What is meant by the term substantial equivalence and how is it used to assess food derived from genetically engineered organisms?

What is meant by the term substantial equivalence and how is it used to assess food derived from genetically engineered organisms?

56: Substantial Equivalence of GM and Non-GM Crops In other words, substantial equivalence means that a new product such as a GM crop must be the same as the non-GM crop except for the traits that were enhanced, added, or removed through genetic engineering.

What is the principle of substantial equivalence?

Definition: Substantial equivalence is a concept, first described in an OECD publication in 1993, which stresses than an assessment of a novel food, in particular one that is genetically modified, should demonstrate that the food is as safe as its traditional counterpart.

What does substantially equivalent to its conventional counterparts mean to the FDA?

In other words, substantial equivalence means that a new product must be the same as the non-genetically engineered crop except for the traits that were enhanced, added, or removed through genetic engineering.

What are GMO and non GMO foods?

“Non-GMO” means non-genetically modified organisms. GMOs (genetically modified organisms), are novel organisms created in a laboratory using genetic modification/engineering techniques. Scientists and consumer and environmental groups have cited many health and environmental risks with foods containing GMOs.

What is substantial equivalency?

Substantial equivalency or “substantially equivalent” means or refers to a determination by the board or its designee that the education, examination and experience requirements contained in the statutes or rules of another state are comparable to or exceed the education, examination and experience requirements …

How do you calculate substantial equivalence?

A device is substantially equivalent if, in comparison to a predicate it:

1. has the same intended use as the predicate; and.
2. has the same technological characteristics as the predicate; or.
3. has the same intended use as the predicate; and.
4. has different technological characteristics and the information submitted to FDA;

What is meant by substantially equivalence?

Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and. has the same technological characteristics as the predicate; or.

What are GMOs in food?

Genetically modified (GM) foods are foods derived from organisms whose genetic material (DNA) has been modified in a way that does not occur naturally, e.g. through the introduction of a gene from a different organism.

What is the difference between organic conventional and GMO food?

How Are GMO Food Products Different from Organic? Organic foods do not contain any pesticides, fertilizers, solvents, or additives. The slight difference with the organic label is that non-GMO prevents the use of herbicides that contain GMOs, but it does not mean it must be grown organically.

What is a substantial equivalency fair housing law?

Substantial equivalency certification is granted if the Department determines that a state or local agency enforces a law that is substantially equivalent to the Fair Housing Act with regard to substantive rights, procedures, remedies, and the availability of judicial review.

Does the CPA Exam transfer between states?

Woislaw: CPA Exam scores can be transferred to any state for the purpose of getting a license, so a student can take the exam in whichever state works best for them. If the state does not have firm mobility, you have to get another license and apply it to the state board of accountancy.

What is the meaning of its equivalent?

1 : equal in force, amount, or value also : equal in area or volume but not superposable a square equivalent to a triangle. 2a : like in signification or import. b : having logical equivalence equivalent statements. 3 : corresponding or virtually identical especially in effect or function.

When did the concept of substantial equivalence come about?

Substantial equivalence. In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time. It was first formulated as a food safety policy in 1993,…

What does substantial equivalence mean in food safety?

Substantial equivalence. As part of a food safety testing process, substantial equivalence is the initial step, establishing toxicological and nutritional differences in the new food compared to a conventional counterpart—differences are analyzed and evaluated, and further testing may be conducted, leading to a final safety assessment.

Can a substantial equivalence report be submitted to the FDA?

A Substantial Equivalence (SE) Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order, under section 905 (j) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

What makes a tobacco product a substantially equivalent product?

A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equivalence Report demonstrates that the new product does not raise different questions of public health.