Research and development exemption

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. 

Id. at comment 38. The EPA noted that the burden of complying with TSCA for a pre-EUP substance may be lessened if the substance falls within the research and development exemption from 5 premanufacture notiftcation requirements. See Chapter 5, PMN Exclusions and Exemptions. 

See the discussion of the research and development exemption from the PMN requirement, infra. 

Therefore, even university researchers must be sure their substances are on the Inventory or qualify for an exemption from the PMN rules. Most university research that is not strictly academic and most industrial research can qualify for the research and development exemption from the PMN requirement if the laboratories comply with strict requirements that apply to the exemption. ... 

Chemicals that are handled in accordance with the research and development exemption from the PMN rules caimot be listed on the Inventory because 8(b) of TSCA, which requires the Inventory to be compiled, says ... 

Before designing the audit protocol, it is important to determine the purpose of the audit. For example, an audit of compliance with export notification requirements will have a different group of functions involved than an audit of how a laboratory manages compliance with the research and development exemption to the PMN requirements. 

A substance manufactured in small quantities for research and development may be eligible for the Research and Development exemption if special procedural and recordkeeping requirements are met, as specified at 40 CFR 720.36 and 720.78. 

Substances intended solely for scientific research and development at below 100 kg per year (per manufacturer) are exempt from notification. 

Substances placed on the market for process-orientated research and development (PORD) are exempt from notification for supply at justified quantities to specified industrial users. The safety data needed for a PORD application varies between the Member States, and may be up to Annex VIIB level (Table 2). PORD exemptions are only valid for 1 year, with the possibility of a 1-year extension. 

Substances used only for process-orientated research and development are exempt from registration for 5 years. The exemption can be extended for a further 5 years in exceptional circumstances, or 10 years for substances used exclusively to develop human or veterinary medicines. The manufacturer or importer has to inform the ECA of the substance identity, labelling and quantity, justify the quality, summarise the research programme and list the customers. 

It is however visible that most of these constraints are not natural or naturally fixed , but can be removed by training, research and development measures specifically targeting organic exporters. A few exemptions are transportation infrastructures and long distances to markets, which cannot be shortened - except if new markets open up, like the Middle East for Africa, or growing domestic or intra-African markets, as well as local or export infrastructure and logistics (e.g. airfreights), which are subject to a more complex overall economic system. 

The Chemical Substances Control Law regulates chemical substances produced by chemical reaction excluding natural products. However, articles and substances regulated by other laws, such as the Food Sanitation Law in Japan and the Pharmaceutical Affairs Law, and exclusively used for the purposes covered by such laws, together with substances used for research and development, are also exempt from the Law. 

Increases the threshold in place for scientific Research and Development (R D) exemptions from 100 kg to 1 tonne. 

Extends process/product-oriented research and development (PPORD) exemptions from one to three years, up to a maximum of five years. 

The most significant developments in metered-dose inhaler technology to occur since the early 1990s have been the introduction of hydrofluoroalkane (HFA) systems as alternatives to chlorofluorocarbon (CFC) systems [174]. This has largely been caused by the link between the use of CFC systems and ozone depletion in the upper atmosphere [152,175]. Albuterol and beclomethasone have been reformulated in HFA products, but as yet the CFC products are still subject to an annually renewable medical exemption. The Food and Drug Administration has recently published its position on alternative propellant formulations, which should initiate the phase-out of CFCs [176]. In the meantime, a number of generic CFC products of albuterol have been manufactured. The opportunity for reformulation of products as they come of patent is likely to increase research and development in this area in the near future. New formulation opportunities will also arise from these developments, including solutions [177], micellar [178,179], and microemulsion [180]. 

From 1929 until 1977, approximately 99% of all PCBs used by U.S. industries were manufactured by the Monsanto Chemical Company at a production facility in Sauget, Illinois (Durfee 1976 lARC 1978). During that period, over 571,000 metric tons (1,250x10 pounds) of PCBs were produced and/or used in the United States (Erickson 1997 Hansen 1999). In 1976, the U.S. Congress banned the manufacture, processing, distribution in commerce, and use of PCBs under the Toxic Substances Control Act (TSCA) and the Resource Conservation and Recovery Act (RCRA). Exemptions may be granted to individual petitioners for use with optical microscopy, and for research and development (see Section 5.3 EPA 1998u). 

Substances supplied at <10 kg a are exempt from notification, but individual Member States may choose to require appropriate technical and commercial data to be submitted. Substances supplied at <100 kg a for scientific research and development are exempt from notification, but records of supply to customers must be available for inspection by the national Competent Authority. Substances can be supplied for process-orientated research and development to a limited number of registoed customers without tonnage limit for up to 1 year (extended to 2 years if justifiable). Individual Member States can decide what information is required, up to the maximum requirement for limited notification . If substances supplied under these three exemption categories are provisionally classified as very toxic , toxic , carcinogenic , toxic for reproduction or... 

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. 

New chemical substances produced only in small quantities solely for research and development are exempt from PMN requirements. This exemption generally excludes small scale field testing of agriculture chemicals from PMN requirements. Field testing of traditional chemicals has a low risk because the area of application is geographically circumscribed and the small quantity used for testing is not likely to spread away from this site. 

In addition to the substances that are defined to be outside of the scope of TSCA because they are not chemical substances, there are many chemicals that are within the scope of TSCA, but exempt from some of the regulatory programs. These exemptions cause significant confusion in the regulated community. It is important to keep in mind that many chemical substances that are exempt from one or more TSCA program are still chemical substances and are still subject to all of the TSCA programs that do not exphc-itly exempt them. The list of chemical substances that are exempt from some TSCA programs but are subject to others includes impurities, byproducts, isolated intermediates, chemicals made or imported for import only, and research and development chemicals. 

A substance that is not on the TSCA Inventory and is manufactured, imported, processed, or distributed for export only may be used for research and development purposes without filing a PMN, provided that the requirements for that exemption from the PMN requirements are met." " ... 

COMMENT EPA should exempt from section 8(e) reporting field tests conducted on research and development (R D) pesticides. 

PMNs are only required for substances that are manufactured or imported for commercial purposes, which is defined in the regulations to mean to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer. Any amount of manufacture or import, no matter how small, can be for a commercial purpose if it is for commercial distribution, test marketing, product research and development, or use as an intermediate. Byproducts and impurities that have no commercial value are made or imported for a commercial purpose if they are made with or present in a product with commercial value that was made or imported for a commercial advantage," " although they may qualify for exemptions from PMN and SNUR requirements. 

After the PMN period has expired, manufacturers and importers who have filed a PMN must notify the EPA within thirty calendar days of commencing manufacture or import of the PMN substance. The notification must be made on the NOC form, which is EPA form 7710-56. The thirty day period begins to run on completion of manufacture of the first amoimt of the PMN substance made for a nonexempt purpose, i.e., when it is made for commercial purposes and not for research and development, test marketing, or another purpose exempt from the PMN filing requirements. For an import, the thirty day period begins to run after the PMN substance has cleared U.S. Customs. ... 

The regulatory requirements for the R D exemption fall into three categories. First, the chemical substance must be made only in small quantities solely for research and development. Second, the manufacturer or importer must evaluate the known health and environmental risks associated with the substance and notify anyone who handles the chemical about those health risks. Third and finally, the R D chemical must only be used by a technically quahfied individual or under that individual s direct supervision. ... 

Research and development that is not for a commercial purpose is not subject to the PMN and Inventory rules at all, and the manufacturer, importer, or processor does not have to comply with the R D exemption. So, for example, a researcher who makes a chemical for purely academic research does not have to comply with the R D exemption. R D is not considered purely academic if it is funded under a contract that anticipates commercialization, or if the researcher holds a patent in the field or has asserted trade secret rights. ... 

EPA New Chemical Information Bulletin, Exemptions for Research and Development and Test Marketing, 2 (Nov. 1986)[hereinafter Chemical Bulletin Exemptions]. 

Manufacturers are expected to follow the provisions of the exemption for research and development (R D) activities during the period of evaluation of eligibility of a substance under the exemption criteria prior to actual manufacture under the exemption provisions. Such R8cD activities will be subject to the R D procedural and recordkeeping provisions in the PMN rule at 40 C.F.R. 720.36 and 720.78, respectively. 

There are several exemptions from the MCAN requirements for microorganisms made or imported solely for research and development. If there is no intentional testing outside of a structure the microorganism is exempt if another federal agency requires compliance with National Institutes of Health Guidelines, or if the research and development is performed under the supervision of a technically qualified individual and there are controls in place to contain or inactivate the microorganisms and involved individuals are notified of certain specified health risks. ... 

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