USA Regulatory News

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

Chemical associations came together and published an open letter on the need for greater involvement and harmonization of regulatory principles. Associations from Argentina, Brazil, Chile, C...

Chemical associations came together and published an open letter on the need for greater involvement and harmonization of regulatory principles. Associations from Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay highlighted the importance of cooperation, considering their common ground in achieving the Sustainable Development Goals 2030, strengthening activities with OECD, and appeasing regulatory differences. 

“Strengthened regulatory cooperation is an opportunity for Latin American countries to promote interaction, public-private engagement, and exchange resources more efficiently, making it possible to raise transparency and public trust in regulatory decisions”, the letter states. 

The guiding principles are based on: 

• Open dialogue, public consultation, transparency, and trust 
• Implementation of hard-law and voluntary initiatives 
• Mutually compatible regulatory models and regional convergence 
• Regulatory assessments and progressive adoptions 

In addition, the associations reaffirmed their commitment to establish and carry on the Latin America Regulatory Cooperation Forum (LARCF) activities. The letter on the Regulatory Cooperation Principle is available in English and Spanish, so is the Commitment Letter (English and Spanish). 

Last Update: 2021-10-29

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,00...

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,000 of the 42,000 chemicals listed there.

In April, EPA listed 390 substances that will be moved to the public section of the inventory. Industries were given a period to raise concerns about the declassification of these chemicals. Of the 390 substances, 13 were found on the public inventory, and some were reported for having invalid accession numbers. This warranted a few changes before US EPA published the 377 substances to lose confidentiality status.

This list includes substances reported by companies as non-confidential in a CDR submission and those flagged during the inventory reset proceed from 2017 to 2018. As released by EPA, it will also be included in the next TSCA inventory update this year.

Last Update: 2021-10-26

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals. Accordi...

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals.

According to the EPA Administrator, Michael Regan, "This comprehensive, national PFAS strategy will deliver protections to people who are hurting, by advancing bold and concrete actions that address the full lifecycle of these chemicals." 

This new roadmap includes the following:

• Imposes new testing and reporting requirements, strengthening the TSCA review of new PFAs

• Tightens restrictions on existing ones.

• Adopts an enforceable drinking water limit for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)

• Applies hazardous substance designations for certain substances.

• For substances not yet on the market, EPA will apply a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter the market.

All these changes are in addition to the earlier revised assumptions about proper usage of personal protective equipment (PPE) and the lack of approval for PFASs submitted through a low volume exemption (LVE). 

Furthermore, to review and tighten restrictions on existing PFAs, EPA plans to issue TSCA section 5(e) orders and impose rigorous safety requirements as a condition of allowing the use of PFAs. You can download a copy of the roadmap here.

Last Update: 2021-10-21