Memoranda

ECHA’s Management Board Supports Efforts To Improve REACH Authorization And Evaluation: On June 20, 2019, ECHA issued a press release entitled “Management Board supports efforts to improve REACH authorisation and evaluation.” In its press release, ECHA provides that its Management Board “has expressed its confidence in the plans to adjust the process for applications for [authorization].” The Management Board also welcomed the joint action plan of ECHA and the EC to improve the...

On July 9, 2019, the Ministry of Ecology and Environment (MEE, formerly the Ministry of Environmental Protection (MEP)) issued a notice of public consultation on the draft revision to the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The deadline to submit comments to MEE regarding the draft revision is August 16, 2019. Comments should be submitted to MEE via e-mail (chem@mee.gov.cn). What Is New? The “Provision on the Environmental Administration of New...

The U.S. Department of Agriculture’s (USDA) Office of Procurement and Property Management published a final rule on July 5, 2019, that will amend the Guidelines for Designating Biobased Products for Federal Procurement (Guidelines) to add 30 sections designating the product categories within which biobased products would be afforded procurement preference by federal agencies and their contractors. 84 Fed. Reg. 32015. These 30 product categories contain finished products that are...

The U.S. Environmental Protection Agency (EPA) published on July 1, 2019, a Federal Register notice announcing the availability of the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). 84 Fed. Reg. 31315. EPA states that the purpose of the risk evaluations is to determine whether a chemical substance presents an unreasonable risk to health...

On June 21, 2019, the Ministry of Ecology and Environment (MEE, formerly the Ministry of Environmental Protection (MEP)) issued a notice on supplementing and improving the Inventory of Existing Chemical Substances in China (IECSC). Per the notice, chemical substances that were legally produced or imported in China before October 15, 2003, but that are not on the IECSC, except for the substance categories exempted from the “Environmental Management of New Chemical Substances” (MEP Order No....

The U.S. Environmental Protection Agency released on June 21, 2019, a proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP);...

The European Commission (EC) began a public consultation on June 12, 2019, on the Fitness Check Roadmap on Endocrine Disruptors. According to the EC, the Fitness Check will contribute to the assessment of whether chemicals legislation in the European Union (EU) delivers its objective to protect human health and the environment by minimizing the overall exposure to endocrine disruptors. The Fitness Check will include an analysis of how different provisions in the broad spectrum of EC...

BoA Issues Landmark Decision In Data Sharing Dispute: On April 15, 2019, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) issued its decision in a data sharing dispute concerning access to data and cost sharing for the substance Acid Orange 7. The Appellants in the case before the BoA were REACH & Colours Kft and REACH & Colours Italia S.r.l. REACH & Colours Kft is the Lead Registrant for Acid Orange 7, and REACH & Colours Italia...

In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published a Proposed Rule Stage item titled “Update to the Hazard Communication Standard,” RIN 1218-AC93, and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March 2019.  The full description of the item is: OSHA and other U.S. agencies have been...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk...

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...

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...

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 of June 30,...

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) decrease from the level set in...

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 states that the draft...

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...