Production under PMNs

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. 

However, for the purposes of this discussion, one can observe that of the more than 1,000 PMNs submitted, over 90% are from large companies. Furthermore, estimated first year production volumes have steadily moved away from low volume chemicals. Arthur D. Little, Inc. estimated that prior to the PMN requirement about 70 percent of commercial new chemicals were produced in quantities under 1,000 pounds per year and all R D chemicals were below this level (6). When the PMN requirements went into effect, however, that proportion fell to 33 percent almost immediately and has since declined to only 11 percent, based on a look at the first 723 PMNs. This can also be compared with the 30 percent of commercial chemicals on the TSCA inventory with an annual production volume of less than... 

The Chemical Manufacturers Association (CMA) had reached similar conclusions about a year ago and filed a petition with EPA suggesting that there was a strong case to be made for exemptive relief under Section 5 (h)(4) of TSCA for many polymers, site-limited intermediates, and chemicals produced in volumes of less than 25,000 pounds per year. (An examination of the effect of PMN costs at various prices and levels of production reveals that the PMN cost, as a percentage of total cost per pound of product, generally rises most rapidly as output falls below 25,000 pounds. See the Appendix for a more detailed discussion.) It is CMA s firm belief that exemption could be granted in terms that would operate to assure "no unreasonable risk" to the public in terms of either health or the environment. 

The effect is much the same at costs of 1 and 2 per pound. The cost increase becomes increasingly dramatic as the production level decreases. As Figure A shows, however, the PMN-cost impact begins to weigh most heavily on each pound of a substance at a level between 20,000 pounds per year and 60,000 pounds per year, depending on the cost of the product. At 25 cents per pound, costs begin to rise rapidly under 60,000 pounds of output, while at 2 per pound the most rapid cost increases occur under 20,000 pounds of production. 

Many commercial chemicals sell for under 1 per pound. At 1 per pound costs begin to escalate most rapidly under 25,000 pounds of output. An exemption, then, should not be set at less than 25,000 pounds per year to minimize the cost of PMN forms on innovative chemical products. 

Under TSCA, the first company that intends to manufacture a new substance in the U.S. must submit a PMN for that substance. However, once EPA completes its 90-day review of the PMN, and after that company begins to manufacture the substance for non-R D purposes, the substance becomes an "existing" chemical in this country. This means that, in the future, neither the PMN submitter nor any other company will be required to submit any further PMN s for that substance, irrespective of any significant changes in production volume or use, and whether any new toxicity data are developed at a later date. (2.)... 

The Sixth Amendment s premarket notification requirements differ markedly from TSCA in three important respects. First, new substances in the EEC always will be considered "new" under the Sixth Amendment, because the notification requirements are person-specific — i.e. when one company submits a PMN for a particular substance, this does not relieve any other company from the requirement to submit its own PMN before that second company may place the same substance on the EEC market.(J3) Second, the Directive includes a scheme for regular follow-up reporting on the commercial development of new substances, with progressively more extensive (and expensive) testing requirements. Finally, the Sixth Amendment creates a one-time notification for each company (for each new substance), throughout the EEC. Thus, once a Member State has completed its review of a company s PMN (without taking any action to require further testing or to impose limitations upon production or use), that company is not required to provide a PMN to any other EEC country in which it subsequently markets the substance.(9)... 

To date, EPA has done three things to encourage and, in some limited cases, require companies to test their new substances.(19) First, from time to time EPA has issued reports, published speeches, prepared Congressional testimony, and otherwise publicized its view that many PMN s lack necessary data to adequately assess the subject chemicals health and environmental effects. Second, on a PMN-by-PMN basis EPA has negotiated with individual companies to provide additional data and analyses. And third, EPA has initiated actions under 5(e) to require additional testing for a very small number of new substances (and to limit or totally prohibit production and use of these chemicals).(20)... 

Under Article 7(1), if the country that receives a notification concludes that further data and information are needed for performing health and environmental assessments of the new substance, it may require the notice submitter to provide those data. This may involve completion of the Annex VII base set (for PMN s that invoke the "escape clause"), and/or performance of further tests specified in Annex VIII, in addition to those contained in Annex VII.(24) Annex VIII specifies a series of sub-chronic and chronic tests, as well as other extensive (and expensive) data requirements that may be required as a part of followup notifications once a chemical enters commercial production and its production volume increases substantially. 

Article 6(1) of the Sixth Amendment requires PMN s to contain information and data necessary for evaluating the potential risks of new substances to humans and the environment. This specifically includes certain exposure information listed in Annex VII, concerning proposed uses and estimated yearly production volumes (in ranges, and broken down by use categories). Further, Article 6(1) requires submission of "a declaration concerning the unfavourable effects of the substance in terms of the various uses envisaged," which appears to require statements of the risks that may be associated with the use categories provided under Annex VII.(26)... 

Followup Reporting Under TSCA. Since 1978, EPA repeatedly has stated its intention to require followup reporting for certain PMN substances once they complete the 90-day notice review period and enter commercial production. The Agency has offered several reasons for implementing a followup program. 

Under 5(e), following receipt and review of a PMN EPA may order a company to develop test data "sufficient to evaluate the health and environmental effects" of the new substance. However, if the PMN submitter objects to the order (and provides sufficient grounds for that objection), the order does not take effect and EPA must obtain an injunction from a U.S. district court to impose the data requirements (and any appropriate production or use restrictions). 

At the heart of the TSCA is a premanufacture notification (PMN) requirement under which a manufacturer must notify the EPA at least 90 days prior to the production of a new chemical. In this context, a new chemical is a chemical that is not listed in the TSCA-based Inventory of Chemical Substances or is an unlisted reaction product of two or more chemicals. Eor chemicals already on this list, a notification is required if there is a new use that could significantly increase human or enviromnental exposure. No notification is required for... 

New chemical products not under the FDA or FIDRA are covered by the Toxic Substances Control Act (TSCA). If these chemicals are intended to become articles of commerce, they are subject only to submission to the EPA of a request for a Pre-Marketing Notice (PMN). The EPA has 90 days to respond to such a request and often, in the absence of extensive data, relies on structure-activity relationship (SAR) predictions. 

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. 

If an importer imports a product for a use not governed by TSCA, and finds that the contemplated sale does not occur, the importer may later sell the product for a TSCA use, so long as the product complies with TSCA (for example, the chemical is on the TSCA Inventory, or quahfies for an exemption from the PMN requirements) and the substance is not further regulated under 5,6, or 7 of TSCA in a way that would preclude the intended use. ... 

A process needs to be established requiring the import specialist to notify the regulatory specialist prior to accepting any import shipment of a new chemical substance, including any article containing a chemical substance or mixture with a separate end use that will be released from the article. The information should come before the shipment arrives at the port of entry, and should be accompanied by a description of the product s use, chemical identity, and its components. A determination needs to be made as to whether the product is for a use regulated under FIFRA, FFDCA, or TSCA. If the product is regulated by TSCA, a further determination needs to be made as to whether it is exempt from the PMN requirements, and if it is not, whether it is on the TSCA Inventory. 

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