Toxic substances

Toxicity

Toxicity of chemical substances manufactured, processed, and distributed is important. Toxicity is a chemical’s ability to cause injury to an organism after exposure. Though all things can be toxic, the level of exposure determines a chemical substance’s toxicity. Toxicity testing is biological testing (usually with an invertebrate, fish, or small mammal) to determine the adverse effects of a compound or effluent. Toxicity testing is designed to determine the associated health effects and the levels and durations of exposure causing those health effects.

Toxic substances for preliminary assessment reporting

Manufacturers and processors or importers of chemical substances, mixtures, and categories listed in 40 CFR 712.30 must submit the “Manufacturer’s Report - Preliminary Assessment Information” UNLESS they are persons who:

• Manufacture or import the chemical substance during the reporting period, solely for purposes of scientific experimentation, analysis, research, or product development research or analysis,
• During the reporting period, manufactured or imported fewer than 500 kilograms of the chemical substance at a single plant site, or
• Qualify as small manufacturers or importers 40 CFR 712.25 of a specific chemical substance unless that chemical is designated by an asterisk.

The preliminary list candidates are selected because they:

• May pose adverse effects to the environment and human health, and
• Require more evaluation because of probable significant exposure to the environment and humans.

The substances listed in the preliminary assessment are candidates for the priority list.

Toxic substances for priority reporting

Manufacturers, importers, and processors of chemical substances, mixtures, and categories listed in 40 CFR 716.120 must submit studies of those substances, mixtures, and categories to EPA. Studies may be any of the following:

• Ongoing,
• Initiated,
• Known but without possession of copies, or
• Previously sent to federal agencies without confidentiality claims.

Toxic substance records

Manufacturers, processors, and distributors of chemical substances and mixtures must:

• Keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture; and
• Permit inspection and submit copies of such records, upon request of any designated representative of the Administrator.

Premanufacture notice

Because new chemical substances are manufactured or imported each year in the U.S. for commercial purposes, it is important that they be assessed for health and environmental hazards before being placed into commerce. Manufacturers and importers must complete the Premanufacture Notice (EPA Form 7710-25) using e-PMN software and submit it electronically to EPA via the Central Data Exchange (CDX) at least 90 days before the manufacture or import of a new chemical substance for non-exempt commercial purposes, unless excluded or exempted.

After EPA risk assessors consider all of the submitted information during the EPA new chemicals review process, EPA makes a final determination whether or not to allow the chemical to enter into commerce and whether to set restrictions or not for entering the chemical into commerce. This process ensures that new chemicals that enter into commerce do not present an unreasonable risk to human health or the environment.

Once the manufacture (or import) of a new chemical substance commences, the manufacturer or importer must complete a Notice of Commencement of Manufacture or Import Form (EPA Form 7710-56) using e-PMN software and submit it electronically to EPA via CDX.

Significant new use notice

Persons must submit a Significant New Use Notice (SNUN) to EPA if they intend to manufacture, import, or process chemicals:

• Which already exist, AND
• Whose use is designated by EPA as a significant new use (based on potential exposure to humans and the environment).

Therefore, if EPA promulgates a significant new use rule (SNUR) under 40 CFR 721, TSCA requires persons to submit a SNUN to EPA at least 90 days before they manufacture (including import) or process the substance for that use. SNUNs are reported using the standard e-PMN form (EPA Form 7710-25) and submitted to EPA via CDX. When submitting a SNUN, the submitter should include a cover letter that provides the Code of Federal Regulations citation of the SNUR and identifies the specific significant new use(s) for which the SNUN is being submitted.

Receipt of a SNUN triggers EPA review of the risks associated with the SNUN and a determination of whether such risks warrant control.