TSCA Premanufacture Notices - Is A PNM Filing Necessary for My Compound?

TSCA Premanufacture Notices - Is A PNM Filing Necessary for My Compound?

The New Chemicals Program has prepared a graphic that details steps for determining whether a submission is required on a chemical substance.

EPA classifies chemical substances as either "existing" chemicals or "new" chemicals. To determine if a substance is a "new" chemical, consult EPA's Toxic Substances Control Act Chemical Substance Inventory -- commonly referred to as the Inventory , which lists "existing" substances. At the more extensive discussion of the Inventory, links are provided to several papers on Inventory nomenclature guidance. Any substance that is not on the TSCA Inventory is classified as a new chemical. Prior to manufacture or import of a new chemical for general commercial use, a notice must be filed with EPA under Section 5 of TSCA.

Note to Importers: Many chemical substances that are manufactured in other countries are not on the TSCA Inventory. If you intend to import any of these chemical substances into the United States, you must follow all U.S. Laws and regulations pertaining to new chemicals. Requirements are discussed in the importers' - exporters' package. This package can be obtained from the TSCA Hotline .

Are any new substances exempt or excluded from PMN reporting?

Some new chemical substances are not subject to PMN reporting. These substances are either (1) excluded from TSCA reporting or (2) exempt from all or part of PMN reporting because EPA has determined that they do not warrant review or require only a short review.

EPA does not review new substances in the following product categories, which are excluded from TSCA authority at Section 3(2)(B) of the Toxic Substances Control Act: 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 reveiwed 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, byproducts, substances manufactured solely for export, nonisolated intermediates, and substances formed during the manufacture of an article. See 40 CFR Section Section 710.4(b) and 720.30(a)-(h) for more information about exclusions from PMN reporting.

EPA has limited or no reporting requirements for new chemical substances in the following cases:

• Low Volume Exemption, (LVE) -- 10,000 kilograms or less of the substance will be manufactured or imported each year under the requirements at (40 CFR Section 723.50) ; these requirements were substantially rewritten on March 29, 1995 .

• Research and development -- the substance is manufactured in small quantities for research and development, and special procedural and recordkeeping requirements are met 40 CFR Section Section 720.36 and .78 ;

• Low releases and low exposures (LoREX) -- the substance is expected to have low release and exposure under the requirements at 40 CFR Section 723.50 ; published March 29, 1995 .

• test marketing, TME -- the substance is being manufactured or imported for TME, under the requirements at 40 CFR Section 720.38 ; or

• polymer -- the substance is a that meets certain specified criteria where the substance is not considered chemically active or bioavailable under the requirements at 40 CFR Section 723.250 .

Are any new substances exempt from PMN reporting?

Some new chemical substances are not subject to PMN reporting. These substances are either (1) excluded from TSCA reporting or (2) exempt from all or part of PMN reporting because EPA has determined that they do not warrant review or require only a short review.

EPA does not review new substances in the following product categories, which are excluded from TSCA authority at CFR#3(2)(B) of the Toxic Substances Control Act:

• 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 reveiwed 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, byproducts, substances manufactured solely for export, nonisolated intermediates, and substances formed during the manufacture of an article. See 40 CFR CFR#CFR#710.4(b) and 720.30(a)-(h) for more information about exclusions from PMN reporting.

EPA has limited or no reporting requirements for new chemical substances in the following cases:

• 10,000 kilograms or less of the substance will be manufactured or imported each year (Low Volume Exemption, LVE) under the requirements at (40 CFR CFR#723.50) ; these requirements were substantially rewritten on March 29, 1995 .
• the substance is manufactured in small quantities for research and development , and special procedural and recordkeeping requirements are met Find the current 40 720 and 720 CFR regulations here! ;
  
• the substance is expected to have low releases and low exposures, LoREX under the requirements at 40 CFR CFR#723.50 ; published March 29, 1995 .
  
• the substance is being manufactured or imported for test marketing, TME , under the requirements at 40 CFR CFR#720.38; or
  
• the substance is a polymer that meets certain specified criteria where the substance is not considered chemically active or bioavailable under the requirements at 40 CFR CFR#723.250 .