Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic.

Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommended against using these hand sanitizers due to concerns over safety, efficacy, and/or risk of incidental ingestion. To address current gaps in exposure characterization, this study describes a survey of ABHSs marketed to children available in the U.S., as defined by several inclusion criteria. A subset of ABHSs (n = 31) were evaluated for ethanol and organic impurities using a modified FDA method. Products with detectable impurity levels were compared to the FDA's established interim limits. Seven children's products had impurity levels exceeding the FDA's recommended interim limits, including benzene (up to 9.14 ppm), acetaldehyde (up to 134.12 ppm), and acetal (up to 75.60 ppm). The total measured alcohol content ranged from 52% to 98% in all hand sanitizers tested, ranging from 39% below, and up to 31% above, the labeled concentration. Future studies should confirm impurity contamination sources. A risk assessment could determine whether dermal application or incidental ingestion of impurity-containing hand sanitizers pose any consumer risk.

Setting occupational exposure limits for antimicrobial agents: A case study based on a quaternary ammonium compound-based disinfectant.

Antimicrobial agents have become an essential tool in controlling the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and guidelines on their use have been issued by various public health agencies. Through its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides, the US Environmental Protection Agency has approved numerous surface disinfectant products for use against SARS-CoV-2. Despite their widespread use and range of associated health hazards, the majority of active ingredients in antimicrobial products, such as surface disinfectants, lack established occupational exposure limits (OELs) to assist occupational health professionals in characterizing risks from exposures to these chemicals. Based on established approaches from various organizations, a framework for deriving OELs specific to antimicrobial agents was developed that relies on a weight-of-evidence evaluation of the available data. This framework involves (1) a screening-level toxicological assessment based on a review of the existing literature and recommendations, (2) identification of the critical adverse effect(s) and dose-response relationship(s), (3) identification of alternative health-based exposure limits (HBELs), (4) derivation of potential OELs based on identified points of departure and uncertainty factors and/or modification of existing alternative HBELs, and (5) selection of an appropriate OEL. To demonstrate the use of this framework, a case study is described for selection of an OEL for a disinfectant product containing quaternary ammonium compounds (quats). Three potential OELs were derived for this product based on irritation toxicity data, developmental and reproductive toxicity (DART) data, and modification of an existing HBEL. The final selected OEL for the quats-containing product was 0.1 mg/m3, derived from modification of an existing HBEL. This value represented the lowest resulting value of the three approaches, and thus, was considered protective of irritation and potential DART.

Assessing and managing the risks of COVID-19 in the workplace: Applying industrial hygiene (IH)/occupational and environmental health and safety (OEHS) frameworks.

As businesses attempt to reopen to varying degrees amid the current coronavirus disease (COVID-19) pandemic, industrial hygiene (IH) and occupational and environmental health and safety (OEHS) professionals have been challenged with assessing and managing the risks of COVID-19 in the workplace. In general, the available IH/OEHS tools were designed to control hazards originating in the workplace; however, attempts to tailor them specifically to the control of infectious disease outbreaks have been limited. This analysis evaluated the IH decision-making framework (Anticipate, Recognize, Evaluate, Control, and Confirm ("ARECC")) as it relates to biological hazards, in general, and to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), specifically. Available IH/OEHS risk assessment and risk management tools (e.g. control banding and the hierarchy of controls) are important components of the ARECC framework. These conceptual models, however, were primarily developed for controlling chemical hazards and must be adapted to the unique characteristics of highly infectious and virulent pathogens, such as SARS-CoV-2. This assessment provides an overview of the key considerations for developing occupational infection control plans, selecting the best available controls, and applying other emerging tools (e.g. quantitative microbial risk assessment), with the ultimate goal of facilitating risk management decisions during the current global pandemic.

Emissions associated with operations of four different additive manufacturing or 3D printing technologies.

In this pilot-scale study, a wide range of potential emissions were evaluated for four types of additive manufacturing (AM) machines. These included material extrusion (using acrylonitrile-butadiene-styrene [ABS]); material jetting (using liquid photopolymer); powder bed fusion (using nylon); and vat photopolymerization (using liquid photopolymer) in an industrial laboratory setting. During isolated operation of AM machines, adjacent area samples were collected for compounds of potential concern (COPCs), including total and individual volatile organic compounds (VOCs), nano- and micron-sized particulate matter, and inorganic gases. A total of 61 compounds were also sampled using a canister followed by gas chromatography and mass spectrometry analysis. Most COPCs were not detected or were measured at concentrations far below relevant occupational exposure limits (OELs) during AM machine operations. Submicron particles, predominantly nanoparticles, were produced during material extrusion printing using ABS at approximately 12,000 particles per cubic centimeter (p cm-3) above background. After subtracting the mean background concentration, the mean concentration for material extrusion printing operations correlated with a calculated emission rate of 2.8 × 1010 p min-1 under the conditions tested. During processing of parts produced using material jetting or powder bed fusion, emissions were generally negligible, although concentrations above background of respirable and total dust were measured during processing of powder bed fusion parts. Results of this pilot-scale study indicate that airborne emissions associated with AM operations are variable, depending on printing and parts handling processes, raw materials, and ventilation characteristics. Although personal samples were not collected in this pilot-scale study, the results can be used to inform future exposure assessments. Based on the results of this evaluation, measurement of submicron particles emitted during material extrusion printing operations and dust associated with handling parts manufactured using powder bed fusion processes should be included in exposure assessments.