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The U.S. Toxic Substances Control Act (TSCA) final rule on the TSCA Inventory Notification (Active-Inactive) Requirements was published in the Federal Register on August 11, 2017, becoming effective as of the same date. This is the third TSCA framework rule under the 2016 TSCA Reform Act, which requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA finalized the rule requiring industry reporting of chemicals manufactured, imported or processed in the U.S. over the past 10 years. This reporting will be used to identify which chemical substances on the TSCA Inventory are “active” in U.S. commerce and will help inform the prioritization of chemicals for risk evaluation.

The rule on the TSCA Inventory Notification Requirements includes the following provisions:

1、A Retrospective Reporting with the EPA for chemical substances on the TSCA Inventory that were manufactured (or imported) during the ten-year time period beginning on June 21, 2006 and ending on June 21, 2016. The reporting period will begin on the date of the publication of the rule and extend for 180 days, ending on February 7, 2018. Manufacturers and importers must submit electronically a new “Notice of Activity” (NOA) Form A. Once the notices are received by the EPA, the chemical substances will be designated as “active” on the TSCA Inventory.

2、Processors will have an additional 240 days until October 5, 2018 to submit retrospective activity notifications for chemical substances on the TSCA Inventory that were manufactured (or imported) during the ten-year time period ending on June 21, 2016. The reporting period will begin on the date of the publication of the rule and last for 420 days. Processors must submit electronically a “Notice of Activity” (NOA) Form A. Upon receipt by the EPA, the chemical substances will be designated as “active” on the TSCA Inventory.

3、Provided the manufacturer, importer or processor fail to submit the above-mentioned notice in accordance with the TSCA Inventory Notification Requirements, the chemical substances will be designated as “inactive” on the TSCA Inventory.

4、 In order to resume the manufacturing, importing or processing of chemical substances designated as “inactive” on the TSCA Inventory, a Notice of Activity (NOA) Form B will have to be submitted electronically. Upon receipt of such notice, the EPA will change the designation of the substances on the Inventory from “inactive” to “active”. Reporting to the EPA must not take place more than 90 days before the anticipated date of manufacturing, importing or processing of the chemical substances.

5、Certain substances are exempted from reporting including: chemicals reported under the 2012 and 2016 Chemical Data Reporting (CDR) rule; substances notified to EPA since June 21, 2016; and chemical substances normally exempt from PMN reporting (naturally occurring substances, polymers, LVEs, R&D, etc.) unless they are already listed on the Inventory.

6、The reporting process will include registration in the EPA electronic reporting system (CDX), submitter and chemical identity information, and a certification statement. If a specific chemical identity information is claimed to be confidential business information by the manufacturer, said manufacturer and the importer/processor may file a joint submission. Substantiation for CBI must accompany the request.

7、The electronic reporting system is currently open; therefore, companies may submit a Notice of Activity Form A.

REACH24H reminds chemical companies that chemical substances must be reported within 180 days after the date on which the final rule is published in the Federal Register. The Notice of Activity Form A is the mandatory retrospective reporting form, while Notice of Activity Form B is a remedial form in case of an overdue submission. Notice of Activity Form B applies exclusively to substances that have not been manufactured, imported or processed during the 10-year period and are designated as inactive yet need to be resumed. Companies that fail to abide by their reporting obligations may be subject to a fine of $38,000 USD per day of non-compliance.

Chemical and trade companies need to ensure a timely response to sort out the chemical substances inventory of their supply chains and ensure a timely submission, thus avoiding losses or discontinued trade resulting from the company’s failure to meet the deadline. As regards companies that are unfamiliar with the U.S. electronic reporting system, those companies involved in mergers & acquisitions in the last ten years, as well as companies that need to keep confidential business information will face strict reporting period requirements. REACH24H has set up a subsidiary office in the U.S with TSCA experts who can assist our clients with their compliance obligations under TSCA regulations.

REACH24H will also continue monitoring key developments to provide our clients with the latest regulatory information on the reformed TSCA framework regulations. If you require any further information on the U.S TSCA regulations, please contact Ms. Liu Xintong at lxt@reach24h.cn (China mainland: +86 0571-87007544).

Published in USA TSCA NEWS

The Toxic Substances Control Act (TSCA), implemented by the Environmental Protection Agency (EPA), is a prominent law in U.S. that aims to prevent unreasonable risks of injury to human health or the environment as well as to limit, prohibit, or ban chemical substances posing imminent hazards. Chemical substances under TSCA are clarified as either “existing substances” or “new substances”, compliance practices of which are different in various ways. For existing substances, manufactures and importers of certain chemicals shall fulfill the obligation Chemical Substance Reporting (CDR) after every four years. As the latest reporting period starting from June 1st, 2016 to September 30th 2016 comes close, REACH24 experts conducted a comprehensive interpretation of the CDR requirements under TSCA to help companies better comply with the regulation and avoid unnecessary trade conflicts.

According to Section VIII of TSCA, companies that manufacture or import certain chemicals that are included on the TSCA Chemical Substance Inventory are required to report production volume and other information for specified years if volumes hit the threshold. For the 2016 CDR, here below are what calls for due attention.

Overview of the 2016 CDR

When to Report?
From June 1st, 2016 to September 30, 2016

Who to Report?
Manufacturers or importers will be required to report if, for any calendar year between 2012 and 2015, a chemical substance was manufactured at or imported into a site in production volumes of 25,000 lbs. or greater. The reporting threshold will be lower at only 2,500 lbs. for certain chemical substances that are subject to TSCA section 5(a)(2), 5(b)(4), or 6 etc.

What to Report?
If reporting is required for a site, submitters must provide production volume information for all four years in this reporting period from 2012 to 2015. In some cases, the processing and use information shall be submitted as well if the thresholds were met.

How to Report?
Submit electronically via Central Data Exchange (CDX)

Suggestions by REACH24H

As manufactures and importers in the United States is the primary subject of CDR reporting, non-U.S. companies do not need to report directly. But for products in trade that contain Confidential Business Information (CBI), a joint submission is still possible. It is worth noting that for non-U.S. companies, if they set up subsidiaries in the U.S., then the subsidiaries may be required to fulfill the CDR obligation directly. In order to prevent the disclosure of significant business information, REACH24 Consulting Group suggests companies that:

  • Identify chemical substances subject to 2016 CDR;
  • Determine if you are required to report;
  • Register in CDX and prepare for online submission;
  • Collect information required to be submitted;
  • Determine if confidentiality claims need to be addressed;

REACH24H Consulting Group has a subsidiary company in the United State with Mr. Robert Kiefer as the general manager and is always readily prepared to assist you in TSCA compliance.

Published in USA TSCA NEWS

Recently, many Chinese manufacturers with the intention of exporting polymers to the United States turned to REACH24H for help, seeking for a better understanding of regulatory obligations and possible ways of polymer exemption under U.S. Toxic Substances Control Act (TSCA). In response to such customer demands, REACH24H provided customers with exclusive compliance reports based on their product information, evaluating if the polymer exemption criteria were well met and pointing out ways to proceed.

TSCA Section Five stipulates that for companies intending to manufacture or import a new chemical substance in the United States for commercial purposes, a PMN (Pre-Manufacturing Notice) must be submitted to the U.S. Environmental Protection Agency (EPA) at least 90 days before manufacturing, importing, processing, or selling this specific new chemical substance. However, EPA found from years of experience in PMN reviews that some polymers, despite being new substances, were most unlikely to present an unreasonable risk of injury to human health or the environment. Therefore, polymer exemption criteria were thereafter established and the burden of deciding if a polymer could be exempted under TSCA was shifted from EPA to companies. In doing so, polymers not listed on the TSCA Inventory can still enter the U.S. market without a PMN submission if all the polymer exemption criteria were well met.

The Polymer Exemption Guidance Manual issued by EPA stipulates that to be eligible for the exemption, a new chemical substance must: meet the polymer definition, not be excluded and meet one of the three exemption criteria. Specifically, the eligible criteria for Polymer Exemption under TSCA include: 1) polymers with a number-average molecular weight (NAVG MW) of 1,000 daltons or greater and less than 10,000 daltons, with restrictions on low MW species and reactive functional groups; 2) polymers with a number-average molecular weight (NAVG MW) of 10,000 daltons or greater, with restrictions on low MW species. Polymers ineligible for exemption include those which degrade, decompose, or depolymerize, and polymers that are prepared from monomers or other reactants that are not on the TSCA Inventory, as are water-absorbing polymers with a number-average MW equal to or greater than 10,000 etc. It is also worth mentioning that the Polymer Exemption cannot be used for a material which contains a non-Inventory monomer or reactant.

Although a polymer meeting the exemption criteria can exempt from a PMN submission, there are still other regulatory obligations that must be fulfilled such as making a certification statement, record keeping and reporting. REACH24H believes that the polymer issue can be both simple and somewhat complicated, depending on whether or not a polymer exemption is possible, hence the need for comprehensive analysis of the specific product under TSCA.


Author

Peyton Zhou

Chemical Regulatory Specialist

REACH24H Consulting Group

Tel: +86-571-87103807


Published in USA TSCA NEWS

The Toxic Substances Control Act, namely TSCA, was enacted by the US Congress in 1976 and came into effect in 1977, implemented by the US Environmental Protection Agency (EPA). The Act intends to prevent unreasonable risks of injury to human health or the environment as well as to limit, prohibit, or ban chemical substances posing imminent hazards. With several amendments, TSCA has become a prominent regulation for effective chemical substance management. Much attention shall be paid to TSCA compliance by manufacturers and importers with regulatory obligations.

Interpretation of TSCA

Chemical substances under TSCA are clarified as either “existing substances” or “new substances”. Any substance that is not on the TSCA Inventory is classified as a new substance. Several categories of substances such as munitions, food, food additives, pesticides, drugs, cosmetics, tobacco, nuclear materials etc. are managed by other US regulations and exempt from TSCA regulation obligations.

The TSCA Inventory is comprised of two databases, namely the confidential part and the public part. There are over 83,000 chemical substances listed in the inventory. Substances included in the inventory are regarded as existing substances while those not included are classified as new substances. Existing and new substances have different regulatory responsibilities.

Responsibilities of New Substances

Manufactures and importers of new substances must complete a Pre-Manufacture Notice (PMN) if none of the exemption conditions were met. Exempted substances are subject to TSCA regulations but can be exempted under certain circumstances such as low volume, low release, low exposure, R&D, polymer, test marketing etc. The process of PMN is shown below:

Responsibilities of Existing Substances

Our Services

  • Substance Search
  • Consulting Service Package and Training
  • Pre-Manufacture Notices (PMN)
  • PMN Exemptions (Test Marketing, Low Volume, Low Release etc.)
  • Significant New Use Notices(SNUN)

About REACH24H

REACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory experts, toxicologists, environmental risk assessors, chemical engineers and IT software development engineers to provide cost-effective access to the marketplace for the clients. REACH24H Consulting Group is also the sub-company of Centre Testing International Corporation (CTI) , a publicly traded company on the Chinese Stock Exchange(300012.SZ). CTI is China’s leading product testing, inspection, certification, and consulting firm, providing comprehensive services for virtually all consumer products. For more information on REACH24H, please Contact us or visit About us.

Published in USA TSCA
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