• Excluded product categories from PMN reporting include tobacco and certain tobacco products, nuclear materials, munitions, foods, food additives, drugs, cosmetics, and substances used solely as pesticides.
• Persons may apply for an exemption from the requirements of TSCA section 5 for test-marketing purposes and research and development purposes.
• EPA has promulgated four rules under TSCA section 5(h)(4) for traditional chemical substance exemptions and three rules for exemptions specific to microbial products of biotechnology.

Some new chemical substances are not subject to premanufacture notice (PMN) reporting. These substances are:

1. Excluded from Toxic Substances Control Act (TSCA) reporting, or
2. Exempt from all or part of PMN reporting because the Environmental Protection Agency (EPA) has determined that they do not warrant review or require only a short review.

Excluded product categories

EPA does not review new substances in the following product categories, which are excluded from TSCA authority at section 3(2)(B):

• Tobacco and certain tobacco products,
• Nuclear materials,
• Munitions,
• Foods, food additives, drugs, cosmetics, and
• Substances used solely as pesticides.

These new substances fall under the jurisdiction of other federal laws and are reviewed by other federal programs. Substances used solely as pesticides are reviewed by a separate EPA Pesticides Program. In addition, the following are excluded from PMN reporting under certain conditions:

• Naturally-occurring materials,
• Products of incidental reactions,
• Products of end-use reactions,
• Mixtures (but not mixture components),
• Impurities,
• By-products,
• Substances manufactured solely for export,
• Nonisolated intermediates, and
• Substances formed during the manufacture of an article.

Limited exemptions

Exemptions reduce reporting requirements, thereby providing relief to submitters from the burdens of the full PMN reporting requirements. EPA has limited or no reporting requirements for new chemical substances in the following cases:

• Test marketing exemption — Under TSCA section 5(h)(1), persons may apply for an exemption from the requirements of TSCA section 5 for test-marketing purposes. EPA may grant the exemption if it finds that the test-marketing activities described by the applicant will not present an unreasonable risk of injury to health or the environment including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the EPA Administrator for the specific conditions of use identified in the application. The applicant must provide the information necessary to make this finding, and EPA must grant or deny the exemption within 45 days. If EPA grants the exemption, it may impose appropriate restrictions on the test-marketing activities.
• Research and development exemption — TSCA section 5(h)(3) exempts from PMN reporting small quantities of chemical substances manufactured only for research and development purposes. Persons using this exemption must have their research overseen by a technically qualified individual and must notify any person involved in the research of any risk. Small quantities of genetically modified microorganisms manufactured solely for research and development purposes are also exempt when additional criteria are met as described in 40 CFR 725.235 (activities conducted inside a structure) and 40 CFR 725.238 and 239 (activities conducted outside a structure).
• TSCA section 5(h)(4) exemptions — TSCA section 5(h)(4) authorizes EPA to exempt any person from the provisions of TSCA section 5 if EPA determines, upon application and by rule, that the chemical substance will not present an unreasonable risk of injury to health or the environment when manufactured, processed, distributed, used, or disposed of under the exemption. To date EPA has promulgated four rules under this section for traditional chemical substance exemptions and three rules for exemptions specific to microbial products of biotechnology:
  • Low volume exemption (LVE) — This exemption applies to substances manufactured in quantities of 10,000 kilograms or less per year. Submitters may request that EPA evaluate their exemption at a lower production volume level, to which the submitter would be legally bound.
  • Low release / Low exposure (LoREX) — This exemption applies to certain chemical substances that meet strict human exposure and environmental release criteria to ensure that these substances will not present an unreasonable risk.
  • Polymer exemption — This exemption applies to polymers that comply with certain chemical characterizations and that therefore will not present an unreasonable risk of injury to health or the environment. Note that TSCA section 5 polymer exemption notices must be submitted electronically, per 40 CFR 723.250.
  • Instant photographic film articles exemption — This exemption applies to chemical substances used in or for the manufacture or processing of instant photographic and peel-apart film articles.
  • TSCA experimental release application (TERA) — This exemption applies to research and development activities that result in intentional environmental releases of intergeneric microorganisms. EPA may grant the exemption if it finds that the activities described by the applicant will not present an unreasonable risk of injury to health or the environment. The applicant must provide the information necessary to make this finding, and EPA must grant or deny the exemption within 60 days. If EPA grants the exemption, it may impose appropriate restrictions on the activities described in the notice.
  • Tier I exemption — This exemption applies to certain microorganisms subject to physical containment and control technologies. EPA has developed specific criteria for the host microorganism, introduced genetic material, and containment technology to ensure that the microorganism will not present an unreasonable risk.
  • Tier II exemption — This exemption applies to the same microorganisms subject to a Tier I exemption without specified physical containment and control technologies. EPA may grant the exemption if it finds that the physical containment and control technologies described by the applicant will control releases of and exposure to the microorganism such that the microorganism will not present an unreasonable risk of injury to health or the environment. The applicant must provide the information necessary to make this finding, and EPA must grant or deny the exemption within 45 days. If EPA grants the exemption, it may impose appropriate restrictions on the activities described in the notice.