To the first point, that EPA can't ensure that industry has followed ethical guidelines, I note that, under the existing rule, an industry would have to show that ethical guidelines had been adhered to in order to have its data accepted. There are exceptions to that requirement, based on the benefit to the public of considering such data. The EPA rules don't require that industry submit an investigation plan before conducting tests, and the EPA might not have that authority. I can't find such a requirement in the HHS rules either. On edit: I note that the proposed 26.101(j), (k) states conditions under which a third party must submit their plan before beginning a study, including the ethical guidelines to be followed. The proposed 26.124 requires that third-party adherence to the guidelines must be fully documented to EPA when the study has been completed. That provision could be tightened up to require ongoing documentation rather than only requiring post-study documentation.
The second point is not addressed in the proposed EPA rules. I note that there is already a ban against conducting such research on prisoners under an HHS rule (45 CFR 46.306), and that HHS must be notified of all proposed EPA studies on human subjects. I do not know for certain whether HHS can veto an EPA study, though I expect that consistent application of US laws would require it. I would agree that testing on prisoners should have a specific mention in the EPA rule.
The third point is addressed, in part, by the following paragraphs:
Sec. 26.220 Prohibition of research involving intentional dosing of
pregnant women, fetuses, or newborns.
Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any
pregnant woman, fetus, or newborn.
Sec. 26.420 Prohibition of research involving intentional dosing of
children.
Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.EPA may accept results from such studies on pregnant women or children under certain conditions, but may not make such studies or support them. Under law, EPA does not have authority to comprehensively prohibit such studies. That doesn't mean that they couldn't be prohibited by some other governmental body.
To look at the existing rules, start here:
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1