USA Regulatory News

Per- and poly-fluoroalkyl substances, mostly referred to as PFAS, are part of Persistent Organic Pollutants (POPs) present in diverse consumer and industrial products. PFAS has a myriad of application...

Per- and poly-fluoroalkyl substances, mostly referred to as PFAS, are part of Persistent Organic Pollutants (POPs) present in diverse consumer and industrial products. PFAS has a myriad of applications due to its increased resistance and durable characteristics. In fact, durability is the reason such chemicals are also referred to as "forever chemicals".

PFAS are substances with fluorinated atoms, which prevent the substances from being broken down and decomposing in the environment. On the contrary, PFAS bioaccumulates in organisms, and its toxicity increases over time. Consequently, organisms may present several dysfunctions during their lifetime, and ultimately lead to death. Due to the severity and difficulties of a single country controlling POPs pollution alone, the United Nations Environment Programme (UNEP) proposed an international treaty to eliminate or restrict the production and use of POPs – the Stockholm Convention.

Recently, the United States (US) Environmental Protection Agency (EPA) published the PFAS Strategic Roadmap: EPA's Commitments to Action 2021-2024, aiming to improve research, restriction, and remediation of polluted sites. However, the agency’s definition of PFAS substances in the National PFAS Testing Strategy differed drastically from the expected common description.

When US EPA refers to PFAS substances as those "chemicals with at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated", it includes around 7 thousand substances. On the other hand, other comprehensive PFAS definitions, such as those used by the Organisation for Economic Co-operation and Development (OECD), lead to expressive higher numbers.

The difference is that OECD opted to consider PFAS as any substance containing a fully or partly fluorinated carbon chain. This opposing view on PFAS substances may be related to recent reports showing regions along the US highly contaminated with the substance. The most recent example occurred in North Carolina, where the drinking water supplies were contaminated with dozens of fluorochemicals.

Since POPs (and all chemicals under the term) are chemicals with high persistence, durability, mobility, and toxicity, it is fundamental that authorities reach a consensus to safeguard and protect the environment and human health, nationally and internationally.

On March 9, 2022, US EPA published the final rule for regulating Phenol, Isopropylated Phosphate (3:1). The regulation for this substance is promulgated under the Toxic Substances Control Act (TSCA).T...

On March 9, 2022, US EPA published the final rule for regulating Phenol, Isopropylated Phosphate (3:1). The regulation for this substance is promulgated under the Toxic Substances Control Act (TSCA).

The final rule concerns the extension of the substance’s compliance date for commercial processing and distribution. The new compliance date for the substance’s prohibition is October 31, 2024.

The final rule is effective from March 8, 2022, and will be promulgated by March 22, 2022. The full document is available on our website here. 

On 9 March 2022, the Environmental Protection Agency (EPA) announces the decision to extend the compliance date for prohibiting the processing and distribution of Phenol, Isopropylated Phosphate (3:...

On 9 March 2022, the Environmental Protection Agency (EPA) announces the decision to extend the compliance date for prohibiting the processing and distribution of Phenol, Isopropylated Phosphate (3:1) [PIP (3:1)] in the US.

This applies to PIP (3:1)-containing articles and the PIP (3:1) used in making those articles. The new extension date for compliance is October 31, 2024. This means that affected businesses, manufacturers, and importers have from now till October 2024 to stop using PIP (3.1) and also to comply with the recordkeeping requirements for manufacturers, processors, and distributors.

This is the final rule which will be formally effective from March 22, 2022. The rule affects you if you are a manufacturer, importer, processor, distributor, or user of PIP (3:1) or PIP (3:1)-containing articles. 

To ensure that the Environmental Protection Agency (EPA) has the best tools for protecting human health and the environment under Toxic Substances Control Act (TSCA), the agency released a draft TSCA...

To ensure that the Environmental Protection Agency (EPA) has the best tools for protecting human health and the environment under Toxic Substances Control Act (TSCA), the agency released a draft TSCA systematic review protocol on the 20th of December 2021.

This protocol is also aimed at strengthening EPA’s approach to review and select the scientific studies used for informing TSCA chemical risk evaluations. This is also to support the Biden-Harris Administration’s commitment of making evidence-based decisions and developing policies guided by the best available scientific data.

The protocol is produced to meet the criteria of ‘comprehensive, workable, objective, and transparent’ which the previous systematic review process failed to meet. The February 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM) TSCA Committee said it was an incomplete and difficult to follow documentation. The revision of the approach and update of TSCA systematic review process by EPA led to the new draft.

The new draft includes key recommendations and approaches for the current TSCA risk evaluation of 20 high priority chemicals and will undergo a peer review at Scientific Advisory Committee on Chemicals (SACC) meeting on April 19 to 22, 2022. The draft also enables the use of recent and future IRIS systematic reviews. Furthermore, it includes new methods aimed at reducing bias and improving evaluation consistency for all chemicals.

Further details specific to how the protocol has been used for each of these chemical risk evaluations are available on EPA’s website. From now till February 18, 2022, the agency is accepting comments on the draft protocol for 60 days.

Last Update: 2022-01-04

In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of products that would fall within the packin...

In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of products that would fall within the packing management. Chile is truly embracing the Extended Producer Responsibility (EPR) to shape national policy. The EPR was officially incorporated into the national administration in 2016 by Law 20.920. 

In March 2021, the Ministry of the Environment (MMA) published Decree 12, responsible for establishing the objectives and obligations associated with containers and packaging under EPR. It also determines that manufacturers must meet progressive collection and recovery targets. The categories are divided into households and non-households and present the yearly progressive ambition as follows: 

• Household packing                                                                                          

• Non-household packing 

Manufacturers placing more than 300 kg of packing material into the market are subject to additional obligations other than fulfilling the indicated goals, which stands out: 

• Enroll in the Register of Emission and Transfer of Contaminants (RETC), and submit data through the platform 
• Present the Management Plan and Manufacturers that integrate such system 
• Submit an Annual Report no later than May 31st of each year.

The Annual Report contents are regulated by Resolution 1.090 enacted in September 2021. 

Accordingly, MMA proposed on September 2021, a resolution guideline to assist the public in identifying and categorizing the packing material addressed by the new packaging policy. Resolution Proposal 1.026 presents criteria for determining products that constitute packing, including the side or auxiliary elements. . Resolution Proposal 1.026 is open for public comments until October 21, 2021. 

Producers and manufacturers have 30 months to comply and avoid future fines and penalties. Those interested in knowing more about the EPR law or complying with the requirements discussed above can contact us @compliance@gpcregulatory.com.

Last Update: 2021-11-30

Chile drafts a new regulation to further promote safe products among the ones used by children. These products will have to comply with the provisions established by the regulation and prese...

Chile drafts a new regulation to further promote safe products among the ones used by children. These products will have to comply with the provisions established by the regulation and present the certificate attesting conformity in order to be marketable.

The Regulation on Safety of Products for Children's Use is headed by the Ministry of Health and requires children’s products to consider flammability, physical, mechanical, chemical, and electromagnetic risks. 

In addition, the resolution proposes new maximum permitted amounts for phthalates and set new migration limits for the following solvents and monomers. They are as follows: 

* If possible that children put it in their mouths. 

The adhesives and glues for school, used in teaching activities in pre-basic, basic and secondary schools, may not contain in their composition pure organic solvents or mixtures in concentrations exceeding the following limits: 

The new rules are aimed at enhancing safety and good risk management of products used by children in Chile, as proposed by the Ministry of Health.

Last Update: 2021-11-30

On November 17, the Mexican Senate unanimously approved the general terms for the new Circular Economy Law (Ley General de Economía Circular – LGEC ). The new legislation p...

On November 17, the Mexican Senate unanimously approved the general terms for the new Circular Economy Law (Ley General de Economía Circular – LGEC ). The new legislation promotes improved waste management rules and advocates for recycling techniques and protection arrangements for collectors.  

Summarily, the main points of the new regulation are:  

•  It refers to all types of waste and promotes efficient use of resources, relying primarily on product redesigning to lower waste generation - “zero waste policy”  
•  It establishes a guideline for the municipality, state, and federation to achieve a circular economy plan.  
•  It imposes on manufacturers, processors, producers, and distributors of electro and electronic appliances to elaborate a waste management plan.

 In addition, the importance and contribution from informal collectors are duly recognized and a program to promote human rights for the category is being planned.  

The Circular Economy bill is currently under the Chamber of Deputies' consideration. 

Last Update: 2021-11-30