of conformity assessment between the United States and the European Union would permit U.S. manufacturers to obtain required European certification at the U.S. location of production. It would open the market for third-party certification services to U.S. laboratories, resulting in greater competition and lower costs to U.S. manufacturers. It would also directly benefit the U.S. independent testing industry. As discussed in Chapter 3, this is a rapidly growing, $10.5 billion industry.
There are several obstacles to successful completion of the U.S.-EU talks.63 As a result of the significant differences in the two sides' conformity assessment systems, negotiations have involved time-intensive exchange of background information and sector-specific data. Differences in the structure and operation of the systems create difficulty in developing means for full, reciprocal access to conformity assessment procedures. Apart from a few exceptions, such as drug certification and automobile emissions testing, the United States relies much more than the EU on manufacturer's declaration for regulatory approval.64 The EU system centers primarily on third-party conformity assessment in regulated sectors. These third-party procedures include testing and certification by independent laboratories, as well as quality system audit and approval by third-party registrars. As noted previously, only "notified bodies"—those designated as technically competent by their national government—may perform these third-party services.
At present, there is no mechanism for any non-European organization to become accepted by the EU as a notified body. Under an MRA, U.S. organizations could become notified bodies and perform testing and certification of exports to the EU. The EU has indicated that any mutual recognition will require some form of U.S. government involvement in guaranteeing the competence of private U.S. conformity assessment organizations before they will be accepted by EU regulatory authorities. As a first step toward creating such a mechanism, in 1994, the National Institute of Standards and Technology created the National Voluntary Conformity Assessment Systems Evaluation (NVCASE) program. Under NVCASE, NIST will recognize U.S. accreditation programs in the United States that are competent to evaluate U.S. conformity assessment organizations.
To minimize government involvement in the private U.S. conformity assessment system, NIST intends to restrict NVCASE primarily to the recognition level of activity.65 (See Figure 3-1 for the levels of conformity assessment in the U.S. system.) NVCASE is designed to evaluate and officially recognize the competence of accreditation bodies (accreditors) who, in turn, accredit testing laboratories, certifiers, and quality system registrars. NVCASE will not directly accredit testing laboratories or certifiers, unless there exists no private-sector accreditation program in a particular industry sector and firms in that sector ask NIST to set up a program. Recognition by NVCASE confers U.S. government approval on all testing, certification, and quality system registration procedures performed by parties who are, in turn, accredited by NVCASE-recognized accreditors. The