Memoranda

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder...

On May 2, 2019, California’s Office of Environmental Health Hazard Assessment (OEHHA) published a definition of nickel (soluble compounds) for the purposes of Proposition 65 (Prop 65). Under the notice, nickel (soluble compounds) are defined to be compounds of nickel with solubility in water of greater than 0.1 moles per liter (mol/L) at 20oC. OEHHA states that this definition is consistent both with the discussion by the Developmental and Reproductive Toxicant Identification...

On April 17, 2019, the U.S. Environmental Protection Agency (EPA) released a final significant new use rule (SNUR) for asbestos using the definition in Title II, Section 202 of the Toxic Substances Control Act (TSCA), which defines asbestos as the “asbestiform varieties of six fiber types -- chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.”  EPA states that it is promulgating the SNUR “to ensure...

The South Korea amendment to the Act on Registration and Evaluation, etc of Chemical Substances (K-REACH) came into effect on January 1, 2019.  All existing chemical substances (i.e., substances that are listed on the existing chemical inventory in South Korea) manufactured in or imported to South Korea at greater than or equal to one ton per year are now subject to registration. Existing chemical substances must be pre-registered by the fast-approaching deadline...

Turkey has obtained new funds from the EU to support implementation of KKDIK (Registration (Kaydı), Evaluation (Değerlendirilmesi), Authorization (İzni) and Restriction (Kısıtlanması) of Chemicals (Kimyasalların)) (Turkey REACH). Turkey has secured € 1.6 million as part of the Instrument for Pre-accession Assistance (IPA) program, “the means by which the EU supports reforms in the ‘enlargement countries’ with financial and technical help.” The funds obtained...

On April 12, 2019, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the Toxic Substances Control Act (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 Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every...

On April 10, 2019, the U.S. Environmental Protection Agency (EPA) released 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 Toxic Substances Control Act (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...

On April 9, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on the fiscal year (FY) 2020 budget for the U.S. Environmental Protection Agency. The April 5, 2019, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee on Energy and Commerce, states that President Trump’s FY 2020 budget requests $6.068 billion for EPA, a $2.76 billion (31 percent)...

On March 25, 2019, the U.S. Environmental Protection Agency (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 # EPA-HQ-OPP-2018-0258.  EPA issued the notice of availability in the Federal Register on March 27, 2019.  84 Fed. Reg. 11538.  EPA...

On March 27, 2019, the U.S. Environmental Protection Agency (EPA) posted a signed final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 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...

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 the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 40 chemicals for which EPA is initiating the prioritization process for risk evaluation. Section 6(b)(2)(B) of the Toxic Substances Control Act (TSCA) requires that, as of three and a half years after enactment (by December 22, 2019), at least 20 high-priority chemicals be undergoing risk evaluations and at least 20 low-priority chemicals be designated by EPA. In a March 21,...

On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 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...

On March 18, 2019, the U.S. Environmental Protection Agency (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). EPA states that it designed this reporting tool “to be user-friendly, with drop-down...

On March 13, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on “Mismanaging Chemical Risks:  EPA’s Failure to Protect Workers.”  The hearing examined the U.S. Environmental Protection Agency’s (EPA) assessment and management of risks to workers from toxic chemicals under the Toxic Substances Control Act (TSCA) and other laws.  The Subcommittee focused on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for...

The U.S. Government Accountability Office (GAO) released on March 6, 2019, a report entitled High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas. GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges. GAO’s report describes the status of high-risk areas and outlines actions necessary...

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has...

The U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) routinely reviews and amends the Hazardous Materials Regulations (HMR) to harmonize the HMR with international regulations and standards.  In February 2019, PHMSA’s Office of Hazardous Materials Safety (OHMS) contracted with the Cambridge Systematics (CS) Team to conduct a risk assessment for the transportation of aerosol containers to align U.S. and international regulations. ...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (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. According to FDA’s...

The U.S. Environmental Protection Agency (EPA) released on February 19, 2019, an update of the Toxic Substances Control Act (TSCA) Chemical Inventory (TSCA Inventory), which lists chemicals that are “active” versus “inactive” in commerce in the U.S.  EPA’s News Release states that a “key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce.”...