TSCA for Dummies

The Toxic Substance Control Act is the most important chemical control law in the United States. It has given Environmental Protection Administration (EPA) various authorities to take certain regulatory actions against both new and existing chemical substances.

Pre-manufacture Notice (PMN) for New Substances

Section 5 of TSCA requires anyone who plans to manufacture or import a new chemical substance to obtain EPA's approval by submitting a pre-manufacture notice (PMN) at least 90 days prior to the manufacture or import. A new substance is defined as one substance that is not listed in TSCA Inventory of Chemical Substances.

Applicant must submit completed PMN to EPA electronically with available data and wait for EPA's 90 day review. Toxicology data is not mandatory, but must be submitted if available.

The possible outcomes of EPA's PMN review include:

• Drop or approval: no further regulatory actions (about 90% of PMNs belong to this case);
• Withdrawal;
• Request additional data;
• Approval with some type of restrictions (Consent orders);
• Approval with Significant New Use Rules (SNURs) establishing some type of restrictions. The restrictions apply to both the submitter and other manufacturers and importers of the same substance.

PMN Exclusions and Exemptions

The following substances are excluded or fully exempt from PMN reporting:

• naturally-occurring materials;
• products of incidental reactions;
• products of end-use reactions;
• mixtures (but not mixture components);
• impurities or byproducts;
• substances manufactured solely for export;
• non-isolated intermediates;
• substances formed during the manufacture of an article.

There are other types of PMN exemptions while some exemptions require EPA's approval (i.e., LVE, LoREX and TME). The table below summarizes the special types of PMN exemptions.

PMN and Notice of Commencement (NOC)

When a PMN is approved, a 'Notice of Commencement' (NOC) is required to be submitted to EPA within 30 days of first importation or production. Following receipt of this NOC, the subject chemical substance will be added to EPA's TSCA Inventory of existing chemical substances for the purposes of future importation and/or domestic production.

It shall be noted that substances that benefit from PMN exemptions do not require NOC and will not be added onto TSCA inventory. However, TSCA certification is stilled required for importing those chemical substances to the United States.

TSCA Section 5 (e) Consent Orders

Consent Orders are PMN approvals with restrictions. For example, the orders may require the PMN submitter to take certain risk management measures to minimize exposure and risks. A chemical substance must be in compliance with the provisions of the consent order before it can be manufactured or imported. TSCA section 5(e) Consent Orders are only binding on the original PMN submitter.

Significant New Use Rules (SNURs)

Section 5 of TSCA authorizes EPA to designate use of a chemical substance as a 'significant new use', and require the submission of information to EPA prior to the chemical substance being manufactured (including imported) or processed for that use. Unlike consent order which is only binding on the PMN submitter, SNURs apply to all manufactures and importers of the same substance.

Substances that are subject to SNUR requirements are designated as such by an 'S' flag in the TSCA Inventory. If your chemical substance is subject to a SNUR and your intended manufacture, processing, or use of the substance is a significant new use, you would be required to submit a Significant New Use Notice (SNUN) 90 days prior to the manufacture of that substance.

SNUNs are reported using the standard PMN form and are subject to a 90-day review process similar to that for a PMN. When submitting a SNUN, the submitter should include a cover letter that provides the CFR citation of the SNUR and identifies the specific significant new use(s) for which the SNUN is being submitted.

Chemical Data Reporting (CDR)

The Chemical Data Reporting (CDR) Rules, previous known as Inventory Updating Reporting (IUR) Rules, require manufacturers and importers to report if, for any calendar year since 2011, a chemical substance was manufactured (including imported) at a site in production volumes of 25,000 lbs. CDR is conducted every 5 years. The submission period for the next CDR will begin on June 1, 2016.

TSCA Certification for Imported Substances

TSCA section 13 requires that importers 'certify' 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. Customs can refuse entry of any shipment that does not have a TSCA certification. This certificate could be a self-declaration.

Source: TSCA for dummies by ChemSafetyPro.COM