EPA Proposes Chemical Testing on Some Children

Specialties Research

Published

  • by LydiaNN
    Specializes in Public Health, DEI.

okay, this isn't strictly a nursing discussion i know, but it certainly is health care related, so i hope it isn't moved to a premium forum. i am thinking we may have discussed this when the idea was first hatched, but now that the deadline is drawing near, it seems worthy of another look. i don't understand how the epa can think this is okay. if there are laws protecting other children from being human guinea pigs, even with their parent's consent, why don't those protections apply to children who are wards of the state? i would suggest that they are even more vulnerable, and if anything, should require an extra layer of consent! (i am editing this to add links to the full text, since you'd need my e-mail password to access the links from the original message.)

[color=#990000]alert: epa proposes testing chemicals and pesticides on orphans & mentally handicapped children

[color=#990000]send a letter to epa here: http://www.demaction.org/dia/organiz...paign_key=1532

forward this alert to friends and colleagues

tuesday, november 15, 2005

public comment period closes

december 12, 2005

public comments are now being accepted by the environmental protection agency (epa) on its newly proposed federal regulation regarding the testing of chemicals and pesticides on human subjects. on august 2, 2005, congress had mandated the epa create a rule that permanently bans chemical testing on pregnant women and children. but the [color=#003399]epa's newly proposed rule, misleadingly titled "protections for subjects in human research," puts industry profits ahead of children's welfare. the rule allows for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:

  1. children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns may be tested on. with permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
  2. parental consent forms are not necessary for testing on children who have been neglected or abused.
  3. chemical studies on any children outside of the u.s. are acceptable.

[color=#990000]send a letter to epa [color=#003399]here!

oca's focal concerns with this proposed rule specifically involve the following portions of text within the epa document (read the full epa proposed rule here: [color=#003399]in pdf: http://www.nacua.org/documents/prote...anresearch.pdf

[color=#003399]in html: http://www.epa.gov/fedrgstr/epa-gene...-12/g18010.htm

70 fr 53865 26.408(a) "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..."

(oca note: under this clause, a mentally handicapped child or infant orphan could be tested on without assent. this violates the nuremberg code, an international treaty that mandates assent of test subjects is "absolutely essential," and that the test subject must have "legal capacity to give consent" and must be "so situated as to exercise free power of choice." this loophole in the rule must be completely removed.)

70 fr 53865 26.408© "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..."

(oca note: under the general rule, the epa is saying it's okay to test chemicals on children if their parents or institutional guardians consent to it. this clause says that neglected or abused children have unfit guardians, so no consent would be required to test on those children. this loophole in the rule must be completely removed.)

70 fr 53864 26.401 (a)(2) "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..."

(oca note: this clause is stating that the administrator of the epa has the power to completely waive regulations on human testing, if the testing is done outside of the u.s. this will allow chemical companies to do human testing in other countries where these types of laws are less strict. this loophole in the rule must be completely removed.)

70 fr 53857 "epa proposes an extraordinary procedure applicable if scientifically sound but ethically deficient human research is found to be crucial to epa's fulfilling its mission to protect public health. this procedure would also apply if a scientifically sound study covered by proposed 26.221 or 26.421--i.e., an intentional dosing study involving pregnant women or children as subjects..."

(oca note: this clause allows the epa to accept or conduct "ethically deficient" studies of chemical tests on humans if the agency deems it necessary to fulfull its mission. unfortunately, the epa report sets up no criteria for making such an exception with any particular study. this ambiguity leaves a gaping loophole in the rule. without specific and detailed criteria, it could be argued that any and every study of chemical testing on humans is "necessary." this loophole in the rule must be removed, based on this inadequacy of criteria and definition.)

[color=#990000]send an email to epa [color=#003399]here!

forward this alert to friends and colleagues

by mail: send two copies of your comments to:

public information and records integrity branch (pirib)

office of pesticide programs

u.s. environmental protection agency

mail code: 7502c

1200 pennsylvania ave., nw

washington, dc, 20460-0001

attention: docket id number opp-2003-0132

(i deleted a request for donation here)

VickyRN, MSN, DNP, RN

49 Articles; 5,349 Posts

Specializes in Gerontological, cardiac, med-surg, peds.

I went to the original EPA site which has the proposal:

http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

It is written in such thick government-ese verbage that its true meaning is very difficult to decipher (especially when coming home from a loooong day) :banghead:

I think this is the passage in question:

Sec. 26.405 Research involving greater than minimal risk but

presenting the prospect of direct benefit to the individual subjects.

EPA will conduct or fund research in which the IRB finds that more

than minimal risk to children is presented by an intervention or

procedure that holds out the prospect of direct benefit for the

individual subject, or by a monitoring procedure that is likely to

contribute to the subject's well-being, only if the IRB finds and

documents that:

(a) The risk is justified by the anticipated benefit to the subjects.

(b) The relation of the anticipated benefit to the risk is at least

as favorable to the subjects as that presented by available alternative

approaches.

© Adequate provisions are made for soliciting the assent of the

children and permission of their parents or guardians, as set forth in

Sec. 26.408.

Sec. 26.406 [Reserved]

Sec. 26.407 [Reserved]

Sec. 26.408 Requirements for permission by parents or guardians and

for assent by children.

(a) In addition to the determinations required under other

applicable sections of this subpart, the IRB 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. In determining whether children are capable of assenting, the

IRB shall take into account the ages, maturity, and psychological state

of the children involved. 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 under circumstances in which consent

may be waived in accord with Sec. 26.116(d).

(b) In addition to the determinations required under other

applicable sections of this subpart, the IRB shall determine, in

accordance with and to the extent that consent is required by Sec.

26.116, that adequate provisions are made for soliciting the permission

of each child's parents or guardian. Where parental permission is to be

obtained, the IRB may find that the permission of one parent is

sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.

© In addition to the provisions for waiver contained in Sec.

26.116, 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 in subpart A of this part and paragraph (b) of this

section, provided an appropriate mechanism for protecting the children

who will participate as subjects in the research is substituted, and

provided further that the waiver is not inconsistent with Federal,

State or local law. The choice of an appropriate mechanism would depend

upon the nature and purpose of the activities described in the

protocol, the risk and anticipated benefit to the research subjects,

and their age, maturity, status, and condition.

(d) Permission by parents or guardians shall be documented in

accordance with and to the extent required by Sec. 26.117.

(e) When the IRB determines that assent is required, it shall also

determine whether and how assent must be documented.

Sec. Sec. 26.409-26.419 [Reserved]

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.

Sec. 26.421 Prohibition of EPA reliance on research involving

intentional dosing of children.

In its regulatory decision-making under the Federal Insecticide,

Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall

not rely on any research involving intentional dosing of any child,

except when such research is deemed scientifically sound and crucial to

the protection of public health, under the procedure defined in Sec.

26.603.

Subpart E--Administrative Actions for Noncompliance

Sec. 26.501 Lesser administrative actions.

(a) If apparent noncompliance with the applicable regulations in

subparts A through D of this part concerning the operation of an IRB is

observed by a duly authorized investigator during an inspection, the

inspector will present an oral or written summary of observations to an

appropriate representative of the IRB. EPA may subsequently send a

letter describing the noncompliance to the IRB and to the parent

institution. The agency will require that the IRB or the parent

institution respond to this letter within a time period specified by

EPA and describe the corrective actions that will be taken by the IRB,

the institution, or both to achieve compliance with these regulations.

(b) On the basis of the IRB's or the institution's response, EPA

may schedule a reinspection to confirm the adequacy of corrective

actions. In addition, until the IRB or the parent institution takes

appropriate corrective action, the Agency may:

(1) Withhold approval of new studies subject to the requirements of

this part that are conducted at the institution or reviewed by the IRB;

(2) Direct that no new subjects be added to ongoing studies subject

to this part;

(3) Terminate ongoing studies subject to this part when doing so

would not endanger the subjects; or

(4) When the apparent noncompliance creates a significant threat to

the rights and welfare of human subjects, notify relevant State and

Federal regulatory agencies and other parties with a direct interest in

the agency's action of the deficiencies in the operation of the IRB.

© The parent institution is presumed to be responsible for the

operation of an IRB, and EPA will ordinarily direct any administrative

action under this subpart against the institution. However, depending

on the evidence of responsibility for deficiencies, determined during

the investigation, EPA may restrict its administrative actions to the

IRB or to a component of the parent institution determined to be

responsible for formal designation of the IRB.

Sec. 26.502 Disqualification of an IRB or an institution.

(a) Whenever the IRB or the institution has failed to take adequate

steps to correct the noncompliance stated in the letter sent by the

Agency under Sec. 26.501(a) and the EPA Administrator determines that

this noncompliance may justify the

[[Page 53866]]

disqualification of the IRB or of the parent institution, the

Administrator may institute appropriate proceedings.

(b) The Administrator may disqualify an IRB or the parent

institution if the Administrator determines that:

(1) The IRB has refused or repeatedly failed to comply with any of

the regulations set forth in this part, and

(2) The noncompliance adversely affects the rights or welfare of

the human subjects of research.

© If the Administrator determines that disqualification is

appropriate, the Administrator will issue an order that explains the

basis for the determination and that prescribes any actions to be taken

with regard to ongoing human research, covered by subparts A through D

of this part, conducted under the review of the IRB. EPA will send

notice of the disqualification to the IRB and the parent institution.

Other parties with a direct interest, such as sponsors and

investigators, may also be sent a notice of the disqualification. In

addition, the agency may elect to publish a notice of its action in the

Federal Register.

(d) EPA may refuse to consider in support of a regulatory decision

the data from human research, covered by subparts A through D of this

part, that was reviewed by a disqualified IRB or conducted at a

disqualified institution, unless the IRB or the parent institution is

reinstated as provided in Sec. 26.504, or unless such research is

deemed scientifically sound and crucial to the protection of public

health, under the procedure defined in Sec. 26.603.

Sec. 26.503 Public disclosure of information regarding revocation.

A determination that EPA has disqualified an institution and the

administrative record regarding that determination are disclosable to

the public under 40 CFR part 2.

Sec. 26.504 Reinstatement of an IRB or an institution.

An IRB or an institution may be reinstated if the Administrator

determines, upon an evaluation of a written submission from the IRB or

institution that explains the corrective action that the institution or

IRB plans to take, that the IRB or institution has provided adequate

assurance that it will operate in compliance with the standards set

forth in this part. Notification of reinstatement shall be provided to

all persons notified under Sec. 26.501©.

Sec. 26.505 Debarment.

If EPA determines that an institution or investigator repeatedly

has not complied with or has committed an egregious violation of the

applicable regulations in subparts A through D of this part, EPA may

recommend that institution or investigator be declared ineligible to

participate in EPA-supported research (debarment). Debarment will be

initiated in accordance with procedures specified at 40 CFR part 32.

Sec. 26.506 Actions alternative or additional to disqualification.

Disqualification of an IRB or of an institution is independent of,

and neither in lieu of nor a precondition to, other statutorily

authorized proceedings or actions. EPA may, at any time, on its own

initiative or through the Department of Justice, institute any

appropriate judicial proceedings (civil or criminal) and any other

appropriate regulatory action, in addition to or in lieu of, and

before, at the time of, or after, disqualification. The Agency may also

refer pertinent matters to another Federal, State, or local government

agency for any action that that agency determines to be appropriate.

Subpart F--Ethical Standards for Assessing Whether to Rely on the

Results of Human Research in EPA Regulatory Decisions

Sec. 26.601 Human research conducted prior to [effective date of the

final rule].

Unless there is clear evidence that the conduct of that research

was fundamentally unethical (e.g., the research was intended to

seriously harm participants or failed to obtain informed consent), or

was significantly deficient relative to the ethical standards

prevailing at the time the research was conducted, EPA will generally

accept and rely on relevant, scientifically valid data from research that:

(a) Was initiated prior to [effective date of the final rule],

(b) Involved intentional exposure of a human subject,

© Did not involve intentional exposure of a pregnant woman,

fetus, newborn, or child, and

(d) Is being considered under the Federal Insecticide, Fungicide,

and Rodenticide Act or the Federal Food, Drug, and Cosmetic Act.

Sec. 26.602 Human research conducted after [effective date of the

final rule].

EPA will generally accept and rely on relevant, scientifically

valid data from research that:

(a) Was initiated after [effective date of the final rule],

(b) Involved intentional exposure of a human subject,

© Did not involve intentional exposure of a pregnant woman,

fetus, newborn, or child, and

(d) Is being considered under the Federal Insecticide, Fungicide,

and Rodenticide Act or the Federal Food, Drug, and Cosmetic Act only if

EPA has adequate information to determine that the research was

conducted in a manner that substantially complies with subparts A

through D of this part.

Sec. 26.603 Exceptions for human research.

(a) Before reaching a decision not to rely on scientifically useful

and relevant data derived from research that does not meet the

applicable standards of Sec. Sec. 26.601 through 26.602, or that

involves intentional exposure of a pregnant woman, fetus, newborn, or

child, EPA will consider whether the data are crucial to a regulatory

decision that would be more protective of public health than could be

justified without relying on the data.

(b) Before making a decision under this section, EPA will solicit

the views of the Human Studies Review Board and provide an opportunity

for public comment.

© If EPA decides to rely on data derived from a study that does

not meet the applicable standards of Sec. Sec. 26.601 through 26.602,

EPA will include in the explanation of its decision a thorough

discussion of the significant ethical deficiencies of the study, as

well as the full rationale for concluding that relying on the study is

crucial to protection of public health.

[FR Doc. 05-18010 Filed 9-8-05; 9:19 am]

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