ing concerns are not dependent on the method used to produce the plant (section 2.2.1).

3.3.1 Health Concerns: Guiding Principles

The principles in the following questions could be used to determine when a detailed analysis of health risks is warranted for transgenic pest-protected plants.

  1. Is the substance found in plant parts that consumers3 eat or workers come into contact with?

    1. Yes or Unknown—go to 2.

    2. No—exempt from health concerns.

  2. Is the substance known to have general chemical and physical properties common to many allergens?

    Note: Criteria outlined in figure 2-1 could offer components for this type of evaluation.

    1. Yes or Unknown—subject to safety assessment.

    2. No—go to 3.

  3. Is the substance similar to substances that people now eat or come into contact with, and can confident predictions of safety based on the similarities be made?

    1. Yes—go to 4.

    2. No or Unknown—subject to safety assessment.

  4. Is the expected exposure to the substance substantially greater than current exposures?

    1. Yes or Unknown—subject to safety assessment.

    2. No—go to 5.

  5. Is there a reasonable chance, based on known properties of the substances, that its production will lead to harmful concentrations of toxicants or allergens that consumers eat or workers come into contact with? 4

    1. Yes or Unknown—subject to safety assessment.

    2. No—exempt from health concerns.

3  

Including human and non-human consumers, such as food animals or pets.

4  

Pleiotropic effects.



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