PFAS Reporting Under TSCA: Extended Submission Period and Compliance Implications
EPA’s TSCA PFAS reporting rule is one of the most challenging compliance requirements that chemical manufacturers, importers, and many downstream users have faced in recent years. The government has shifted the start and end dates of the data submission period to May 2025. This change impacts recordkeeping, internal deadlines, software preparedness, and planning for anyone importing PFAS between 2011 and 2022. A summary of the amendment: Who needs to pay attention: High-level information required by the rule: Under Section 8(a)(7) PFAS reporting, companies must provide comprehensive information, including (but not limited to): (The adjustment to the submission period does not alter these core reporting and recordkeeping requirements.) Practical effect of the submission period extension: Suggested immediate tasks: 1.Check ownership and scope Decide which internal team (regulatory, product stewardship, or compliance) will manage the effort. 2.Develop a PFAS inventory (2011–2022) Collect production, customs, and procurement information (HTS codes and article records). Flag all materials containing PFAS. 3.Compile all necessary documents Include waste/disposal logs, production records, purchase orders, supplier declarations, SDSs, formulas, and test results. Maintain metadata and chain of custody. 4.Identify gaps and data sources Build a spreadsheet mapping required reporting elements, data sources, and responsible contacts (starting with key product lines and years). 5.Plan for CBI claims Decide what, if anything, will be claimed as CBI. Prepare legal and technical justifications with supporting evidence. 6.Monitor EPA software and instructions Track updates on the EPA PFAS reporting portal. Subscribe to the EPA TSCA PFAS page and Federal Register announcements. 7.Consider external support If in-house resources are limited, seek help from regulatory lawyers, technical experts, or industry associations familiar with PFAS reporting. Best practices for recordkeeping: Risk and enforcement: Under TSCA, companies may face enforcement actions and fines for failing to report or for submitting inaccurate information. The extended submission window does not change these obligations. Instead of pausing work, companies should use the extra time to improve accuracy and completeness. To stay updated: The TSCA PFAS reporting window now runs from April 13 to October 13, 2026 (with April 13, 2027 for small article importers). While the extension provides more time to collect data and prepare systems, it is not an excuse to delay critical tasks. Companies should immediately decide on their CBI strategy, build inventories, finalize documentation, and stay aligned with EPA updates on reporting tools and guidance. ComplianceXL can help organizations navigate these new timelines by providing expertise in PFAS inventory creation, CBI justification, and TSCA submission management. With the right planning and compliance strategy, companies can avoid risks and ensure timely, accurate reporting. FAQs 1. What are the reporting rules for TSCA PFAS? Between January 1, 2011, and December 31, 2022, companies that manufactured or imported PFAS for commercial use are required to report under TSCA Section 8(a). Required data includes: 2. How has the submission deadline changed?
Understanding PVC Reach Compliance Rules in Europe and the United States
Polyvinyl chloride (PVC) is a widely used thermoplastic polymer with various applications across industries, including construction, automotive, healthcare, and consumer goods. However, its production and disposal pose significant environmental challenges, particularly related to emissions, waste management, and regulatory compliance. The regulatory landscape for PVC is evolving, with ongoing revisions aimed at addressing environmental concerns and promoting circular economy practices. In Europe, the REACH Regulation (EC 1907/2006) restricts hazardous chemicals used in PVC production. The Construction Products Regulation (EU 305/2011) ensures that PVC used in construction meets specific safety and performance criteria. PVC recycling is regulated under directives such as the Packaging and Packaging Waste Directive and the End-of-Life Vehicles (ELV) Directive. In the United States, PVC Reach is primarily regulated by the Environmental Protection Agency (EPA) under several laws. Key among these are the Toxic Substances Control Act (TSCA) and the Consumer Product Safety Act, which regulate substances like vinyl chloride, a major component of PVC. Complying with environmental regulations helps minimise the risk of fines, shutdowns, and reputational damage. It also reduces harmful emissions, such as dioxins and vinyl chloride, limits waste discharge, and helps protect air, soil, and water quality. Moreover, regulations encourage industries to adopt advanced technologies and quality control measures, promoting the use of safer alternatives to PVC. ComplianceXL provides specialized PVC compliance consulting services and monitors regulatory updates on behalf of its clients. We also assist customers in maintaining up-to-date supplier certificates and declarations as part of a comprehensive compliance data management strategy. FAQs: 1. What are the key environmental challenges in PVC production? Major challenges include high emissions of harmful chemicals such as dioxins, chlorine, and vinyl chloride monomer; difficulties in waste management; the use of hazardous additives like phthalates; and high energy consumption during production. 2. How can PVC manufacturers manage emissions effectively? Manufacturers can implement advanced filtration systems, adopt closed-loop production processes, and utilize cleaner technologies—such as replacing toxic plasticizers with environmentally friendly alternatives.
Comprehensive Risk Evaluation for Asbestos
In a bid to protect public health and the environment, the U.S. Environmental Protection Agency (EPA) has undertaken a comprehensive quantitative analysis of the risks associated with asbestos exposure. This evaluation, conducted under the Toxic Substances Control Act (TSCA), aims to shed light on the dangers posed by asbestos, with a particular focus on chrysotile, the most used form of asbestos in the United States. In this blog post, we delve into the key findings of the EPA’s Risk Evaluation for Asbestos: Part 2 and how it impacts both industry and individuals. We’ll also explore how organizations like Compliancexl are assisting in managing asbestos exposure risks. Common Usage of Asbestos in the United States Chrysotile, a type of asbestos, is prevalent in various industries across the United States, especially in manufacturing, processing, and distribution. Its primary application lies within the chlor-alkali industry. However, the EPA’s Risk Evaluation for Asbestos reveals alarming findings: asbestos poses unreasonable risks to workers, occupational non-users, consumers, and bystanders due to the chemicals it contains, impacting both human health and the environment. Understanding the EPA’s Assessment The EPA’s assessment is a two-part endeavour. Part 1 scrutinized 32 different conditions of asbestos use, providing crucial insights into its risks. To ensure safety, users are strongly advised to adhere to safety data sheets and labels when handling asbestos-containing products. In Part 2, the EPA widened its scope to include various asbestos types such as chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite, actinolite, and Libby Amphibole Asbestos, along with its constituents. The goal is to establish regulations and rules under TSCA 6(a) to eliminate these unreasonable risks. The Impact on Health and Safety The risks associated with asbestos are far-reaching, contributing to severe health issues like lung cancer, mesothelioma, and asbestosis. By taking proactive measures to eliminate these unreasonable risks, the EPA aims to safeguard the health and well-being of individuals who may come into contact with asbestos-containing materials. EPA’s Commitment to Public Engagement To ensure a transparent and inclusive process, the EPA has released a white paper on Risk Evaluation for Asbestos: Part 2. Furthermore, a draft will be made available for public comment later this year. The EPA values feedback, comments, and suggestions from the public and relevant stakeholders, which will be considered in the finalization of actions and rules to mitigate the risks associated with asbestos use and disposal. Amid these developments, Compliancexl stands ready to assist organizations in recognizing the health and safety risks associated with asbestos while aiding their efforts to comply with regulatory requirements. Our comprehensive services ensure that organizations understand and adhere to the regulations surrounding asbestos exposure. In conclusion, understanding the risks associated with asbestos is of utmost importance. Through the EPA’s extensive Risk Evaluation for Asbestos, complemented by the expertise of Compliancexl, we can effectively mitigate these risks and prioritize the well-being of individuals and the environment. FAQs : 1. What are the risks associated with ASBESTOS usage and disposal? ASBESTOS pose unreasonable risks. Asbestosis, mesothelioma, and lung cancer are among them. 2. To reduce risks, what steps have been taken? The Environmental Protection Agency will propose rules to reduce the use of chemicals or substitute alternatives for ASBESTOS. Contact one of our global compliance specialists today! Contact Us
EPA adds eight high priority chemicals for further testing under TSCA
The US Environmental Protection Agency (EPA) announced, on 24 March 2022, the results of a second round of tests under section 4 of TSCA (Toxic Substances Control Act). The purpose of this is to collect additional information on eight of the next 20 chemicals undergoing risk evaluation. They include six chlorinated solvents and two flame retardants. According to EPA, additional data on these chemicals is necessary and it is utilizing the authority in its TSCA test order to require companies to submit information regarding avian and aquatic environmental hazards and consumer exposure. This is the third time EPA has used section 4 of the amended TSCA to issue test orders. The EPA issued test orders in January 2021 for the same eight chemicals, which required that aquatic environmental hazards and worker exposures by inhalation and skin be tested. EPA’s risk evaluations of these chemicals will be robust, credible, and use the latest available data thanks to the information obtained from these orders. The process of developing section 4 test orders is complex, time-consuming, and resource-intensive since many scientific and regulatory aspects are involved. There is a document uploaded by EPA describing the development, draft, and issuance of section 4 test orders. EPA may require companies to submit existing data, if available, or to conduct new tests. Organizations are encouraged to form consortia to reduce costs and burden and avoid duplication of testing. The eight chemicals listed below are subject to section 4 test orders: Chlorinated Solvents 1,1,2-Trichloroethane 1,2-Dichloroethane 1,2-Dichloropropane Trans-1,2-Dichloroethylene o-Dichlorobenzene p-Dichlorobenzene Flame Retardants 4,4’-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) Phosphoric acid, triphenyl ester (TPP) In December 2019, TSCA designated eight chemicals as high priorities for risk evaluation. EPA issued final scope documents for these chemicals in September 2020. The next step in the process is to publish draft risk evaluations for public comment.
EPA Announces Path Forward for TSCA Chemical Risk Evaluations
On 30th Jun 2021, US EPA announced an important policy change under TSCA. These changes are surrounding risk evaluation by the previous administration and the path forward for the 10 chemicals to undergo risk evaluation. The changes include revisiting the assumption of PPE, changes in consideration of exposure pathway, and revisiting the assessments for determining unreasonable risk for the whole chemical. EPA plans to reopen the risk evaluation of 1,4-dioxane and further examine methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane. In continuation, EPA will develop a screening-level approach to assess ambient air and surface water fenceline, to identify potential unreasonable risks to fenceline communities associated with air and water exposures. Way forward, EPA will make this information available for public comments and will be reviewed by the Scientific Advisory Committee on Chemicals. Whole Chemical Approach EPA has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos) in continuation to determine risks associated with PPE and include a whole chemical risk determination for these three chemicals. Read more on the EPA website: EPA Announces Path Forward for TSCA Chemical Risk Evaluations
Did you know? TSCA added 5 new PBT Substances
Initially the Toxic Substances Control Act (TSCA) by Environmental Protection Agency (EPA) applied only to the production, importing, and processing of chemicals. This new rule has added restrictions on the TSCA chemicals present in the article. It has created an impact on many manufacturers for the first time. It is time to reconsider your compliance status to address compliance risks because of these new additions. As per Jan 6, 2021, 5 Persistent, Bioaccumulative and Toxic (PBT) substances are restricted under TSCA are: PIP 3:1- Phenol, isopropylated phosphate DecaBDE- Decabromodiphenyl ether HCBD – Hexachlorobutadiene PCTP – Pentachlorothiophenol 2,4,6- TTBP – 2,4,6-tris(tert-butyl) phenol Out of the above 5 chemicals, PIP 3:1 and DecaBDE, are commonly seen in electronic equipment. pbt chemicals TSCA has provided the restriction threshold only for PCTP (1% at product or mixture level) and 2,4,6- TTBP (≤ 0.3% by weight in any container with a volume of less than 35 gallons), for all the other three substances are fully restricted. PIP 3:1 is the chemical that is restricted on mass scale because of its wide range presence in electronic equipment. It’s used in Cables, all type of Controllers, Insulators, Connectors, Computers, Circulators, Fans, Batteries, Display, Liquid crystals, Cylinders, Gas Boxes, Magnets, Motors, and Oscillators. The more restriction is on PIP 3:1, because its not restricted in any of the regulations before. Whereas, DecaBDE is already restricted under RoHS and listed in REACH SVHC. The Deadline to remove PIP 3:1 from the products that are sold or manufactured in US is Sep 4, 2021.The deadline for DecaBDE removal from products , was March 8, 2021 and for the products that are exported to US is Jan 6, 2022. 2,4,6- TTBP should be removed from the products and commercial distribution should be stopped after Jan 6, 2026. It is found in fuel, fuel related additives and cleaners. Manufacturing, processing, and distribution of HCBD/HCBD containing products was prohibited from March 8, 2021. It’s used as a halogenated aliphatic hydrocarbon. Manufacturing, processing PCTP/ PCTP containing products was prohibited from March 8, 2021 and commercial distribution should be stopped after Jan 6, 2022. Mainly industrial uses and no consumer uses. Talk one of global compliance experts to know how the new additions to TSCA restricted PBTs and stay compliant.
Major material compliance regulations affecting the food and beverage industry – What you need to know?
(Material compliance regulations are a critical part of the global food and beverage industry. These regulations are essential to ensure the health and safety of consumers.) Globalization has opened up boundaries for players in the food and beverage industry. To preserve brand identity and maintain end-to-end material compliance regulations, the processors of food and beverages have to adhere to different global standards. Resultantly, it has become important for manufacturers to update themselves about the major regulatory bodies located worldwide. They have to be in complete sync with the safety standards laid down by these bodies that varies across nations. Need for Global Standards and Material Compliance Regulations Manufacturers, processors and other stakeholders of the F&B industry have to increase their ability to understand the governing regulatory standards. They must keep abreast of all regulatory changes to ensure consumer consumption safety and achieve compliance. Depending on the nature of processing, F&B manufacturers should be aware of these (and all other relevant) material compliance regulations to meet consumer safety concerns. CA Prop 65 FDA TSCA FFDCA FCM – food contact materials EU Food Regulations, etc. CA Prop 65 The Proposition 65 program is administered by the Office of Environmental Health Hazard Assessment (OEHHA). OEHHA is a part of the California Environmental Protection Agency (CalEPA). Prop 65 requires businesses to adhere to the legal and scientific requirements while using chemicals. Warning labels and signs are sent out to manufacturers when they intentionally cause significant exposures to the chemicals known to cause harm. Prop 65 requires food and beverage processors, manufacturers and others in the supply chain to let Californians know about exposures to chemicals that cause cancer, birth defects or other reproductive harm. OEHHA’s has a list of chemicals that can be categorized as ‘potential carcinogen’ or carrying ‘reproductive toxicity. The list is available on OEHHA’s website. Given this, manufacturers should have detailed knowledge about the Proposition 65 list, how the regulators can govern warnings, as well as all other aspects of CA Prop 65. FDA A long list of chemicals and materials are pre-approved by the U.S. Food and Drug Administration (FDA) for contact with foodstuffs. FDA registration is a must for units that manufacture, pack, process, pack, or provide storage for dietary supplements, beverages and food; these products may be for the consumption of animals or humans in the United States. A U.S. Agent for FDA compliances and communications has to be designated by companies situated outside the United States. The Food Safety Modernization Act (FSMA) has altered several food safety regulations laid down by FDAs. It is important for companies to attain FDA compliance by investing in Food Safety Plans, Food Defense Plans, HACCP Plans, FDA inspections, FSVPs for importers, etc. As a primary governing body, FDA handles food additive standards. Most materials on this list are used in hygienic gaskets, compression packings and seals. TSCA The Toxic Substances Control Act (TSCA or TOSCA), passed in 1976, is administered by the Environmental Protection Agency (EPA) in the United States. It is responsible for the regulation of new or existing chemicals used in the industry. A self-declaration document, the TSCA certificate is needed to show customs that the chemical substances used by companies, and imported into the United States, are in full compliance with TSCA requirements. TSCA regulations are used to evaluate all potential risks from existing or new chemicals. Full material compliance is necessary on the part of the food and beverages industry to address any unreasonable risks caused by the used chemicals on human health or the environment. FFDCA The United States Federal Food, Drug, and Cosmetic Act of 1938 (APA) was passed in 1938. It established the quality standards for drugs, food, cosmetic and medical devices manufactured and marketed in the United States. FFDCA tightens the controls over drugs and food. It has introduced new consumer protection laws for the food and beverages industry. Any non-adherence on the part of companies is likely to invite prosecution. This Act also takes care of federal enforcement and oversight of the laid down standards. FCM – Food Contact Materials The EU regulations on food contact materials may apply to all FCMs or certain materials only. These EU laws are likely to be enforced along with the national legislation of Member States – in case specific EU regulations do not exist. They check for the harmful effects on health attributed to ingestion of food constituents, especially those that do not adhere to FCM standards. The regulations and amendments related to FCM impact the F&B companies in different countries. They mainly emphasize on important aspects like traceability and the safeguard measures of different EU framework regulations. The compliances for Food contact notification of USFDA are also checked for by the EFSA for FCM standards. The European Food Safety Authority (EFSA) is responsible for FCM safety. For instance, the EU level Union legislation related to food contact materials ensures proper functioning of internal markets and protects consumers’ health. EU Food Regulations The European Union (EU) administers the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). It aims to protect the environment and human health from the risks linked to different hazardous chemicals. The principal aim of ‘General Food Law’ is to safeguard consumer’s interest and human health with respect to food and beverage. Companies in all stages of production or processing of food products have to comply with these regulations. The EU food regulations (food and feed safety laws) applies to F&B companies involved with the distribution of feed and food. Conclusion As a part of the food and beverage industry, you have to ensure the safety and high quality of all products. This is possible through the proper management of material compliance regulations and the prescribed comprehensive tests. Get in touch with trusted experts to maintain compliance with international standards, while keeping your data secure. Talk to a Global Compliance Specialist today!
Did you know? ECHA has identified 300 chemicals as candidates for regulatory action
On 21 April 2021, ECHA published its third report on Integrated Regulatory Strategy. It provides latest information on Agency’s work regarding the identification and management of chemicals that are hazardous. It aims at accelerating data generation, identifying of groups of substances of concern, and regulatory action. Last year, ECHA addressed the chemical with similar structure in groups instead of each chemical individually. This increased the total number of chemicals assessed in 2020 to 1900.As per the report, RMOA (Regulatory management option analysis) it was concluded that 290 substances were identified for further regulatory risk management. These chemicals require more data to be submitted and hazard confirmation before taking any regulatory action. These substances include potential CMRs, few potential EDs, PBTs and respiratory sensitizers. The conclusion will be shared and publicly available on ECHA’s website by end of 2021. Under EU legislation, harmonized classification is a prerequisite for risk management actions. Over 100 chemicals identified would warrant harmonized classification, but still not picked up by the authorities. Lack of harmonized classification can cause a delay in risk management action by the authorities, The progress is made in clarifying the need for regulatory action of substances registered above 1 ton. ECHA recommend that, while the agency continue to work on optimizing group approach for substances: Member states, without delay should initiate regulatory risk management for the substances that require further action. Member states should collaborate with each other to maximize their outcome of work. Industries should make use of the developed programs to help them to review and update the REACH Dossiers. Updates must be done proactively, even before authorities take regulatory actions. ECHA aims to provide clarification by 2027 for which registered substances are a high priority for regulatory risk management or data generation, and which are currently a low priority for further regulatory action. Talk to one of our global compliance specialist today!
Did you know TSCA Section 6(h) has New deadline for PBT Chemicals?
To reduce the exposure of persistent, bio accumulative and toxic (PBT) chemicals, TSCA (Toxic Substances Control Act) issued 5 final rules on Jan 6, 2021. On Feb 5, 2021, final rules were passed and on March 6, 2021, it came into force. It means, if you do not have the data regarding the below 5 chemicals, you are non-compliant with the US market requirements. Since, section 6 substances are prohibited, it can have penalties up to $50,000 USD for each violation and imprisonment. Decabromodiphenyl ether (DecaBDE): flame retardant in plastic enclosures – used in aerospace, textiles, television, wires, cables and automotive vehicles industries. Its toxic to aquatic life, generates immunological effects, liver effects and carcinogenicity. Phenol, isopropylated phosphate (3:1); (PIP (3:1)) – A plasticizer, flame retardant -used in lubricating oils, greases, adhesives, sealants and plastic articles. Its toxic to aquatic life, create reproductive and developmental and neurological effects. 2,4,6-Tris(tert-butyl)phenol; (2,4,6-TTBP) – intermediate/reactant – used in fuel ,oils, lubricant and maintenance and repair of motor vehicles and machines. Its toxic to aquatic life, create developmental effects. Hexachlorobutadiene (HCBD): Halogenated aliphatic hydrocarbon – byproduct during the manufacture of chlorinated hydrocarbons and burnt as waste fuel. Its toxic to aquatic life, possible human carcinogen, creates renal, reproductive, and developmental effects. Pentachlorothiophenol (PCTP): Makes rubber more pliable, used as a plasticizer in industries, affects liver and reproductive organs. All these chemicals are widely used in the industries like- electronic, medical, automotive and defense. So, all these industries should immediately evaluate their products. Do you want to know, how this update affects your business, talk to one of our global compliance specialists today!