California Standards Board Adopts Permanent Silica Standard

The Occupational Safety and Health Standards Board, the standards-setting agency within the California Division of Occupational Safety and Health (Cal/OSHA), voted in late December to permanently adopt the state’s emergency temporary standard for silica. The standard is particularly intended to protect people who work with artificial, human-made stone from the incurable, progressive lung disease silicosis, according to a news release by California’s Department of Industrial Relations.

 

The permanent silica standard “continues and strengthens” Cal/OSHA’s emergency temporary standard for the substance, DIR states. The emergency temporary standard was approved in December 2023 and required employers to implement engineering controls, training, and exposure monitoring for workers engaged in high-exposure tasks such as cutting, grinding, polishing, and cleanup of artificial and natural stone. According to DIR, the protections specified in the permanent standard “provide enhanced safety measures, improved monitoring for workers, and a stronger reporting process, along with other important provisions.”

 

The California Department of Health has identified more than 230 workers in the state who have developed silicosis, including 14 workers who have died from the disease. Workers who cut artificial stone are at greatest risk for developing silicosis because the material may contain 93 percent or more crystalline silica, a Cal/OSHA fact sheet explains (PDF).

 

During the 12 months that the emergency temporary standard was in effect, Cal/OSHA conducted 85 inspections related to silica. Twenty-six percent of the shops inspected received orders that temporarily shut down equipment or processes that posed immediate safety risks. Cal/OSHA issued citations in 95 percent of closed inspections, with the vast majority resulting in violations. According to DIR, this highlights the significant enforcement actions needed to improve the safety of workplaces with silica exposures.

 

More information about Cal/OSHA’s permanent silica standard, as well as a link to download the new standard as a PDF, may be found in DIR’s news release. Additional resources on silica are available from DIR’s website.

 

 

The EPA recently released the Interim Decision for Ethylene Oxide (EtO) – a pesticide used on 50 percent of all sterilized medical devices in the United States and on approximately 30 percent of dried herbs and spices. EtO is known to cause cancer, including lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma and myeloma in people. Workers who use EtO and people who work, live, or go to school or daycare near facilities that use EtO may breathe in emissions at levels that can increase cancer risk. The greatest risk is for people who work for their entire careers at facilities directly handling EtO with insufficient worker protections in place.

 

The Interim Decision includes mitigation measures that, in addition to the measures included in the 2024 EtO National Emissions Standards for Hazardous Air Pollutants (NESHAP), will reduce exposure to workers and nearby communities. Together, these two EPA actions provide a comprehensive approach to addressing EtO pollution concerns, including cancer risk, that will increase safety in communities and for workers while supporting ongoing supply chain needs for sterilized medical equipment. This decision advances President Biden’s commitment to ending cancer as we know it as part of the Cancer Moonshot, as well as the Administration’s commitment to securing environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.

 

EPA regulates EtO’s use as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EtO has both antimicrobial uses, such as sterilization of medical devices, and conventional uses, such as fumigation of dried herbs and spices. In some instances, such as with sterilization of medical devices like surgical kits, EtO is the only available option, making it essential for protecting human health. Every 15 years, EPA evaluates potential human health and environmental effects associated with the use of a pesticide through the registration review process. As part of EtO’s registration review, the agency assessed cancer risk from working in sterilization and health care facilities that use EtO, living in communities near EtO facilities, and consuming dried herbs and spices treated with EtO.  

 

After a 75-day public comment period with over 60 stakeholder meetings with industry, other federal agencies, unions, and nonprofit organizations, EPA identified a broad set of protections under FIFRA that aim to reduce exposure to all EtO sterilization facility workers and to others who work, live, or go to school near sterilization facilities. Specifically, the Decision includes a reduced EtO concentration rate limit for new medical device sterilization cycles to reduce levels of exposure for workers; a lowered worker exposure limit of 0.5 ppm after three years, 0.25 ppm after five years, and 0.1 ppm after 10 years (compared to the current Occupational Safety and Health Administration standard of 1 ppm);  phased cancellation of the use of EtO on specific dried herbs and spices; and cancellation of the use of EtO when safer and effective alternatives are available.

Some of the highlights of the Interim Decision include:

Commercial Sterilizers

 

Healthcare Facilities

EPA expects that registrants will submit label amendments that include the changes outlined in the Interim Decision within 60 days after publication. The agency plans to quickly review the label amendments so that products sold and distributed by registrants will include the changes outlined in the Interim Decision. The timing for implementation for individual mitigation measures ranges from two years to 10 years, taking into consideration the costs, technology availability, potential impacts to the medical device supply chain and other logistical elements. Additionally, EPA will issue a Data Call-In (DCI) to gather information on worker exposure. Specifically, the DCI will require submission of worker exposure data for commercial sterilizers and warehouses in order to understand the worker exposure impacts of complying with EPA’s Clean Air Act EtO commercial sterilization NESHAP and implementing the mitigation measures identified in this Interim Decision. EPA will reevaluate this Interim Decision within eight years, earlier than the typical 15-year cycle, based on the submitted worker exposure data, in order to identify further opportunities to reduce EtO exposures.

 

 

The Bureau of Labor Statistics (BLS) announced in December that fatal occupational injuries fell from 5,486 in 2022 to 5,283 in 2023, a decrease of 3.7 percent. The rate of fatal work injuries in 2023 was 3.5 per 100,000 full-time workers, compared to 3.7 per 100,000 in 2022.

 

Transportation incidents were the most frequent cause of fatal work injuries in 2023, accounting for 1,942 or 36.8 percent. Construction had the most fatal injuries of all industrial sectors with 1,075—the sector’s highest total since 2011—followed by transportation and warehousing with 930.

 

Transportation and material moving occupations were the occupational group with the most fatalities in 2023 with 1,495, which nevertheless represented a 7.7 percent decrease from 2022. The occupation with the highest rate of fatal injuries continued to be farming, fishing, and forestry, with 24.4 per 100,000 full-time workers, nearly twice the rate of the next highest sector, transportation and material moving.

 

 

The EPA recently announced a settlement with global manufacturer Borealis Compounds, Inc. to resolve violations of chemical safety requirements. EPA had alleged that the company violated the Toxic Substances Control Act (TSCA), a federal law that regulates the manufacture, use, and reporting of chemicals, at its Port Murray, New Jersey facility. Borealis has agreed to pay a $450,000 civil penalty and ensure compliance with TSCA regulations moving forward, including reporting on chemicals and provisions to protect workers.

 

“This settlement underscores EPA’s commitment to holding companies accountable for safeguarding public health and meeting federal chemical safety standards,” said EPA Regional Administrator Lisa F. Garcia. “In this case, their failure to follow the rules and not document the chemicals properly.”

 

The settlement resolves violations discovered during a February 2022 inspection and subsequent EPA review. EPA determined that Borealis Compounds, LLC failed to comply with TSCA’s reporting, recordkeeping, and notification requirements for specific chemical substances used at its facility. Notably, the company did not provide the required protective equipment for workers while handling polyethylene in a process called compounding and failed to meet reporting obligations for this substance.  Polyethylene compounding is a process where different materials are mixed to create a new type of polyethylene plastic. Borealis also neglected to submit mandatory chemical data reporting for twelve other substances imported by the facility in quantities greater than 25,000 pounds.

 

The Borealis facility in Port Murray employs approximately 140 people and produces plastic compounds used in wire and cable products. The company has since corrected the violations and worked cooperatively with EPA to resolve this matter. Under the agreement, Borealis has committed to full compliance with TSCA and related regulations moving forward.

 

Learn more about EPA’s enforcement of the Toxic Substances Control Act.

 

 

The Environmental Protection Agency (EPA) and Department of Justice announced a settlement agreement with Fayat S.A.S, and nine of its subsidiaries — BOMAG GmbH, Bomag Americas Inc., BOMAG (China) Construction Machinery Co. Ltd., MARINI S.p.A., RAVO B.V., Charlatte of America Inc., PTC S.A.S., Secmair S.A.S. and MATHIEU S.A. — for alleged violations of the Clean Air Act’s mobile source emission standards regulations for alleged violations of the Clean Air Act’s mobile source emission standards regulations.

 

The complaint alleges that, between 2014 and 2018, Fayat and its subsidiaries illegally imported and sold hundreds of pavers, rollers and other nonroad equipment containing diesel engines that failed to meet Clean Air Act emission requirements. The complaint also alleges that Fayat failed to comply with Clean Air Act labeling and reporting requirements. The agreement requires Fayat to pay a civil penalty of $11 million and requires the company to complete a project to reduce the harm caused by excess nitrogen oxides and particulate matter emissions.

 

“Fayat’s import of nonroad vehicles with outdated diesel engines violates the Clean Air Act standards for emissions from mobile sources and threatened exposure to harmful diesel air emissions,” said Acting Assistant Administrator Cecil Rodrigues for EPA’s Office of Enforcement and Compliance Assurance. “Today’s announcement demonstrates that EPA will hold accountable companies that put outdated equipment into commerce that pollutes the air and risks exposing communities to toxic air pollutants.”

 

“Fayat failed to ensure that the equipment it introduced into the United States market complied with Clean Air Act requirements designed to protect the public’s health from harmful emissions,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division (ENRD). “We will not tolerate violations of Clean Air Act standards. The settlement requires both a substantial civil penalty and a project that will reduce emissions in the Mobile, Alabama, area and contribute to improved public health.”

 

In addition to paying a civil penalty, Fayat will, as part of the agreement, undertake a project to reduce the harm from the emissions. The company will retrofit a tugboat currently in service in Mobile, AL. Retrofitting the tugboat includes removing and destroying two engines and auxiliary generators and replacing them with two new engines and two new generators that meet current emission controls.

 

The proposed consent decree, lodged in the U.S. District Court for the District of Columbia, is subject to a public comment period and final court approval. Information on submitting comment and access to the settlement agreement is available on the Justice Department’s Proposed Consent Decree webpage.

 

The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.

 

The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.

 

FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.

 

Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.

 

 

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