Federal Development Update for May 2019


Registration Now Open For “TSCA: Three Years Later”: Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present the one day conference “TSCA: Three Years Later” on June 24, 2019. Panelists Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA), and Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, will dive into a host of topics, including the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. This conference (in-person and webinar) is free and open to the public, but registration is required by June 21, 2019, at the ELI website.

WEBINAR -- Preserving Cosmetics On A Global Scale: It Is Harder Than You Think, May 22, 2019, 1:00 p.m. - 2:00 p.m. EDT: B&C affiliate The Acta Group (Acta®) is pleased to present the complimentary webinar “Preserving Cosmetics on a Global Scale: It Is Harder than You Think,” featuring Karin F. Baron, MSPH, Senior Regulatory Consultant, Acta; Scott J. Burya, Ph.D., Regulatory Chemist, Acta; and Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs and Director of Toxicology, Acta.

WEBINAR -- Sustainable Investment In Agriculture, May 22, 2019, 12:00 p.m. - 1:00 p.m. EDT: The International Bar Association (IBA) Agricultural Law Section, supported by the American Bar Association (ABA) Section of Environment, Energy, and Resources, Committee on Pesticides, Chemical Regulation, and Right-to-Know, the Environmental Law Institute, and the National Agricultural Law Center, presents “Sustainable Investment in Agriculture,” with a focus on emerging legal issues in the area of sustainable and responsible investment in agriculture. Lynn L. Bergeson, Managing Partner, B&C, and Vice Chair, IBA, Agricultural Law Section, will moderate.

Subscribe To B&C’s “All Things Chemical™ Podcast” For New Episodes Every Other Thursday: All Things Chemical brings you intelligent, insightful, and engaging conversation about everything related to industrial, pesticidal, and specialty chemicals, as well as the law and business issues surrounding chemicals. Recent episodes include “Innovation and New Chemicals in the TSCA Program” and “Ambassador Howard Gutman on What Every CEO Needs to Know Right Now.” Listen now on our website, or subscribe with Apple PodcastsGoogle PlayStitcher, or Spotify so you never miss an episode.

TSCA/FIFRA/TRI

EPA Issues Final SNUR For Asbestos, Will “Close Loophole And Protect Consumers”: On April 25, 2019, EPA issued a final significant new use rule (SNUR) for asbestos using the definition in Title II, Section 202 of TSCA, which defines asbestos as the “asbestiform varieties of six fiber types -- chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.” 84 Fed. Reg. 17345. The restricted significant new use of asbestos (including as part of an article) is manufacturing (including importing) or processing for uses that are neither ongoing nor already prohibited under TSCA. Persons subject to the SNUR may not undertake any of these activities; they are 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. 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. The final SNUR is effective June 24, 2019. More information is available online.

Ninth Circuit Issues Order Requiring EPA To Rule On Objections To Denial Of Tolerance Revocation For Chlorpyrifos Within 90 Days: On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636. The February 6, 2019, Ninth Circuit decision to grant EPA’s request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for chlorpyrifos. After the rehearing, the en banc panel issued a writ of mandamus directing EPA “to issue, no later than 90 days after the filing of this order, a full and fair decision on LULAC’s objections” to an initial EPA order denying a 2007 petition to revoke all tolerances for chlorpyrifos. The en banc order states that the court has discretion to construe the Petitioners’ opening brief as a request for mandamus relief, even though the Petitioners sought judicial review of EPA’s initial denial decision without waiting for EPA to rule on their objections and even though they did not file a petition for mandamus under the applicable procedural rule. The court then states that “[c]onsidering the history and chronology of this matter and the nature of the claims, we conclude mandamus is appropriate, and we hereby GRANT the Petition for a Writ of Mandamus.” The court states that “EPA represented that it could issue a final decision with respect to petitioners’ objections within 90 days of an order issued by this court” during oral argument on March 26, 2019. The en banc ruling, however, does not discuss the jurisdictional issues presented when the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections. Moreover, the ruling does not discuss the substantive dispute concerning EPA’s authority to decline to revoke the tolerances and cancel the registrations for chlorpyrifos based on the current administrative record. More information on the protracted litigation concerning chlorpyrifos is available on our blog under key words chlorpyrifos and ninth circuit.

EPA Announces Proposed Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA Inventory: On April 23, 2019, EPA issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory. 84 Fed. Reg. 16826. The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule. TSCA Section 8(b)(4)(C) requires EPA to promulgate a rule establishing a plan to review all CBI claims to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory that were asserted in an NOA Form A. This rule must be promulgated not later than one year after the publication of the first TSCA Inventory containing all “active” substance designations. TSCA also requires EPA to implement the CBI review plan so as to complete all CBI claim reviews not later than five years after such TSCA Inventory publication, with the possibility of a two-year extension. EPA states that since it released the updated TSCA Inventory on February 19, 2019, the deadline for issuing a final rule is February 19, 2020, and the deadline for completing all the CBI claim reviews is February 19, 2024. If EPA invokes the two-year extension under TSCA, the deadline for completing all the CBI claim reviews would then become February 19, 2026. As reported in our February 21, 2019, memorandum, “EPA Releases Updated TSCA Inventory,” of the 40,655 chemicals in commerce, more than 80 percent (32,898) have identities that are not CBI and fewer than 20 percent (7,757) have identities that were claimed as CBI. EPA notes that other types of CBI claims are outside the scope of the review plan under TSCA Section 8(b)(4)(C) through (E), and hence are outside the scope of the proposed rule. Those claims are governed by other statutory and regulatory provisions. Substantiation and review of CBI claims for other data elements in an NOA Form A are governed by TSCA Section 14(g) and 40 C.F.R. Section 710.37(b) and (c)(1). EPA states that substantiation and review of CBI claims for specific chemical identity in an NOA Form B -- “a forward-looking reporting form required when reintroducing an ‘inactive’ chemical substance into U.S. commerce for a nonexempt commercial purpose” -- are governed by TSCA Section 8(b)(5) and 40 C.F.R. Section 710.37(a)(2). Comments are due by June 24, 2019. More information is available in the full memorandum.

EPA Proposes TSCA CDR Revisions And Update To Small Manufacturer Definition For TSCA Section 8(a): On April 25, 2019, EPA issued a proposed rule that would amend TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. 84 Fed. Reg. 17692. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR. EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small. Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner. Comments are due by June 24, 2019.

D.C. Circuit Partially Denies Petition For Review Of TSCA Inventory: On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit issued its order on petition for review of the EPA final rule on TSCA Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule: (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. More information is available in our blog.

EPA Releases Proposed Interim Registration Review Decision For Glyphosate: On May 6, 2019, EPA announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 19782. In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.” Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies including:

  • “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;
     
  • “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;
     
  • Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and
     
  • “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”
     

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID. The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361. Public comments are due by July 5, 2019. In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2019), EPA’s response to comments on the human health risk assessment (dated April 23, 2018), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018).

EPA Denies TSCA Section 21 Petition To Initiate A Reporting Rule Under TSCA Section 8(a) For Asbestos: On May 8, 2019, EPA denied a petition it received under TSCA Section 8(a) from the Attorneys General of Massachusetts, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and the District of Columbia requesting that EPA initiate a rulemaking proceeding under TSCA Section 8(a) for the reporting of the manufacture (including import) and processing of asbestos. 84 Fed. Reg. 20062. EPA does not believe that petitioners have demonstrated that it is necessary to initiate a rulemaking proceeding under TSCA Section 8(a) to obtain additional information to conduct its risk evaluation on asbestos and any potential subsequent risk management. Given EPA’s understanding of asbestos and reporting under TSCA Section 8(a), as a result of implementation of the CDR rule and other TSCA Section 8(a) rules, EPA does not believe that the requested reporting requirements would collect the data the petitioners believe the Agency lacks. Where EPA lacks information, it has relied on models. Use of modeled data is in line with EPA’s final Risk Evaluation Rule and EPA’s risk assessment guidelines. EPA intends to provide opportunity for peer and public review of the draft asbestos risk evaluation, which EPA will use to refine the risk evaluation of asbestos.

EPA Announces Meeting Date For TSCA Science Advisory Committee On Chemicals: On May 9, 2019, EPA announced meeting dates for its TSCA Science Advisory Committee on Chemicals (SACC). 84 Fed. Reg. 20354. The purpose of the meeting is to consider and review the draft Risk Evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) and associated documents. The in-person meeting will also include a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public for the committee’s discussion of information claimed as CBI. As previously announced in April, the public is invited to comment on the draft risk evaluation for PV29 and related documents, including the draft charge questions, in advance of and during this peer review meeting. The TSCA SACC will consider these comments during its discussions. The four-day meeting will be held from 9:00 a.m. to approximately 5:30 p.m. Eastern Time, June 18-21, 2019. The meeting may also be available via webcast. Written comments are due May 17, 2019. Requests to make oral comments during the meeting will be included on the meeting agenda if received on or before May 28, 2019. For further details, please consult the Federal Register.

EPA Issues Notice To Manufacturers And Processors On The TSCA Inactive Inventory: On May 15, 2019, EPA announced the availability of a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the TSCA Inventory Notification (Active-Inactive) Requirements rule. 84 Fed. Reg. 21772. Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive. Because the action was signed on May 6, 2019, inactive designations will become effective on August 5, 2019.

Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory. Manufacturers and processors can notify EPA via an NOA Form B, found in EPA’s Central Data Exchange (CDX). Upon receiving such notification, EPA will change the designation of substances from inactive to active.

EPA Extends Comment Period On Draft Guidance For Pesticide Registrants On Plant Regulator Label Claims, Including Plant Biostimulants: On May 15, 2019, in response to public requests for an extension of the comment period, EPA announced it is extending the comment period for the draft guidance document for an additional 60 days. 84 Fed. Reg. 21773. Comments are now due on July 28, 2019. More information on the draft guidance document can be found in our blog.

EPA Requests Comments On Ad Hoc Panelists For FIFRA SAP Meeting On Proposed Guidelines For Efficacy Testing Of Certain Flea And Tick Products: On May 3, 2019, EPA announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300: Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests. The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) website. Comments on the candidates are due by May 18, 2019, to the Designated Federal Official (DFO) Dr. Suhair Shallal (shallal.suhair@epa.gov). EPA is requesting these comments prior to the FIFRA SAP public in-person meeting scheduled for June 11-14, 2019, from 9:00 a.m. to 5:00 p.m. (EDT), which will review EPA’s proposed guidelines referenced above and the supplemental document Sample Size for Pet Product Studies. 84 Fed. Reg. 15214. The charge questions to the panel are available here. More information is available in our blog.

EPA Corrects 200 ppb Level Description In Technical Amendment To Data Requirements For Antimicrobial Pesticides Final Rule: On May 3, 2019, EPA announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text. The final rule will become effective on July 2, 2019. More information is available in our blog.

RCRA/CERCLA/CWA/CAA/PHMSA

D.C. Circuit Upholds EPA’s Decision To Not Expand Ozone Transport Region: On April 23, 2019, the U.S. Court of Appeals for the D.C. Circuit rejected a petition from several East Coast states that would have required EPA to impose stricter ozone controls on upwind states. EPA on November 3, 2017, denied a petition submitted by several states seeking to expand the Ozone Transport Region (OTR) under the Clean Air Act (CAA). 82 Fed. Reg. 51238. On December 9, 2013, the states of Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island, and Vermont filed a petition with EPA requesting that EPA expand the OTR by adding the states of Illinois, Indiana, Kentucky, Michigan, North Carolina, Ohio, Tennessee, West Virginia, and the areas of Virginia not already in the OTR to address the interstate transport of air pollution with respect to the 2008 ozone National Ambient Air Quality Standards (NAAQS). In its denial, EPA stated that it believes that other CAA provisions “provide a better pathway for states and the EPA to develop a tailored remedy that is most effective for addressing any remaining air quality problems for the 2008 ozone NAAQS identified by the petitioners.” The final action was effective on November 4, 2017. The states then turned to the appeals court, seeking a reversal of EPA’s dismissal of the petition. The court ruled that EPA acted legally and appropriately in rejecting the petition. It stated that achieving compliance by relying on the CAA’s “good neighbor provision,” which requires EPA to impose a federal plan on states that contribute significantly to other states’ ability to meet air quality standards, was the appropriate approach. The court stated that “EPA thus concluded that, compared to the blunt impact of expanding the region, these other tools provided more effective and efficient approaches to the ozone transport problem in light of limited agency resources.”

EPA Declines To Revise RCRA Regulation Of Oil And Gas Waste: On April 23, 2019, EPA stated that it would not revise the current regulatory status under the Resource Conservation and Recovery Act (RCRA) for wastes generated by oil and gas production. The determination came in a letter to environmental groups from Barry Breen, EPA’s Acting Assistant Administrator for the Office of Land and Emergency Management. Currently, EPA regulates wastes from the exploration, development, and production of crude oil, natural gas, and geothermal energy under RCRA’s Subtitle D non-hazardous waste regulations at 40 C.F.R. Part 257. In 2016, the Environmental Integrity Project and the Natural Resources Defense Council sued EPA, seeking a revision in how EPA regulates oil and gas wastes. Under a settlement agreement reached in the case, EPA by March 15, 2019 (changed to April 23, 2019, due to the government shutdown) was to issue a proposed rule revising the Part 257 regulations or make a determination that the regulations did not warrant revision. EPA’s April 23, 2019, letter states that “revising the regulations is not necessary at this time.”

EPA Releases Interpretive Statement On Whether CWA NPDES Permit Program Applies To Releases Of A Pollutant From A Point Source To Groundwater: On April 23, 2019, EPA announced it was making available its Interpretive Statement addressing whether the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) permit program applies to releases of a pollutant from a point source to groundwater (Interpretive Statement) for comment. 84 Fed. Reg. 16810. EPA is issuing the Interpretative statement to “provide clarity on [EPA’s] interpretation of the [CWA] given the mixed record of prior [EPA] statements and a split in the federal circuit courts regarding this issue.” EPA’s Interpretive Statement states that it “sets forth [its] interpretation of the [CWA NPDES] permit program’s applicability to releases of pollutants from a point source to groundwater that subsequently migrate or are conveyed by groundwater to jurisdictional surface waters” and “EPA concludes that the [CWA] is best read as excluding all releases of pollutants from a point source to groundwater from NPDES program coverage and liability under Section 301 of the CWA, regardless of a hydrologic connection between the groundwater and a jurisdictional surface water.” EPA also released a fact sheet on its Interpretive Statement, available online. The April 23 Federal Register notice states that the Interpretative Statement reflects EPA’s consideration of the public comments received in response to its February 20, 2018, Federal Register notice (83 Fed. Reg. 7126) which requested comment on EPA’s previous statements regarding whether pollutant discharges from point sources that reach jurisdictional surface waters via groundwater or other subsurface flow that has a direct hydrologic connection to the jurisdictional surface water may be subject to CWA regulation. EPA received over 50,000 comments from a wide range of stakeholders, many of which affirmed that additional clarity from EPA was necessary. EPA reached its conclusion based on the comments received and on “a holistic analysis of the [CWA], its text, structure, and legislative history.” EPA also references numerous policy considerations that support excluding groundwater discharges from NPDES permitting, including existing state and federal authorities and statutes that play a role in regulating groundwater quality (e.g., Safe Drinking Water Act (SDWA) Underground Injection Control (UIC) program). EPA is soliciting public comments on the Interpretive Statement, specifically regarding what may be needed to provide further clarity and regulatory certainty on this issue. Comments are due by June 7, 2019. More information is available in our blog.

EPA Issues Draft Interim Recommendations To Address Groundwater Contaminated With PFOA And PFOS: EPA on April 25, 2019, issued interim recommendations for addressing groundwater contaminated with perfluorooctanoic acid (PFOA) and/or perfluorooctane sulfonate (PFOS). The interim recommendations are to be applied to sites being evaluated and addressed under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and corrective action under RCRA. The interim guidance is available online. The guidance provides interim recommendations for screening levels and preliminary remediation goals (PRG) to inform final cleanup levels for PFOA and/or PFOS contamination of groundwater that is a current or potential source of drinking water. EPA states that its recommendations are consistent with existing EPA guidance and standard practices, in addition to applicable statutes and regulations. For groundwater contaminated with PFOA or PFOS, EPA instructs its regional offices to consult on a case-by-case basis with the Office of Land and Emergency Management (OLEM) prior to using the Fund and the Office of Enforcement and Compliance Assurance (OECA) prior to taking enforcement action. The interim recommendations are as follows: sites should be screened using a level set to a Hazard Quotient of 0.1 for PFOA or PFOS individually, which is currently 40 parts per trillion (ppt); and for sites where groundwater is contaminated and is a current or potential source of drinking water, the PRG should be 70 ppt, unless a state or tribal Maximum Contaminant Level for PFOA or PFOS is in place. In situations where groundwater is being used for drinking water, EPA expects that responsible parties will address levels of PFOA and/or PFOS over 70 ppt. EPA is taking comment on the interim recommendations until June 10, 2019.

EPA Issues RCRA Guidance On Planning For Natural Disaster Debris: On May 2, 2019, EPA released the 2019 “Planning for Natural Disaster Debris” guidance. This document is an update to the version that EPA published in March 2008. It is designed to help communities create disaster debris management plans. The guidance is intended to assist communities in planning for natural disaster debris. Information is included on recommended components of a debris management plan, suggested management options for various natural disaster debris streams, case studies, and EPA’s recommended pre-incident planning process to help prepare communities for effective disaster debris management. The guidance is available online.

PHMSA To Hold Public Meeting On Emergency Response Guidebook: On May 7, 2019, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that it will hold a public hearing to solicit input on the 2020 edition of the Emergency Response Guidebook (ERG2020). 84 Fed. Reg. 19999.. The meeting will be held on June 17, 2019, at DOT’s Conference Center at 1200 New Jersey Avenue SE, Washington, DC 20590 from 8:30 a.m. to 2:30 p.m. (EDT). PHMSA developed the ERG for use by emergency services personnel to provide guidance for initial response to hazardous materials transportation incidents. During the meeting, PHMSA intends to hold a public discussion of the methodology used to determine the appropriate response protective distances for poisonous vapors resulting from spills involving dangerous goods considered toxic by inhalation. PHMSA also will solicit comments related to new methodologies and considerations for future editions of the ERG. Additionally, the meeting will include discussions on the outcomes of field experiments, ongoing research efforts to understand environmental effects on airborne toxic gas concentrations, and updates to be published in the ERG2020.

PHMSA Solicits Nominees To Serve On Lithium Battery Safety Advisory Committee: On May 9, 2019, PHMSA announced that it is soliciting nominees for a new Lithium Battery Safety Advisory Committee. The announcement was published in the Federal Register on May 14, 2019. 84 Fed. Reg. 21411. The committee is mandated by Section 333(d) of the FAA Reauthorization Act of 2018 (Pub. L. 115–254) and will be established in accordance with the Federal Advisory Committee Act (FACA) of 1972. The committee will facilitate communication among manufacturers of lithium ion and lithium metal cells and batteries, manufacturers of products incorporating both large and small lithium ion and lithium metal batteries, air carriers, and the federal government. This communication is intended to promote the safe transportation of lithium ion and lithium metal cells and batteries and improve the effectiveness and economic and social impacts of related regulation. No later than 180 days after the establishment of the committee, it must submit to DOT and appropriate committees of Congress a report that describes and evaluates the steps being taken in the private sector and by international regulatory authorities to implement and enforce requirements relating to the safe transportation of bulk shipments of lithium ion cells and batteries. The committee will also identify any areas of regulatory requirements for which there is consensus that greater attention is needed. Membership of the committee will consist of representatives from:

  • Large volume manufacturers of lithium ion and lithium metal cells and batteries;
     
  • Domestic manufacturers of lithium ion and lithium metal batteries or battery packs;
     
  • Manufacturers of consumer products powered by lithium ion and lithium metal batteries;
     
  • Manufacturers of vehicles powered by lithium ion and lithium metal batteries;
     
  • Marketers of products powered by lithium ion and lithium metal batteries;
     
  • Cargo air service providers based in the United States;
     
  • Passenger air service providers based in the United States;
     
  • Pilots and employees of air service providers;
     
  • Shippers of lithium ion and lithium metal batteries for air transportation;
     
  • Manufacturers of battery-powered medical devices or batteries used in medical devices; and
     
  • Employees of DOT and other government agencies.
     

Nominations must be submitted to PHMSA by June 4, 2019.

FDA

FDA Issues Correction Regarding OTC Proposed Rule: On April 18, 2019, the U.S. Food and Drug Administration (FDA) announced it was correcting the over-the-counter (OTC) proposed rule regarding sunscreen monograph products to improve the accuracy of the proposed rule -- specifically to make the formulas legible. 84 Fed. Reg. 16220. Comments are due by June 27, 2019.

FDA Requests Comment On Nutrition Facts Label: On April 19, 2019, FDA announced it would be soliciting comments on the collection of information for the nutrition facts label and supplement facts label. 84 Fed. Reg. 16513. FDA states that it promulgated regulations in 21 C.F.R. Section 101.9 setting forth how nutrition information is presented to consumers and the regulations also establish standards to define serving size and require that certain products provide additional information within the nutrition facts label that conveys that information to consumers.Specifically, Sections 101.9 and 101.36 list nutrients that are required or permitted to be declared; provide Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; provide requirements for foods represented or purported to be specifically for children under the age of four years and pregnant and lactating women and establish nutrient reference values specifically for these population subgroups; and provide the format and appearance of the nutrition facts label. Comments are due by June 18, 2019.

FDA Announces Public Meeting For Its Preparation For ICCR-13: On May 2, 2019, FDA announced a public meeting for its preparation for the upcoming International Cooperation on Cosmetics Regulation Thirteenth Annual Meeting (ICCR-13) to be held at the FDA Center for Food Safety and Applied Nutrition, 5001 Campus Dr., Wiley Auditorium (first floor), College Park, MD 20740 on June 5, 2019, from 2:00 p.m. to 4:00 p.m. (EDT)84 Fed. Reg. 18850. FDA’s announcement states that the intention of the ICCR multilateral framework is to pave the way for the removal of regulatory obstacles to international trade while maintaining global consumer protection. Input from this public meeting will help FDA prepare for the ICCR-13 meeting that will be held July 9-11, 2019, in Montreal, Canada.FDA intends to have an agenda available by May 29, 2019.Parties interested in participating must register by May 22, 2019, by sending information (including name, title, affiliation, address, e-mail, and telephone) to Jonathan Hicks (Jonathan.Hicks@fda.hhs.gov).

FDA Releases Final Guidance For Industry On Preparation Of Food Contact Notifications For FCSs In Contact With Infant Formula And/Or Human Milk: On May 9, 2019, FDA announced the availability of a final guidance for industry titled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.” 84 Fed. Reg. 20370. FDA states that this guidance is intended to provide industry with its current thinking on how to prepare a food contact notification (FCN) submission for its review and evaluation of the safety of food contact substances (FCS) used in contact with infant formula and/or human milk. FCSs that would be affected by this guidance document may include infant formula packaging for both liquid (concentrate and ready to feed) and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

NANOTECHNOLOGY

Workshop Report Published On EU-U.S. Priorities In Nanosafety: On March 5-6, 2019, a workshop on “Fostering EU-U.S. Cooperation in Nanosafety” was held. According to the workshop report, the workshop intended to answer two main questions:

  1. What should be the future research priorities in nanosafety and other advanced materials; and
     
  2. What are the opportunities for European Union (EU)-U.S. cooperation priorities in nanosafety.
     

More information, including the research priorities identified and potential instruments for advancing EU-U.S. cooperation, is available in our April 29, 2019, blog item.

ISO Issues Method To Quantify Air Concentrations Of Carbon Black And Amorphous Silica In The Nanoparticle Size Range In A Mixed Dust Manufacturing Environment: The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies -- Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.” The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in a mixed dust industrial manufacturing environment.

France Bans Titanium Dioxide Food Additive Beginning In 2020: On April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020. The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES). ANSES reiterated its previous general recommendations on nanomaterials aimed at limiting the exposure of workers, consumers, and the environment by promoting products that are safe and equivalent products in terms of function and efficiency, without nanomaterials. According to the Ministry’s press release, an order regarding the ban has been signed and will be published as soon as possible.

Recommendations On Priorities For IARC Monographs Include Multi-Walled Carbon Nanotubes, Nanomaterials: An Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the International Agency for Research on Cancer (IARC) Monographs program during 2020-2024. IARC announced on April 18, 2019, that the recommendations were published in The Lancet Oncology, “Advisory Group recommendations on priorities for the IARC Monographs.” The list of agents previously evaluated by IARC Monographs and recommended for evaluation with high priority includes multi-walled carbon nanotubes. The list of medium priority agents includes nanomaterials, “e.g., titanium dioxide or nanosilica.”

FDA Extends Comment Period For Proposed Rule For OTC Sunscreen Drug Products: On April 18, 2019, FDA published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, OTC sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. As reported in our February 21, 2019, blog item, “FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials,” FDA invites comment on several issues concerning nanomaterials. Comments are now due on June 27, 2019.

NIOSH Seeks Comment On Proposed Information Collection Project That Will Survey Engineered Nanomaterial Occupational Safety And Health Practices: On April 23, 2019, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice inviting comment on a proposed information collection project entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.” The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of engineered nanomaterials in the workplace. Comments are due June 24, 2019. More information is available in our April 24, 2019, blog item.

OECD Chemical Safety And Biosafety Progress Report Includes Update On Work Regarding Manufactured Nanomaterials: The Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials. More information is available in our May 3, 2019, blog item.

Germany Announces Research Project To Establish Criteria For Assessment Of The Human Health And Environmental Risks Of Novel (Nano) Materials: On April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials. According to BfR, one of the main goals of InnoMat.Life is to establish criteria catalogs such that novel materials can be grouped together with regard to their hazard potential. The project takes into account the full material life cycle, from synthesis to disposal. More information is available in our May 6, 2019, blog item.

NIA Webinar On Nanosafety Available On YouTube: On May 7, 2019, the Nanotechnology Industries Association (NIA) held a webinar on “Nano in Action: Nanosafety.” Participants heard about the latest research and support tools intended to advance the development of safe materials from speakers involved in human and environmental safety research and services. The webinar also addressed how regulations and standards are evolving to build commercial and consumer confidence in nanomaterials. A list of all NIA webinars is available on NIA’s website, as well as on its YouTube channel. B&C is a proud NIA member.

EC JRC Announces Publication Of Article On Measuring Nanoparticles In Medicinal Products: The European Commission’s (EC) Joint Research Center (JRC) announced on May 10, 2019, publication of an article entitled “Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL. A step by step approach combining orthogonal measurements with increasing complexity” in the April 10, 2019, issue of the Journal of Controlled Release. The work is part of the collaboration between U.S. National Cancer Institute’s Nanotechnology Characterization Laboratory (NCI-NCL) and the European Nanomedicine Characterization Laboratory (EUNCL). More information is available in our May 10, 2019, blog item.

ACS Will Hold Free Webinar On Working Safely With Nanomaterials In The Laboratory: On May 16, 2019, the American Chemical Society (ACS) will hold a webinar on working safely with nanomaterials in the laboratory. Chuck Geraci, NIOSH Associate Director for Emerging Technologies, will moderate a panel including:

  • Ken Kretchman, Director of Environmental Safety, NC State University;
     
  • Craig Merlic, Professor of Chemistry, University of California, Los Angeles; and
     
  • Debbie Decker, Chemical and Laboratory Safety Officer, University of California, Davis.
     

18th Annual NanoBusiness Conference Will Be Held In June In Washington, D.C.: The NanoBusiness Commercialization Association (NanoBCA) will hold its 18th Annual NanoBusiness Conference on June 4, 2019, in Washington, D.C. Speakers will include Lynn L. Bergeson, Managing Director, B&C. A complete list of speakers is available in our April 17, 2019, blog item.

BIOBASED/RENEWABLE PRODUCTS

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.

LEGISLATIVE

Representative Boyle Launches Effort To Research And Regulate PFAS: On April 29, 2019, Representative Brendan Boyle (D-PA) launched a two-pronged effort to address per- and poly-fluorinated alkyl substances (PFAS) contamination. Mr. Boyle led a bipartisan group of Representatives in urging the House Appropriations Committee to fund fully a $10 million nationwide study on the impact of PFAS contamination in Fiscal Year (FY) 2020. Mr. Boyle also sought to enact the study in the FY19 National Defense Authorization Act. Mr. Boyle also introduced a bill (H.R. 2377) that would require EPA to amend the SDWA to promulgate a national primary drinking water regulation for total PFAS substances.

House Bill Would Require Funding For Green Infrastructure Projects: On May 1, 2019, while Congressional leaders negotiated a $2 trillion infrastructure plan with the White House, Representative Debbie Mucarsel-Powell (D-FL) introduced the Water Infrastructure Sustainability and Efficiency Act (H.R. 2458). The bill would require at least 20 percent of Clean Water State Revolving Funds be invested in green infrastructure and environmentally-innovative water projects.

House Passes Legislation To Keep U.S. In Paris Climate Accord: On May 2, 2019, the House of Representatives passed its first climate change bill in a decade. The Climate Action Now Act (H.R. 9), passed by a vote of 231-190, would keep the U.S. in the Paris Agreement on Climate Change. It specifically would require President Trump to develop and update annually a plan for the U.S. to meet its nationally determined contribution under the Paris Agreement. The bill would require this plan to describe steps to cut greenhouse gas emissions by 26 percent to 28 percent below 2005 levels by 2025, and confirm that other parties to the agreement with major economies are fulfilling their announced contributions. In addition, the bill prohibits federal funds from being used to withdraw from the agreement. The House’s passage of the bill is largely symbolic, however, as Senate Majority Leader Mitch McConnell (R-KY) has said that he would not bring the bill up for a vote in the Senate.

Chemical Poisons Reduction Act Of 2019 Introduced In House: On May 2, 2019, Representative Peter DeFazio (D-OR) introduced the Chemical Poisons Reduction Act of 2019 (H.R. 2471). The bill would ban the use of two compounds that are used to control predator populations. Specifically, the bill would ban the use of sodium fluoroacetate (commonly known as Compound 1080) and sodium cyanide to kill predatory animals. Although EPA banned Compound 1080 in 1972, after lobbying from the livestock industry, EPA re-approved the compound for use in the “Livestock Protection Collar” (collars containing the compound that are placed around the necks of sheep and burst when punctured by a predator) in 1985. Sodium cyanide is contained within M-44 devices, which are spring-activated ejectors that deliver a dose when pulled. The top of the ejector is wrapped with an absorbent material that has been coated with a substance that attracts canines. When the device is activated, a spring ejects the poison. The U.S. Fish and Wildlife Service and state agencies regularly use both of these poisons in their predator control programs.

House Subcommittee Holds Hearing On Bill To Ban Asbestos: On May 8, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change convened a hearing entitled “Ban Asbestos Now: Taking Action to Save Lives and Livelihoods.” Energy and Commerce Chair Frank Pallone, Jr. (D-NJ) opened the hearing, and his opening statement was withering in its criticism of EPA on its inaction on asbestos. Pallone stated: “It has been 30 years since EPA finalized that ban. And it has been 28 years since that ban was struck down in court. Twenty-eight years of frustration, of sickness and loss. We have known the dangers of asbestos for decades. Enough is enough.” The hearing focused on H.R. 1603, the Alan Reinstein Ban Asbestos Now Act. The bill would ban the manufacture, import, processing, and distribution of asbestos. It would also require EPA to assess and report on the risks posed by “legacy asbestos” found in buildings. Mr. Pallone stated that the Frank R. Lautenberg Chemical Safety Act for the 21st Century empowered EPA to ban asbestos. “In fact, this Committee’s report on the Lautenberg Act – written under Republican leadership – states, and I’m quoting now: ‘To many members of the Committee, an important measure of TSCA reform proposals has been whether the proposal would enable EPA to take broader regulatory action to protect against unreasonable risks from asbestos. The Committee expects this legislation to enable that regulatory action.’” He added, however, that:

Unfortunately, it is now clear that, despite the best efforts of our Committee, the Trump EPA is not using the tools we gave it to regulate dangerous chemicals. Asbestos is the poster-child for the problems we are seeing in the implementation of the Lautenberg Act. EPA’s actions under the Lautenberg Act have been so legally suspect that I believe we need to pass this bill regardless of whether EPA were to announce that it is moving forward with a full ban of asbestos. We don’t have time for more legal maneuvering and a drawn-out court battle while tens of thousands of people are dying. It is deeply disappointing that 40 years after EPA began work to ban asbestos under TSCA and three years after we passed the Lautenberg Act to reform that statute, we need to pass another law to ban this deadly substance. But it is clear that Congress must act, and so we will.

Testifying at the hearing were: Alexandra Dunn, Assistant Administrator, EPA, OCSPP; Linda Reinstein, Co-founder, Asbestos Disease Awareness Organization; Rebecca Reindel, MS, MPH, Senior Safety and Health Specialist, on behalf of the AFL-CIO; Celeste Monforton, DrPH, MPH, Lecturer, Texas State University, on behalf of the American Public Health Association; and Mike Walls, Vice President of Regulatory and Technical Affairs, American Chemistry Council. Member statements, witness testimonies, and an archived webcast of the hearing are available online.

House Democrats Unleash Torrent Of PFAS Legislation: On May 8 and 9, 2019, Democrats in the House unleashed several bills aimed at addressing contamination by PFAS. Leading the charge was House Energy and Commerce Committee Chair Frank Pallone, Jr. (D-NJ) on May 8, 2019, who introduced H.R. 2533, the Providing Financial Assistance for SDWA. The bill would authorize sweeping investments for water infrastructure, creating a grant program to upgrade the country’s drinking water systems with treatment technology that can remove PFAS. It is intended to allow affected communities to remove PFAS and other substances from their drinking water. The bill would amend the SDWA to require EPA to establish, within 180 days of enactment, a program to award grants to PFAS-affected water systems to pay the capital costs associated with eligible treatment technologies. The legislation further directs EPA to create a list of eligible treatment technologies, defined as those which can remove all detectable amounts of PFAS from drinking water. Other bills on PFAS introduced on May 8, 2019, are:

  • H.R. 2570, which is intended to ensure that polluters pay ongoing water treatment costs associated with contamination from PFAS;
     
  • H.R. 2577, a bill that would amend the Emergency Planning and Community Right-to-Know Act (EPCRA) to include PFAS on the Toxics Release Inventory (TRI);
     
  • H.R. 2591, legislation that would prohibit the incineration of PFAS;
     
  • H.R. 2596, which would amend TSCA with respect to manufacturing and processing notices for PFAS;
     
  • H.R. 2600, a bill to regulate PFAS under TSCA;
     
  • H.R. 2605, which would require EPA to issue a final rule adding as a class all PFAS substances with at least one fully fluorinated carbon atom to the list of hazardous air pollutants under CAA Section 112(b);
     
  • H.R. 2608, the PFAS Testing Act of 2019, which would require EPA to test PFAS chemicals under TSCA;
     
  • H.R. 2626, which would encourage federal agencies to enter into agreements with states for the remediation of PFAS contamination; and
     
  • H.R. 2638, a bill that would require EPA to issue guidance to minimize the use of firefighting foam containing PFAS.
     

Legislation Seeks To Protect Public Health And Coral Reefs From Sunscreen Chemicals: On May 8, 2019, Senator Jeff Merkley (D-OR) introduced two pieces of legislation to address the alleged threat that sunscreen chemicals pose to coral reefs, and to study the impact of these chemicals on human health and the environment. The Oxybenzone and Octinoxate Impact Study Act of 2019 (S. 1371) would require EPA to study the impacts of those two chemicals on human health and the environment. The Reef Safe Act of 2019 (S. 1375) would require FDA to develop standards for a “Reef Safe” label for sunscreens. Companion legislation (H.R. 2588) was introduced in the House by Representative Tulsi Gabbard (D-HI).

Appropriations Bill Would Fund PFOA/PFAS Cleanup On Military Bases: On May 9, 2019, the House Appropriations Committee passed legislation funding Department of Defense (DOD) construction programs. One of the provisions of the legislation would fund remediation for PFOS and PFOA. The FY 2020 Military Construction-Veterans Affairs bill provides $60 million for the remediation. The Committee report on the bill states that members are concerned about PFOS and PFOA contamination at U.S. military institutions. The bill only covers military installations funded through the Base Realignment and Closure (BRAC) account that are affected by PFOS/PFOA, but the report notes that “the issue is not limited to the Defense Department and affects many communities across the Nation.” Members are “encouraged” by EPA’s announced plan to evaluate the need for a maximum contaminant level (MCL) for PFOA/PFAS under the SDWA, as well as EPA’s consideration of designating these compounds as hazardous substances under CERCLA.

MISCELLANEOUS

ATSDR Announces Availability Of Draft Toxicological Profile For Glyphosate: On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATDSR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. Comments are due by July 8, 2019. More information on glyphosate issues is available on our blog.

NIOSH Seeks Comment On Mesothelioma National Registry: On April 8, 2019, NIOSH announced the opening of a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the U.S., as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. 84 Fed. Reg. 13928. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment. The FY 2019 appropriations act (H.R. 6157) charged NIOSH with initiating a feasibility study for a National Mesothelioma Registry. The conference report accompanying H.R. 6157 explicitly directs NIOSH to “initiate a feasibility study for a patient registry, which would include developing case finding methodology to determine incidence and prevalence, demographics, and risk factors.” The comment period closes on July 8, 2019.

USITC Releases Report Estimating The Economic Impact Of The United States-Mexico-Canada Agreement: On April 18, 2019, the U.S. International Trade Commission (USITC) released its report assessing the likely economic impact of the United States-Mexico-Canada Agreement (USMCA). The report is required under the Bipartisan Congressional Trade Priorities and Accountability Act of 2015. The report, United States-Mexico-Canada Agreement: Likely Impact on the U.S. Economy and Specific Industry Sectors, assesses the likely impact of the agreement on the U.S. economy as a whole and on specific industry sectors and the interests of U.S. consumers. The USITC investigated the impact the agreement would have on the U.S. gross domestic product (GDP); exports and imports; employment; and the production, employment, and competitive position of industries likely to be affected by the agreement. The report concludes that, if fully implemented and enforced, USMCA would have a modest positive impact on U.S. real GDP and employment. Specifically, the report estimates that USMCA would raise U.S. real GDP by $68.2 billion (0.35 percent) and U.S. employment by 176,000 jobs (0.12 percent). U.S. exports to Canada and Mexico would increase by $19.1 billion (5.9 percent) and $14.2 billion (6.7 percent), respectively. U.S. imports from Canada and Mexico would increase by $19.1 billion (4.8 percent) and $12.4 billion (3.8 percent), respectively. The elements of the agreement that would have the most significant effects on the U.S. economy are provisions that reduce policy uncertainty about digital trade and certain new rules of origin applicable to the automotive sector. The report highlights USMCA’s new international data transfer provisions, including provisions that largely prohibit forced localization of computing facilities and restrictions on cross-border data flows. Because the North American Free Trade Agreement (NAFTA) already eliminated duties on most goods and significantly reduced nontariff measures, USMCA’s emphasis is on reducing remaining nontariff measures on trade and the U.S. economy. This includes addressing other issues that affect trade, such as workers’ rights, harmonizing regulations, and deterring certain potential future trade and investment barriers. USMCA’s requirements are estimated to increase U.S. production of automotive parts and employment in the sector, but also to lead to a small increase in the prices and small decrease in the consumption of vehicles in the United States. USMCA would reduce the scope of the investor-state dispute settlement (ISDS) mechanism, a change that, based on modeling results, would reduce U.S. investment in Mexico and would lead to a small increase in U.S. domestic investment and output in the manufacturing and mining sectors. The report is available online.

ATSDR Requests Comment On Proposed Substances To Be Evaluated For Toxicological Profiles: On April 19, 2019, ATSDR issued a Federal Register notice seeking nominations for substances ATSDR should evaluate for developing toxicological profiles. 84 Fed. Reg. 16511. ATSDR also is soliciting nominations for non- CERCLA substances. CERCLA requires ATSDR to develop a list annually of substances to be considered for toxicological profiles. ATSDR must prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances (the Substance Priority list (SPL)). This list identifies 275 hazardous substances found at CERCLA National Priorities List (NPL) sites that ATSDR and EPA have determined pose the most significant current potential threat to human health. The ATSDR toxicological profile succinctly characterizes the toxicologic and adverse health effects information for these toxic substances. Each peer-reviewed profile identifies and reviews the key literature that describes a substance’s toxicologic properties. Other pertinent literature is also presented, but is described in less detail than the key studies. The focus of the profiles is on health and toxicological information; therefore, each toxicological profile begins with a relevance to public health discussion that would allow a public health professional to make a real-time determination of whether the presence of a particular substance in the environment poses a potential threat to human health. The adequacy of information to determine a substance's health effects is described in a health effects summary. Data needs that are of significance to the protection of public health are identified by ATSDR and EPA. The list of substances to be considered for toxicological profile development is available online. Nominations must be submitted by May 20, 2019.

CSB Calls On EPA To Update HF Study In Wake Of 2017 Husky Refinery Fire: On April 24, 2019, the US Chemical Safety Board (CSB) released a letter calling on EPA to review its existing hydrofluoric acid (HF) study to determine the effectiveness of existing regulations as well as the viability of utilizing inherently safer alkylation technologies in petroleum refineries. In the last four years, CSB has investigated two refinery incidents where an explosion elevated the threat of a release of HF. CSB urged EPA to review its 1993 HF study to ensure the health and safety of communities near petroleum refineries utilizing HF. CSB’s letter to EPA is available online.

CEQ Issues Instructions To Federal Agencies On Meeting Energy And Environmental Performance Requirements: On May 3, 2019, the White House Council on Environmental Quality (CEQ) issued instructions to federal agencies for meeting energy and environmental performance requirements. 84 Fed Reg. 19056. The guidance documents are intended to guide federal agencies to comply with Executive Order (E.O.) 13834, “Efficient Federal Operations,” signed by President Trump on May 17, 2018. The purpose of the E.O. is to direct agencies on the management of federal facilities, vehicles, and operations to achieve statutory requirements, while prioritizing actions to reduce waste, cut costs, and enhance resilience of federal infrastructure and operations for effective accomplishment of agency missions. CEQ issued the following instructions:

  • Guiding Principles for Sustainable Federal Buildings;
     
  • Federal Renewable Energy Certificate Guide;
     
  • Interim Guidance for Calculating Federal Compliance with Waste Diversion Goals;
     
  • Federal Agency Implementation of Water Efficiency and Management Provisions;
     
  • Guidance for Federal Agencies on Sustainable Practices for Designed Landscapes;
     
  • Sustainable Locations for Federal Facilities:
     
  • Federal Greenhouse Gas Accounting and Reporting Guidance; and
     
  • Federal Agency Implementation of Workplace Charging: Guidance for Level 1 Charging Receptacles and EV Supply Equipment.
     

The instructions are available online.

ATSDR Announces Release Of Draft Toxicological Profiles: ATSDR on May 9, 2019, announced that it has released and is taking comment on several draft toxicological profiles. 84 Fed. Reg. 20359. ATSDR has released draft profiles for:

  • Dinitrophenols;
     
  • 2-Butanone;
     
  • Mirex and Chlordecone;
     
  • 1,2-Diphenylhydrazine;
     
  • 1,2,3-Trichloropropane;
     
  • Lead; and
     
  • Endrin.
     

The draft profiles are available online. Comments on the draft profiles are due by August 7, 2019.

EPA Seeks Comment On Draft Policy For Enhancing EPA/State Actions On Enforcement: On May 13, 2019, EPA released a draft policy of “Enhancing Planning and Communication Between the EPA and States in Civil Enforcement and Compliance Assurance Work.” 84 Fed. Reg. 20882. The draft policy is available online and EPA is soliciting comments on it until June 12, 2019.The guidance is intended to set out expectations and procedures for enhancing planning and communication on civil enforcement between EPA and state agencies implementing federal environmental programs.

OSHA Issues Final Rule Revising 14 Standards: On May 14, 2019, the Occupational Safety and Health Administration (OSHA) issued a final rule revising 14 provisions in the recordkeeping, general industry, maritime, and construction standards. 84 Fed. Reg. 21416. OSHA believes that the regulatory provisions it revised may be confusing, outdated, or unnecessary. OSHA expects the revisions will increase understanding and compliance with the provisions, improve employee safety and health, and save employers an estimated $6.1 million per year. This is the fourth final rule under OSHA’s Standards Improvement Project, which began in 1995 in response to a Presidential memorandum to improve government regulations.

Almost 200 Parties To The Basel Convention Approve Amendment To Include Restrictions On Plastic Waste And Hazardous Chemicals: On May 10, 2019, 180 governments adopted decisions aimed at protecting human health and the environment from plastic wastes and hazardous chemicals. Governments that are parties to the Basel Convention on the Control of Transboundary Movements of Hazardous Waste and their Disposal approved an amendment to the Convention to include 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. At the same time, a new Partnership on Plastic Waste was established to mobilize business, government, academic and civil society resources, interests and expertise to assist in implementing the new measures, to provide a set of practical supports -- including tools, best practices, technical and financial assistance -- for this agreement. 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. Amendments to other global agreements were also adopted. Parties agreed to amend the Stockholm Convention on Persistent Organic Pollutants to eliminate two chemical groups, which together total about 4,000 chemicals, listed in Annex A of the Stockholm Convention, namely dicofol and PFOA and its salts and PFOA-related compounds. Listing in Annex A to the Convention obliges Parties to eliminate these chemicals from use. Amendments to the Rotterdam Convention on the Prior Informed Consent Procedure (PIC) for Certain Hazardous Chemicals and Pesticides in International Trade also were adopted by Parties. Phorate (a pesticide) and hexabromocyclododecane were added to Annex III of the Convention, making them subject to the Prior Informed Consent (PIC) Procedure, through which countries can decide on future imports of these chemicals. A further decision to approve procedures and mechanisms on compliance with the Rotterdam Convention was also adopted by the Parties. The amendments were agreed to during a two-week meeting in Geneva entitled “Clean Planet, Healthy People: Sound Management of Chemicals and Waste.” Approximately 1,400 delegates from around 180 countries converged for the meetings of the Conferences of Parties to the Basel, Rotterdam, and Stockholm Conventions (Triple COP).

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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