The Environmental Protection Agency has just closed the public comment period for a proposed new regulation meant to ban the testing of pesticides on children – a regulation a consumer-health organization says would actually put at risk youngsters who happen to be orphans or mentally handicapped.
While Congress directed the EPA to craft a regulation that would ban chemical testing on pregnant women and children, the Organic Consumers Association, or OCA, says the rule proposed by the agency is “riddled with exceptions” that pose great dangers.
The public comment period for the proposed rule, “Protections for Subjects in Human Research,” closed Monday.
“The EPA website and the introductory description of the rule are very long winded and flowery, claiming this rule abides by the congressional mandate to ban all testing of women and children, without exception,” OCA states on its website. “In fact, if you read the rule, which is 30 pages of fine print, there are multiple exceptions.”
The rule says it will “1) Categorically prohibit any intentional dosing studies involving pregnant women or children as subjects; and 2) adopt the Department of Health and Human Services regulations that provide additional protections to pregnant women and children as subjects of other than intentional dosing studies.”
That assurance, however, falls flat when the exceptions to the regulation are considered, OCA contends.
The proposed rule calls for an Independent Review Board, or IRB, to “determine that adequate provisions are made for soliciting the assent of the children” who would be involved in testing.
“In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity and psychological state of the children involved,” the rule states. “This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, 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. …”
That assent exception, OCA contends, “violates the Nuremberg Code, an international treaty that mandates assent of test subjects is ‘absolutely essential.’”
The interest group points out that children who “cannot be reasonably consulted,” such as those that are mentally handicapped or orphaned newborns, may be tested on with the permission of the institution or guardian in charge of the individual.
OCA also highlights the part of the proposal that allows the IRB to waive parental or guardian permission when it is “not a reasonable requirement to protect the subjects (for example, neglected or abused children).”
The group further notes another exception that allows the EPA administrator to waive certain testing requirements for research done outside the U.S.
OCA slams the EPA for what it calls its “public relations” spin:
“Nowhere in the rule does the EPA say that all intentional dosing studies are banned, yet that is exactly what Congress had asked them to do. In fact, the rule goes so far as to make allowances for what it refers to as ‘ethically deficient human research.’ (70 FR 53857). In short, the EPA is making public relations claims that completely contradict what is clearly written in black and white in the actual proposed rule.”
OCA urged its members to submit comments to the EPA in opposition to the proposed rule. Craig Minowa, an environmental scientist with the group, says the organization was responsible for about 20,000 public comments that were submitted.
Minowa explained Congress directed EPA in August to come up with a regulation “because there isn’t a specific rule that would ban these types of tests, which is why these types of tests are taking place right now.”
He says EPA didn’t fulfill the mandate of Congress because it included exceptions in the rule.
“With a congressional mandate of creating a rule with no exceptions, really the EPA should be able to release a one-page document that clearly states there are no exceptions,” Minowa told WND. “But instead it releases a 30-page document with small text and al sorts of loopholes.”
Minowa believes it was “pressure from the chemical industry” that prompted EPA to include the exceptions.
Congress took action when a proposed study of toxic chemicals on poor children in Florida was publicized last year, a study that ultimately was canceled.
According to Eryn Witcher, press secretary of EPA, the agency is now reviewing public comments and will propose a final rule at the end of January.
Witcher reiterated the introduction of the rule, saying it “bans the intentional dosing of pregnant women and children with pesticides for toxicity studies.”
Said Witcher: “We essentially asked the National Academy of Sciences for their input on what our rule should look like, and we followed their recommendations.”
The spokeswoman told WND the regulation is a “landmark” and would extend “very rigorous protections” to Americans.
When asked about those who are critical of the exceptions in the rule, Witcher repeated her contention that the proposal “flat-out bans” intentional dosing of pregnant women and children.
OCA isn’t the only consumer group opposing the rule.
Jeff Ruch, executive director of Public Employees for Environmental Responsibility, said in a statement this week: “The good news is that EPA, for the first time, is pledging to abide by the Nuremberg Code, adopted after World War II to prevent a repetition of the horrific Nazi human experiments. The bad news is that EPA’s proposal breaks this long-overdue pledge by offering a plan peppered with loopholes that encourage unethical conduct and omit key protections for infants, pregnant women and other vulnerable populations.”
Minowa says there are lawmakers ready to hold EPA accountable: “A few members of Congress are set to take action if the EPA doesn’t close those loopholes.”