Premanufacture notification exemption

Fed. Reg. 16316 (Mar. 29, 1995) Premanufacture Notification Exemptions Revisions of Exemptions for Polymers Final Rule 60 FR 16316 Polymer Exempt 3-29-95... 

Fed. Reg. 16477 (Apr. 26, 1985) Premanufacture Notification Exemption Exemption for Chemical Substances Manufactured in Quantities of 1,000 Kg or Less Per Year 50 FR 16477IVE 4-26-85... 

Fed. Reg. 16336 (Mar. 29, 1995) Premanufacture Notification Exemption Revision of Exemption for Chemical Substances Manufactured in Small Quantities Low Release and Exposure Exemption Final Rule 60 FR 16336 LVE LoREX 3-29-95 64 Fed. Reg. 31987 (June 15, 1999) Recordkeeping Requirements for Low Volume Exemption and Low Release and Exposure Exemption Technical Correction 64 FR 31987 LoREX 6-15-99 67 Fed. Reg. 76282 (Dec. 11, 2002) Sustainable Futures—Voluntary Pilot Project Under the TSCA New Chemicals Program Notice 67 FR 76282 Sustainable 12-11-02... 

Fed. Reg. 4295 (Jan. 27,2010) Premanufacture Notification Exemption for Polymers Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers 75 FR 4295 Polymer Exempt 1-27-10 Amended TSCA Section 5 Enforcement Response Policy (Jan. 8,1989) Sect 5 ERP Amend 1 -8-89, as further amended by memorandum from John J. Neylan, III, Director, Policy and Grants Division, Office of Compliance Monitoring, Amendment to the TSCA Section 5 Enforcement Response Policy—Penalty Limit For Untimely Submissions (July 1,1993) Sect 5 ERP Amend 7-1-93... 

Chemical Information Rule Health and Safety Data Reporting Premanufacture Notification (and Exemptions)... 

Chemical substances not included on the TSCA inventory are considered new chemical substances, with some exemptions, and require compliance with premanufacturing notification requirements set forth under Section 5(a)(1)(A) of... 

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 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. 

Impurities are exempt from the premanufacture notification regulations. 

An intermediate that is nonisolated does not need to be on the TSCA Inventory, and is exempt from the premanufacture notification requirements. It is still a chemical substance, and is subject to other TSCA regulations. 

Another source of the partial TSCA exemption for chemicals for export only is the Premanufacture Notification (PMN) regulations. The preamble to the original PMN regulations confirms that EPA did not adopt the proposed requirement that manufacturers of new chemicals solely for export submit notices under section 5(a) of the Act. ... 

The R8tD exemption from the premanufacture notification rule is addressed in Chapter 5. PMN Exclusions and Exemptions, and the exemption from Significant New Use Rules is addressed in Chapter 12, Significant New Use Rules. 

Before a company files an EUP it may research the pesticidal properties of a chemical substance. In those cases, if the R D activities are focused on investigating substances potential for use as pesticides, then the company does not need to comply with TSCA s restrictions on managing of R D chemicals. If the company does other types of research in addition to research on pesticides, then it must show by some affirmative evidence that its only intent with respect to the chemical at issue is to develop it as a pesticide. As a consequence, pesticides can be exempted from the premanufacture notification requirements of TSCA 5 even before an EUP is filed, but the substance will be subject to other TSCA requirements, such as reporting significant adverse effects under TSCA 8(e). 

New chemicals are added to the Inventory through the premanufacture notification (PMN) procedure. The Inventory and the PMN procedures are closely related if a substance must be on the Inventory it must get there through the PMN procedure, and if a substance goes through the PMN procedure the ultimate obj ective is Inventory listing, or an EPA approved exemption. For this reason, the Inventory regulations and the PMN regulations have parallel requirements. 

Importers are not specifically mentioned in the statutory or regulatory statements of the PMN requirement, but in both the statute and the regulations manufacture is defined to include both manufacture and import and so all of the premanufacture notification rules that apply to manufacturers also apply to importers. Importers do not need to ensure that substances in articles are on the Inventory because articles are exempt from the PMN process. However, it is important to review the definition of article to check that all of the substances in the article meet the definition. Importers must file PMNs on all new chemicals that they import in bulk or as part of a mixture. ... 

There are numerous exclusions and exemptions from the premanufacture notification (PMN) process. Chemicals that are excluded from the Toxic Substances Control Act (TSCA) definition of chemical substances are excluded from the PMN requirements, as well as all TSCA programs. Chemicals that are excluded from the definition of chemical substances include mixtures (but not the constituents of a mixture, each of which is a chemical substance ), pesticides, tobacco, firearms, nuclear materials, food, food additives, drugs, cosmetics, and devices under the Federal Food, Drug, and Cosmetic Act. ... 

An example of a substance exempted by the (h)(5) exemption is the chemical reaction product that is formed when paint dries. That same chemical would be subject to PMN regulations if it were intentionally made as a commercial product for distribution as a chemical product or an intermediate, but not when it is formed as a result of the use of paint. If the paint is applied to an article, then the chemicals formed on use of the paint are also exempt from the premanufacture notification requirements under the (h)(6) exemption. 

Salts generally have to be hsted on the Inventory even if the acid form of the same chemical is on the Inventory. In the limited circumstance when a salt that is not on the Inventory is formed upon end use of another substance, mixture or article, or when an additive functions as intended, it may be exempt from premanufacture notification requirements under the (h)(5), (h)... 

Draft PMN Q A, 2-25, question 218-3 (noting that other exemptions such as the ones in 40 C.ER. 720.30(h)(6) and (h)(7) could also exempt a salt that is not on the Inventory from the premanufacture notification requirements). 

Another example of a substance exempt from premanufacture notification under this section is a chemical that may be formed when fibers are made. If the fibers are used in a way that depends wholly or partially on their shape or design, and they do not undergo any chemical changes on end use except those chemical changes that have no commercial purpose apart from the item that they form a part of, then the fibers are articles. If new chemical substances are formed when a fiber that is an article is made from an existing chemical, those new chemical substances are exempt from the premanufacture notification requirements because of the (h)(6) exemption. 

One of the specific products that quahties for this exemption is a flow modifier. If a flow modifier is added to a product, it will typically undergo chemical reactions that will change the characteristics of the product. If the flow modifier is distributed as a separate chemical substance, it must be on the Inventory because it is either manufactured or imported for a commercial purpose. However the substances that form when the flow modifier is put into the product and change the physical properties of the product are exempt from the premanufacture notification requirements. ... 

Several of the exemptions from the PMN requirements do not apply on their face to SNURs because they state they are exemptions from certain of the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic Substances Control Act, and that is a reference to the premanufacture notification program only. The SNUR program is authorized in TSCA 5(a)(1)... 

To demonstrate the concept, consider the seemingly simple requirement of TSCA that only chemicals on the TSCA Inventory, or that are exempt from the requirements of being on the TSCA Inventory, can be manufactured, processed, used in, or imported into, the United States. If a chemical is not otherwise exempt from the TSCA Inventory requirements, and is not on the TSCA Inventory, a premanufacture notification must be filed prior to introducing it into commerce. The task here is to identify those business processes in the company where new chemicals can enter the company, and then decide how best to control those entry points to ensure no new chemicals are... 

Similarly, when a substance is the subject of an EVE or LoREX exemption from the premanufacture notification requirements of TSCA 5, the ERA will allow the exemption to be transferred to the buyer, but if the seller will continue to manufacture the substance it may not want to transfer it. Even if the seller does choose to transfer the exemption to the buyer, it will have... 

Fed. Reg. 54688 (Nov. 3,1981) Premanufacture Notification Receipt of Petition Requesting Commencement of Exemption Rulemaking Proceedings 46 FR 54688 PMN Exemptions 11-3-81... 

Procedures governing assessment of new suppUers, evaluations of raw materials, supplier audits, TSCA premanufacture notification and exemptions, and preparation of specifications, labels, and MSDSs. 

TSCA has a complex set of exemptions from its many requirements, but few of these exemptions apply to 8(e) reporting. For example, R D chemicals are not subject to premanufacture notification requirements, but an adverse effect demonstrated by an R D chemical must be reported under 8(e). Qualifying studies on all of the following types of chemicals must be reported, even though some of them are exempt from other TSCA requirements ... 

G.1 Research and Development (R D) Exemption from the Premanufacture Notification 210... 

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be notified before new substances are supplied in the marketplace. In the UK this Directive is enacted by the Notification of New Substances Regulations 1993 (NONS). Exempt are ... 

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