USA Regulatory News

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a rep...

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a reproductive toxicant, specifically targeting the female reproductive endpoint. The decision, made through the "State's Qualified Experts" mechanism, follows the conclusive findings of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) that BPS is a contributor to female reproductive toxicity.

The listing of BPS under Proposition 65, effective from December 29, 2023, highlights the potential hazards of the substance and necessitates warning requirements for significant exposures.

During the DARTIC meeting, OEHHA staff presented a comprehensive review of the scientific evidence regarding the female reproductive toxicity of bisphenol S. Following the presentation, the DARTIC voted unanimously (9-0) in favor of the determination that BPS induces female reproductive toxicity based on scientifically valid testing according to widely accepted principles. This led to the addition of BPS to the Proposition 65 list, specifically for female reproductive toxicity.

Proposition 65

Proposition 65, established in November 1986 as a ballot initiative, protects California’s drinking water sources from contamination by chemicals known to cause cancer, birth defects, or other reproductive harm. It requires businesses to inform Californians of potential exposure to such chemicals and to provide warnings.

These chemicals may be present in products, homes, workplaces, or released into the environment. Proposition 65 empowers Californians to make informed decisions about their chemical exposures and prohibits businesses from knowingly discharging significant amounts of listed chemicals into drinking water sources.

Understanding Bisphenol S

Bisphenol S (BPS) is a constituent of polyethersulfone (PES) plastic, commonly used in the manufacture of rigid plastic products and synthetic fibers used in clothing and textiles. Beyond its application in curing fast-drying epoxy glues, BPS serves as a corrosion inhibitor and is frequently used as a reactant in polymer reactions. BPS can improve color longevity in fabrics and is often chosen as a substitute for BPA in certain paper receipts. It can also be found in the protective coatings that line some food cans, and consumers should be aware that products labeled as "BPA-free" may contain BPS. The common characteristic of BPS and BPA as endocrine disruptors lies in the presence of the hydroxy group on the benzene ring, enabling them to mimic estradiol.

These developments highlight the ongoing efforts to identify and regulate potentially harmful substances. As stakeholders navigate these changes, it is increasingly important to stay informed about chemical listings and associated warnings.

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by th...

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance supports stakeholders in submitting cosmetic product facility registrations and product listings to the FDA. It outlines submission responsibilities, necessary information, submission procedures, timelines, and specific exemptions from registration and listing requirements.

Portal

The guidance provides details about a newly launched electronic registration and listing portal called Cosmetics Direct. This portal is now accessible. Additionally, the FDA is in the process of creating paper forms, Form FDA 5066 and Form FDA 5067, to serve as alternative tools for submitting cosmetic product registration and listing information. These forms are expected to be available soon on the Registration & Listing of Cosmetic Product Facilities and Products platform.

The FDA will use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. To streamline the registration process, facility owners or operators are required to obtain an FEI number before submitting their facility registration. To check for an existing FEI number, please use the FEI Search Portal.

It is important for the responsible person to obtain the relevant FEI number(s) for each facility where their cosmetic products are manufactured or processed, as these facility registration number(s) are necessary for product listing submissions. In the case of a small business that is exempt from registration and does not have a facility registration number, the product listing can be submitted using the facility name and address.

Exemptions

MoCRA provides exemptions from facility registration and product listing for specific small businesses.

However, these exemptions do not apply to facilities or responsible persons associated with the manufacture or processing of certain cosmetic products, including the following:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that, under customary or usual conditions of use, are intended to change the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use. 

Delayed Enforcement 

The FDA will not enforce the cosmetic product facility registration and product listing requirements for an additional six months after the December 29, 2023 deadline, until July 1, 2024. During this period, regulated industries will have more time to meet these obligations.

Additionally, the FDA will not enforce the registration requirement for facilities that begin cosmetic product manufacturing or processing after December 29, 2022, and the listing requirement for products first marketed after that date until July 1, 2024.

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation...

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation under the Toxic Substances Control Act (TSCA). Chemical companies will be required to submit records of the significant adverse impacts on human health and the environment caused by MBOCA. This action is consistent with EPA's mission to protect human health and the environment.  

EPA is collecting environmental and health data on a chemical for the first time in over 30 years, hoping that the data will improve its understanding of the chemical's potential adverse effects on human health or the environment and streamline the risk assessment process. 

MBOCA is used in various industrial applications, particularly in the manufacturing and processing of rubbers, plastics, polymers, resins, and other compounds. MBOCA is a potential human carcinogen, and its inclusion in the 2014 update to the TSCA Work Plan, indicates the need for more evaluation. EPA expects to start a risk review of MBOCA within 9-12 months, as the Agency recently started the statutory priority process for five chemicals, including MBOCA.  

Chemical companies are required to keep records of any reports regarding the chemical's adverse effects on the environment or human health. EPA is authorized by TSCA Section 8(c) to obtain copies of these records. 

EPA has published a Quick Guide to CDX Submissions and a TSCA Section 8(c) Recordkeeping and Reporting Fact Sheet to help respondents in meeting their obligations. Records should be submitted using the Agency's online Central Data Exchange (CDX) system.  

On December 21, 2023, the U.S. Environmental Protection Agency (EPA) released the much-anticipated 2023 Mercury Inventory Report, an important document that sheds light on the supply, use, and trade o...

On December 21, 2023, the U.S. Environmental Protection Agency (EPA) released the much-anticipated 2023 Mercury Inventory Report, an important document that sheds light on the supply, use, and trade of mercury in the United States. This is the second inventory report since the finalization of the 2018 Mercury Inventory Reporting Rule, reinforcing the nation's commitment to managing elemental mercury and mercury compounds as outlined in the 2016 amendments to the Toxic Substances Control Act (TSCA).

The 2023 report, a significant milestone, captures data effective from January 1, 2020, enforcing the 2016 TSCA amendment that bans the export of five mercury compounds. This information not only aids the United States in implementing the Minamata Convention on Mercury but also contributes to the global effort to protect human health and the environment from the adverse effects of mercury exposure.

Mercury, known to cause kidney damage, respiratory failure, and other severe health effects, poses a significant threat. The report highlights the importance of monitoring and regulating its supply, use, and trade. Mercury, being non-biodegradable, has the potential to accumulate in the environment over time.

Key highlights of the 2023 Mercury Inventory Report include:

1. Inactive Mercury Compounds: Thirty-one mercury compounds are now listed as "inactive" under the Chemical Substance Inventory since the 2020 report.
2. Decrease in Mercury Use: An overall decrease of approximately 13% in the use of mercury in the domestic manufacture, sale, and export of mercury-added products, signaling a shift toward effective alternatives.
3. Sector-specific Reductions: Notable reductions include a 20% decrease in mercury used for products like switches, relays, sensors, and valves, as well as a significant 56% decrease in the use of dental amalgam.
4. Low Totals in Specific Products: Mercury in domestically manufactured and imported batteries, measuring devices, and other miscellaneous products is reported to be less than 0.1 metric tons.

This comprehensive report contributes to the ongoing efforts to implement the Minamata Convention, addressing anthropogenic emissions and releases of mercury globally.

Background:

EPA's commitment to monitoring mercury dates back to March 2017 when the initial inventory report was published. Subsequent actions include the 2018 final rule, establishing reporting requirements for triennial inventories. The data comes directly from companies that manufacture, import, or use mercury, providing more reliable and complete information.

The 2023 Mercury Inventory Report builds on the foundation laid by its predecessor, the 2020 Report, which incorporated contextual reporting requirements resulting in more extensive information on the industries that purchased mercury-added products, the countries of origin and destination for imports and exports, and the specific ways that mercury was used in certain manufacturing processes. Late submissions and additional data were incorporated into the 2023 report, reflecting EPA's dedication to transparency and accuracy.

In November 2021, a final rule eliminated the exemption for persons importing pre-assembled products containing a mercury-added component, reinforcing EPA's commitment to refining regulations based on court orders.

The release of the 2023 Mercury Inventory Report highlights EPA‘s continued efforts to protect public health and the environment by closely monitoring and regulating the use of mercury in the United States.

On December 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will prioritize five toxic chemicals for risk evaluation under the Toxic Substances Control Act (TSCA), with risk...

On December 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will prioritize five toxic chemicals for risk evaluation under the Toxic Substances Control Act (TSCA), with risk evaluations initiated if the chemicals are designated as High Priority Substances within the 12-month statutory process. 

EPA intends to prioritize the following five chemicals under the Toxic Substances Control Act (TSCA).  

• Acetaldehyde (CAS RN 75-07-0), 

• Acrylonitrile (CAS RN 107-13-1), 

• Benzenamine (CAS RN 62-53-3), 

• 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CAS RN 101-14-4) 

• Vinyl Chloride (CAS RN 75-01-4). 

EPA plans to prioritize five chemicals each year, establishing a consistent pace for risk assessments. This is the first step towards regulating existing chemicals, assessing if health and environmental protection is needed. It also serves environmental justice by addressing the effects of toxic chemicals on workers, consumers, and communities. If a chemical poses an unacceptable risk, EPA must immediately initiate a risk management process to eliminate those risks. 

Details on the five substances 

Acetaldehyde, a probable human carcinogen is used primarily in the manufacture and processing of petrochemicals, adhesives, and other chemicals. Acetaldehyde may cause various health problems, including respiratory system irritation. 

Acrylonitrile, a probable human carcinogen, has adverse health effects, including respiratory system irritation. It is also used in the production and processing of various chemicals, including plastic materials, paints, and petrochemicals. 

Benzenamine, a probable human carcinogen, is used in the manufacture and handling of petrochemicals, resins, polymers, dyes, and pigments. Exposure to benzenamine can lead to various health problems, including adverse effects on blood, fetal development, and reproduction. 

MBOCA, is a probable human carcinogen. It is used in the manufacture and handling of resins, plastics, rubbers, and other chemicals. Extensive data indicate that exposure to MBOCA can damage genetic material in cells, potentially leading to adverse health effects, especially in infants and children. 

Vinyl chloride, a chemical used in the manufacture and processing of plastic materials like PVC and plastic resins, has been linked to various health problems, including liver poisoning.  It is also a known human carcinogen. In the 1970s, concerns raised by EPA and the White House Council on Environmental Quality led to the enactment of the "original" TSCA in 1976, which mandates the safe manufacture and use of chemicals and addresses the adverse health effects of vinyl chloride. 

Selection process 

EPA selected the five chemicals from the 2014 TSCA Work Plan for further assessment based on their hazards and exposure potential.  

The selection process considered factors such as their use, potential impact on overburdened communities, known hazards, and available information. EPA met with federal partners, industry, environmental organizations, labor organizations, state and local governments, and tribes to discuss the prioritization process. Following the Federal Register notice, EPA will open a public comment period and request further information on uses and potential risks of these chemicals.  

EPA expects to designate these chemicals as high priority for risk evaluation but will continue to review and consider information to make a final designation. The process will include assessing of the hazard and exposure potential, environmental effects, potential exposure, storage near drinking water sources, and chemical usage. 

In a significant development on December 14, 2023, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for Tris(2-chloroethyl) phosphate (TCEP), a flame retardant widely ...

In a significant development on December 14, 2023, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for Tris(2-chloroethyl) phosphate (TCEP), a flame retardant widely used in paints, coatings, textiles, and aerospace applications. This is a crucial step under the Toxic Substances Control Act (TSCA) and opens the door for public comment.

Unprecedented Findings: Unreasonable Risks to Health and Environment

EPA's draft risk evaluation, based on the latest scientific evidence, has preliminarily found that TCEP poses unreasonable risks to both human health and the environment. This finding comes as the first among the 20 High-Priority Substances prioritized in 2019. EPA's improved risk evaluation process includes a thorough assessment of potential exposure risks to sensitive subpopulations such as workers, children, and subsistence fishers.

TCEP Background: A Chemical with Lingering Threats

TCEP, which has a long history of use in various industries, has been linked to serious health effects, including kidney cancer, reproductive issues, neurological disorders, developmental challenges, and kidney-related effects. Despite a substantial reduction in U.S. production since 2014, TCEP still finds application in certain paints, coatings, and aerospace products. Importantly, its non-chemical binding to materials allows it to leach into the environment, raising concerns about water, sediment, soil, and air contamination.

Worker Risks and Consumer Exposure

For workers, the EPA assessment identified unreasonable risks from both inhalation and dermal exposure, even without assuming universal and proper use of Personal Protective Equipment (PPE). Consumer exposure, particularly through inhalation and ingestion, reveals risks associated with TCEP leaching from textiles and products into indoor air. Children may be at increased risk if they are frequently exposed to TCEP-containing materials.

Environmental Impact: Fish, Water, and Subsistence Fishers at Risk

The presence of TCEPs in water can lead to its accumulation in fish, posing unreasonable risks to those who consume them. Subsistence fishers and tribal populations, who rely heavily on fish for food and cultural practices, face elevated risk. EPA's evaluation also includes environmental impact on aquatic organisms chronically exposed to TCEP through surface water and sediment.

Call for Action: Public Comment and Peer Review

EPA's draft risk evaluation is now open for public comment until January 5, 2024. Interested parties can participate via the docket EPA-HQ-OPPT-2023-0265 on www.regulations.gov. Additionally, a virtual preparatory meeting on March 5, 2024, will precede the letter peer review by independent scientific experts that will start on March 13, 2024. The Agency encourages the submission of specific exposure information to help refine the risk estimates for the final evaluation.

Next Steps

Should EPA conclude in the final risk evaluation that TCEP poses unreasonable risks, the Agency is committed to taking swift action. This includes the development of risk mitigation options to safeguard both human health and the environment.

The U.S. Environmental Protection Agency (EPA) has initiated the registration review process by releasing a draft biological evaluation (BE) for 11 rodenticides that will assess their effects on speci...

The U.S. Environmental Protection Agency (EPA) has initiated the registration review process by releasing a draft biological evaluation (BE) for 11 rodenticides that will assess their effects on species and critical habitats protected under the Endangered Species Act (ESA). The 60-day public comment period is now open and comments will be accepted until January 29, 2024.

Substances covered:

The 11 rodenticides covered by the draft biological evaluations are:

• First generation anticoagulants (FGARs):
  • Warfarin
  • Chlorophacinone
  • Diphacinone
• Second generation anticoagulants (SGARs):
  • Brodifacoum
  • Bromadiolone
  • Difenacoum
  • Difethialone
• Non-anticoagulant rodenticides:
  • Bromethalin
  • Cholecalciferol
  • Strychnine
  • Zinc phosphide

ESA Requirements:

The Endangered Species Act (ESA) requires federal agencies, including EPA to protect species listed as threatened or endangered and protect their designated critical habitats. The registration review process which falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), constitutes an EPA "action" under the ESA.

Consultation Process:

Should EPA determine that a pesticide may impact listed species or their designated critical habitat, formal consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (collectively referred to as the Services) must be initiated.

Settlement Agreement Deadline:

A settlement agreement sets a deadline of November 2024 for EPA to finalize nationwide consultation effects determinations for the active ingredients brodifacoum, bromadiolone, warfarin and its sodium salt, and zinc phosphide. The agreement also empowers EPA to make effects determinations and consult, as needed, on additional rodenticide active ingredients under review.

Findings:

The preliminary assessment indicates that these rodenticides could adversely impact 1% to 8% of all listed species (9 to 136 ESA-protected species) and 4% of habitats (38 critical habitats). Adverse effects include potential harm or mortality to at least one individual of a protected species.

However, the Agency predicts that less than 5% of listed species and 1% of critical habitats may be at risk in the future from current pesticide use.

To address concerns, the draft Biological Evaluation (BE) suggests maintaining existing mitigation measures from the previous year and a pilot program. Additionally, the draft proposes modifications to earlier recommendations and introduces new actions, such as restricting the placement of bait station near structures, prohibiting direct application to water, and avoiding usage in areas or at times when secondary predatory species might be exposed.

Further actions include mandatory carcass searches for second-generation anticoagulant (SGAR) applications, monitoring burrow holes after field applications, and updating registration conditions to include a clause for notification to EPA if additional measures are deemed necessary.

The final BE and associated opinions will assist EPA in identifying potential use restrictions or any additional requirements for pesticide registration or labelling that may be essential to protect listed species and their habitats.