Do you import or export chemicals or chemical products? If so, you are subject to TSCA, the Toxic Substances Control Act (15 United States Code Section 2610-2695d) and its implementing regulations (40 Code of Federal Regulations Parts 700 -789). The following summary will help you come up to speed on the law and its requirements.
The Toxic Substances Control Act (click here for a copy of the law) provides EPA with authority to require reporting, record-keeping and testing requirements, and import/export restrictions relating to chemical substances and mixtures. Certain substances are generally excluded from TSCA, including foods, drugs, cosmetics and pesticides.
TSCA prohibits importation of chemical substances, mixtures and articles containing chemicals that would violate TSCA or any applicable rule under TSCA if manufactured in the United States. Section 13 of TSCA requires importers to “certify” that their imported chemical substances or mixtures are either: (1) in compliance with TSCA Sections 5, 6, and 7 at the time of import; or (2) not subject to TSCA. Imported chemicals must be listed on the TSCA Inventory or treated as new chemicals for which a Premanufacture Notice (“PMN”) requirement applies before the chemical can be brought into the United States. The U.S. Customs Service can refuse entry of any shipment that does not have a TSCA certification.
The importer of record must provide certification by signing the following statement to be typed, preprinted on the invoice, or otherwise included in the entry documentation for the imported chemicals:
A “blanket” certification must be filed with the port director on the letterhead of the certifying firm, must list the products covered by name and Harmonized Tariff Schedule of the United States subheading number, must identify the foreign supplier by name and address, and must be signed by an authorized person. In deciding whether to approve a blanket certification, the port director will consider the reliability of the importer and Customs broker. An importer for whom blanket certification has been approved must include, on the invoice used in connection with the entry and entry summary procedures for each shipment covered by “blanket” certification, a statement incorporating the certification by reference.
A “negative” certification is necessary when certain materials and/or uses are not subject to TSCA, for example, when the imported material will be used only as a pesticide; the material being imported is source material, special nuclear material or byproduct material; the material being imported will be used only as a firearm, shell or cartridge; or the material being imported will be used only as a food, food additive, drug, cosmetic, or device. Additionally, articles and finished goods are generally exempt from TSCA notification requirements entirely.
We recommend that companies keep a record of the chemical imports and documentation to support their TSCA certifications. A sample form of record-keeping might look like this:
TSCA Section 12(b) requires exporters to notify the U.S. Environmental Protection Agency (“EPA”) before export of any substance for which:
1. test data is required under TSCA Sections 4 or 5(b);
2. an order has been issued under TSCA Section 5;
3. a rule has been proposed or promulgated under TSCA Sections 5 or 6; or
4. an action is pending or relief has been granted under TSCA Sections 5 or 7.
As of January 16, 2007, EPA has established de minimis concentration levels below which notification is not required for the export of a chemical for which export notification under TSCA Section 12(b) would otherwise be required. Specifically, export notification is not required for any chemical substance or mixture if the chemical is being exported at a concentration of less than 1% by weight or volume, unless that chemical is a known or potential human carcinogen or a polychlorinated biphenyl (PCB). The de minimis concentration level for known or potential human carcinogens is 0.1% by weight or volume. Export notification for PCBs will not be required if such PCBs are being exported at a concentration of less than or equal to 50 parts per million by weight or volume.
If the exported chemical is subject to export notification requirements under TSCA Sections 5(f), 6, or 7, the EPA regulations require written notice of the first actual or intended export to a particular country in a specific calendar year. TSCA Sections 4, 5(a) (2), 5(b), and 5(e) require notification only for the first export or intended export to a particular country.
For purposes of determining whether a chemical is subject to TSCA export notification requirements, the EPA recommends that the exporter search a number of databases to determine the regulatory status of the chemical under TSCA, including:
1. EPA’s Inventory/List of Chemical Substances Subject to TSCA Section 12(b) Export Notification Requirements (current as of October 24, 2008);
2. EPA’s Substance Registry System;
3. A search of the Federal Register and the Code of Federal Regulations (“CFR”) for TSCA regulations and/or orders targeting specific chemical abstract system (“CAS”) numbers;
4. EPA’s Sunset date/Status of TSCA Section 4 – Export Notification Requirements (revised on September 1, 2009); and
5. Call the EPA’s TSCA Hotline –
We recommend that companies keep a record of the chemical imports and documentation to support their TSCA certifications. A sample form of record-keeping might look like the table below and include (1) a review of the EPA’s TSCA 12(b) list; (2) searches of EPA’s Substance Registry System for updated summaries of regulatory actions applicable to each chemical substance; (3) a review of the sunset list, and (4) a search of the Federal Register and Code of Federal Regulations (40 C.F.R. Parts 700-1068) for recent regulations/orders affecting export status.
The EPA’s Administrator Lisa Jackson recently announced (September 29, 2009) the need for a major TSCA overhaul to enhance health, safety and the environment. Jackson said in relevant part:
“[a] child born in America today will grow up exposed to more chemicals than a child from any other generation in our history. A 2005 study found 287 different chemicals in the cord blood of 10 newborn babies – chemicals from pesticides, fast food packaging, coal and gasoline emissions, and trash incineration. They were found in children in their most vulnerable stage. Our kids are getting steady infusions of industrial chemicals before we even give them solid food. Now, some chemicals may be risk-free at the levels we are seeing. I repeat: some chemical may be risk-free. But as more and more chemicals are found in our bodies and the environment, the public is understandably anxious and confused. Many are turning to government for assurance that chemicals have been assessed using the best available science, and that unacceptable risks haven’t been ignored.
Right now, we are failing to get this job done. Our oversight of the 21st century chemical industry is based on the 1976 Toxic Substances Control Act. It was an important step forward at the time – part of a number of environmental wins from the 1970s, like the Clean Air Act and the Clean Water Act, not to mention the formation of the EPA. But over the years, not only has TSCA fallen behind the industry it’s supposed to regulate – it’s been proven an inadequate tool for providing the protection against chemical risks that the public rightfully expects.
Manufacturers of existing chemicals aren’t required to develop the data on toxicity and exposure needed to assess potential risks and demonstrate to EPA that chemicals meet risk-based safety standards. EPA has tools to require the industry to conduct testing, but they are cumbersome and time-consuming. As a result, there are troubling gaps in the available data on many widely used chemicals in commerce.”
The move for an overhaul of TSCA drew mixed reactions from industry groups and environmentalists. But there is wide spread agreement that the current system of chemical controls needs modernization.
Among the EPA six core principles:
• Chemicals need to be reviewed against safety standards that are based solely on considerations of risk – not economics or other factors – and we must set these standards at levels that are protective of human health and the environment. • Standards cannot be applied without adequate information, and responsibility for providing that information should rest on industry. Manufacturers must develop and submit the hazard, use, and exposure data demonstrating that new and existing chemicals are safe. If industry doesn’t provide the information, EPA should have the tools to quickly and efficiently require testing, without the delays and procedural obstacles currently in place. • EPA and industry must include special consideration for exposures and effects on groups with higher vulnerabilities – particularly children. Children ingest chemicals at a higher ratio to their body weight than adults, and are more susceptible to long-term damage and developmental problems. Our new principles offer them much stronger protections. • EPA must have clear authority to take action when chemicals fall short of the safety standard. EPA needs flexibility to consider a range of factors – but must also have the ability to move quickly. In all cases, EPA and chemical producers must act on priority chemicals in a timely manner, with firm deadlines to maintain accountability. This will not only assure prompt protection of health and the environment, but provide business with the certainly that it needs for planning and investment. • Encourage innovation in green chemistry, and support research, education, recognition, and other strategies that will lead us down the road to safer and more sustainable chemicals and processes. All of this must happen with the utmost transparency and concern for the public’s right to know. • EPA’s safety assessments must be properly resourced, with industry contributing its fair share of the costs of implementing new requirements.
There are about 83,000 chemicals on the TSCA inventory. Roughly 7,000 chemicals are produced or imported in quantities greater than 25,000 pounds annually. EPA believes that TSCA must be reformed to assure chemical safety in a rapidly changing world, and restoring public confidence that EPA is protecting the American people.
Read EPA Administrator Lisa Jackson’s comments on TSCA reform by clicking here:
TSCA is a detailed and complex law to regulate chemicals. TSCA reform will target changes that will impact health, safety and the environment. If you are part of the regulated community, you will want to closely follow new legislative initiatives and EPA’s regulatory reforms. Some are calling for a harmonized approach, such as the REACH program in Europe. Others seek a new regulatory scheme with increased state-led initiatives. Whatever your colors, chemicals that are manufactured, imported, exported, processed, used, sold, recycled or disposed of in the United States will become more closely regulated, with the cost burden passed on to the regulated community and ultimately, if there is a level playing field, to the end-users and consumers.
Please contact us if you have any TSCA-related questions or are interested in tracking the regulatory reforms.