Exemption from TSCA

The U.S. Congress enacted the Toxic Substances Control Act (TSCA) (TSCA, Public Law [Pub. L.] 94 69) in 1976, to become effective 1 January 1977. The act authorizes US-EPA to secure information on all new and existing chemical substances and to control any of these substances that could cause an unreasonable risk to public health or the environment. Dmgs, cosmetics, foods, food additives, pesticides, and nuclear materials are exempt from TSCA (US-EPA 2006a). 

While pesticides are exempted from TSCA, fertilizers and other substances used in the growing of crops are not exempt. Thus, any chemical to be used for such purposes must be listed on the TSCA Inventory. 

The law mandates a 90-day prior notice, known as pre-manufacture notice (PMN), to be submitted to the US EPA before production or import of a new chemical substance for a non-exempt commercial purpose. Any chemical which is not listed on the Inventory of existing chemicals is considered new for the purpose of PMN. Eight product categories are exempt from TSCA s regulatory authorities. These are, pesticides, tobacco, nuclear material. 

The TSCA guidance on pesticides appears to be straightforward. To be exempt from TSCA a substance must be manufactured, processed, or distributed in commerce as a pesticide. The EPA stated that substances that... 

If an intermediate is a registered manufacturing use pesticide under FIFRA, it is considered to be a pesticide and is exempt from TSCA. ... 

Therefore, these radioactive materials are exempt from TSCA. 

The referenced provision of the Internal Revenue Code imposes a tax on pistols, revolvers, firearms, shells, and cartridges.Therefore, these articles are exempt from TSCA. 

While the statute itself does not use the word firearm, the regulations do specifically exempt any pistol, firearm, revolver, shells and cartridges from the definition of chemical substance. Presumably, because only the listed articles are exempted from TSCA, the gunpowder used to fill the shells is subject to all of the TSCA regulations. 

The EPA follows the general principle that a substance is exempt from TSCA when the Food and Drug Administration (FDA) first regulates it. ... 

Articles are not listed on the TSCA Inventory, and no PMN is required for an article.Articles are not exempted from TSCA programs other than the PMN, Inventory and part of the SNUR programs. An article is defined as ... 

In addition, a person who uses a substance is exempt from TSCA 8(c) recordkeeping if the allegation concerns ... 

It is a common misconception that chemical substances or mixtures exempt from TSCA 5 requirements are wholly outside the purview of TSCA on a statutory basis. This is not so and this misconception presents a dangerous risk of non-compliance. 

In some instances, employees may obtain substantial risk information before the substance is subject to TSCA. For example, the substance maybe a pesticide that is exempt from TSCA, or the substance may not be present in the United States. If the substance becomes subject to TSCA because it is used for a non-pesticidal purpose, or because it is imported into the United States, such information becomes reportable. Therefore, all such information shall be provided to a person in one of the designated functions or the TSCA Coordinator within one business day whether or not the person who obtained that information believes that the substance is subject to TSCA. Upon doing so, the employee fully discharges his or her reporting obligation under 8(e) under ERA policy. 

As discussed in the PMN Exclusions and Exemptions Chapter, 5(h)3 of the Toxic Substances Control Act (TSCA) exempts from TSCA 5(a) and (b) (the PMN and Significant New Use rules, respectively) small quantities of chemicals if used solely for research and development (R D) purposes under specified circumstances. TSCA s PMN rules apply to manufacturers and importers the Significant New Use Rules apply to processors as well as manufacturers and importers. 

Includes both chemicals on the initial Inventory and those subsequently added. Does not include substances formally exempted from TSCA notification. 

Polyethylene (CAS 9002-88-4) is listed on the TSCA Inventory [38] as an existing chemical with no SNUR (although polymers are generally exempt from TSCA in the United States under regulations at 40 CFR 723.250). Thus TSCA places no restrictions on the use of polyethylene. 

Likewise, the Sixth Amendment differs substantially from TSCA in its exemption for "substances placed on the market in quantities of less than one tonne per year per manufacturer." Art. 

Section 12 covers export regulations. There is an exemption from most provisions of TSCA for chemicals that are exported, provided that it can be shown that there is no unreasonable risk of injury to health or the environment of the United States. 

Certain allegations of human health and environmental adverse effects are exempt from the requirements of the TSCA Section 8(c) rule including those that (1) are made anonymously (2) identify known human effects and (3) those that are directly attributable to an incident of environmental contamination that has already been reported to the US Government under any applicable authority. 

Currently, the United States neither imports nor exports PCBs. Section 6(e)(3)(A) of TSCA (Pub. L. 94-969, 90 stat. 2003,15 USC 2601 et. seq.) prohibited all manufacture and importation of PCBs after January 1, 1979. On January 2, 1979, however, EPA announced that companies that had filed petitions for exemptions from the PCB manufactuiing/importation ban could continue manufacturing or import activity until EPA acted on the application petition. As of July 7,1997, the U.S. Court of Appeals for the Ninth Circuit overturned the Import for Disposal Rule. EPA can now only allow imports of PCBs by issuing exemptions to importers via the petition process under Section 6(e) of TSCA. See the... 

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

The TSCA specifically exempts from the definition of chemical substance ... 

Some substances that appear to meet the definition of an exempt substance are nevertheless subject to TSCA requirements. Dual-use chemical substances can be subject to the TSCA and another statute. For example, a chemical is subject to FIFRA if used as a pesticide, but subject to TSCA if used as a general solvent. Fikewise, even though mixtures as defined under the TSCA are exempt from the definition of a chemical substance, they are still subject to certain TSCA requirements [9]. In addition, each component of a mixture is considered a chemical substance within the TSCA. 

In addition to substances specifically excluded from the TSCA, the EPA has exempted other types of substances from certain TSCA requirements. For example, certain chemical substances—including certain impurities and byproducts—are excluded from TSCA Section 5 requirements because although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part [10]. 

Another category that the EPA exempts from various TSCA requirements is articles. An article is defined as ... 

Articles are exempt from various provisions of the TSCA, including (1) a person who imports or processes a chemical substance subject to specific information-gathering rules under 40 CFR Part 704 is exempt from reporting and recordkeeping rules to the extent that the chemical substance is imported or processed solely as part of an article [12] (2) notices of export are not required for articles, except for polychlorinated biphenyl (PCB) articles and other articles that EPA specifically makes subject to export notice requirements [13] ... 

The TSCA Inventory, established under Section 8(b) ofthe Act, comprises substances considered to exist in US commerce. A substance not already included on the Inventory is considered to be a new chemical substance pursuant to TSCA Section 3(9). Under TSCA Section 5(a), a person must submit a Premanufacture Notification (PMN) to the EPA at least 90 days before commencing manufacture or import, for a commercial purpose, of a chemical substance not on the Inventory, unless the substance is exempt from reporting. After PMN review and upon receipt of a Notice of Commencement of Manufacture or Import (NOC), the EPA adds the chemical substance to the Inventory, which then becomes an existing chemical substance. Certain nanoscale substances that will be manufactured or imported for commercial purposes are expected to be new chemical substances and therefore subject to the TSCA new chemical reporting requirements, as are any other new chemical substances. 

In the notice, the EPA stated that it generally considers CNT to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory. [12] Many CNT may therefore be new chemicals under TSCA Section 5. Manufacturers or importers of CNT not on the TSCA Inventory must submit a PMN (or applicable exemption) under TSCA Section 5 where required under 40 CER Part 720 or Part 723. To determine the TSCA Inventory status of a CNT, a manufacturer may submit to the EPA a bona fide intent to manufacture or import under 40 CER Section 720.25. 

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