a rule proposing to retain the current National Ambient Air Quality Standard (NAAQS) for sulfur oxides (SOX). 83 Fed. Reg. 26752. The current primary NAAQS is 75 parts per billion (ppb), as the 99th percentile of daily maximum 1-hour sulfur dioxide (SO2) concentrations, averaged over three years. EPA states that, based upon its review of the standard, that the current standard “is requisite to protect public health, with an adequate margin of safety, from effects of SOX in ambient air and should be retained, without revision.” EPA notes that these proposed conclusions are consistent with the recommendations of the Clean Air Act Scientific Advisory Committee (CASAC). CASAC concurred with EPA that “the current scientific literature does not support revision of the primary NAAQS for SO2.” CASAC further stated that it “supports retaining the current standard, and specifically recommends that all four elements (indicator, averaging time, form, and level) should remain the same.” EPA is accepting comment on the proposed rule until July 23, 2018.
2015 Waters of the United States (WOTUS) Rule — States Covered By Preliminary Injunction (As Of June 11, 2018):The Georgia court’s injunction covers the following 11 states: Georgia, Alabama, Florida, Indiana, Kansas, North Carolina, South Carolina, Utah, West Virginia, Wisconsin, and Kentucky.
The earlier North Dakota district court injunction covers the following 13 states: Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, and Wyoming.
States (alphabetical order) not covered by either injunction are:
FDA Issues Warning Letter Regarding Violations Of CGMP: On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Product Quest MFG, LLC (Product Quest) regarding its drug manufacturing facility, Ei LLC, located in Kannapolis, North Carolina. The letter summarizes the violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were observed during an inspection that took place from October 2-6, 2017, and states that because their “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, [their] drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The letter requests further compliance and documentation of same, stating failure to “promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.” Prior to this Warning Letter, Product Quest committed to many improvements on the contamination controls and other corrective and preventive actions. The violations included: failure to maintain adequate separate defined areas necessary to prevent contamination or mix-up, failure to establish and follow adequate written procedures for cleaning and maintenance of equipment, and failure to investigate thoroughly any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
FDA Releases Small Entity Compliance Guide (SECG) On Final Rule Extending Food Safety Modernization Act (FSMA) Compliance Dates: On May 14, 2018, FDA announced the availability of a guidance for industry entitled “The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation — Small Entity Compliance Guide.” 83 Fed. Reg. 22193. FDA states in the Federal Register notice that the SECG is intended to help small entities comply with the final rule issued on August 24, 2016 (81 Fed. Reg. 55784) that extended the date for compliance with certain provisions in four final rules:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 C.F.R. Part 117);
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 C.F.R. Part 507);
- Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption (21 C.F.R. Part 112); and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 C.F.R. Part 1, Subpart L).
FDA states that it extended the compliance dates of these four rules to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules.
FDA Denies FAP Regarding Safe Use Of PHOs; Announces Final Determination On PHOs: On May 21, 2018, FDA denied a food additive petition (FAP) submitted by the Grocery Manufacturers Association (GMA) requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated oils (PHO) in certain food applications. 83 Fed. Reg. 23382. FDA states in the Federal Register notice that it denied the petition because it “determined that the petitioner did not provide sufficient information … to conclude that the requested uses of PHOs are safe.” Further, to allow the food industry sufficient time to identify suitable replacement substances for the petitioned uses of PHOs, FDA “extended the compliance date for certain uses of PHOs, including the conditions of use covered by the FAP.” Specifically:
- FDA is extending the compliance date to June 18, 2019, for the manufacturing of food with the petitioned uses of PHO; FDA states that food manufactured with the petitioned uses after June 18, 2019 “may be subject to enforcement action”; and
- For food manufactured with the petitioned uses before June 18, 2019, FDA is extending the compliance date to January 1, 2021.
FDA states that this time frame will “allow manufacturers, distributors, and retailers to exhaust product inventory of foods made with the petitioned uses before the manufacturing compliance date.” FDA requests objections and requests for a hearing on the notice to be submitted by June 20, 2018.
On May 21, 2018, FDA announced its final determination that there is no longer a consensus among qualified experts that PHOs, the primary dietary source of industrially produced trans fatty acids (IP-TFA), are generally recognized as safe (GRAS) for any use in human food. 83 Fed. Reg. 23358. The initial compliance date was set for June 18, 2018. In this notice, however, FDA extends the compliance date for certain uses of PHOs, as detailed above.
CBD Petitions FDA To Ban Use Of Sunscreen: On May 23, 2018, the Center for Biological Diversity (CBD) petitioned FDA to ban the use of two sunscreen chemicals that allegedly damage coral reefs, ecosystems, the CBD claims were already threatened by higher ocean temperatures. The petition targets oxybenzone and octinoxate, two chemicals noted already to be targeted by the Hawaii state legislature. According to the petition, even small amounts of the chemicals can damage the reefs. FDA will evaluate the petition and then decide whether it should be granted.
FDA Releases SECG On Registration Of Food Facilities And FDA Regulation: On May 29, 2018, FDA announced the availability of a final guidance for industry entitled “Registration of Food Facilities: What You Need To Know About the FDA Regulation — Small Entity Compliance Guide.” 83 Fed. Reg. 24479. FDA states that the SECG is intended to help small entities comply with a final rule issued in the Federal Register on July 14, 2016, entitled “Amendments to Registration of Food Facilities” (81 Fed. Reg. 45911). The SECG reflects changes made by the final rule and contains editorial changes for clarity.
FDA And USDA Announce Harmonized Good Agriculture Practices Audit Program: On June 5, 2018, FDA and the U.S. Department of Agriculture (USDA) announced, as part of their ongoing effort to make the oversight of food safety stronger and more efficient, the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FSMA’s Produce Safety Rule. FDA states that the USDA H-GAP Audit Program is an “audit developed as part of the Produce GAP Harmonization Initiative, an industry-driven effort to develop food safety GAP standards and audit checklists for pre-harvest and post-harvest operations,” and the initiative is a “collaborative effort on the part of growers, shippers, produce buyers, audit organizations and government agencies, including USDA.” The USDA H-GAP audit is applicable to all fresh produce commodities, all sizes of on-farm operations, and all regions in the United States.
Report Available On March 2018 EUON Stakeholder Dialogue Meeting: The European Union Observatory for Nanomaterials (EUON) has posted the workshop report from the March 9, 2018, Stakeholder Dialogue meeting. According to the report, the annual meeting focused on providing an update on EUON and allowing stakeholders an opportunity to share their views on expectations on the future development of EUON. A brief summary of the speaker presentations is available in our May 18, 2018, blog item, “Report Available on March 2018 EUON Stakeholder Dialogue Meeting.”
Abstracts For 2018 ICOH Congress Include Several Regarding Nanomaterials: The 32nd Triennial Congress of the International Commission on Occupational Health (ICOH) was held April 29 through May 4, 2018, in Dublin, Ireland. Occupational and Environmental Medicine (OEM) has published the abstracts for the Congress online. Links to the abstracts concerning nanomaterials are available in our May 16, 2018, blog item.
NICNAS Case Studies Provide Guide To Categorizing Chemicals Under New Scheme: On May 16, 2018, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced the availability of six case studies intended to help stakeholders understand how the categorization process for new industrial chemicals will work under the new Australian Industrial Chemicals Introduction Scheme (AICIS). The case studies cover typical scenarios for introducing cosmetic and non-cosmetic new chemicals, and show how introducers would categorize chemicals as exempted or reported under the new scheme, including whether the chemical is considered to be nanoscale. More information is available in our May 22, 2018, blog item, “NICNAS Case Studies Provide Guide to Categorizing Chemicals under New Scheme.”
ECHA Interviews KEMI Regarding Nano Reporting Requirement: The May 2018 ECHA Newsletter includes an interview with Robert Johansson, Head of the Swedish Chemicals Agency’s (KEMI) Chemical Statistics and Registries Unit. As reported in our December 7, 2017, blog item, KEMI has established a mandatory reporting scheme to obtain information on the quantities and types of nanomaterials used in Sweden, with the first reports due in February 2019. According to Johansson, “[t]his information can then provide a basis for making changes to legislation or taking other measures regarding nanomaterials, in areas such as healthcare, the environment or workplace safety.” More information is available in our May 23, 2018, blog item, “ECHA Interviews KEMI Regarding Nano Reporting Requirement.”
OECD Tour de Table Reports On Developments On Safety Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) published a May 17, 2018, document entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. The document compiles information provided by delegations for the February 2018 OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on current developments on the safety of manufactured nanomaterials. It aims to summarize relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level. More information on the reported developments is available in our May 30, 2018, blog item, “OECD Tour de Table Reports on Developments on Safety of Manufactured Nanomaterials.”
OECD Assesses Biodurability Of Nanomaterials And Their Surface Ligands: OECD has published a May 22, 2018, report entitled Assessment of Biodurability of Nanomaterials and their Surface ligands. The purpose of the report was to compile the relevant information on the biodurability of the pristine and functionalized nanomaterials in biological and environmental media in vitro and in vivo, as well as describing methods for measuring the stability and halftimes of nanomaterials. The report presents the in vitro and in vivo systems that are used to measure biodurability in biological and environmental systems for the pristine nanomaterials of the OECD Sponsorship Program. In addition, the report describes the effect of the physicochemical properties of these nanomaterials and the properties of the biological and environmental media, as well as surface coating and ligands on their dissolution and biodegradation. The report recommends that the existing identified in vitro and in vivo standard techniques be validated in relation to their ability to predict the pathogenic potential and environmental persistence of nanomaterials to increase the predictive potential of these tests.
EUON Reports On Nordic Information Campaign On REACH-Relevant Regulation For Nanomaterials: On May 23, 2018, EUON published an article entitled “Nordic information campaign on REACH-relevant regulation for nanomaterials.” According to EUON, Norway, Sweden, Finland, and Denmark are coordinating an information campaign through the N-Nano project group of the Nordic Chemical Working Group of the Nordic Council of Ministers. The goal of the campaign is to develop a web-based tool to provide information on European Union (EU) chemical legislation requirements for nanomaterials, such as preparing a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration for nanomaterials. The tool, which will be available in English, will focus on small- and medium-sized companies that may not have sufficient in-house expertise on regulations covering nanomaterials. The information campaign is expected to be completed by the end of 2018.
ISO Standard Analyzes Nano-Objects Using Asymmetrical-Flow And Centrifugal Field Flow Fractionation: In June 2018, the International Standardization Organization (ISO) published standard ISO/TS 21362:2018, “Nanotechnologies — Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation.” The document identifies parameters and conditions, as part of an integrated measurement system, necessary to develop and validate methods for the application of asymmetrical-flow and centrifugal field-flow fractionation to the analysis of nano-objects and their aggregates and agglomerates dispersed in aqueous media. According to ISO, in addition to constituent fractionation, analysis can include size, size distribution, concentration, and material identification using one or more suitable detectors. The standard provides general guidelines and procedures for application, and specifies the minimal reporting requirements necessary to reproduce a method and to convey critical aspects.
EUON Updates Website, Adds Two Searchable Databases: On June 11, 2018, EUON announced that its website now features the following two searchable databases, NanoData and eNanoMapper. EUON states that it has also revamped its home page with more dynamic content, including the latest news on nanomaterials and nanotechnology from the web. The update includes new information about nanomaterials within the EU regulatory framework, how they are used in different sectors, such as food, medicine, and environmental research, and how to use nanomaterials safely at work.
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.
OSHA Employer Notification Act Introduced: On May 17, 2018, Representative Todd Rokita (R-IN) introduced the OSHA Employer Notification Act (H.R. 5870). The bill would amend Section 10(a) of the Occupational Safety and Health Act of 1970 to require OSHA to notify an employer immediately after issuing a citation or notice of proposed penalty against the employer. The notification can be electronic or by telephone. The bill bans OSHA from announcing publicly the citation or notice against the employer for at least one full business day after notifying the employer. If OSHA is unable to notify the employer after one full business day of the issuance of the citation, it may then make a public announcement of the determination. If a proposed penalty or notice is subsequently settled, withdrawn, or vacated, the bill would require OSHA to delete any public notices about the penalty or notice.
House Appropriations Committee Passes EPA Funding Bill: The House Appropriations Committee on June 6, 2018, passed the fiscal year (FY) 2019 Interior and Environment Appropriations bill on a vote of 25-20. The legislation includes funding for EPA. The bill would provide EPA with $7.958 billion in funding for FY 2019, about $100 million less than its FY 2018 budget of $8.058 billion. President Trump had proposed a FY 2019 budget for EPA of $6.1 billion. One of the amendments adopted during the debate would maintain existing “Buy America” standards at EPA. Another amendment adds report language regarding EPA’s 2010 guidance issued under Section 401 of the Clean Water Act (CWA) to provide clarity to states and tribes on certain certifications. The panel also approved amendments to issue in final guidance on reviews of CWA National Pollutant Discharge Elimination System (NPDES) permits, and to accelerate approval of new renewable fuel standard (RFS) pathways.
Senate Bill Seeks To Amend CWA Dredge-And-Fill Permit Reviews: On June 6, 2018, Senators Shelley Moore Capito (R-WV), John Barrasso (R-WY), John Boozman (R-AR), and Jim Inhofe (R-OK) introduced the Regulatory Certainty Act of 2018 (S. 3009). The bill seeks to clarify the period of time that EPA has to terminate or prohibit the issuance of existing dredge-and-fill permits under Section 404 of the CWA. The purpose of the bill is to prevent “regulatory overreach confusion” by limiting the period of time to 30 consecutive days between the review of a 404 permit and the issuance day. Senator Capito stated that the current process slows down development and construction projects.
Water Technology Acceleration Act Introduced In Senate: Senator Tammy Baldwin (D-WI) on June 6, 2018, introduced the Water Technology Acceleration Act (S. 3012). The bill has three main aims: (1) create a grant that would fund public-private partnerships that deploy, test, and improve emerging water technologies; (2) assist communities in implementing new water technologies, and urge EPA to adopt new water treatment innovations; and (3) assist communities in implementing new technologies for wastewater treatment and storm runoff.
FY 2019 EPA Appropriations Bill Approved By Senate Appropriations Committee: On June 14, 2018, the Senate Appropriations Committee approved a $35.853 billion measure to fund the U.S. Department of the Interior, U.S. Forest Service, EPA, and other agencies. The bill maintains EPA’s funding for FY 2019 at $8.058 billion, equal to the FY 2018 enacted level. (Democrats cite a budget of $8.824 billion. The discrepancy seems to arise from the exclusion in the Republican figures of funding tied to clean water and drinking water funds, Superfund, and the Water Infrastructure Finance and Innovation Act.) Funding is focused on returning EPA to its core mission of environmental cleanup. The Clean Water and Drinking Water State Revolving Funds would receive more than $2.86 billion, an increase over the FY 2018 enacted level. Additionally, the Water Infrastructure Finance Act (WIFIA) program is funded at $63 million, which will enable billions in loans to address water infrastructure challenges. Categorical grant programs that help states implement environmental regulations are increased by $17 million under the bill. The funding level conflicts with the House FY 2019 funding bill, which slashes $100 million from EPA’s budget. The bill also would fund the Council on Environmental Quality (CEQ) at$3.005 million, an increase of $5,000 above the FY 2018 enacted level for CEQ.
Chair Of U.S. Chemical Safety And Hazard Investigation Board Steps Down; Dr. Kristen Kulinowski Is Appointed Interim Head: On May 21, 2018, Vanessa Allen Sutherland announced that she is resigning from the U.S. Chemical Safety and Hazard Investigation Board (CSB) effective in June 2018. The CSB investigates the root cause of industrial chemical incidents and advocates for the implementation of safety recommendations to better protect workers, the public, and the environment. President Obama nominated Sutherland to the Chairperson, and she was confirmed in August 2015. During her tenure as Chair, Sutherland was responsible for closing out 12 incident investigations. The Trump Administration has proposed eliminating the Board; Congressional resistance has prevented this result. On June 12, 2018, Dr. Kristen Kulinowski was appointed interim head of the Board. Kulinowski joined the Board in 2015 and previously worked as a research staff member at the Institute of Defense Analyses Science & Technology Policy Institute, a federal research organization that provides support to government agencies, including the White House’s Office of Science and Technology Policy, the National Science Foundation, and the National Science Board, and as a senior faculty fellow in chemistry at Rice University, among other positions.
USDA Announces Webinar On Bioengineered Food Disclosure Structure: On May 23, 2018, theUSDA Agricultural Marketing Service (AMS) announced the availability of an informational webinar regarding the proposed National Bioengineered Food Disclosure Standard (NBFDS or standard). 83 Fed. Reg. 23827. The proposed standard would require food manufacturers and other entities that label foods for retail sale to disclose information about bioengineered food and bioengineered food ingredients. The pre-recorded webinar will provide an overview of the background, provisions, and potential impacts of the proposed standard. Establishment and implementation of the new standard is required by recent amendments to the Agricultural Marketing Act of 1946. The webinar is available on the AMS website at https://www.ams.usda.gov/rules-regulations.
Proposition 65: Three Months Until Effective Date For OEHHA’s Amended Proposition 65 Clear And Reasonable Warnings Requirements: There are less than three months until the effective date of the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations. By August 30, 2018, companies must comply with the revised regulations for consumer products, occupational, and environmental exposures. Companies that have not already revised warnings to comply with the new requirements must now review their consumer products, occupational exposures, and environmental exposure scenarios in light of OEHHA’s revised policies and warnings to ensure compliance with the new requirements. More information is available in our memorandum.
EPA Extends Comment Period For Science Rule: On May 25, 2018, EPA extended the comment period of the proposed rule entitled “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA issued on April 30, 2018. 83 Fed. Reg. 24255. The Federal Register notice states that EPA will extend the comment period from May 30, 2018, to August 16, 2018. EPA states that it is making these changes “in response to public requests for an extension of the comment period and for a public hearing.” It is noteworthy that the extension was issued on the heels of EPA’s receipt of letters, one submitted by eight Attorneys General and another by 20 Senators, addressing the proposal, as described below. Comments can be filed in Docket ID No. EPA-HQ-OA-2018-0259 on www.regulations.gov. EPA’s notice also announces that it will be holding a public hearing for the proposed rule on July 17, 2018, from 8:00 a.m. to 8:00 p.m. (EDT) in Washington, D.C. that will provide “the public with an opportunity to present oral comments regarding [the Science Rule]”; and will “provide interested parties the opportunity to present data, views, or arguments concerning the proposal.” The notice states that EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. More information is available at http://pesticideblog.lawbc.com/entry/epa-extends-comment-period-for-science-rule-schedules-hearing.
OSHA Proposes Extension To Compliance Dates For Certain Provisions Of Beryllium Standard: On June 1, 2018, OSHA proposed to extend the compliance date for certain ancillary requirements of the general industry beryllium standard to December 12, 2018. 83 Fed. Reg. 25536. This extension applies to all processes, operations, or areas where workers may be exposed to materials containing beryllium that fall under the scope of the general industry standard. The proposed extension allows OSHA to complete a planned proposed rule that is designed to clarify the standard and to simplify compliance. OSHA has also issued a memorandum stating that the ancillary requirements that are affected by this rulemaking will not be enforced until June 25, 2018. Any provisions for which the standard already establishes compliance dates in 2019 (change room and showers) and 2020 (engineering controls) are unaffected by this rulemaking. Comments, hearing requests, and other information are due by July 2, 2018.
OSHA Memorandum Outlining Enforcement Of Silica Standard For General Industry And Maritime: On June 8, 2018, OSHA issued a memorandum outlining the initial enforcement of the standard for respirable crystalline silica in general industry and maritime. Most provisions of the standard become enforceable on June 23, 2018. The standard establishes a new 8-hour time-weighted average permissible exposure limit, action level, and associated ancillary requirements. During the first 30 days of enforcement, OSHA will offer compliance assistance for employers who make good faith efforts to comply with the new standard. OSHA intends to issue interim enforcement guidance until a compliance directive on the new standards is finalized. OSHA’s Small Entity Compliance Guide for the Respirable Crystalline Silica Standard for General Industry and Maritime discusses methods of compliance, such as using engineering and work practice controls, assessing exposure levels, respirator use, medical surveillance, and written exposure plans.
EPA Issues Advance Notice Of Proposed Rulemaking On Increasing Transparency In Cost Benefit Analyses Of Rules: On the heels of its proposal to increase scientific transparency in the rulemaking process, EPA on June 13, 2018, issued an advance notice of proposed rulemaking (ANPRM) seeking comment on how EPA should promulgate regulations that provide a consistent and transparent interpretation relating to the consideration of weighing costs and benefits in making regulatory decisions in a manner consistent with applicable authorizing environmental statutes. 83 Fed. Reg. 27524. Most of the statutes EPA administers require or allow some consideration of cost and benefits when setting standards. There are variations, however, in terminology and specificity provided in each law regarding the nature and scope of the cost and benefit considerations. In the ANPRM, EPA is soliciting comment on specific issues pertinent to how to conduct cost-benefit analyses consistently and also on whether and how these regulations, if promulgated, could also prescribe specific analytic approaches to quantifying the costs and benefits of EPA regulations. Specific issues upon which EPA seeks comment are as follows:
- The Nature of Potential Concerns Regarding Perceived Inconsistency and Lack of Transparency — EPA requests more information about the nature and extent of the concerns relating to possible inconsistency and lack of transparency in considering costs and benefits in the rulemaking process. The most helpful comments would provide specific examples with context and specify relevant statutory provisions. What impact could greater consistency or transparency have on regulated entities, states, tribes, and localities, and the public?
- Potential Approaches for Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process — EPA requests comment on approaches for increasing consistency and transparency when and how EPA considers cost and benefits in setting pollution standards, consistent with statutory direction.
- Potential for Issuing Regulations to Govern EPA’s Approach in Future Rulemaking — EPA requests comment on opportunities and challenges associated with promulgating regulations to govern EPA’s approach to cost and benefit considerations in future rulemakings. EPA is soliciting comment on whether and how best to develop such regulations.
The comment period closes on July 13, 2018.
President Nominates Current CEQ Chief Of Staff To Serve As Chair: President Trump on June 12, 2018, nominated Mary Bridget Neumayr to be a Member of the CEQ and upon confirmation by the Senate to serve as the CEQ Chair. Ms. Neumayr currently serves as Chief of Staff of the CEQ. Prior to joining CEQ in March of 2017, she served in a variety of positions with the Committee on Energy and Commerce in the U.S. House of Representatives, including Deputy Chief Counsel of Energy and Environment in 2017; Senior Energy Counsel from 2011 to 2017; and Counsel from 2009 to 2010. Ms. Neumayr also served as Deputy Counsel for environment and nuclear programs at the U.S. Department of Energy from 2006 to 2009, and Counsel to the Assistant Attorney General for the Environment and Natural Resources Division at the U.S. Department of Justice from 2003 to 2006. Prior to her government service, Ms. Neumayr was in private legal practice from 1989 to 2003. She received her B.A. from Thomas Aquinas College and her J.D. from the University of California, Hastings College of the Law. President Trump’s first nominee to serve as CEQ Chair — Kathleen Hartnett White — withdrew her name from consideration in February after facing opposition from Senate Democrats over her skepticism of man-made climate change.
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