Table 3.

Critical Questions for Agencies Contemplating Federal Regulation of DTC Genetic Tests

1.	Has Congress addressed the specific issue? If so, is the agency acting in accordance with that congressional intent? If not, is the agency interpreting the statute reasonably?
2.	Has Congress provided sufficient “intelligible principles” by which the agency can discharge its regulatory duties? In other words, is the statutory scheme under which the agency is acting a lawful delegation of congressional power?
3.	Is the agency considering only those factors that were intended by Congress when Congress enacted the statutes delegating regulatory authority to the agency? In other words, is the agency acting squarely within the mission with which it has been charged by Congress?
4.	Is the agency omitting or neglecting an important aspect of the problem during its deliberations and policymaking?
5.	Are the agency's explanations of its policies in line with the evidence or is some aspect of the explanation contrary to the evidence?