Abused, Neglected, and Now Used for Testing?

Thu Dec. 1, 2005 8:41 PM EST

Ah, the federal Environmental Protection Agency: often the target for anti-regulation zealots and frequently the bane of restive developers. But now it may open the door for chemical testing on abused, neglected, and orphan children. As surreal as that may sound, the EPA is indeed revising its testing procedures to allow for just that, in response to a Congressional order given in the beginning of this August for the EPA to ban testing on children and pregnant women without exception.

Critics say that the regulation, in defiance of the Congressional mandate, creates allowances for chemical testing on children:

  • if they "cannot be reasonable consulted"—for example, those who are mentally handicapped or newborn orphans
  • if their guardians' parental competencies are legally compromised, such those deemed negligent
  • if the EPA tests are operated outside the U.S., with administrative approval.
  • The EPA dismissed these concerns, stating in a press release that "EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children." However the plain text is available for the public to pursue and draw its own conclusions.

    The misnamed document, Protections for Subjects in Human Research, filed with the federal register on September 12 of this year, includes the following loopholes (emphasis mine):

    The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent... If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement..."

    If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements... "

    To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research...An invitation for open public comment on this docket will continue from today until December 12. The Organic Consumer's Organization, ever alert to chemical regulation, is leading the fight to erase the offending articles with an urgent action alert. The EPA intends to create a final draft of the rule by the end of January 2006.

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