No Globalization of Chemical Substances Control

    Alex Scott has a four-page article entitled, "Seeking Chemical Safety for All", in the June 11 Issue of Chemical and Engineering News.
    The essence of the article is a discussion on the merits of possible techniques to globalize regulations for the control of chemical substances.
    In the US, we have the Toxic Substances Control Act (TSCA). TSCA's  purpose is to protect human health and the environment from unreasonable risks presented by the manufacture and use of chemicals. All chemicals used in manufacturing must be on the TSCA Inventory. EPA maintains the TSCA Inventory of chemicals, which have been approved for use
    There are over 90,000 existing “chemical substances” on the TSCA Inventory. New or additional chemicals can be placed on the TSCA inventory by a manufacturer petitioning the EPA. No new chemicals or an existing chemical not on the TSCA Inventory can be used, unless EPA is given 90 days advance notice of intent to manufacture or use. The EPA has 90 days to evaluate a chemical and decide whether to regulate it; include it in the TSCA inventory. The EPA will consider submitted physical and toxicological data, which may present hazards in its manufacture or intended use. If the new chemical will present an unreasonable risk, or if there is insufficient information, the EPA can prohibit or limit use of the chemical until such data is supplied.
    The European Union (EU) has a similar system known as the Registration, Evaluation, Authorization, & Restriction of Chemical Substances (REACH).
    The subject of Alex Scott's article is a discussion on the merits of hazardous chemical control regulations being applied on a global basis. The EU is proposing that this should be done and should be based on REACH. The US does not seem to have made a proposal that TSCA should be used as the global standard, but several major US chemical companies appear to favor globalization, on the basis that uniformity in export/import, manufacturing and use regulations would be an efficient way to proceed. Alex's article presents various reasons for and against use of REACH on a global basis, but all arguments seem to neglect one key point. That is, the technical data necessary for registration and approval. For either TSCA or REACH approval, technical data must be supplied by the company interested in registration/approval and obtaining such data can be quite costly.
    With the many chemicals approved by TSCA and REACH, technical data has historically been supplied by the companies originally intending to manufacture and or use the chemical substance. This information is on file at TSCA and REACH, and apparently is available to anybody desiring to manufacture or use the chemical. This seems inherently unfair to me. It is basically a socialization concept, wherein the secondary manufacturer/user, can profit on the work of others, with the support of government. It is not clear to me how the system works, but I know how it should work. For any new manufacturer/user to involve itself with a particular chemical in the TSCA Inventory, EPA should require submission of independent technical data. The new entrant then would have the option of generating its own data or obtaining, through the usual technology transfer negotiations, the same data used by the original company in its registration. This comes at some cost to the new entrant, and is obviously more fair than allowing him a free ride.
    Geert Dancet is the Executive Director of the European Chemicals Agency (ECHA). He is a proponent of allowing REACH data to be used by all free riders. This is not an unusual approach for someone in the socialistic EU.
    Michael Walls is Vice President of Regulatory and Technical Affairs for the American Chemistry Council (ACC). The ACC is strongly opposed to such globalization. V.P. Walls says the ACC favors regulations that," promote innovation and protect proprietary interests". To me, "protecting proprietary interests" means that technical data supplied to the EPA should be regarded as confidential "know-how" and should not be available to secondary users without their going through the process of technology transfer negotiation with the original data generator. If that's what V. P. Walls means, hooray for the ACC and capitalism is still alive.
    Other than the socialistic/capitalistic controversy there is also the problem of national autonomy. Traditionally, the world has operated on the basis of each nation being allowed the right of self determination. More recently, attempts have been made to modify that through United Nations actions and the meddling of other countries, such as the US in Iraq.
    There is a logical basis for national autonomy, in that countries differ from one another, through a variety of elements, such as geography, culture, religion, economy, etc.. Many countries are what we consider "undeveloped", in that the inhabitants have a lower standard of living than "developed" countries, or even a global average. One of the ways to give an undeveloped country an opportunity for development is through manufacture and use of chemicals. The socialistic approach of REACH would appear on the surface to be advantageous to such countries, but in all likelihood would actually be a detriment. REACH limitations would be simultaneously imposed, and because of their detrimental applicability to the particular situation would kill the project.
    Considering both the negative aspects of socialization and the detriment to undeveloped countries, I am a strong proponent of not globalizing chemical substance regulations. Each country should develop opportunities and restrictions most adaptable to it. There should be no free availability of technical data from either TSCA or REACH. Each of those organizations should conclude that technical information supplied to them by manufacturers/users is confidential proprietary information and not available to others for use in obtaining registrations. That technical information should be available to newcomers through the standard market action of technology transfer.