Recent Federal Developments – Update from Bergeson & Campbell, PC

WEBINAR — FIFRA Hot Topics In Pesticide, Biocides, And Other Agricultural Chemicals Regulation And Litigation, April 24, 2019, 1:00 p.m. – 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C^®) is pleased to present the complimentary webinar “FIFRA Hot Topics in Pesticide, Biocides, and Other Agricultural Chemicals Regulation and Litigation.” Throughout the first few months of 2019, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) issues have been dynamic, complicated, and controversial with regard to both individual pesticides, as well as continued debates about larger state, national, and international policies. Join Richard P. Keigwin, Jr., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA); Amy Plato Roberts, Regulatory Affairs Manager, Lallemand Plant Care, North America; Lisa M. Campbell, Partner, B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C, for this brisk and illuminating discussion. Registration is available online.

New Episode Of All Things Chemical™ Podcast With Former U.S. Ambassador To Belgium, Howard Gutman: B&C’s recent All Things Chemical™ podcast episode, “Ambassador Howard Gutman on What Every CEO Needs to Know Right Now,” covers a lot of ground. Howard provides his perspective on what to pay attention to with regard to Brexit, energy policy, climate change, trade, the globalized economy, and the 2020 presidential election. Howard also provides advice on how to manage business perception, create opportunities from regulatory changes, and even shares some helpful thoughts on how to fill board seats to be more innovative. Listen online or download the episode from Apple Podcasts, Google Play, Stitcher, or Spotify.

TSCA/FIFRA/TRI

EPA Releases Budget Justification That Increases Budget For Chemical Risk, Review, And Reduction Program: On March 11, 2019, EPA released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates for the Committee on Appropriations. EPA’s budget request reduces the overall budget by $2.76 billion (31 percent), to $6.068 billion, but requests $66.418 million to support its Chemical Risk Review and Reduction (CRRR) program, an increase of $5.313 million. EPA zeros out the other programs under Toxics Risk Review and Prevention, however, including the Endocrine Disruptor Screening Program (EDSP), the Pollution Prevention (P2) program, and the Lead Risk Reduction Program. EPA states that it will “absorb the remaining functions [of the EDSP] within the Pesticides Program using the currently available tiered testing battery,” “continue to meet core statutory requirements under the Pollution Prevention Act of 1990 in other programs,” and that “[l]ead paint certifications will continue under the [CRRR] Program.” More information is available in our blog item.

EPA Releases New Tools To Meet Mercury Reporting Requirements: On March 18, 2019, EPA released new tools intended to help companies, organizations, and individuals fulfill their reporting requirements under the mercury reporting requirements rule. Those required to report under the mercury rule can now do so online through the Mercury Electronic Reporting (MER) application accessed through EPA’s Central Data Exchange (CDX). As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019. Based on the information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use. More information is available in our full memorandum.

EPA Releases 24 Study Reports Used To Develop The Draft Risk Evaluation For C.I. PV 29: On March 22, 2019, EPA issued a memorandum stating that it was releasing 24 studies in the Colour Index (C.I.) Pigment Violet (PV) 29 docket (Docket No. EPA-HQ-OPPT-2018-0604) that were reviewed by EPA to develop its Draft Risk Evaluation for C.I. PV 29. EPA states that these studies are being made available to the public prior to the TSCA Science Advisory Committee on Chemicals (SACC) expert panel peer review of the draft risk evaluation. Because the entirety of the reports was originally erroneously claimed to be confidential business information (CBI), the reports were not included in the public docket previously. Fifteen of the study reports have been released without any redactions while nine reports were partially redacted. EPA provides a full list of the studies and their confidential status in the memorandum. The 24 study reports represent the following disciplines: #1-17 Human Health; #18-20 Environmental Hazard; #21-22 Environmental Fate; and #23-24 Physical Chemical properties. Twenty of the 29 studies made available in the dockets were summarized in the European Chemicals Agency’s (ECHA) registration dossier for C.I. PV 29; EPA refers to them as “robust summaries” and states that it has compared the information contained in the robust summaries against the information contained in the study reports for accuracy. They were posted to the docket in November 2018.

EPA Bans Consumer Sales Of Methylene Chloride Paint Removers, Seeks Comment On Program For Commercial Uses: On March 27, 2019, EPA published a final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420. EPA states that it “determined that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality.” Under the final rule, paint removal products containing methylene chloride will not be able to be sold at any retain or distribution establishments that have consumer sales, including e-commerce sales. The final rule also requires manufacturers, processors, and distributors to notify retailers and others in their supply chains of the prohibitions and to keep records. The final rule is effective May 28, 2019. The prohibitions will begin on November 22, 2019, 180 days after the effective date of the final rule, providing time for establishments selling this chemical to consumers to come into compliance with the ban. Additionally, EPA is soliciting public input for a future rulemaking that could establish a training, certification, and limited access program as an option for risk management for all the commercial uses of methylene chloride in paint and coating removal. 84 Fed. Reg. 11466. Comments on the advance notice of proposed rulemaking (ANPR) are due on or before May 28, 2019. For more information, see our full memorandum.

EPA To Host Webinar On New Approaches For Respiratory Sensitization: On April 11, 2019, EPA announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended TSCA, specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT). Registration is required. The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”

The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAMs) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances. EPA states that these webinars on the use of NAMs in risk assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.

EPA Updates New RT25 Data To Help Beekeepers And Farmers Protect Pollinators: On March 21, 2019, EPA announced it was updating its Residual Time to 25% Bee Mortality (RT₂₅) Data Table with information it has collected since the table was first published in 2014. EPA states that the “RT₂₅ data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies the agency has analyzed as part of [its] routine pesticide regulatory activities.” One example that EPA provides regarding how this new data will work is that farmers can now “choose pesticides that quickly lose their toxicity to bees,” and that applying the products in the evening “helps ensure that by morning the pests have been dealt with and blooming crops are safe for bees.” EPA states that RT₂₅values are a function of a number of factors, including application rate, physical-chemical properties, dissipation, crop, and pesticide formulation. The values provided were compiled from registrant-submitted data submitted to fulfill the data requirement for Honey Bee (Apis mellifera) Toxicity of Residues on Foliage study (OCSPP Guideline 850.3030). EPA states that the honey bee toxicity of residues on foliage study “is a laboratory test designed to determine the length of time over which field weathered foliar residues remain toxic to honey bees, or other species of terrestrial insects” and, depending on the chemical tested, “either the technical grade active ingredient or a specific formulation was tested using either the honey bee, alfalfa leaf cutting bee, or alkali bee.” The data table lists the test material, the species tested, and the plant species on which residues were aged. EPA plans to update the table annually as it collects additional data going forward. More information on EPA’s actions intended to protect pollinators is available on EPA’s website. In addition to providing the residual toxicity values, the table also illustrates the wide range of toxicity values among the various pesticides. RT₂₅ times for the different active ingredients can range between a few and over 500 hours to reach the RT₂₅ threshold. Even different formulations using the same active ingredient can have a significant difference in toxicity values. This illustrates the importance of reading the specific label instructions for a pesticide, even one that might be generally familiar to the user. EPA’s publication of this information online also imposes a duty for EPA continually to update the table, especially to capture any changes in the information appearing in an earlier listing of the data. If, upon further review or later data submissions there are changes to the table for a product, EPA will need to alert users to potentially important changes in the information. Again, this illustrates the need for reading the label for each pesticide at the time of application, since some important information may have changed.

EPA Releases Draft Guidance For Pesticide Registrants On Plant Regulator Label Claims, Including Plant Biostimulants: On March 25, 2019, EPA finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket No. EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. EPA states that the draft guidance, issued under FIFRA, is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA, thereby subjecting the products to regulation as pesticides under FIFRA. EPA notes that when determining whether a plant biostimulant may trigger pesticide registration requirements, or may be excluded or exempt from FIFRA regulation, a “key consideration is what claims are being made on product labels.” Comments on the draft guidance are due by May 28, 2019. More information is available in our full memorandum.

Final SNURs Break New Ground Under Amended TSCA: On April 5, 2019, EPA published a final rule that establishes final significant new use rules (SNUR) under TSCA for 13 chemical substances that are the subject of premanufacture notices (PMN). 84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs. The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk. The final rule is effective June 4, 2019. More information is available in our full memorandum.

EPA Releases Draft Risk Assessments For Several Pesticides: EPA on April 8, 2019, issued draft human health and/or ecological risk assessments for several pesticides. 84 Fed. Reg. 13915. The assessments are intended to aid EPA’s review of the registration of these pesticides under FIFRA. The pesticides are 2,4-DB, aliphatic solvents, chlorine gas, dimethyl disulfide (DMDS), iodine and iodophors, methomyl, methyl bromide, naphthalene, phenmedipham, thiodicarb, tralopyril, and triclosan. The assessments are available online. EPA is taking comment on them until June 7, 2019.

EPA Announces Proposed Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA Inventory: On April 10, 2019, EPA released a proposed rule regarding its plan to review certain CBI claims to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory. 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. Once the proposed rule is published in the Federal Register, a 60-day comment period will begin. More information is available online.

EPA Proposes TSCA CDR Revisions And Update To Small Manufacturer Definition For TSCA Section 8(a): On April 12, 2019, EPA released a proposed rule that would amend the TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. 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. Publication of the proposed rule in the Federal Register will begin a 60-day comment period. A prepublication version of the proposed rule is available here. More information is available in our full memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA

EPA Proposes To Update RCRA Ignitability Standards: EPA on April 2, 2019, issued a rule proposing to update the regulations for the identification of ignitable hazardous waste under the Resource Conservation and Recovery Act (RCRA). 84 Fed. Reg. 12539. The proposal also would update the RCRA test methods that currently require the use of mercury thermometers. EPA believes the proposed revisions would provide greater clarity to hazardous waste identification, provide flexibility in testing requirements, improve environmental compliance, and, thereby, enhance protection of human health and the environment. The rule proposes several revisions to the RCRA regulations defining the ignitability characteristic (40 C.F.R. § 261.21):

• Update the flash point test methods required for determining if a liquid waste is an ignitable hazardous waste;
• Codify existing guidance regarding the regulatory exclusion in the ignitable characteristic for aqueous liquids containing alcohols;
• Codify existing sampling guidance regarding waste mixtures having multiple phases when determining whether a waste exhibits the ignitability characteristic;
• Update cross references to Department of Transportation (DOT) regulations and to remove obsolete information; and
• Provide alternatives to the use of mercury thermometers in the air sampling and stack emissions methods in Test Methods for Evaluating Solid Waste: Physical/Chemical Methods (SW–846).

The comment period closes on June 3, 2019.

PHMSA Convenes Four Public Meetings On Transportation Of Dangerous Goods: On March 28, 2019, DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that it is hosting four public meetings on issues related to the transportation of dangerous goods and hazardous materials. 84 Fed. Reg. 11865. The first meeting was held in preparation for the International Civil Aviation Organization’s (ICAO) Dangerous Goods Panel (DGP) Working Group 19 meeting (WG/19), held on April 1-5, 2019, in Montreal, Canada. The second meeting will be held in preparation of the 55th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG), being held July 1-5, 2019, in Geneva, Switzerland. The third meeting will be held in preparation of the 27th meeting of the ICAO DGP (DGP/27), being held September 9-20, 2019, in Montreal, Canada. The fourth meeting will be held in preparation to the 56th session of the UNSCOE TDG, being held December 2-11, 2019, in Geneva, Switzerland. PHMSA has not yet set the dates for the public meetings. Instead, PHMSA states that each of the meetings will take place approximately two weeks preceding the international meeting. PHMSA will convene the meetings at DOT headquarters in Washington, DC. Details on each meeting will be made available online under “Upcoming Events.”

FDA

FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Developers: In a statement released in March by Susan Mayne, Ph.D., Director of the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced food waste, or plants with reduced levels of harmful elements, among others). To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program that provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways. The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process.

FDA To Hold Public Meeting On Intentional Adulteration Rule Draft Guidance: On March 19, 2019, FDA announced that it will hold a public meeting on April 17, 2019, to discuss the draft guidance for compliance and implementation of the “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule (Intentional Adulteration rule), which was issued under the FDA Food Safety Modernization Act (FSMA). 84 Fed. Reg. 9987. The public meeting will be held from 8:30 a.m. to 2:00 p.m. (EDT) at the CFSAN, Harvey Wiley Building auditorium (first floor), 5001 Campus Drive, College Park, Maryland 20740. Written comments are due by July 5, 2019.

FDA Announces Produce Safety Rule Enforcement Discretion Policy: On March 28, 2019, FDA announced that it intends to exercise enforcement discretion for the requirements of the FSMA Produce Safety Rule via its new Guidance for Industry titled “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds.” 84 Fed. Reg. 11644. The guidance states that FDA is “considering pursuing rulemaking to address the unique circumstances of these commodities,” but, in the meantime, FDA “will not expect entities growing, harvesting, packing, or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities.” FDA states that it will consider revising its intent to exercise enforcement discretion “if, for example, new information becomes available regarding safety concerns associated with the production and consumption of these commodities.” FDA is accepting comments in Docket No. FDA-2019-D-1266. There is no comment deadline.

FDA’s Efforts To Advance Food Safety Included In FY 2020 Budget: On March 28, 2019, Scott Gottlieb, M.D., Commissioner of Food and Drugs, FDA, testified before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (statement available here), and on April 3, 2019, he testified before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (statement available here). FDA’s FY 2020 budget requests a total of $6.1 billion, an overall increase of 12 percent or $643.1 million compared to the FY 2019 Annualized Continuing Resolution (CR). The FY 2020 budget includes $1.4 billion for food safety, an increase of $67 million compared to the FY 2019 Annualized CR, broken down into the following categories:

• Strengthening Response Capabilities for Foodborne Outbreaks: FDA’s FY 2020 budget includes $16.3 million to improve signal detection and response timelines for human and animal food contamination and outbreaks of foodborne illness so that contaminated food is detected and removed from the marketplace as quickly as possible, and implements recent Office of Inspector General (OIG) recommendations to strengthen FDA’s food recall process.
• Advancing FSMA: FDA’s FY 2020 budget includes $16.5 million to support FSMA Cooperative Agreements with funding for animal and human foods preventive controls inspections and human foods produce safety inspections through the state cooperative agreement programs (CAP).
• Promoting Innovation and Emerging Technology While Maintaining Product Safety: FDA’s FY 2020 budget includes $36.2 million to ensure that FDA keeps pace with how changes in the marketplace affect the human and animal food supply — including modernizing the regulatory framework for biotechnology products, assessing products in a risk-based manner, providing predictable pathways for commercialization, and enhancing the scientific review of human and animal food ingredients to foster innovative products getting to market and to improve nutrition.

FDA Issues Technical Amendments For FSMA Final Rules: On April 2, 2019, FDA announced it was correcting three FSMA final rules. 84 Fed. Reg. 12490. The three final rules are Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 C.F.R. Part 117) (80 Fed. Reg. 55908) and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 C.F.R. Part 507) (80 Fed. Reg. 56170), both issued September 17, 2015, and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 C.F.R. Part 112) (80 Fed. Reg. 74354), issued November 27, 2015. All of the changes are minimal, the majority of them deleting subsection references that were incorrect. The effective date of this final rule was April 2, 2019.

NANOTECHNOLOGY

Report Available From January 2019 Mexico-EU Workshop On Nanosafety: On January 22-24, 2019, a Mexico-European Union (EU) workshop on nanosafety was held in Mexico. The aim of the workshop was to establish a stronger connection between the Mexican and European research communities within the context of bringing scientific information to the risk assessment, risk management, and policy levels. According to the workshop report, Mexico is eligible to participate in the EU’s Horizon 2020 and Ninth EU Framework Programs, and the January workshop was intended to inform Mexico and the EU with what has been achieved already and where each can benefit from the other’s knowledge and infrastructure. More information, including key collaborations identified during the workshop, is available in our April 12, 2019, blog item.

EC Committee Accepting Comment On Preliminary Opinion On Solubility Of Synthetic Amorphous Silica: On March 15, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the solubility of synthetic amorphous silica (SAS). The EC asked whether the SCCS considers that SAS are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation. The EC also asked whether SCCS could indicate to which kind of silica this solubility applies. Finally, the EC asked whether SCCS has any further scientific concerns with regard to the solubility of SAS. Comments on the preliminary opinion are due May 17, 2019. More information is available in our March 19, 2019, blog item.

“Stories From The NNI” Discusses Nanotechnology And Workplace Safety With Dr. Chuck Geraci: The March 18, 2019, episode of the National Nanotechnology Initiative’s (NNI) podcast series, “Stories from the NNI,” is a conservation with Dr. Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH). Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and Dr. Geraci discuss how NIOSH works with industry to ensure workplace safety, the progress that has been made in the environmental, health, and safety effects of nanomaterials (nanoEHS) over the last 15 years, and areas where nanotechnology can help solve problems in the future. Other recent episodes include guests such as Dr. Marcie Black, Chief Executive Officer (CEO) and Co-Founder of Advanced Silicon Group, Martin Ben-Dayan, CEO and Founder of MetaShield LLC, and Professor Pedro Alvarez of Rice University.

CPSC Will Hold Public Hearing On Its Agenda And Priorities For FYs 2020 And 2021: The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for FYs 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020. 84 Fed. Reg. 10050. CPSC’s 2018-2022 Strategic Plan notes that CPSC “is the only agency with mission responsibility for addressing unreasonable risks associated with human exposure to nanotechnology in consumer products.” According to CPSC’s FY 2020 Budget Request, CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products in FYs 2019 and 2020. Requests to make oral presentations and written comments are due April 17, 2019. More information is available in our March 21, 2019, blog item.

ISO Publishes Standard On Matrix Of Properties And Measurement Techniques For Graphene And Related 2D Materials: The International Organization for Standardization (ISO) has published standard ISO/TR 19733:2019, “Nanotechnologies — Matrix of properties and measurement techniques for graphene and related two-dimensional (2D) materials.” In the standard, characterization and measurement techniques for particular properties of graphene and related 2D materials that need to be standardized are organized in a form of a matrix. ISO suggests that the matrix could serve as an initial guide for developing the necessary international standards in characterization and measurements of graphene and related 2D materials.

ECHA PEG Reviewing Draft Appendix For Nanoforms Applicable To The Guidance On Registration And Substance Identification: ECHA has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification. The draft guidance is being reviewed by a Partner Expert Group (PEG). Section 2 of the draft Appendix explains general requirements regarding the registration of nanoforms. Section 3 explains the concept of a nanoform, and how to distinguish a nanoform from another, and Section 4 focuses on how to create and justify sets of different nanoforms. As reported in our December 4, 2018, blog item, the EC amended several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials. The information requirements will apply beginning January 1, 2020.

Presentations Available From EFSA Stakeholder Workshop On Nanoscience And Nanotechnology: The European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain. The workshop was an opportunity for stakeholders, EFSA, and its experts to have an open discussion and share their experiences on implementing the EFSA guidance, focusing on human and animal health. More information, including links to presentations from the workshop, is available in our April 10, 2019, blog item.

NNI Holds First 2019 NanoEHS Webinar: NNI’s 2019 public webinar series on nanoEHS began on April 9, 2019, with a presentation by Dr. Robert MacCuspie (Natural Immunogenics Corp.) on “Characterization and Quantification of Engineered Nanomaterials: Drivers of NanoEHS Research.” Upcoming webinars will include “Environmental, Health, and Safety Resources for Handling, Transporting, and Disposing of Nanomaterial-Containing Products” on May 16, 2019, at 1:00 p.m. (EDT) and “Nanomaterials in the Environment” on June 11, 2019, at 12:00 p.m. (EDT). NNI will post more details on its website, including registration information, in the future.

California Committee Includes Ultrafine Titanium Dioxide On Its Draft Priority 1 List For PEL Review: The California Division of Occupational Safety and Health’s (Cal/OSHA) Health Effects Advisory Committee (HEAC) for the Development of Permissible Exposure Limits (PEL) will meet on June 4, 2019. According to the meeting agenda, HEAC will discuss the selection of Priority 1 substances for HEAC review. HEAC has posted a draft 2019 Priority 1 List consisting of ten chemical substances. The draft List includes titanium dioxide, ultrafine (<100 nanometers (nm)). More information is available in our March 29, 2019, blog item.

TechConnect World 2019 Will Include Panel On Applying The Best Health, Safety, And Environment Practices To Advanced Manufacturing:TechConnect World Innovation Conference and Expo will be held June 17-19, 2019. It will include the third installment of a panel started three years ago, “Tools and Techniques: Applying the Best Health, Safety, and Environment Practices to Advanced Manufacturing.” The Symposium Co-Chairs include:

• Sally Tinkle, Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute;
• Chuck Geraci, Associate Director, NIOSH;
• Jo Anne Shatkin, President, Vireo Advisors; and
• Wu-Sheng Shih, Project Manager, Brewer Science Inc.

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

Senate Bill Would Reauthorize Oil Pollution Act: On March 25, 2019, Senator Dan Sullivan (R-AK) introduced a bill to amend the Oil Pollution Act of 1990. The bill (S. 865) specifically would reauthorize the Oil Spill Liability Trust Fund, which provides for oil spill cleanup. The financing mechanism for the fund expired on January 1, 2019, leaving a meager $6.5 million in its coffers. The bill would impose a tax of nine cents per barrel on crude oil at refineries. The legislation is similar to a bill introduced earlier this year by Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR).

Bicameral Bills Would Mandate Blood Testing For PFAS: On March 25, 2019, legislation was introduced in the Senate and House that would require the Department of Defense to test the blood of the department’s firefighters for chemical exposure. The bills would require testing during annual physical examinations to gauge exposure of firefighters to per- and perfluoroalkyl substances, commonly known as PFAS. These compounds are often components in firefighting foams and other flame retardants. The Senate bill (S. 858) is sponsored by Jeanne Shaheen (D-NH) and Lisa Murkowski (R-AK); the House bill (H.R. 1863) is sponsored by Donald Norcross (D-NJ).

Senate Rejects New Green Deal: On March 26, 2019, the Senate rejected the New Green Deal. In a procedural vote, lawmakers unanimously rejected to consider or debate a resolution (S. J. Res. 9) that would codify Representative Alexandria Ocasio-Cortez’s (D-NY) so-called New Green Deal. The vote was 57 nays, with 43 Democrats voting “present.” The resolution declares that the government has a duty to create a Green New Deal with the goals of:

• Achieving net-zero greenhouse gas emissions;
• Establishing millions of high-wage jobs and ensuring economic security for all;
• Investing in infrastructure and industry;
• Securing clean air and water, climate and community resiliency, healthy food, access to nature, and a sustainable environment for all; and
• Promoting justice and equality.

The resolution calls for accomplishment of these goals through a ten-year national mobilization effort. The resolution also enumerates the goals and projects of the mobilization effort, including:

• Building smart power grids (i.e., power grids that enable customers to reduce their power use during peak demand periods);
• Upgrading all existing buildings and constructing new buildings to achieve maximum energy and water efficiency;
• Removing pollution and greenhouse gas emissions from the transportation and agricultural sectors;
• Cleaning up existing hazardous waste and abandoned sites;
• Ensuring businesspersons are free from unfair competition; and
• Providing higher education, high-quality health care, and affordable, safe, and adequate housing to all.

Bills Seek To Empower Women Through Climate Change Commitments:On March 26, 2019, Senator Mazie Hirono (D-HI) and Representative Barbara Lee (D-CA) introduced the Women and Climate Change Act of 2019. The legislation (S. 868, H.R. 1880) would affirm the United States’ commitment to empowering women through economic development planning and international climate change policies. It also includes practices to help communities on a path toward clean and sustainable development. The Women and Climate Change Act would direct federal agencies to mitigate the effects of climate change on women and girls around the world by establishing coordinated and comprehensive strategies. The legislation establishes a Federal Interagency Working Group on Women and Climate Change within the U.S. Department of State. Members of this working group include, but are not limited to, designees from the Department of State, the Agency for International Development, the Centers for Disease Control and Prevention, EPA, the National Oceanic and Atmospheric Administration, the National Institutes of Health, the National Science Foundation, and the White House Council on Environmental Quality.

Independent Agency Regulatory Analysis Act Introduced In Senate: On March 26, 2019, Senators Rob Portman (R-OH), Ron Johnson (R-WI), Susan Collins (R-ME), Joni Ernst (R-IA), and James Lankford (R-OK) introduced legislation to require independent regulatory agencies to analyze the costs and benefits of new regulations and tailor new rules to minimize unnecessary burdens on the economy and job creators. The Independent Agency Regulatory Analysis Act (S. 869) would subject the Securities and Exchange Commission, the Commodity Futures Trading Commission, the National Labor Relations Board, the Federal Communications Commission, and other independent federal regulatory agencies to consider these costs and benefits.

House Bill Would Prohibit U.S. Contributions To UN Panel On Climate Change: On March 26, 2019, Representative Blaine Leutkemeyer (R-MO) introduced a bill to “ensure taxpayer dollars are never again used to fund the United Nation’s Intergovernmental Panel on Climate Change, the United Nations Framework Convention on Climate Change, and the Green Climate Fund.” The No Tax Dollars for the United Nations Climate Agenda Act (H.R. 1881) would prohibit any U.S. contributions to these funds. Luetkemeyer released the following statement: “A nice name doesn’t camouflage the fact that these entities are fraught with waste and fraud, and engaged in dubious science. My bill will stop this egregious abuse of taxpayer dollars and prevent American taxpayers from footing the bill for these programs.”

House Subcommittees Hold Hearing On EPA’s IRIS Program: On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program: Reviewing its Progress and Roadblocks Ahead.” The hearing focused on issues with EPA’s Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act (Chemical Assessments Report) and High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (High-Risk Report). More information is available in our full memorandum.

House Bill Would Require U.S. To Meet Agreements Under The Paris Climate Accord: On March 27, 2019, Representative Kathy Castor (D-FL), Chair of the Select Committee on the Climate Crisis, introduced the Climate Action Now Act (H.R. 9). The bill would prohibit any federal funds from being used to take any action to withdraw the U.S. Paris Agreement on Climate Change. It also would require President Trump to develop and make public a plan for how the U.S. will meet the pollution reduction goals set forth in the agreement.

Senate Bill Would Ban Chlorpyrifos: On March 28, 2019, Senator Tom Udall (D-NM)introduced legislation to ban chlorpyrifos. The Protect Children, Farmers and Farmworkers from Nerve Agent Pesticides Act of 2019 (S. 921) would amend FIFRA to prohibit the registration of pesticides containing chlorpyrifos. It also would amend the Federal Food, Drug, and Cosmetics Act (FFDCA) to ban all uses of chlorpyrifos on food. The bill is supported by a broad coalition of organizations. A full list of organizations supporting the legislation is available online.

Bicameral Legislation Seeks To Create Carbon Trading Program: On March 28, 2019, Senator Chris Van Hollen (D-MD) and Representative Don Beyer (D-VA) introduced the Healthy Climate and Family Security Act. The bills (S. 940 and H.R. 1960) seek to create a cap and dividend program to add lower carbon emissions and blunt the dangers of climate change. The bills would cap carbon pollution and gradually reduce emissions of carbon dioxide. The legislation would cap emissions at 50 percent below 2005 levels by 2030 and 80 percent below 2005 levels by 2040. This is consistent with the recommendations of the most recent Intergovernmental Panel on Climate Change finding. It auctions carbon pollution permits to the first sellers of oil, coal, and natural gas into the U.S. market, and returns 100 percent of the auction proceeds each quarter in the form of a Healthy Climate Dividend.

Bill Would Require PFAS Survey: On March 28, 2019, Representative Dan Kildee (D-MI) jumped into the legislative fray surrounding PFAS contamination. Kildee introduced a bill (H.R. 1976) that would require the United States Geological Survey to perform a nationwide survey of perfluorinated compounds. The bill was referred to the Natural Resources Committee.

Sustainable Chemistry Bills Introduced In Senate And House: On April 3, 2019, Senator Christopher Coons (D-DE) introduced the Sustainable Chemistry Research and Development Act of 2019 (S. 999). A companion bill was introduced in the House by Representative Dan Lipinski (D-IL) (H.R. 2051). The legislation would seek to support innovations in chemistry that benefit the economy, the environment, and human health. The bill encourages the development of new and innovative chemicals, products, and processes with an improved environmental footprint through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment, according to Senator Coons. A March 2018 GAO report (GAO-18-307) outlined how sustainable chemistry can inspire new products and processes, create jobs, and enhance benefits to human health and the environment. It also identified options for addressing challenges, such as establishment of a national initiative to support sustainable chemistry research and education and the development of tools for assessing sustainable chemistry products and processes. The bill would establish a coordinating entity under the National Science and Technology Council within the White House Office of Science and Technology Policy. The agencies involved in this entity will work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the U.S. and coordinate federal efforts in sustainable chemistry. These agencies are also encouraged to include sustainable chemistry in their existing research, development, technology transfer, commercialization, education, and training programs, including support for partnerships between universities and the private sector. Finally, the legislation encourages the validation of tools for assessment of sustainable chemistry processes or products. This bill does not include any regulatory components or authorize new spending.

House Bill Would Require Cyanide Emission Limits For Petroleum Refineries: The Protecting Communities from Hydrogen Cyanide Act of 2019 (H.R. 2092) would require EPA to establish numerical limits on hydrogen cyanide from petroleum refineries. Introduced on April 4, 2019, by Colorado Democrat Diana DeGette, the bill would amend Section 112(n) of the Clean Air Act (CAA) to require EPA promulgate a numerical emission limitation for hydrogen cyanide emissions from petroleum refineries. The legislation also would require “real-time” fenceline air monitoring of emissions of hydrogen cyanide at each petroleum refinery and real-time online public reporting of the monitoring results. The bill also would require EPA to establish a community release alert system for residents exposed to emissions of hydrogen cyanide from refineries. The bill would require EPA to set the limits at the maximum degree of reduction in emissions that EPA deems achievable. The limits also must have an ample margin of safety to protect public health, prevent an adverse environmental effect, and prevent adverse cumulative effects to fetal health, children’s health, and the health of vulnerable subpopulations. EPA would have one year to promulgate the limits; owners and operators of petroleum refineries then would have an additional year to come into compliance.

Senate EPW Committee Approves Carbon Capture Legislation: The Senate Environment and Public Works Committee (EPW) on April 10, 2019, approved legislation that is intended to promote carbon capture and reuse. The bill (S. 383) would amend the CAA to direct EPA to flex its authority under Section 103 to provide research grants on carbon capture, utilization, and storage (CCUS) projects. The bill also would allow developers of carbon dioxide pipelines to streamline environmental review of their projects under the National Environmental Policy Act (NEPA).

House Bill Would Amend CWA To Speed Infrastructure Projects:Representative David B. McKinley (R-WV), on April 10, 2019, introduced the Water Quality Certification Improvement Act of 2019 (H.R. 2205). The bill is intended to advance energy infrastructure projects. This legislation would clarify Section 401 of the Clean Water Act (CWA). Specifically, the legislation would clarify that the scope of a Section 401 review is limited to water quality impacts only. It also would clarify that states, when evaluating water quality, can only consider discharges that would result from the federally permitted or licensed activity itself, not from other sources. Under the bill, states would be required to publish clear requirements for water quality certification requests and to make final decisions on whether to grant or deny a request in writing based solely on water quality reasons.

MISCELLANEOUS

Jason E. Johnston, M.S. Co-Authors “Benchmarking The Current Codex Alimentarius International Estimated Short-Term Intake Equations And The Proposed New Equations” In The Journal Of Agriculture And Food Chemistry: B&C and The Acta Group (Acta^®) are pleased to announce the publication of “Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations,” co-authored by Jason E. Johnston, M.S., Senior Scientist with B&C and Acta. The article was published by the Journal of Agriculture and Food Chemistry and can be accessed at http://pubs.acs.org/doi/abs/10.1021/acs.jafc.8b05547. The five co-authors of the study were assembled by Cheryl Cleveland through CropLife America to react to a recent proposal to revise the International Estimated Short-Term Intake (IESTI) equations used in establishing Codex Maximum Residue Limits for pesticide residues on agricultural commodities. The authors conducted a series of dietary exposure assessments to benchmark exposures estimated using the existing and proposed IESTI equations against distributions of actual exposures. The authors of this study compared dietary exposures for pesticide residues in strawberries, tomatoes, and apples at five levels of refinement to place results from the IESTI equations into context relative to real-world exposures. The benchmarking exercise showed that the current IESTI equations are conservative predictors of dietary exposures, which suggests that there is no need to introduce further conservatism that would result from adoption of the proposed IESTI equations.

EPA Releases IRIS Update That Includes PFAS Assessment: On April 2, 2019, IRIS issued an update that included PFAS with assessments under development, specifically perfluorohexane sulfonic acid (PFHxS) and perfluorodecanoate (PFDA). For both of these PFAS substances, EPA’s first step, Systematic Review Protocol, is projected to be completed in the fourth quarter of FY 2019. The update states that these assessments have begun development in support of EPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan released in February 2019. The update also discontinues four assessments (hexabromocyclododecane (HBCD), acrylonitrile, n-butyl alcohol, and certain phthalates) and suspends nine assessments (ammonia, chloroform, ethylbenzene, formaldehyde, manganese, naphthalene, nitrite/nitrate, polycyclic aromatic hydrocarbon (PAH) mixtures, and uranium). As stated in our memorandum on EPA’s recent prioritization, EPA can and is expected to use the formaldehyde IRIS assessment that has been ongoing along with other existing hazard and exposure assessments in its risk evaluation of formaldehyde under TSCA.

EPA Announces IRIS Assessment Plan For Methylmercury: On April 4, 2019, EPA announced a 30-day public comment period associated with the release of the draft IRIS Assessment Plan for Methylmercury. 84 Fed. Reg. 13286. The document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program’s initial problem formulation activities. The assessment plan outlines the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. A webinar is planned for May 15, 2019. Comments are due by May 6, 2019.

ATSDR Makes Available Draft Toxicological Profile For Glyphosate: On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on a draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comment on relevant studies and/or data to consider in preparing the document in final. Comments are due by July 8, 2019.

President Issues Executive Orders To Promote Energy Infrastructure: On April 10, 2019, President Trump issued an Executive Order (EO) on Promoting Energy Infrastructure and Economic Growth (EO 13868). Under the order, EPA is required to review and update its guidance regarding certification under CWA Section 401. DOT must update its regulations to reflect the modern Liquefied Natural Gas development ongoing in the U.S. The EO also addresses regulatory and permitting “barriers” to financing new energy infrastructure. President Trump also signed an EO to improve the process for issuing Presidential permits for certain cross-border infrastructure projects (EO 13867). The EO clarifies that any decision to issue or deny a permit shall be made solely by the President.

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