USA Regulatory News

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.

In a significant move to protect public health, the U.S. Environmental Protection Agency (EPA) issued orders on December 1, 2023, directing Inhance Technologies LLC (Inhance) to cease the production o...

In a significant move to protect public health, the U.S. Environmental Protection Agency (EPA) issued orders on December 1, 2023, directing Inhance Technologies LLC (Inhance) to cease the production of per- and polyfluoroalkyl substances (PFAS). These chemicals, which are integral to the manufacture of fluorinated high-density polyethylene (HDPE) plastic containers, have been identified as posing health risks by leaching into various consumer, industrial, and agricultural products.

PFAS

Known for their persistence in the environment and in the human body, PFAS accumulate over time, contributing to long-term health risks even at low exposure levels. Studies, including those by the Centers for Disease Control, reveal that nearly all individuals tested already have traces of PFAS in their blood. The substances can enter the human body through drinking water, consumption of contaminated fish, and exposure to PFAS-contaminated groundwater.

HISTORY

The Environmental Protection Agency (EPA) is intensifying efforts to address per- and polyfluoroalkyl substance (PFAS) contamination following a series of incidents. In 2019, Easton, Massachusetts, struggled with perfluorooctanoic acid (PFOA) contamination in its drinking water, which was traced back to a mosquitocide. EPA investigations revealed that the PFAS in the mosquitocide originated from fluorinated high-density polyethylene (HDPE) plastic containers manufactured by Inhance. These containers, when fluorinated, release various PFAS, including PFOA, which can migrate into liquid products like pesticides.

The regulatory process gained momentum in March 2022 when EPA issued a Notice of Violation to Inhance, for failing to disclose its PFAS manufacturing activities. With a single company historically producing up to 200 million containers annually, EPA recognized the substantial risk to drinking water supplies. Legal action ensued forcing the company to submit, albeit belatedly, significant new use notices (SNUNs) for the nine PFAS it produces.

The release of just 2.2 Kg of the nine PFAS could contaminate vast quantities of water, surpassing the proposed maximum contaminant level of 4 parts per trillion for PFOA in drinking water. Consequently EPA, under the Toxic Substances Control Act (TSCA), is prohibiting the continued manufacture of three highly toxic PFAS—PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)— which are produced during the fluorination of HDPE. For the remaining six PFAS (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA, and PFODA), EPA mandates Inhance to cease production and conduct additional testing before potential restart, acknowledging the inherent risks to health and the environment.

WAY FORWARD

Starting February 28, 2024, EPA's recent orders emphasize its commitment to addressing PFAS-related risks. The regulatory action not only signals EPA's dedication to mitigating the risks of PFAS exposure but also highlights the Agency's commitment to protecting public health and the environment from the harmful effects of persistent chemical contaminants. Importantly, alternative processes to the current fluorination method offer industries the opportunity to meet product packaging standards without compromising public safety.

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requ...

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The previous deadline of December 29, 2023, has been pushed back to July 1, 2024, providing the cosmetics industry with additional time to comply with these regulatory obligations.

This decision comes in the wake of the FDA's commitment to facilitating a smooth transition for industry stakeholders in complying with the new regulatory landscape mandated by MoCRA. The Agency recognizes the importance of ensuring that cosmetic manufacturers and processors have adequate time to submit facility registration and product listing information.

Background and Timeline:

1. Suspension of Voluntary Cosmetic Registration Program (VCRP): In March 2023, the FDA announced the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the imminent implementation of the facility registration and product listing authorities mandated by MoCRA.
2. Draft Guidance on Cosmetic Product Regulations: By August 2023, the FDA issued draft guidance on cosmetic product facility registration and product listing, aligning with the requirements set forth by MoCRA. This draft, once finalized, will offer crucial recommendations and instructions for individuals submitting cosmetic product facility registrations and product listings to the FDA.
3. Introduction of Electronic Submission Portal: In September 2023, the FDA introduced an opportunity for public comment on its newly developed draft electronic submission portal named "Cosmetics Direct," along with the paper forms (Forms FDA 5066 and 5067). Emphasizing the importance of electronic submissions for efficiency, the Agency anticipates the availability of electronic submission options and supporting documentation in early December 2023.

Details of the Delayed Enforcement:

The FDA's decision to delay enforcement aims to provide regulated industries with the necessary time to comply with MoCRA's new authorities, which include facility registration and product listing requirements. Specifically, the delay extends to July 1, 2024, for both the statutory deadline of December 29, 2023, and specific registration and listing requirements.

This extension also includes a grace period for owners or operators of facilities that commenced manufacturing or processing a cosmetic product after December 29, 2022, and for cosmetic products first marketed after that date.

MoCRA Authorities and Exemptions:

Cosmetic product manufacturers and processors are required to register their facilities, update information promptly, and renew registrations every two years. Responsible persons, such as manufacturers, packers, or distributors, must list each cosmetic product marketed, including ingredients, and provide annual updates.

Exemptions are granted to certain small businesses. However, such exemptions do not apply to facilities that manufacture or process, or to responsible persons for, the following cosmetic products:

• 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 are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

As the FDA extends the MoCRA implementation deadline, industry stakeholders are encouraged to take advantage of the additional time granted to ensure a seamless transition to compliance with the new regulations.

On November 20, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a proposed rule designed to enhance protection against two toxic chemicals—decabromodiphenyl ether (decaBDE) and phenol,...

On November 20, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a proposed rule designed to enhance protection against two toxic chemicals—decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)). These persistent, bioaccumulative, and toxic (PBT) chemicals, previously subject to risk management provisions under the Toxic Substances Control Act (TSCA), are now the focus of enhanced workplace safety measures and water release restrictions.

The proposed rule aims to protect workers, communities, and critical industries such as nuclear energy, transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production.

The 2021 Rule

In response to TSCA, EPA moved quickly to address five PBT chemicals to protect human health and the environment, finalizing risk management rules in January 2021. In February, a review was initiated to ensure adherence to science and law, considering feedback from manufacturers who anticipated compliance challenges. In March, prompted by Biden-Harris Administration directives, EPA sought public input on the PBT rules, leading to proposed amendments for two of the five chemicals. Notably, the regulations for the remaining three PBT chemicals (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD) and pentachlorothiophenol (PCTP)) remain unchanged.

Details of the proposed rule

Under the proposed rule, EPA is targeting two specific PBT chemicals:

DecaBDE: A flame retardant widely used in nuclear power and aerospace applications, decaBDE has been linked to adverse health effects. EPA's 2021 rule prohibited its manufacture, processing, and distribution, with exceptions. The new proposal introduces further measures by requiring personal protective equipment (PPE) for specific decaBDE activities, prohibiting water releases during production, and extending the compliance date for certain applications crucial for nuclear facilities.

PIP (3:1): This versatile chemical found in hydraulic fluids, coatings, electronics, and various industries poses risks to aquatic life and human health. The proposed rule extends compliance dates for certain applications, introduces worker protections, and outlines a phase-out approach for certain uses of PIP (3:1). EPA will host a public webinar to provide an overview of the proposed rule, with a 45-day comment period after publication.

The proposed measures will strengthen protection against these hazardous chemicals while ensuring that essential uses can continue safely.

For more details and to provide public comments, visit www.regulations.gov (Docket: EPA-HQ-OPPT-2023-0376).

Effective November 17, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) has included coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers in the ...

Effective November 17, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) has included coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers in the list of chemicals known to cause cancer in California. This addition is made under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, as outlined in the Health and Safety Code.

The decision to list these chemicals was based on information provided in a public notice published in the California Regulatory Notice Register on September 22, 2023.

Understanding 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 mandates 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.

OEHHA’s Determination

Coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers meet the criteria to be listed as known to cause cancer under Proposition 65.

The International Agency for Research on Cancer (IARC) categorizes coal-tar pitch and fluoro-edenite fibrous amphibole as Group 1 ("carcinogenic to humans") and silicon carbide whiskers as Group 2A ("probably carcinogenic to humans"). IARC found sufficient evidence of carcinogenicity in humans and animals for coal-tar pitch and fluoro-edenite fibrous amphibole, and in animals for silicon carbide whiskers.

For an updated Proposition 65 chemical list, refer to the OEHHA website.

On 20 October 2023, the United States Environmental Protection Agency (EPA) issued a rule that strengthens reporting requirements for per- and polyfluoroalkyl substances (PFAS) to the Toxics Release I...

On 20 October 2023, the United States Environmental Protection Agency (EPA) issued a rule that strengthens reporting requirements for per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI). The rule eliminates an exemption that allowed facilities to withhold information on PFAS when the chemicals were used in low concentrations.  

PFAS are commonly referred to as "forever chemicals" and are found in low concentrations in a variety of products. By removing of the reporting exemption, the rule applies to all industry sectors, including metal mining and chemical manufacturing, as well as federal facilities that manufacture or use any of the 189 PFASs listed in the TRI. This rule ensures that facilities can no longer withhold information regarding the amounts of PFAS that they manage or release into the environment. 

Toxics Release Inventory 

EPA’s TRI Toxics Tracker (TRI) compiles annual data from various industries, including manufacturing, mining, power generation and chemical production. It includes information on the quantities of chemicals released into the environment or managed as waste.  

This data helps communities understand how local facilities handle listed chemicals and supports informed decisions by businesses, governments, non-governmental organizations (NGOs), and the public. EPA's updated online TRI tools, such as the TRI-listed chemicals, allow communities to map reporting facilities, view chemical releases, waste management, and pollution prevention efforts. 

PFAS in the Toxics Release Inventory 

The 2020 National Defense Authorization Act (NDAA) initially added 172 PFAS chemicals to the TRI for reporting in 2021, with a framework for adding more in the future. Facilities were required to report if they used more than 100 pounds of these substances, a lower threshold than most other TRI-listed chemicals.  

However, the previous administration's codification of the NDAA did not address the availability of the de minimis exemption or other reporting burden reduction provisions, which had allowed facilities reporting to TRI to avoid reporting minimal concentrations of PFAS chemicals.  

The new rule nullifies the prior exemption for all chemicals on the TRI list of chemicals of special concern, including lead, mercury, and dioxins that accumulate in the body over time. 

California's Governor signed Assembly Bill No. 496 (AB496) on October 8, 2023, making it illegal to manufacture and sell cosmetics containing 26 specific substances in the state. This regulatory m...

California's Governor signed Assembly Bill No. 496 (AB496) on October 8, 2023, making it illegal to manufacture and sell cosmetics containing 26 specific substances in the state. This regulatory measure expands on California's Toxic-Free Cosmetics Act, passed in 2020 which restricted the use of 24 harmful chemicals in cosmetics, including mercury and formaldehyde.

California's Toxic-Free Cosmetics Act forbids a person or business from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product containing any of several specified intentionally added ingredients, except under certain conditions, beginning January 1, 2025. A list of the prohibited ingredients can be found here and it includes for example:

• Endocrine-disrupting chemicals like Dibutyl phthalate, Diethylhexyl phthalate

• Phenyl diamine salts and parabens

• Polyfluoroalkyl substances like sulphonates, acids, and more

 From January 1, 2027, Assembly Bill No. 496 would broaden this prohibition by including specific prohibited ingredients. A list of the ingredients prohibited under AB496 can be found here and it includes:

• Borates, tetraborates, octaborates, and boric acid salts and esters

• Anthraquinone, and dyes which are found in some hair-coloring products

• Aldehydes and more. 

These chemicals are associated with a higher risk of cancer, genetic flaws, harm to the developing fetus, decreased fertility, severe skin burns, and organ or eye damage. Furthermore, they can cause long-term harm to aquatic organisms. They are no longer allowed in cosmetics and personal care products sold in the European Union but are allowed in personal care products sold in the United States.

A cosmetic product that meets the requirements of Assembly Bill No. 496 may contain trace amounts of an ingredient due to natural or synthetic impurities, resulting from manufacturing processes, storage, or packaging migration, but this does not constitute a violation.