Toxic Substances Control Act, 1976                                                                                                            Back

The TSCA had three amendments and has totally 4 Titles

      I   - the Control of Toxic Substances

      II  - the Asbestos Hazard Emergency Response Act

      III – the Indoor Radon Abatement Act

      IV  - the Lead-based Paint Exposure Reduction Act.

      TSCA places on manufacturers the responsibility to provide data on the health and environmental effects of chemical substances and mixtures. TSCA gives EPA comprehensive authority to regulate the manufacture, use, distribution in commerce, and disposal of chemical substances.

These are:

·         authority to require testing of chemicals that pose a significant risk

·         pre-manufacture review

·         authority to limit or prohibit the manufacture, use, distribution of existing chemical substances

·         record-keeping and reporting

·         export notice to inform foreign governments

·         import certification to ensure compliance of imported substances

TSCA is intended to limit chemical substances that pose an "unreasonable" risk for use and not all chemical substances that pose risks. This is done before a chemical is introduced.

Activities subject to TSCA

TSCA applies to persons/companies that are involved in activities that concern TSCA-regulated substances. Some terms are not defined (use, dispose) and others are defined broadly (manufacture, process, distribute).

"Manufacture" includes importing plus the traditional meaning. Manufacturers must submit testing data (to EPA), submit pre-manufacture notification (PMN), avoid PCB manufacture, maintain and submit records, allow inspections and certify compliance for imported substances. All substances produced as a result of the manufacturer's manufacturing activity come under this act. "Process" and "processor" are defined, but are somewhat broad in scope to include many, who were not originally intended to be covered under TSCA. "Use" is not defined, but there are requirements placed on users. "Distribute" and "distribution" have been defined, but not very clearly. Nevertheless, certain requirements are placed. "Dispose" is not defined; there are no direct obligations placed on disposers.

TSCA inventory

EPA is required to compile, keep current and publish a list of chemical substances, used to distinguish between existing and new chemical substances. The initial compilation of TSCA inventory was done in 1977 and required the definition of terms like chemical substance, manufactured for commercial purpose and specifically excluded substances - mixtures, pesticides etc. Corrections could be made in the inventory for previously made errors. New chemicals that have been cleared by the PMN review are added to the list and those on the list not being currently manufactured commercially are de-listed.

In 1986, an Inventory Update rule was issued that required manufacturers to submit manufacture data. The inventory has 5 volumes to categorize chemicals in different ways. Only the Master File version of the inventory has confidential chemicals also listed in it; search on confidential chemicals is done only for "real" intent of manufacture.

New chemical review

Manufacture of chemical substances must be done after clearing TSCA requirements of being in the list or PMN. A PMN must have chemical data, conditions of manufacture and testing data. Specific tests are not listed. EPA has been provided with specific time limits for taking action. Certain substances are covered under other laws and not under TSCA. PMN requirements are exempt for test marketing, R&D, low volumes, certain polymers, Polaroid exemption, new chemicals imported in articles, impurities, by-products, non-isolated intermediates, chemicals formed during manufacture of an article, chemicals incidentally formed by intended additives.

Preparing PMN and seeing through EPA

PMN remains a hurdle for a manufacturer for marketing a new chemical quickly and effectively. A PMN strategy will help to avoid certain problems. Types of PMN are:

·         standard PMN for single chemical substance

·         consolidated PMN for similar substances

·         joint PMN for data submitted by 2 companies jointly, and

·         exemption PMN for low volume, low exposure chemicals

Standard PMN is filed in around 75% of the cases, consolidated PMN is usually for many salts of the same acid, and joint PMN is usually for a substances that has incorporated a proprietary substance from another manufacturer. PMN must be submitted as early as possible to avoid production delays; all relevant information must be gathered and submitted to avoid a return of PMN. A comprehensive risk assessment will also help in avoiding delays and restrictions by EPA. In order to ensure conformity with EPA's procedures, it is advisable to use checklists of requirements.

Regulation of new chemicals and uses

EPA has 90 days to decide on a PMN. EPA may delay manufacture by additional 90 days for a good cause, or may limit or prohibit manufacture, or may ban manufacture. An administrative order for regulating a chemical substance may be issued by EPA if there is insufficient data on risks or an "unreasonable" risk is determined. A consent order, while not provided for by the act, is used by EPA to allow manufacture while exercising regulation.

EPA may evaluate data in 4 ways:

·         Invalid

·         Equivocal

·         Valid and positive

·         Valid and negative (negative due to no reasonable risk)

For adverse evaluation, the company has to defend the data. For fast approvals, a company may follow the fast-track system by agreeing to certain terms. Petitions may be filed for disagreements. Unilateral orders are issued to ban a manufacture of a substance. Specific requirements are placed on manufacturers while a delay/limiting order is in place. For a significant new use, a Significant New Use Rule (SNUR) may be issued that requires filing of a SNU notice (SNUN). In order to standardize procedures without issuing notice-and comment rulemaking, EPA issued the Generic SNUR Rule for standard SNUs

Biotechnology

EPA biotechnology policy is developing amidst substantial controversy. EPA requires compliance with PMN for new microorganisms. PMN submitters usually use EPA guidelines. Similar to chemical substances, a review process is followed for PMNs. New regulations were proposed in 1994 and defined "new microorganism" and required a microbial commercial activity notification MCAN. EPA has proposed to control R&D for microorganisms in a more stringent manner due to their reproducing capability.

Testing under TSCA

Congress created the Interagency Testing Committee (ITC) to prioritize considerations. Relevant factors to be considered by the ITC include quantity, exposure, relation to other chemicals, and available data. Testing may be required for chemical substances having unreasonable risk or the data is unavailable (risk trigger).

EPA uses the term "risk" as a function of hazard and exposure. Testing may be required if the chemical substance is manufactured in substantial quantities, or is expected to be released to the environment in substantial quantities, there is insufficient data (exposure trigger).

EPA has a broad scope in determining the types and amount of testing required. Any study whose purpose is to satisfy a TSCA test rule must meet EPA Good Laboratory Practice (GLP) standards that prescribe minimum requirements for a laboratory. EPA now uses single-phase rule making for tests, instead of the two-phase process used earlier. All manufacturers who come under a testing rule have to communicate with EPA regarding their status (testing/exemption).

Exemption may be granted in case of data equivalency shown by a chemical substance to another chemical that has been already tested. Exempted persons have to reimburse a portion of the costs for the ones for whom testing is required. A test rule may be contested, but only for the validity of the procedure followed in framing a rule, not the test rule itself. EPA must take regulatory action when a chemical poses significant risk to humans.

Reporting and Retention of Information

TSCA establishes reporting and record-keeping requirements to provide EPA with information on which to base regulatory and enforcement actions and to track patterns of adverse reactions to chemicals. This is required of companies for their chemical manufacturing, importing and processing activities. The second model rule in this regard was controversial and was not required since 1980. Allegation on adverse effects of chemicals by employees must be kept on file for 30 years. They must be submitted to the EPA if requested. The scope of effects that can be reported has been narrowed down. Health and safety studies must be conducted for chemicals specifically listed and must be kept on record.

Existing chemical regulation

EPA has full authority to regulate chemicals that pose an unreasonable risk to human health or environment. In order to regulate a chemical, EPA must conduct a risk assessment.

Factors to be considered for a risk assessment are:

·         effects on health and environment

·         the magnitude of exposure to humans and environment

·         the benefits of the subs. and availability of substitutes

·         the reasonably ascertainable economic consequences of the rule.

EPA has issued chemical specific rules for 6 chemicals. EPA issued a ban on manufacture, import, processing, and distribution of asbestos, but the rule was overturned by US Court of Appeals. Manufacture, processing, and distribution of completely halogenated CFCs for propellant uses is prohibited except for essential uses. EPA prohibits use of Chromium (VI) as a corrosion inhibitor in comfort cooling towers (CCTs) as part of air conditioning and refrigeration systems. EPA prohibits mixing nitrosating agents with metalworking fluids that contain specific PMN substances. The manufacture, processing, or distribution of PCBs in commerce for use in US is prohibited unless conducted in a manner that EPA has determined is "totally enclosed".

Relationship with other laws

Substances controlled under FIFRA and FFDCA are excluded from jurisdiction under TSCA. Raw materials and inert components are subject to TSCA until they become a part of a pesticide product. For other laws, a referral is made to the agency having jurisdiction. If EPA adopts a testing rule under TSCA, a state and local regulation for the same chemical (other than disposal) is prohibited.

Inspections and enforcement

An EPA agent may inspect any establishment or conveyance used for manufacture, processing, storing or transporting chemical substances/mixtures. No warrant is required, but may be used after denial. Inspections may be for new chemical activity, PCB violations, reporting and record keeping or combinations of above.

The procedure to be followed for an inspection is

·         pre-inspection preparation

·         notification and entry

·         opening conference

·         sampling and documentation

·         closing conference

·         report preparation and follow-up

EPA has the authority to issue subpoenas in order to gather information. Civil penalties are assessed after considering 9 factors that pertain to the nature, circumstances, extent, and gravity of the violation and also pertain to the violators culpability, compliance history, financial position and other matters as justice requires.

TSCA Civil Penalty Policy requires a 2-step process:

·         Gravity based Penalty

·         Adjustment of GPB based on additional factors

Violations fall under the following categories:

·         Chemical control violations

·         Control Associated Data Gathering Violations and

·         Hazard Assessment Violations

Penalties may be reduced by 80 % as a result of confessing and cooperating. EPA issued a "Self-Policing Policy" in 1995. It seeks to eliminates all GPBs that for violation of fed environmental laws that are voluntarily discovered and promptly reported to EPA. EPA reserves the right to impose fines on the economic benefits gained by non-compliance.

A company must satisfy 9 conditions to qualify for a penalty reduction:

·         systematic discovery (allows for full penalty reduction)

·         voluntary discovery

·         prompt disclosure

·         independent discovery

·         correction and remediation

·         prevent recurrence

·         no repeat violations

·         other violations excluded

·         cooperation

EPA encourages negotiates settlements of civil penalty proceedings. This may result in more diligence - audits, or make provisions for additional compliance. A Settlement with Conditions SWC may require the undertaking of a remedial action.

For serious violations and non-settled negotiations, penalty actions lead to administrative hearings. Willful violation is a misdemeanor punishable by up to 1-year imprisonment and $25,000 per day. For a company's employee violating the law, the company is not shielded from criminal liability. Under TSCA any person may initiate action against another person who is alleged to be in violation. Any person may petition the Administrator to initiate action.

Importation and Exportation

TSCA defines the term "importer" and requires that any chemical substance that is imported be complying with TSCA. For an exclusion of imported substance from certification, a substance must be excluded from the TSCA. PMN must be filed unless a substance is imported as a part of an article. A shipment may be detained by customs if suspected to be non-compliant.

TSCA exempts from most provisions of the Act any chemical substance, mixture or article manufactured, processed, or distributed solely for export from US. Record keeping and reporting requirements remain. For chemical substances regulated under TSCA, EPA requires an export notice for the first shipment to each country. Notification is required for first shipment of the year to each country for other substances. Requirements on chemical substances for export are not as stringent as for commercial use in the US.