EPA is developing policy on human chemical testing

30 November 2004 21:07  [Source: ICIS news]

WASHINGTON (CNI)--The US Environmental Protection Agency (EPA) said Tuesday that until it can establish a definitive policy, it will decide on a case-by-case basis whether to accept industry-sourced chemical tests using human subjects, saying it is following a court order to do so.

 

Responding to public interest group charges earlier today that it is condoning use of “human beings as chemical guinea pigs,” EPA said its developing policy on human studies addresses how the agency “intends to strengthen its program for protecting participants in research with human subjects.”

 

Earlier today, Public Employees for Environmental Responsibility (Peer) charged that in proposing to accept industry studies that use human subjects, EPA “abdicates its moral responsibility to ensure that data submitted by industry does not use human beings as chemical guinea pigs.” Peer is a national environmental organization of federal, state and local government employees.

 

Peer based its charges on a draft copy of EPA’s developing policy notice, alleging that EPA plans to “impose no rules to prevent unethical practices” by chemical industry researchers using human subjects.

 

But EPA spokesman William Jordan told CNI that while the draft policy notice published by Peer is in many respects similar to the final policy statement EPA will publish later, “The document made available by Peer is an early draft that is still under review” and “may well change before it is published for public comment.”

 

Jordan said that the developing EPA policy notice on human testing is designed to reflect recommendations from the National Academy of Sciences (NAS) and a June 2003 federal court order.

 

NAS guidelines on human testing, Jordan said, “specifically recommend that ‘EPA should accept scientifically valid studies conducted before its new rules [on human testing] are implemented unless there is clear and convincing evidence that the conduct of those studies were fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain informed consent) or that the conduct was deficient relative to then-prevailing ethical standards.’”

 

NAS is a taxpayer-funded agency that advises the US government on scientific and technical issues. NAS findings often influence Congress.

 

Jordan also noted that in developing its policy on acceptance of data resulting from human studies, EPA is following June 2003 instructions from the US Court of Appeals for the District of Columbia Circuit. Those instructions, said Jordan, require EPA “to review each human study on a case-by-case basis, applying ‘statutory requirements, the Common Rule and high ethical standards as a guide.’” The “Common Rule” is a set of regulations designed to ensure that human participants in research conducted or supported by the federal government receive appropriate protections.

 

Jordan said the draft policy notice criticized by Peer simply seeks to establish “a credible plan - including rule making, scientific participation, development of guidance, etc. - to develop final [EPA] policy in this area.”

 

He said that when it is published later this year or early in the new year, the EPA policy notice will invite public comment on the agency’s proposed approaches concerning human testing.

By: Joe Kamalick
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