Memoranda

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 February 21, 2019, press...

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.”...

The European Commission (EC) began a public consultation on February 11, 2019, on the evaluation of food contact materials (FCM).  The purpose of the evaluation is to assess whether the current European Union (EU) legislative framework for FCMs is fit for purpose and delivers as expected.  The evaluation covers the functioning of Regulation (EC) No 1935/2004 (Regulation) in its entirety and the rules and tools provided for by the legislation, such as specific implementing...

The U.S. Consumer Product Safety Commission (CPSC) published a Federal Register notice on February 11, 2019, announcing that it will hold a public hearing to receive information from interested parties about possible changes to www.SaferProducts.gov, CPSC’s Publicly Available Consumer Product Safety Information Database, to improve the website’s usefulness and ease of use. 84 Fed. Reg. 3134. CPSC also requests written comments on possible improvements. The public hearing will...

On January 21, 2019, New York Governor Andrew M. Cuomo (D) announced as part of his Executive Budget a proposal intended to protect New Yorkers from unknown exposure to toxic chemicals.  According to Governor Cuomo’s press release, the Consumer Right to Know Act would authorize the New York State Department of Environmental Conservation (NYSDEC), in consultation with the New York State Department of Health (NYSDOH) and the New York State Department of State (NYSDOS), to develop...

On January 28, 2019, the U.S. Environmental Protection Agency (EPA) published its Year in Review: 2018 (YIR). The YIR lists the following accomplishments: The YIR provides the following “by the numbers” summary: Water As reported in our December 11, 2018, memorandum, “EPA Releases ‘Waters of the U.S.’ (WOTUS) Replacement Rule Proposal,” on December 11, 2018, EPA Acting Administrator Andrew Wheeler announced EPA’s and the U.S. Army Corps of Engineers’ (Corps) release of...

As Brexit is eclipsing nearly all other developments in Europe these days, we write to alert you to another important development underway in the European Union (EU). As discussed in detail below, the European Commission (EC) has initiated a process to evaluate and likely revise the EU framework addressing the regulation of food contact materials (FCM). Regulation (EC) No 1935/2004 (Regulation) provides this framework and has done so since its adoption in October 2004 with varying...

After over a year of review and revision, on January 8, 2019, the Chinese Ministry of Ecology and Environment (MEE) published the “Chemical Environmental Risk Assessment and Control Regulation (Draft)” (Regulation) for public comment. The draft Regulation would update the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The deadline to submit comments to MEE regarding the Regulation is February 20, 2019. Comments should be submitted to MEE via e-mail...

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 prior to registration and pre-registration must be completed...

On January 9, 2019, the New York Department of Environmental Conservation (NYDEC) announced it was delaying its enforcement of the New York Household Cleansing Product Information Disclosure Program (Disclosure Program) to October 1, 2019. NYDEC’s announcement was published in the Environmental Notice Bulletin. As previously reported, on June 6, 2018, NYDEC released its Disclosure Program setting forth extensive requirements for manufacturers of certain consumer...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2019. In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in the New...

On December 21, 2018, the U.S. Environmental Protection Agency (EPA) denied a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA initiate rulemaking to amend the TSCA Chemical Data Reporting (CDR) rule to increase reporting of asbestos. EPA denied the September 27, 2018, petition on the grounds that the petitioners, the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental...

On December 12, 2018, the House passed the Conference Report for H.R. 2 (the Agriculture Improvement Act of 2018, also known as the Farm Bill) to provide for the reform and continuation of agricultural and other programs of the United States Department of Agriculture (USDA) through fiscal year 2023. The Senate passed the Conference Report on December 11, 2018. Sec. 10101. Specialty crops market news allocation. Sec. 10102. Local agriculture market program. Sec. 10103. Organic...

On December 11, 2018, the U.S. Environmental Protection Agency’s (EPA) Acting Administrator Andrew Wheeler announced EPA’s and the U.S. Army Corps of Engineers’ (Corps) release of their highly anticipated proposed replacement definition of “Waters of the U.S.” (WOTUS) that defines the scope of waters and wetlands that fall under federal Clean Water Act (CWA) jurisdiction. The 2018 WOTUS rule proposal is currently available in pre-publication format on EPA’s...

On November 16, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to Proposition 65 (Prop 65) regulations setting forth the circumstances when a “retail seller” is required to provide a consumer product exposure warning.  Retail sellers are defined under the regulations as: [A] person or business that sells or otherwise provides consumer products directly to consumers by any means, including via the internet. For purposes of this...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29...

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...

Effective October 26, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) added nickel (soluble compounds) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65 (Prop 65).  Importantly, “soluble” is not defined in the listing.  On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts”...

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those acted on since entry into force of amended TSCA), the 13 chemical substances are not also subject...