Exemption from Test Rules

In addition to the PMN process, chemical manufacturers and importers may be required to perform other testing on health and environmental effects of their products under TSCA. A person who imports or intends to import a chemical substance or mixture subject to a test rule under Section 4 must comply with Section 4 requirements unless the importation qualifies for an exemption included in the regulations at 40 CFR Section 790.42, or under a specific test rule listed under Parts 766 or 799. Following promulgation of a test rule under Section 4 of TSCA, the responsibility to comply with the rule continues for a period of 5 years from the date the data from all required tests have been submitted or an amount of time equal to that which was required to develop the test data, whichever is longer. Importers therefore have a continuing responsibility to determine whether a chemical substance or mixture which they import or intend to import is subject to a test rule. 

Small volume chemicals for research and development and non-isolated chemical intermediates are automatically exempt from notification. The EPA may also grant exemption by rule for substances not presenting unreasonable risk to health or the environment or used only for test marketing. PMN exemption is available for low volume chemicals which are supplied at 1 tonne a, but an exemption notice must be submitted 21 d before manufacture or import begins. Certain polymers are exempt from full PMN, and instead a limited PMN is submitted 21 d before manufacture or import begins. 

The PMN process is in many ways the heart of the entire TSCA regulatory program. PMNs, together with applications for exemptions from the PMN rules (the Test Marketing Exemption, Low Volume Exemption, and low release and exposure exemption (LoREX)) are the main way for the EPA to... 

Sometimes the PMN substance will be in a category of chemicals that is subject to a test rule under 4 of TSCA. ° When that happens, the tests required by the test rule must be submitted with the PMN. ° If EPA grants the submitter an exemption from compliance with the test rule because equivalent data is being developed under another test rule, the PMN cannot be filed until that data has been submitted. Note that this could be at least... 

A person who has received a test marketing exemption for a significant new use is exempted from compHance with the SNUR, unless the SNUR specifically overrides this general rule. ... 

Chemical substances, mixtures, or articles containing substances or mixtures manufactured, processed or distributed in commerce solely for export and labeled for export only are generally exempt from the provisions of TSCA. This exemption does not apply (i) to 8 reporting and recordkeeping requirements, (ii) if the EPA determines that the chemical substance, mixtures or article will present an unreasonable risk of injury to health or the environment in the United States, or (iii) if the EPA determines it requires testing to make the determination in sub provision (ii) above. An export notice will also not be required for chemicals denied entry into the United States that are being returned to the country of origin, unless a TSCA 5, 6, or 7 rule or order applies to the chemical. ... 

Testing can be very expensive, and Congress anticipated industry s concern about fair cost-sharing. The statute therefore required EPA to issue rules for cost-sharing. EPA comphed and issued rules requiring a company that is exempted from testing to reimburse other companies that conduct the testing. 

A manufacturer or processor may apply to the EPA for an exemption from a test rule. A manufacturer or processor subject to a test rule may submit a request for exemption from any or all of the required tests if it can show that the EPA has aheady received and adopted a proposed study plan for the testing, the chemical substance at issue is equivalent to a test substance or mixture for which the required data is being submitted, or the submission of the required test data would be duphcative. An applicant for an exemption must submit a sworn statement agreeing to reimburse entities who actually generated the required data. ... 

Anyone subject to a test rule has an obligation, from the date the test rule becomes effective until the end of the reimbursement period, to either test or to obtain an exemption and pay reimbursement. The reimbursement period is that period that begins with the submission to the EPA of data from the last non-duplicative test to be completed under a test rule and ends after an amount of time equal to that required to develop the data or after five years, whichever is later. 

C.F.R. Part 970, Subpart E—Exemptions from Test Rules. 

Many of the exemptions from PMN requirements are applicable to SNURs, but because SNURs cover processors the SNUR rules are adapted to cover processing when required. A person who has received a test marketing exemption for a significant new use ° or has been granted an exemption under TSCA 5(h) (5)is exempt from SNUR requirements. A person who manufactures, imports, or processes a SNUR substance solely for research and development or as an impurity or as a byproduct that is burned as a fuel, disposed of as waste, or from which other substances are extracted for commercial purposes is exempt from SNUR requirements. An importer or processor who imports or processes the substance as part of an article is exempt from the SNUR requirements, but a manufacturer of an article is not." A person who manufactures, imports, or processes a SNUR substance solely for export is exempt from filing a SNUN so long as the substance is labeled as... 

This Procedure applies to the Test Marketing Exemption (TME)from the PMN and SNUR rules. Use of the PMN form to apply for the TME is optional but encouraged and this Procedure assumes use of the PMN form for that purpose. ... 

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 new chemicals or chemicals subject to a Significant New Use Rule (SNUR), if used solely for research and development (R D) purposes underspecified circumstances. R D substances are often sampled for outside testing to laboratories or to customers. If the product is not on the TSCA Inventory, or is the subject of a SNUR, the R D substance must be sampled in a way that meets the TSCA exemption requirements for research and development samples. TSCA s PMN rules apply to manufacturers and importers SNURs apply to processors as well as manufacturers and importers. 

Any person required by a rule under subsection (a) of this section to conduct tests and submit data on a chemical substance or mixture may apply to the Administrator (in such form and manner as the Administrator shall prescribe) for an exemption from such requirement. 

This final rule exempts renovations that affect only components that a certified renovator, using a test kit recognized by EPA, determines are free of lead-based paint. EPA has deleted the regulatory thresholds for lead-based paint from this definition because they unnecessarily complicate the exception. A certified renovator is a person who has taken an accredited course in work practices. This training will include how to properly use the EPA-approved test kits. This final rule also establishes the process EPA will use to recognize test kits. 

This document describes the procedure required to submit an application to the EPA to exempt a chemical substance from the requirements of the PMN and SNUR rules because the substance will be manufactured or imported for test marketing purposes only. The steps include gathering information to submit the application using the PMN form, and post-approval steps to comply with the exemption requirements. 

B) submission of data by the applicant on such substance or mixture would be duplicative of data which has been submitted to the Administrator in accordance with such rule or which is being developed pursuant to such rule, the Administrator shall exempt, in accordance with paragraph (3) or (4), the applicant from conducting tests and submitting data on such substance or mixture under the rule with respect to which such application was submitted. 

A) if the exemption under paragraph (2) of any person from the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that test data is being developed by one or more persons pursuant to a rule promulgated under subsection (a) of this section, then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator) -... 

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