Lynn L. Bergeson Named President Of The Product Stewardship Society: The Product Stewardship Society (PSS) Board of Directors inducted Lynn L. Bergeson as President during its annual board meeting preceding the Product Stewardship conference held in Columbus, Ohio, on September 10 - 12, 2019. Ms. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and President of The Acta Group (Acta®), will serve as President through 2021. Ms. Bergeson has served on the PSS Board of Directors since 2015.
WEBINAR -- RCRA Improvements Rule: An Update And Discussion, October 16, 2019, 1:00 p.m. - 2:00 p.m. (EDT): On November 28, 2016, the U.S. Environmental Protection Agency (EPA) issued the final “Generator Improvements Rule” under the Resource Conservation and Recovery Act (RCRA). 81 Fed. Reg. 85732. The potential scope of the revised regulatory program is immense -- the changes will affect almost 700,000 facilities. The rule is the most comprehensive overhaul of the RCRA generator requirements in 30 years. Although the rule took effect on May 30, 2017, it is not effective in RCRA-authorized states until the states adopt the provisions, which many are now doing. Join Christopher R. Bryant, Senior Regulatory Consultant, B&C, and Lynn L. Bergeson, Managing Partner, B&C, via webinar on October 16, 2019,for an update and discussion on the impact of this rule. Register online now.
EPA Seeks Comment On Manufacturer Requests For Risk Evaluation Of DIDP And DINP: On August 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it seeks comment on manufacturer requests for the risk evaluations of two chemicals used in plastic production, diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 84 Fed. Reg. 42914. EPA notes that the manufacturer-requested risk evaluations of DIDP and DINP “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA). EPA states that it “is also taking public comments on additional conditions of use [(COU)] the Agency identified to include in the risk evaluations.” Comments are due October 3, 2019. Please read the full memorandum for more information on these manufacturer-requested risk evaluations of DIDP and DINP.
EPA Announces FIFRA SAP Public Meeting; Requests Nominations Of Ad Hoc Expert Reviewers: On August 13, 2019, EPA announced that a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will be held November 19-22, 2019. 84 Fed. Reg. 40047. The meeting location will be announced in the future on the FIFRA SAP website. The title of the SAP meeting is “Approaches for Quantitative Use of Surface Water Monitoring Data in Pesticide Drinking Water Assessments.” Pesticide registrants have long advocated for the opportunity to use monitoring data in drinking water assessments in place of estimates generated using current modeling approaches. It is expected that EPA will present work that the Environmental Fate and Effects Division (EFED) has completed to permit use of surface water monitoring data. The notice also requests nominations for ad hoc reviewers with particular expertise related to the particular issues to be addressed by this panel. Nominations were due on or before
EPA Announces Progress Report On Achieving Reregistration Goals: On August 26, 2019, EPA announced the availability of its progress reports in meeting its performance measures and goals for pesticide reregistration during fiscal years (FY) 2013-2016. 84 Fed. Reg. 44616. The report is available at http://www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0125. Comments are due on by October 25, 2019.
EPA Issues Formaldehyde Standards For Composite Wood: On August 21, 2019, EPA issued final formaldehyde standards for composite wood products. 84 Fed. Reg. 43517. The rule addresses and implements certain technical measures to align the federal standards with the California Air Resources Board (CARB) Airborne Toxic Control Measures. EPA expresses its view that the measures will streamline compliance programs for the supply chain. The rule was immediately effective.
EPA Seeks Comment On Adding Hemp As A New Use Site: On August 23, 2019, EPA announced the receipt of ten applications to amend currently registered pesticide products to add hemp as a new use site. 84 Fed. Reg. 44296. The ten application amendments are the result of the 2018 Farm Bill, signed into law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC). EPA states in the notice that FIFRA Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these ten applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve “a changed use pattern.” Instead, EPA states that it has decided to provide an opportunity to comment in this instance “because of the potential significant interest from the public” and to be “completely transparent about these applications.” EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future. EPA also states that the products with requested label amendments contain active ingredients for which EPA “has previously determined the residues will be safe under any reasonably foreseeable circumstances.” Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities. Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season. Although the federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every state has changed its laws to conform to the new classification. EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky. Senator Rand Paul (R-KY) has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use. As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop. Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits. This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can be applied to hemp. As EPA has noted, the active ingredients in the ten products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue. Comments are due on or before September 23, 2019.
EPA Issues Final SNURs For 145 Chemical Substances: On August 20, 2019, EPA published final significant new use rules (SNUR) under TSCA for 145 chemical substances that are the subject of premanufacture notices (PMN). 84 Fed. Reg. 43266. According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e). The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. The final SNURs will take effect October 21, 2019. EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to TSCA Section 13 import certification requirements. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.
EPA Proposes Revised Crop Groups For Herbs And Spices: On August 27, 2019, EPA published a proposed rule in the Federal Register that makes several changes to the current “Crop Group 19: Herbs and Spices Group.” 84 Fed. Reg. 44804. This latest proposal, which is the fifth in a series of crop group amendments, was created in response to a petition developed by the International Crop Group Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4). The goals of the crop group amendment program include reducing regulatory burden, coordination with international definitions, and removing barriers to trade. The major components of this proposal are revision of the commodity definition for marjoram; addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19: Herbs and Spices Group” with two new crop groups, “Crop Group 25: Herb Group” and “Crop Group 26: Spice Group.” Recognizing that the existing combined Crop Group 19 Herb and Spice Group has limited the establishment of crop group tolerances, EPA has proposed creating the two new separate crop groups to benefit herb and spice growers. The new crop groups are quite large, containing 317 herb commodities in Crop Group 25 and 166 spice commodities in Crop Group 26. The proposal specifies all commodities in the new crop groups (and the subgroups therein, i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup. Comments are due on or before October 28, 2019.
EPA Releases Frequently Asked Questions For Series 810 Test Guidelines: On August 28, 2019, EPA released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines. There has been some concern in the regulated community regarding the need for clarification on the guidelines before they became effective. EPA’s new FAQs are intended to provide these clarifications, but the timing of their issuance may be of concern to some. Also of interest is whether additional FAQs will be issued in the future. As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018:
- 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for Efficacy Testing;
- 810.2100: Sterilants, Sporicides, and Decontaminants, Guide for Efficacy Testing; and
- 810.2200: Disinfectants for Use on Environmental Surfaces, Guide for Efficacy Testing.
The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests. 83 Fed. Reg. 8666. EPA states that these FAQs “provide prompt and transparent guidance to all applicants regarding commonly asked questions concerning the 810 guidelines updated in February 2018.” With the exception of confirmatory testing (as described under Office of Chemical Safety and Pollution Prevention (OCSPP) Guideline 810.2000, Section (B)(7)), all studies initiatedon or after August 28, 2019, should be in compliance with the 2018 revised guidelines for testing. The study initiation date is defined under 40 C.F.R. Section 160.3 as the date the protocol is signed by the study director. Studies that were initiated prior to the implementation date but submitted to EPA for review after the implementation date may use either the previous 2012 version of the guidelines or the 2018 revised guidelines, as appropriate. EPA states that it “intends to address confirmatory testing through a separate guidance, which will be made available for public comment prior to finalization.” The FAQs include general testing questions and questions related to each specific guideline. The appendices to the FAQs include examples of label use directions for dilutable products, repeat testing guidance with example scenarios, and sample virucidal calculations.
Environmental Modeling Public Meeting Announced By EPA EFED: On September 4, 2019, EPA’s Office of Pesticide Programs’ (OPP) EFED announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019. 84 Fed. Reg. 46521. The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory context. In a press release to the public, EPA indicates that the topics covered at the October meeting will include sources of usage data (relating to the actual application of pesticides, in terms of the quantity applied or units treated); spatial applications of usage data; model parameterization; extrapolation of usage data to fill in gaps; temporal variability of usage; and updates on ongoing topics. Presentations concerning the incorporation of pesticide usage data into environmental exposure and ecological risk assessments will also be included. Registration is required. Requests to participate in the meeting must be received on or before September 23, 2019.
EPA Requests Comment On Process To Evaluate Synergists Effects Of Mixtures Of Pesticides: On September 9, 2019, EPA’s OPP published a notice announcing the availability of, and an opportunity for comment on, a document describing an “interim process” that OPP’s EFED is currently using to evaluate potential synergistic effects of mixtures of pesticide active ingredients on non-target organisms. 84 Fed. Reg. 47287. As part of a lawsuit challenging the 2012 decision by EPA to register Enlist Duo Herbicide (a combination of 2,4-D and glyphosate), OPP scientists learned that patent applications for some registered pesticide products included claims that particular combinations of active ingredients provide “synergistic” control of target species. Although EPA was not at that time considering potential synergies in assessing the risk for ecological effects on non-target organisms, based on the patent application claims regarding synergy for Enlist Duo, EPA decided to request that the reviewing court vacate its registration decision and remand the application for Enlist Duo for further study of these effects and any measures that might be needed to mitigate the risk to non-target organisms. This decision sparked much controversy, and many in industry were concerned that patent application claims were not being correctly interpreted by EPA for the category of pesticide products at issue. The new document is titled: “Process for Receiving and Evaluating Data Supporting Assertions of Greater Than Additive (GTA) Effects in Mixtures of Pesticide Active Ingredients and Associated Guidance for Registrants.” EPA states that it “has generally been applying this interim process since 2016.” The process described in the document has five steps: (1) registration applicants must search for any granted patents that include synergy (GTA) claims for combinations of pesticides; (2) applicants must review the patent claims and supporting data for relevance to ecological risk assessment; (3) applicants must report to EPA all effects testing data from the relevant patents; (4) applicants must do a statistical analysis (using a method prescribed by EPA) to determine whether any observations of GTA effects are statistically significant; and (5) EPA will review all submitted information to decide whether it should be utilized in ecological risk assessment. In the notice, OPP lists five specific areas pertaining to the interim risk assessment process described in the document on which it is requesting comment:
- Are there technical aspects of the interim process that warrant change? If so, what changes are recommended?
- What aspects of the process could be applied to the evaluation of open literature sources of GTA effects pesticide interactions?
- Should EPA consider standardizing a more detailed search and reporting approach, and how should EPA do that?
- Should EPA continue the evaluation process as described in this document? If so, what performance metrics (e.g., number of evaluations) should EPA consider before deciding the utility of this approach?
- What applicant burden is associated with the activities described in this memorandum, including compiling, analyzing, and submitting the information? Specifically, does an estimate of 80-240 hours of burden per applicant cover the respondent burden associated with the interim process?
When the National Research Council (NRC) evaluated the importance of toxicological interactions between pesticide active ingredients in 2013, the NRC concluded that such interactions are rare, but that EPA should nonetheless consider such interactions when the best available scientific evidence supports such an evaluation. EPA makes it clear that it is uncertain concerning the utility for risk assessment of the information used by manufacturers to support synergistic effects claims in pesticide patents. According to EPA, 24 applicants for new registrations have submitted patent data to date, but only three of these submissions contained information that indicated a need for further testing and no submission ultimately led to any adjustment of the ecological risk assessment. At this juncture, EPA will continue collecting patent data that may be pertinent to GTA effects, but when it has sufficient experience upon to base a general policy, it may either continue or improve this process or discontinue it after explaining why. When EPA requested that the reviewing court vacate and remand the registration EPA had granted for Enlist Duo, the parties seeking judicial review located data in the patent applications that EPA had not previously seen or reviewed and that EPA believed could possibly be pertinent to potential adverse effects on non-target plants. EPA concluded that it should revisit the decision based on the additional data. Although EPA decided to request vacatur and remand, the applicant Dow AgroSciences had arguably followed all of the procedures then in place, because FIFRA Section 3(c)(5) allows EPA to waive data requirements pertaining to efficacy, and EPA typically registers pesticide products that are not intended to protect public health without any independent evaluation of efficacy data. Nevertheless, in general, EPA may choose to evaluate pesticidal efficacy data; such circumstances in the past often involved cases where EPA was required to consider whether pesticide benefits are sufficient to outweigh identified risks. In the Enlist case, EPA determined that it should do so where potential synergy in pesticidal efficacy is pertinent to evaluating ecological effects on non-target species. What EPA must decide now is how often efficacy data that have been deemed adequate by the Patent and Trademark Office to support a patent for a new pesticide mixture will have any material significance in the context of ecological risk assessment. Before EPA makes a determination whether or not patent data have sufficient pertinence to continue requiring routine collection and evaluation of such data, EPA has decided it is prudent to afford all stakeholders an opportunity to comment on whether EPA has been asking the right questions. Comments are due by October 24, 2019.
EPA Proposes Rule On State Clean Water Act Permitting Certifications: On August 22, 2019, EPA published a proposed rule, “Updating Regulations on Water Quality Certification,” in the Federal Register (Section 401 Rule). 84 Fed. Reg. 44080. The Section 401 Rule sets forth proposed updates and clarifications to the scope and procedure for states and tribes to exercise their review authority under Clean Water Act (CWA) Section 401 known as 401 certification. CWA Section 401 grants authority to states and tribes to review any proposed activity that requires a federal license or permit and may result in discharge to waters of the United States (i.e., federally protected waterways) to ensure it will comply with applicable water quality standards, effluent limitations, toxic pollutant restrictions, and water quality requirements under state or tribal law. Typical activities certified by states/tribes under Section 401 authority include CWA Section 404 dredge-and-fill permits, CWA Section 402 discharge permits (i.e., point sources), and Federal Energy Regulatory Commission (FERC) hydropower licenses. States and tribes may grant or deny requests for certification, or grant certification with conditions that must be met by the permittee.
EPA proposed its Section 401 Rule in response to Executive Order 13868, “Promoting Energy Infrastructure and Economic Growth,” issued by President Trump on April 10, 2019, in an effort to reduce barriers and delays in federal permitting for pipeline construction and other energy infrastructure. The Executive Order directed EPA to take a preliminary step and revise guidance on the CWA Section 401 certification process, and then to propose a rule implementing the revision. EPA’s proposed Section 401 Rule makes clear that the scope of Section 401 review and/or conditions attached to granting certification are limited to considerations of water quality impacts from potential point source discharges to a water of the United States. States and tribes must tailor any conditions for granting 401 certification within this scope such that a state may not require activities that are ancillary and not directly related to water quality impacts (e.g., nature trail construction). Additionally, EPA clarifies in its proposal that a certifying state or tribe must act on a certification decision within one year of the request and there is no tolling provision that will stop the clock at any time in the one-year period. EPA is accepting comment on the proposal through October 21, 2019.
Court Upholds 2015 Ozone NAAQS: On August 23, 2019, the U.S. Court of Appeals for the D.C. Circuit upheld EPA’s primary National Ambient Air Quality Standard (NAAQS) for ozone. EPA in 2015 lowered the primary and secondary NAAQS for ozone from 75 parts per billion (ppb) to 70 ppb. 80 Fed. Reg. 65292 (Oct. 26, 2015). In Murray Energy Corp. v. EPA, Case No. 15-1385, some states and industry sought to repeal the 2015 ozone NAAQS on the grounds that they were arbitrary and capricious because EPA failed to provide a reasoned explanation for lowering the standard to 70 parts per billion (ppb). Environmental groups challenged the rule as too lenient, further arguing that it would occasionally permit ozone levels to exceed 70 ppb; they also challenged a grandfathering provision of the rule. The court denied both industry’s and environmental groups’ challenges to the primary ozone standard. The 70 ppb limit thus remains in place. The court, however, did side with environmentalists’ challenges to the secondary ozone standard. The court ruled EPA failed to justify its decision to use a three-year average benchmark without lowering the secondary ozone standard to account for single-year spikes in ozone exposures, and that it arbitrarily declined to set a level to protect against adverse welfare effects associated with visible leaf injury. The court consequently remanded the secondary ozone standard to EPA for reconsideration. Environmental groups also prevailed on their challenge of a grandfathering provision in the 2015 rule. In the rule, EPA allowed sources that had completed applications for preconstruction permits before the 2015 rule was adopted to demonstrate compliance with the previous NAAQS rather than the new, more stringent primary and secondary standards. The court found that EPA impermissibly did so and vacated the grandfathering provisions of the rule.
Final Rule Declines To Expand Scope Of SPCC Program: On September 3, 2019, EPA issued a final rule declining to expand the scope of the Spill Prevention, Control, and Countermeasure (SPCC) regulations under the CWA to address additional hazardous substances. 84 Fed. Reg. 46100. The decision is somewhat of a reversal of an Obama era pledge to assess whether the scope of the SPCC program warrants expansion. EPA issued the final rule in response to a Consent Decree with environmental groups. On July 21, 2015, the Environmental Justice Health Alliance for Chemical Policy Reform, People Concerned About Chemical Safety, and the Natural Resources Defense Council sued EPA for failing to comply with an alleged duty to issue regulations to prevent and contain CWA hazardous substances spills from non-transportation-related onshore facilities, including aboveground storage tanks, under CWA Section 311(j)(1)(C). Environmental Justice Health Alliance for Chemical Policy Reform v. EPA, 15-cv-5705 (S.D.N.Y. July 21, 2015). On February 16, 2016, the United States District Court for the Southern District of New York entered a Consent Decree between EPA and the litigants establishing a schedule under which EPA was to issue a final rule on the issue. Instead of issuing a rule to add hazardous substances to the scope of the SPCC program, however, EPA decided there is no need for new regulatory requirements under CWA Section 311(j)(1)(C) at this time. EPA explained that it believes existing regulations are adequate to meet its obligations under that provision and that no new regulatory program is warranted. EPA defended its decision by stating that, based on the reported frequency and impacts of identified CWA hazardous substances discharges, and EPA’s evaluation of the existing framework of EPA regulatory requirements relevant to preventing CWA hazardous substances discharges, the existing framework of regulatory requirements serves to prevent CWA discharges. Additionally, EPA identified relevant requirements in other federal regulatory programs and determined that they further serve to prevent CWA hazardous substances discharges. The rule is effective on October 3, 2019.
Proposed Rule Would Relax Methane Emission Standards For Oil And Gas Industry: EPA issued a proposed rule that would relieve segments of the oil and gas industry sector from complying with standards intended to cut emissions of methane. The proposed rule would revise the 2012 and 2016 New Source Performance Standards (NSPS) for the oil and natural gas industry that, according to EPA, “would remove regulatory duplication and save the industry millions of dollars in compliance costs each year, while maintaining health and environmental protection from oil and gas sources that the Agency considers appropriate to regulate.” The proposal even posits whether EPA has the authority to regulate methane emissions. EPA stated that it is proposing the rule in response to President Trump’s Executive Order on Promoting Energy Independence and Economic Growth. That order directs agencies to review existing regulations that potentially “burden the development or use of domestically produced energy resources,” including oil and natural gas, and to rescind or suspend regulatory requirements if appropriate. The proposed rule would remove all sources in the transmission and storage segment of the oil and natural gas industry from regulation under the NSPS, both for ozone-forming volatile organic compounds (VOC) and for greenhouse gases (GHG). The existing NSPS regulates GHGs through limitations on emissions of methane. EPA also proposed to rescind the methane requirements in the 2016 NSPS that apply to sources in the production and processing segments of the industry. As an alternative, EPA also is proposing to rescind the methane requirements that apply to all sources in the oil and natural gas industry, without removing any sources from the current source category. EPA also is seeking comment on alternative interpretations of EPA’s legal authority to regulate pollutants under Section 111(b) of the CAA. The pre-publication version of the rule is available online,
EPA Publishes Maps Indicating Where States Have Adopted RCRA Pharmaceutical Waste Rule: On February 22, 2019, EPA issued a rule streamlining standards for hazardous waste pharmaceuticals. 84 Fed. Reg. 5816. The rule went into effect on August 21, 2019. The rule also amended the P075 hazardous waste listing for nicotine such that U.S. Food and Drug Administration (FDA)-approved over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums, and lozenges) are not hazardous waste when discarded. EPA on September 4, 2019, posted an online, interactive map displaying the states and territories where the rule is in effect. There are two maps that show:
- Locations where the management standards for hazardous waste pharmaceuticals (40 C.F.R. Part 266 Subpart P) are in effect; and
- Locations where the amendment to the P075 listing for nicotine (40 C.F.R. § 261.33) is in effect.
Underneath the map is a table with this state adoption and authorization information, and links to the state and federal regulations. As states adopt these regulations, EPA will update the maps.
EPA Proposes Amendments To NESHAP For Wood Products: On September 6, 2019, EPA proposed amendments to the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Plywood and Composite Wood Products (PCWP). 84 Fed. Reg. 47074. The amendments come as a result of EPA’s residual risk and technology review (RTR) for this sector. The CAA requires EPA to conduct RTRs of NESHAP source categories periodically. EPA is proposing to amend provisions addressing periods of startup, shutdown, and malfunction (SSM); add provisions regarding electronic reporting; add repeat emissions testing requirements; and make technical and editorial changes. EPA states that these revisions will improve the effectiveness of the NESHAP. EPA estimates, however, that the proposed amendments would not reduce emissions of hazardous air pollutants (HAP) from this source category, but would result in improved monitoring, compliance, and implementation of the rule. The comment period closes on October 21, 2019.
EPA Proposes Amendments To NESHAP For Cellulose Products Sector: On September 9, 2019, EPA proposed revisions to the NESHAP for Cellulose Products Manufacturing. 84 Fed. Reg. 47346. The revisions are the result of EPA’s RTR that EPA is required to conduct under the CAA. EPA is proposing to amend provisions addressing SSM provisions; to add provisions regarding periodic emissions testing and electronic reporting; to provide more flexibility for monitoring requirements; and to make technical and editorial changes. While the proposed amendments would not result in reductions in emissions of HAPs, EPA states that they would result in improved monitoring, compliance, and implementation of the rule. The comment period closes on October 9, 2019.
EPA Superfund Task Force Sunsets And Issues Final Report: On September 9, 2019, EPA Administrator Andrew Wheeler announced that the Superfund Task Force has completed its work. He also announced the issuance of the Task Force’s final report, which he claimed outlines “significant accomplishments over the past two years at Superfund sites across the country.” EPA intends to integrate the work of the Task Force into EPA’s ongoing cleanup work moving forward. Commissioned in May 2017 to provide recommendations on how EPA could streamline and improve the Superfund program, the Task Force issued its initial report in July 2017 with 42 recommendations in five goal areas. According to the final report, which is available online, these are the highlights of the Task Force in the five goal areas:
- Goal 1: Expediting Cleanup and Remediation -- The Task Force developed several tools to expedite cleanup and remediation at sites, including the Administrator’s Emphasis List, a list of sites targeted for the Administrator’s immediate and intense attention. The Agency will continue using the Emphasis List to focus on sites needing immediate and intense attention and will update the list quarterly. Substantial progress has been made at sites on this list, the report states.
- Goal 2: Re-Invigorating Responsible Party Cleanup and Reuse -- The Task Force developed new enforcement guidance for EPA’s regional offices to accelerate remedial design starts at potentially responsible party (PRP)-lead Superfund sites. Moving forward, the guidance’s recommended settlement strategy will be considered by EPA regions as a matter of national practice.
- Goal 3: Encouraging Private Investment -- The Task Force recognized that EPA should support, where appropriate, innovative approaches to promote third-party investment in cleanup and reuse of contaminated properties consistent with statutory authorities. By the end of 2019, EPA plans to issue a memorandum to EPA regional offices to promote this approach where appropriate and in the interest of the Superfund Program.
- Goal 4: Promoting Redevelopment and Community Revitalization -- The Task Force worked to increase the number of National Priority List (NPL) sites that are returned to communities for redevelopment through focused management attention and improved program practices. In FY 2018, EPA achieved the goal sitewide ready for anticipated use at 51 sites, the highest total since FY 2013. EPA will continue to post specific information about sites available for redevelopment prominently on the Superfund Redevelopment website for stakeholders, developers, and businesses seeking information.
- Goal 5: Engaging Partners and Stakeholders -- The Task Force initiated a number of ongoing outreach activities to engage communities near Superfund sites.
EPA And Corps Issue Final Rescission Of 2015 “Waters Of The U.S” Rule: On September 12, 2019, EPA Administrator Andrew Wheeler announced EPA and the U.S. Army Corps of Engineers’ (Corps) publication of the agencies’ 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 CWA jurisdiction (Repeal Rule). 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 more 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.
The 2015 Rule is the subject of ongoing litigation in several federal district courts brought by over 30 states and a diverse cross section of industry and agricultural stakeholders. As a result of various judicial stays and decisions, there is currently a patchwork where the 2015 rule currently applies in roughly half of the states. The Repeal Rule will remove the 2015 WOTUS definition from the Code of Federal Regulations and replace it with the pre-2015 regulatory text. This is intended as a temporary placeholder to maintain the regulatory status quo until EPA and the Corps issue the “Step Two” Replacement Rule. EPA and the Corps expect to issue the final Replacement Rule in late 2019/early 2020, however, it is highly likely there will be a lengthy legal battle that follows and prevents implementation pending the outcome of litigation and an inevitable U.S. Supreme Court review.
FDA Predictive Toxicology Roadmap Workshop Scheduled For September 18, 2019: On August 20, 2019, FDA announced that a free public workshop titled “Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities” will be held on September 18, 2019 from 8 a.m. to 4 p.m. (EDT). 84 Fed. Reg. 43144. FDA will highlight work that has been done to support and implement FDA’s Predictive Toxicology Roadmap (Roadmap), which is a framework for integrating predictive toxicology methods into safety and risk assessments. Issues identified by FDA in the Roadmap (link here) include “determining an acceptable human dietary exposure for hazards in foods (including food additives, veterinary drug residues, and contaminants).” Interested parties, which may attend the workshop in person or view the event by webcast, must register by September 16, 2019.
FDA Comments On Best Practices To Prevent Adulteration: On August 28, 2019, FDA reminded industry of best practices to prevent tampering and intentional adulteration of foods and cosmetics in response to recent media reports regarding product tampering in grocery stores. The agency referenced relevant guidance documents, such as “Guidance for Industry: Food Security Preventive Measures Guidance for Retail Food Stores and Food Service Establishments” and the Food Safety Modernization Act’s (FSMA) “Final Rule entitled Mitigation Strategies to Protect Food Against Intentional Adulteration,” highlighted steps industry can take to safeguard products, and provided additional resources to assist industry.
Smarter Food Safety Meeting Scheduled For October 21, 2019: On August 29, 2019, FDA announced that a public meeting titled “FDA’s New Era of Smarter Food Safety” will be held on October 21, 2019, from 8:30 a.m. to 5 p.m. (EDT). The meeting is expected to include discussion of FDA’s efforts to develop a “Blueprint for a New Era of Smarter Food Safety,” announced earlier this year, which is intended to address areas such as traceability, digital technologies, and evolving business models. Meeting specifics will be made available later this month.
FDA Announces New Portal For Submitting Notifications: On September 6, 2019, FDA announced that two offices in the Center for Food Safety and Applied Nutrition (CFSAN) are now able to receive submissions through an online portal named the CFSAN Online Submission Module (COSM). COSM is a web-based platform that facilitates notification preparation and enables users to submit notifications to FDA electronically. The Office of Food Additive Safety (OFAS) will receive Food Contact Notifications (FCN), Generally Recognized As Safe Notices (GRN), Food Additive Petitions (FAP), Color Additive Petitions, and other submission types through the portal. The Office of Dietary Supplement Programs (ODSP) will receive New Dietary Ingredient Notifications (NDI) and Structure Function Claim Notifications (SFC) through the portal.
Food Standards Of Identity Meeting Scheduled For September 27, 2019: On August 29, 2019, FDA announced that a public meeting titled “Horizontal Approaches to Food Standards of Identity Modernization” will be held on September 27, 2019, from 8:30 a.m. to 5 p.m. (EDT). 84 Fed. Reg. 45497. FDA is interested in discussing efforts to modernize food standards of identity (SOI) to protect consumers against economic adulteration, maintain the characteristics and integrity of food, and promote innovation and flexibility in the food industry. Requests to make oral presentations must be received by September 12, 2019. Interested parties who may attend the workshop in person or view the event by webcast must register by September 20, 2019.
New Podcast Episode Available On “All Things Nano With Lisa E. Friedersdorf, Ph.D.”: In the August 15, 2019, episode of B&C’s All Things Chemical™ Podcast, “All Things Nano with Lisa E. Friedersdorf, Ph.D.,” Lynn L. Bergeson sat down with Dr. Friedersdorf, the Director of the National Nanotechnology Coordination Office (NNCO), to discuss all things nano. In their conversation, Dr. Friedersdorf breaks down the central goals and challenges of the National Nano Initiative (NNI), a governmental program designed to facilitate research and development in nanotechnology, educate people about nanotechnology, and ensure the responsible development of nano by understanding nano’s potential environmental, safety, and health implications. Dr. Friedersdorf explains how her work at NNCO helps direct and ensure that the many, many billions of dollars of funding available for nanotechnology applications and implications are allocated in ways that are efficient and invite the greatest return on investment and coordinated with other international nano initiatives.
EC Requests Scientific Opinion On Three Coatings For Nano Forms Of Zinc Oxide As A UV Filter In Dermally Applied Cosmetic Products: On August 19, 2019, the Scientific Committee on Consumer Safety (SCCS) posted a request from the European Commission (EC) for a scientific opinion on three coatings for nano zinc oxide as an ultraviolet (UV) filter in dermally applied cosmetic products -- methicone, silica, and isostearic acid. The deadline for SCCS’s opinion is March 2020. More information is available in our August 20, 2019, blog item.
NIOSH Publishes One-Pager On NTRC’s Accomplishments And Future Activities: On August 20, 2019, the National Institute for Occupational Safety and Health (NIOSH) posted a one-pager on the Nanotechnology Research Center (NTRC). NTRC’s future activities include:
- Publishing the final Current Intelligence Bulletin: Health Effects from Occupational Exposure to Silver Nanomaterials;
- Working with industry to develop practical, “real world” evaluation of hazard and risk represented by nanomaterials through their life cycles; and
- Participating in development of international standards with the Organization for Economic Cooperation and Development (OECD) and the International Organization for Standardization (ISO) Technical Committee (TC) 229.
NIEHS-Funded Research Finds That Graphene Shield Shows Promise In Blocking Mosquito Bites: On August 26, 2019, the National Institute of Environmental Health Sciences (NIEHS) announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing. The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences. The abstract states that “[t]he results show that graphene or graphene oxide nanosheet films in the dry state are highly effective at suppressing mosquito biting behavior on live human skin. Surprisingly, behavioral assays indicate that the primary mechanism is not mechanical puncture resistance, but rather interference with host chemosensing.”
President’s 2020 Budget Requests More Than $1.4 Billion For NNI: On August 30, 2019, NNI published its supplement to the President’s 2020 budget request. The supplement serves as NNI’s annual report required under the 21st Century Nanotechnology Research and Development Act and addresses the requirement for U.S. Department of Defense (DOD) reporting on its nanotechnology investments. According to NNI, the President’s 2020 budget requests more than $1.4 billion for NNI, “a continued investment in basic research, early-stage applied research, and technology transfer efforts that are leading to the breakthroughs of the future.” More information is available in our September 9, 2019, blog item.
Registration Opens For NNI Webinar On Industrial Perspective On Nanotechnology For A New Generation Of Gas Sensors: On October 2, 2019, NNI will hold a webinar on “Nanotechnology for a New Generation of Gas Sensors: An Industrial Perspective on Fundamental, Applied, and Commercialization Aspects.” In the webinar, Dr. Radislav Potyrailo (GE Global Research) will discuss: (1) possibilities for new principles of gas sensing based on nanomaterials and nanostructures; and (2) the development of sensors capable of quantifying individual chemical components in mixtures, rejecting interferences, and enhancing response stability in wearable, stationary, and other formats. Registration for the webinar is now open.
Course On Nano-Risk Governance Portal Will Be Held During NanoSafety Cluster Week: The National Research Center for the Working Environment (NFA) in Denmark will hold a course on October 10, 2019, on the Nano-Risk Governance Portal, a new portal for the risk management of nanomaterials. NanoSafety Cluster Week will be held October 7-10, 2019, in Copenhagen, Denmark. More information is available in our August 29, 2019, blog item.
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.
House Passes Package Of Energy Bills: On September 9, 2019, the House of Representatives returned to work after a six-week August recess and passed a package of energy-related bills. By a roll call vote of 295-114, the House approved a bill (H.R. 1768) that would extend the Diesel Emissions Reduction Act through 2024. The vote would keep alive an EPA program that takes older diesel-powered equipment off the market. House lawmakers also approved: H.R. 1420 to improve energy efficiency in federal buildings; H.R. 2114 to provide states with financial and technical support on energy security; and H.R. 1760 that would require the Department of Energy (DOE) to create a uranium program.
Bipartisan E-Waste Act Introduced In Senate:Warning that U.S. exports of electronic waste (e-waste) provide raw materials for foreign-made counterfeit products and result in unsafe environmental disposal, Senators Sheldon Whitehouse (D-RI) and Lamar Alexander (R-TN) on September 9, 2019, introduced legislation to stop the flow of e-waste to China and other countries that counterfeit U.S. technology. The Secure E-waste Export and Recycling Act (S. 2448) seeks to ensure that e-waste does not become the source of counterfeit products that reenter military and civilian electronics in the U.S. According to a statement accompanying the bill’s introduction, the U.S. is one of the world’s largest producers of e-waste, but has few limits on its export. As U.S. exports of e-waste grow, so does the counterfeit chip market in China that sells fake military-grade chips into the U.S. military supply chain. American national security faces a grave threat from counterfeit electronics that have flooded the supply chains of defense contractors, according to a 2012 report by the Senate Armed Services Committee. Many of the counterfeit products are parts taken from e-waste smuggled into China from the U.S. and other countries that have been remade to be sold new. The legislation strives to combat counterfeiters by requiring domestic recycling of untested, nonworking e-waste. The legislation would provide a regulatory framework for creating a comprehensive national approach for the export of used electronics. The bill allows for tested, working equipment to continue to be exported to promote reuse. Senator Whitehouse predicted that the legislation also “would support the domestic recycling industry, create new jobs here at home, and dispose of our electronic waste in a sustainable way.” Brokers exporting e-waste to developing nations undercut many responsible recyclers in the U.S., he explained. Keeping the e-waste in the country ensures U.S. recyclers “get business.” According to the Coalition for American Electronics Recycling (CAER), the bill is expected to help create up to 42,000 well-paying jobs for Americans in the e-waste industry. On June 27, 2019, Representatives Adriano Espaillat (R-NY) and Paul Cook (R-CA) introduced the House version of the bill (H.R. 3559).
House Subcommittee Holds Hearing On Growing The Clean Energy Economy: On September 10, 2019, the House Small Business Subcommittee on Rural Development, Agriculture, Trade and Entrepreneurship held a hearing on the clean energy economy. In a notice, the Subcommittee stated that there are growing opportunities for small companies, including farmers, to respond to energy challenges through new and innovative solutions. The clean energy economy covers many industries that are dominated by small businesses, including construction, agriculture, and renewable energy sectors. This hearing allowed the Subcommittee to explore the economic opportunities for our small businesses that come through efforts to address unpredictable weather patterns, reduce fossil fuel consumption, cut GHG emissions, and increase energy efficiency. Witnesses shared how small businesses are growing and creating good-paying jobs within clean energy sectors as well as what they need to continue to succeed. Testifying before the Subcommittee were Lynn Abramson, President, Clean Energy Business Network; Thomas Brooks, General Manager, Western Dubuque Biodiesel LLC; Michael Williams, Deputy Director, BlueGreen Alliance; and David Spigelmyer, President, Marcellus Shale Coalition. Hearing information, witness testimony, and an archived webcast of the hearing are available online.
House Select Committee On Climate Crisis Holds Hearing On Manufacturing Jobs: On September 10, 2019, the House Select Committee on the Climate Crisis held a hearing entitled “Solving the Climate Crisis: Manufacturing Jobs for America’s Workers.” The hearing focused on what steps Congress can take to boost U.S. manufacturing of clean energy technologies and creating new manufacturing jobs. Testifying before the Committee were: Zoe Lipman, Director, Vehicles and Advanced Transportation Program, BlueGreen Alliance; Tarak Shah, consultant and former DOE Chief of Staff to the Undersecretary for Science and Energy; Josh Nassar, Legislative Director for the United Auto Workers; and Edward Stones, Global Business Director for Energy and Climate Change at Dow Chemical Company. An archived webcast of the hearing is available online.
Contentious House Hearing Held On PFAS: The House Oversight and Reform Subcommittee on the Environment on September 10, 2019, held a hearing on per- and polyfluoroalkyl substances (PFAS) contamination. The hearing’s title set the tone for what turned into a sometimes contentious event as Committee Democrats lambasted witnesses representing PFAS manufacturers. Entitled “The Devil They Knew: PFAS Contamination and the Need for Corporate Accountability,” the hearing was a follow-up to the Subcommittee’s July 24, 2019, hearing on the human impact of PFAS contamination and state-level efforts to regulate the chemicals. The hearing was intended to examine the health risks associated with PFAS chemicals; what chemical manufacturers knew about this science and when they knew it; the current levels of PFAS contamination in the U.S.; and industry efforts to clean up contaminated sites. Testifying before the Subcommittee were two lawyers representing plaintiffs suing PFAS manufacturers in class-action lawsuits. A second panel of PFAS manufacturers also testified. The witnesses were:
- Robert A. Bilott, Partner Taft Stettinius & Hollister LLP;
- Lori Swanson,Former Attorney General State of Minnesota;
- Denise R. Rutherford, Senior Vice President of Corporate Affairs, The 3M Company;
- Paul Kirsch, President of Fluoroproducts, The Chemours Company; and
- Daryl Roberts, Chief Operations & Engineering Officer, DuPont de Nemours, Inc.
The hearing was the first time that representatives of major companies manufacturing PFAS products testified before a hearing on issues associated with PFAS contamination. Subcommittee Chair Harley Rouda (D-CA) wasted little time attacking the companies. In his opening statement he stated: “These companies with us here today have screwed up, and we need to hold them accountable for doing so,” adding that “I hope the people representing those companies today will admit their mistakes so we can all move forward.” Messrs. Kirsch and Roberts and Ms. Rutherford echoed each others’ statements by agreeing to work with lawmakers to address PFAS contamination. Mr. Roberts stoked the ire of Democratic lawmakers when he stated that there is little scientific data demonstrating that PFAS exposure caused “adverse human health effects.” In response, Representative Dan Kildee (D-MI) labeled that claim as “ridiculous.” Representative Debbie Wasserman Schultz (D-FL) also had harsh words for the companies, stating that they “are playing into our national emergency.” Referring to the use of PFAS chemicals in firefighting foam, she added: “You have sickened our first responders and our members of our military, and I don't know how you sleep at night.” Witness testimonies and an archived webcast of the hearing are available online.
House Subcommittee Holds Hearing On CFATS Amendments And Extension: On September 11, 2019 -- the 18th anniversary of the September 11th terrorist attacks -- a House Subcommittee held a hearing on legislation intended to protect chemical facilities from terrorist attacks. The House Energy and Commerce Subcommittee on the Environment and Climate Change convened the hearing to consider the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2019 (H.R. 3256). The bill would amend and reauthorize the Department of Homeland Security’s (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) program. The CFATS program requires high-risk chemical facilities (as defined by DHS) to address risk by meeting risk-based performance standards in 18 areas. Congress created CFATS in 2006 and intended to sunset it in 2009 (Pub. L. 109-295). DHS promulgated the regulations establishing CFATS on April 9, 2007. 72 Fed. Reg. 17688. Congress extended the program through annual appropriations until passage of the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014, which extended CFATS through the beginning of 2019. On January 18, 2019, the President signed H.R. 251, the Chemical Facility Anti-Terrorism Standards Program Extension Act, which extended the program through April 2020. In addition to extending CFATS through May 1, 2025, the bill also would amend the program in several substantive ways. The bill would require DHS to verify information submitted by covered chemical facilities before reducing the tier assignments of those facilities and establishing a voluntary security program for facilities not covered by CFATS requirements. It also would direct facility owners and operators to include employees in security planning and to inform employees that the facility is covered by the CFATS program. DHS would be authorized to disapprove any site security plan that fails the verification or that does not contain contact information for local emergency planning officials and a policy to contact such officials annually regarding emergency response procedures. The bill also revises DHS’s risk assessment methodology for assigning facilities to risk tiers to ensure that risks of all malicious acts, not just terrorism, are covered. It also broadens the harms considered beyond loss of human life and severe economic consequences. DHS also would be required to share more threat information with state and local emergency response officials and to publish information on practices that can assist chemical facilities in preventing, reducing, and mitigating chemical security risks. House Energy and Commerce Committee Chair Frank Pallone (D-NJ) opened the hearing calling for lawmakers to “work in a bipartisan fashion to move legislation forward again,” adding that “[i]t’s critical that we get this done. And three major chemical incidents this year -- one in Crosby, Texas, another in LaPorte, Texas and a third in South Philadelphia, Pennsylvania -- underscore the need to do more.” He predicted that H.R. 3256 would make welcome improvements to the CFATS program and strengthen the role of workers at covered facilities. Environment and Climate Subcommittee Chair Paul Tonko (D-NY) echoed Mr. Pallone’s sentiment, adding that “[e]veryone here understands the importance of a multi-year extension, which would give the program a vital measure of certainty and stability.” Testifying before the Subcommittee were:
- David Wulf, Acting Deputy Assistant Secretary for Infrastructure Protection, Department of Homeland Security;
- Matthew Fridley, Corporate Manager of Safety, Health, and Security, Brenntag North America, Inc., On behalf of the National Association of Chemical Distributors;
- Michele Roberts, National Co-Coordinator, Environmental Justice Health Alliance (EJHA);
- John Paul Smith, Legislative Representative, United Steelworkers (USW); and
- Scott Whelchel, Chief Security Officer and Global Director of Emergency Services and Security, Dow Chemical Co., On behalf of the American Chemistry Council.
Witness testimony and an archived webcast of the hearing are available online.
Senate EPW Committee Holds Hearing On Nomination Of New CSB Head: On September 11, 2019, the Senate Environment and Public Works (EPW) Committee, held a hearing on the nomination of Katherine Andrea Lemos, Ph.D., to chair the Chemical Safety and Hazard Identification Board (CSB). Dr. Lemos previously served in the Federal Aviation Administration and on the National Transportation Safety Board. She is currently the Director of Programs for Northrop Grumman Corporation’s Aerospace Sector. According to the White House, which nominated her on June 19, 2019, Dr. Lemos has a distinguished background in system safety, accident investigation, human factors, and advanced technology research and integration. She also has broad experience across the product life cycle in analyzing and promoting product, process, and operational performance. An archive webcast of the hearing is available online.
Senator Cardin Introduces Resolution To Block Clean Power Plan Replacement Rule: On September 9, 2019, Senator Ben Cardin (D-MD) introduced a resolution (S.J. Res. 53) that would block implementation of EPA’s rule replacing the Obama era Clean Power Plan (CPP). On July 8, 2019, EPA issued a final rule repealing and replacing the CPP, one of President Obama’s landmark environmental protection rules. 84 Fed. Reg. 32520. Unlike the CPP, the Affordable Clean Energy (ACE) rule does not set limits on emissions from coal-fired utilities. Instead, EPA gives states latitude in determining how to control emissions of GHG emissions from coal-fired power plants within their borders. The rule redefines the “best system of emission reduction” (BSER) for carbon dioxide from such plants. Specifically, the rule identifies heat rate improvements as BSER. The ACE rule also establishes emissions guidelines for states to use when developing plans to limit carbon dioxide at their coal-fired power plants and provides states with a list of applicable emissions control technology that power plants can use to ensure compliance with the rule. EPA bars the use of certain options for compliance, including carbon capture and storage, fuel switching, and emissions trading. EPA abandoned an approach that would have eased the New Source Review (NSR) regulations that are triggered if power plants implement significant changes or modifications at their facilities. Also contained within the rule are new implementing regulations for ACE and future existing-source rules under 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. Senator Cardin’s resolution would “disapprove” of the rule under the authority of the Congressional Review Act.
California DPR Issues Cancellation Notices For Chlorpyrifos, And Establishes A Work Group To Recommend And To Develop Alternatives To Chlorpyrifos: On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to 13 California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva). Each of these notices is referred to as an “Accusation,” and each affected registrant has 15 days to request a hearing concerning the proposed cancellation. DPR's issuance of these notices followed a final decision by EPA to deny an administrative petition to revoke the tolerances and cancel the U.S. registrations for chlorpyrifos. DPR states: "Despite the Trump administration’s reversal of a decision to ban the pesticide at the federal level, California continues to move forward to protect public health, workers, and the environment.” Although it is unusual for a state to act unilaterally to cancel a state registration for a pesticide that is still registered under FIFRA, FIFRA Section 24(a) provides that states may separately regulate federally registered pesticides so long as they do not purport to authorize any sale or use that is otherwise prohibited under FIFRA. The risk assessment that supports DPR’s proposal to cancel chlorpyrifos products is based on five animal studies published in 2016, 2017, and 2018 that report neurotoxicity from chlorpyrifos at exposure levels that are considerably lower than the levels that cause acetylcholinesterase inhibition. Based on its evaluation of these studies, DPR has concluded that developmental neurotoxicity is the critical endpoint for chlorpyrifos and has derived a point of departure for chlorpyrifos risk assessment. Based on this assessment, DPR previously concluded that chlorpyrifos should be designated as a Toxic Air Contaminant (TAC). DPR presented its TAC findings to California’s Scientific Review Panel at a meeting on July 30, 2018, and the Panel subsequently concluded that the DPR assessment of the developmental neurotoxicity of chlorpyrifos was “based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding.” On the same day DPR issued its cancellation notices for chlorpyrifos, DPR also announced it has established an Alternatives to Chlorpyrifos Work Group with experts from “agriculture, California universities, environmental justice groups, farmworker health and safety organizations, and pesticide manufacturers…” DPR has asked this Work Group to develop short-term practical alternatives to chlorpyrifos, along with a five-year action plan. The Work Group is supposed to conclude its work by the spring of 2020. The budget for 2019-2020 approved by the California Legislature also includes $5 million in grant funding to develop sustainable alternatives to chlorpyrifos. More information is available here.
EPA Ends Use Of SEPs In Settlements With State And Local Governments: On August 21, 2019, Assistant Attorney General Jeffrey Bossert Clark announced in an internal memorandum that EPA will no longer use Supplemental Environmental Projects (SEP) in settlements with state and local government polluters. The memorandum states that SEPs in settlements go beyond what is required under federal, state, or local laws. As such, their use is precluded. As a basis for this decision, Mr. Clark referred to a November 2018 memorandum from the Attorney General establishing a new policy governing civil consent decrees and settlement agreements with state and local governments. In that memorandum, the Attorney General stated that consent decrees “must not be used to achieve general policy goals or to extract greater or different relief from the defendant than could be obtained through agency enforcement authority or by litigating the matter to judgment.” The August 2019 memorandum cited this policy and went into detail explaining why SEPs are inappropriate and subject to the new policy. Consequently, the use of SEPs in settlement agreements is now unambiguously precluded.
U.S. Codex Office To Hold Hearing On Antimicrobial Resistance: On August 28, 2019, the U.S. Department of Agriculture’s Codex Office announced that it will hold a public meeting to receive comments on agenda items and draft positions to be discussed at the 7th Session of the Codex Ad Hoc Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) of the Codex Alimentarius Commission. 84 Fed. Reg. 45121. The TFAMR conference will be held in Pyeongchang, Republic of Korea, on December 9 - 13, 2019. The public meeting is scheduled for November 21, 2019, from 1:00 - 4:00 (EST) in Washington, DC. Documents related to the TFAMR session are accessible online. Codex was established in 1963 by the United Nations’ Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
NIEHS-Funded Research Finds That Graphene Shield Shows Promise In Blocking Mosquito Bites: On August 26, 2019, NIEHS announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing. The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences. According to the abstract, the researchers hypothesized that graphene films may provide mosquito bite protection for light, fiber-based fabrics. The researchers investigated the fundamental interactions between graphene-based films and the mosquito species Aedes aegypti through a combination of live mosquito experiments, needle penetration force measurements, and mathematical modeling of mechanical puncture phenomena. The abstract states that “[t]he results show that graphene or graphene oxide nanosheet films in the dry state are highly effective at suppressing mosquito biting behavior on live human skin. Surprisingly, behavioral assays indicate that the primary mechanism is not mechanical puncture resistance, but rather interference with host chemosensing.” The researchers propose that the interference is “a molecular barrier effect that prevents Aedes from detecting skin-associated molecular attractants trapped beneath the graphene films and thus prevents the initiation of biting behavior.” According to the abstract, placing water or human sweat on the external film surface circumvents the molecular barrier effect. In this scenario, the abstract states, “pristine graphene films continue to protect through puncture resistance -- a mechanical barrier effect -- while graphene oxide films absorb the water and convert to mechanically soft hydrogels that become nonprotective.”
Climate Leadership Council Releases Carbon Dividends Plan: On September 11, 2019, the bipartisan Climate Leadership Council (CLC) updated its carbon dividends plan. The CLC states that, if implemented in 2021, the plan will halve U.S. emissions of carbon dioxide by 2035, as compared to 2005 levels. The findings are based on recent modeling by Resources for the Future. The four pillars of CLC’s updated plan are:
- A Gradually Rising Carbon Fee -- The plan would set an economy-wide carbon fee starting at $40 a ton and increasing every year at 5% above inflation.
- Carbon Dividends -- All net proceeds from the carbon fee will be returned to the American people on an equal and quarterly basis. A family of four will receive approximately $2,000 in carbon dividend payments in the first year.
- Significant Regulatory Simplification -- The third pillar is the streamlining of regulations that are no longer necessary upon the enactment of a rising carbon fee. In the majority of cases where a carbon fee offers a more cost-effective solution, the fee will replace regulations. All current and future federal stationary source carbon regulations, for example, would be displaced or preempted.
- Border Carbon Adjustment -- Carbon-intensive exports to countries without comparable carbon pricing systems will receive rebates for carbon fees paid, while carbon-intensive imports from such countries will face fees on the carbon content of their products.
Basel Ban On Plastic Wastes Goes Into Effect In December: On May 10, 2019, governments that are parties to the Basel Convention on the Control of Transboundary Movements of Hazardous Waste and their Disposal (Basel Convention) approved an amendment to include three types of plastic waste. The legally-binding framework “will make global trade in plastic waste more transparent and better regulated, whilst also ensuring that its management is safer for human health and the environment,” the Secretariat of the Basel Convention wrote. The amendment requires Basel Convention parties to obtain prior informed consent before shipping certain plastic wastes to nations that have adopted the Basel Convention. The amendment could make it difficult, if not impossible, for the U.S., which is not a party to the Basel Convention, to export plastic wastes to countries that eventually adopt the amendment. Two Basel Convention parties -- Croatia and St. Kitss and Nevis -- recently ratified the amendments. Croatia’s September 6, 2019, ratification pushed the amendment over the threshold necessary for ratification. Consequently, the amendments will go into effect on December 5, 2019. The U.S. is not a party to the Basel Convention. On July 3, 2019, EPA Administrator Andrew Wheeler filed a formal objection with OECD on OECD’s plans to add plastic wastes to export controls under the OECD Council Decision, As Amended, on the Control of Transboundary Movements of Wastes Destined for Recovery Operations (OECD Decision). Amendments to the Basel Convention are automatically incorporated into OECD’s rules on waste imports and exports, provided that no OECD member country objects within 60 days. EPA’s July 3 objection thus stalls, at least for now, OECD’s adoption of the amendments. Wheeler stated in his objection that “subjecting plastic scrap to the Amber control procedure would impede trade for recycling and could reduce the level of recycling among OECD countries.” Should trade in plastics be blunted, Wheeler added, “we anticipate that more OECD-generated plastic scrap will be disposed in landfills, sent for incineration or used for fuel, which are less-preferred options on the waste-management hierarchy.”
OSHA Announces Top Ten Most Frequently Cited Violations For FY 2019: Patrick Kapust, Deputy Director of Enforcement Programs at the Occupational Safety and Health Administration (OSHA), on September 10, 2019, listed the top ten violations most frequently cited by OSHA in FY 2019. Speaking at the National Safety Congress, Mr. Kapust stated that the violations are:
- Fall Protection -- General Requirements
- Hazard Communication
- Respiratory Protection
- Powered Industrial Trucks
- Fall Protection -- Training Requirements
- Machine Guarding
- Eye & Face Protection
SEC Proposes Updated Disclosures Under Regulation S-K: On August 23, 2019, the Securities and Exchange Commission (SEC) proposed amendments to Regulation S-K “to modernize the description of business, legal proceedings and risk factor disclosures that registrants are required to make pursuant to Regulation S-K. “ 84 Fed. Reg. 44358. Importantly, SEC has proposed to increase the $100,000 “monetary sections” threshold for reporting disclosure of a proceeding under environmental laws to which a governmental authority is a party to $300,000 to account for inflation. In addition, SEC has proposed to revise the reporting requirement pertinent to material environmental control facilities expenditures to eliminate the requirement for the registrant’s succeeding FY. Comments are due by October 22, 2019.