substantial equivalence

There are controversies over the definition and application of substantial equivalence.

The court defines substantial equivalence as 100 percent parity.

The application of substantial equivalence has been criticized.

The agreement recognizes that there is substantial equivalence of programs accredited by those signatories.

The Commissioner has confirmed what we said: that the notion of substantial equivalence was completely confusing and ill-defined.

The 1976 legislation deviated the clarification and proper evaluation of competitive or "substantial equivalence" medical devices.

It stated that substantial equivalence does not measure risks, but instead identifies differences between existing products and new foods, which might pose dangers to health.

In Pusztai's opinion the lack of substantial equivalence was reason enough to discontinue any further experimentation with the potatoes.

The simplified procedure based on substantial equivalence will be abandoned and authorisations will be limited to a period of 10 years.

FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with Section 510(k) of the act.

There has been discussion about applying new biochemical concepts and methods in evaluating substantial equivalence, such as metabolic profiling and protein profiling.

"And if public schools are increasing their standards and increasing their performance, 'substantial equivalence' means nonpublic schools have to rise as well."

The debate encompasses the ecological impact of genetically modified plants, the safety of genetically modified food and concepts used for safety evaluation like substantial equivalence.

In each case, these applications have been simplified or substantial equivalence applications, because astaxanthin itself is recognised as a food component in the EU diet.

They suggested that all GM foods should have extensive biological, toxicological and immunological tests and that the concept of substantial equivalence should be abandoned.

It concluded that "The concept of substantial equivalence is an adequate tool in order to identify safety issues related to genetically modified products that have a traditional counterpart".

If the newly incorporated protein is not similar to that of other proteins found in food or if anomalies arise in the substantial equivalence comparison, further toxicological testing is required.

The Rowett study aimed to examine the substantial equivalence of the modified potatoes and to test for any adverse effects on rats fed the potatoes for ten days and three months.

The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent.

Furthermore, if a law assuring such substantial equivalence, approximating 100 percent, for school year 1997-1998 and providing as well for special educational needs, is not adapted by September 1996, we will consider applications for relief.

In 1999, Andrew Chesson of the University of Aberdeen warned that substantial equivalence testing "could be flawed in some cases" and that some current safety tests could allow harmful substances to enter the human food chain.

The court's unanimous ruling gives New Jersey three years to raise spending levels in 30 "special needs" districts - essentially hard-pressed cities like Newark, Camden and Paterson - to "substantial equivalence" with what the state's affluent communities spend on their schools.

Regulators are aware of these issues and workshops and consultations organized by the OECD, WHO, and FAO have worked to acquire data and develop standards for conventional foods, for use in assessing substantial equivalence.

An opinion piece in the Los Angeles Times in 2001 by Barbara Keeler and Marc Lappe supported legislation in the US Congress to set aside the substantial equivalence standard and instead mandate that safety studies be performed.

We will not intervene, except as noted below, if substantial equivalence of the special-needs districts and the wealthier districts in expenditures per pupil for regular education is achieved for school year 1997-1998 along with provision for the special educational needs of students in those special-needs districts.