EPA & Human Testing?
Page 1 of 1 [ 4 posts ]
18 Nov 2005, 4:41 am
Was unsure where to post this exactly.
From the EPA's webpage:
Quote:
EPA is proposing a rule for public comment, "Protections for Subjects in Human Research", (or PDF version, PDF, 409 KB, 30 pages) that will establish stringent enforceable ethical safeguards governing the conduct of third-party intentional dosing human studies intended for submission to EPA under the pesticide laws. EPA proposes to prohibit all new third-party intentional dosing research on pesticides with children and pregnant women intended for submission to EPA, and to prohibit EPA's conduct or support of any intentional dosing human studies involving pregnant women or children.
For any new, intentional dosing studies with pesticides, this proposal would require researchers to do the following:
comply with the requirements of the Common Rule (current ethical standards for research conducted or supported by the federal government); more information about the Common Rule.
submit detailed study protocols to EPA prior to initiation so that EPA can review them to ensure that the study meets the new ethical protections and is scientifically sound; and
once the study is conducted, provide detailed information to EPA describing how the study met the necessary ethical protections.
This proposed rule would also put in place standards that EPA would follow in determining whether to rely on human studies. The Agency is also proposing to establish a Human Studies Review Board to review study protocols and selected available studies. It is also important to note that the new protections would apply to pesticide intentional dosing studies conducted by EPA, those supported or sponsored by EPA, and those conducted by a pesticide manufacturer or other researchers for submission to EPA. The protections in the proposed rule are consistent with the recommendations from the National Academy of Sciences. EPA welcomes public input, and the proposal includes a ninety-day public comment period. How to comment.
For more information, see the Federal Register notice or the summary fact sheet on the proposed regulation.
Background on Human Testing
Over the years, scientific research with human subjects has provided much valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research, as well as scientific issues related to the role of such research in assessing risks.
Studies conducted by or supported by the federal government since 1991 must meet the ethical guidelines in the government-wide Common Rule (see EPA's 40 CFR 26 - Protection of Human Subjects). Studies conducted by third parties, including other governments or private industry/organizations, currently are not required to meet the Common Rule (although many do or adhere to other international ethical standards). EPA has used a variety of human data in its various regulatory programs. The major types of studies include: epidemiologic and occupational studies, clinical results, accident reports, surveys, and controlled human dosing experiments. More information about human studies. Various types of human studies have often been considered by program offices in their decisions (e.g., National Ambient Air Quality Standards, water quality criteria and drinking water standards, cleanup levels, and pesticide registration).
Implementation of the FY 2006 EPA Appropriations Act
On August 2, 2005 , the President signed into law the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Pub. L. No. 109-54 (Appropriations Act), which provides appropriated funds for the Environmental Protection Agency and other Federal departments and agencies. Section 201 of the Appropriations Act addresses EPA activities regarding intentional dosing human toxicity studies for pesticides as follows:
None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The Administrator shall allow for a period of not less than 90 days for public comment on the Agency’s proposed rule before issuing a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board. The final rule shall be issued no later than 180 days after enactment of this Act.
The Agency has carefully reviewed the new Appropriations Act provision. Consistent with its interpretation of the intent of Congress, rather than waiting for the beginning of FY 2006 (October 1, 2005), EPA is already discontinuing reliance on third-party, intentional human dosing toxicity studies in its decision-making under FIFRA and FFDCA.
Starting October 1, 2005, EPA will no longer accept and will discontinue all consideration of and reliance on third-party intentional dosing human toxicity studies for pesticides until a final rulemaking on human studies is issued. We expect this rulemaking to be accomplished by the end of January 2006, as directed by Congress.
Although the moratorium imposed by the Appropriations Act will require some adjustments to our existing schedules for risk assessment and regulatory decision-making, the Agency intends to make every effort to meet the Congressionally mandated deadline for reassessing all existing tolerances by August 3, 2006. The Agency is confident that actions necessary to ensure critical human health protections will not be delayed significantly.
EPA’s proposed human studies rule fulfills the requirements of this provision of the Appropriations Act, as explained in Unit XI of the preamble to the proposal.
The Agency has not conducted or supported any intentional dosing human toxicity studies for pesticides in the past; no such studies are in progress; and EPA has no intention to conduct them at any time in the future.
EPA is preparing additional materials to explain to people both inside and outside the Agency how the Agency is implementing this provision of the Appropriations Act and to ensure EPA’s full compliance with its requirements.
Recent Actions and Public Involvement
Over the last few years, public interest groups have raised concerns about the use of some third-party studies involving intentional dosing of humans to identify or quantify a toxic effect, particularly in the context of pesticide registration actions.
In December 2001, EPA asked the National Academy of Sciences (Letter to National Academy of Sciences) to advise the Agency on the many difficult scientific and ethical issues associated with the consideration of such human studies.
Also, in December 2001, EPA issued a press release stating that, among other things, while the NAS studied the issue, third-party intentional dosing studies conducted for the purpose of identifying or quantifying toxic effects would not be considered or relied on by the Agency in its regulatory actions, unless consideration of such data were legally required or necessary to protect public health.
In March 2002, the pesticide industry sued EPA over this approach, and the U.S. Court of Appeals for the District of Columbia Circuit ruled that EPA's interim approach was not established through required notice and comment rulemaking and should be vacated. In a June 2003 decision, the court stated that, as a consequence, "the agency's previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation."
In May 2003, EPA issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit comments on a proposed approach to developing criteria and standards for deciding on whether to consider various types of human subject research.
In February 2004, the National Academy of Sciences released its recommendations on the scientific and ethical issues posed by EPA's possible use of third-party studies that intentionally dose human subjects with toxicants to identify or quantify the effects of those toxicants.
In a February 2005 Federal Register notice the Agency has announced the initiatives it will undertake to evaluate and adopt, as appropriate, the recommendations it received from the National Academy of Sciences.
For any new, intentional dosing studies with pesticides, this proposal would require researchers to do the following:
comply with the requirements of the Common Rule (current ethical standards for research conducted or supported by the federal government); more information about the Common Rule.
submit detailed study protocols to EPA prior to initiation so that EPA can review them to ensure that the study meets the new ethical protections and is scientifically sound; and
once the study is conducted, provide detailed information to EPA describing how the study met the necessary ethical protections.
This proposed rule would also put in place standards that EPA would follow in determining whether to rely on human studies. The Agency is also proposing to establish a Human Studies Review Board to review study protocols and selected available studies. It is also important to note that the new protections would apply to pesticide intentional dosing studies conducted by EPA, those supported or sponsored by EPA, and those conducted by a pesticide manufacturer or other researchers for submission to EPA. The protections in the proposed rule are consistent with the recommendations from the National Academy of Sciences. EPA welcomes public input, and the proposal includes a ninety-day public comment period. How to comment.
For more information, see the Federal Register notice or the summary fact sheet on the proposed regulation.
Background on Human Testing
Over the years, scientific research with human subjects has provided much valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research, as well as scientific issues related to the role of such research in assessing risks.
Studies conducted by or supported by the federal government since 1991 must meet the ethical guidelines in the government-wide Common Rule (see EPA's 40 CFR 26 - Protection of Human Subjects). Studies conducted by third parties, including other governments or private industry/organizations, currently are not required to meet the Common Rule (although many do or adhere to other international ethical standards). EPA has used a variety of human data in its various regulatory programs. The major types of studies include: epidemiologic and occupational studies, clinical results, accident reports, surveys, and controlled human dosing experiments. More information about human studies. Various types of human studies have often been considered by program offices in their decisions (e.g., National Ambient Air Quality Standards, water quality criteria and drinking water standards, cleanup levels, and pesticide registration).
Implementation of the FY 2006 EPA Appropriations Act
On August 2, 2005 , the President signed into law the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Pub. L. No. 109-54 (Appropriations Act), which provides appropriated funds for the Environmental Protection Agency and other Federal departments and agencies. Section 201 of the Appropriations Act addresses EPA activities regarding intentional dosing human toxicity studies for pesticides as follows:
None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The Administrator shall allow for a period of not less than 90 days for public comment on the Agency’s proposed rule before issuing a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board. The final rule shall be issued no later than 180 days after enactment of this Act.
The Agency has carefully reviewed the new Appropriations Act provision. Consistent with its interpretation of the intent of Congress, rather than waiting for the beginning of FY 2006 (October 1, 2005), EPA is already discontinuing reliance on third-party, intentional human dosing toxicity studies in its decision-making under FIFRA and FFDCA.
Starting October 1, 2005, EPA will no longer accept and will discontinue all consideration of and reliance on third-party intentional dosing human toxicity studies for pesticides until a final rulemaking on human studies is issued. We expect this rulemaking to be accomplished by the end of January 2006, as directed by Congress.
Although the moratorium imposed by the Appropriations Act will require some adjustments to our existing schedules for risk assessment and regulatory decision-making, the Agency intends to make every effort to meet the Congressionally mandated deadline for reassessing all existing tolerances by August 3, 2006. The Agency is confident that actions necessary to ensure critical human health protections will not be delayed significantly.
EPA’s proposed human studies rule fulfills the requirements of this provision of the Appropriations Act, as explained in Unit XI of the preamble to the proposal.
The Agency has not conducted or supported any intentional dosing human toxicity studies for pesticides in the past; no such studies are in progress; and EPA has no intention to conduct them at any time in the future.
EPA is preparing additional materials to explain to people both inside and outside the Agency how the Agency is implementing this provision of the Appropriations Act and to ensure EPA’s full compliance with its requirements.
Recent Actions and Public Involvement
Over the last few years, public interest groups have raised concerns about the use of some third-party studies involving intentional dosing of humans to identify or quantify a toxic effect, particularly in the context of pesticide registration actions.
In December 2001, EPA asked the National Academy of Sciences (Letter to National Academy of Sciences) to advise the Agency on the many difficult scientific and ethical issues associated with the consideration of such human studies.
Also, in December 2001, EPA issued a press release stating that, among other things, while the NAS studied the issue, third-party intentional dosing studies conducted for the purpose of identifying or quantifying toxic effects would not be considered or relied on by the Agency in its regulatory actions, unless consideration of such data were legally required or necessary to protect public health.
In March 2002, the pesticide industry sued EPA over this approach, and the U.S. Court of Appeals for the District of Columbia Circuit ruled that EPA's interim approach was not established through required notice and comment rulemaking and should be vacated. In a June 2003 decision, the court stated that, as a consequence, "the agency's previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation."
In May 2003, EPA issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit comments on a proposed approach to developing criteria and standards for deciding on whether to consider various types of human subject research.
In February 2004, the National Academy of Sciences released its recommendations on the scientific and ethical issues posed by EPA's possible use of third-party studies that intentionally dose human subjects with toxicants to identify or quantify the effects of those toxicants.
In a February 2005 Federal Register notice the Agency has announced the initiatives it will undertake to evaluate and adopt, as appropriate, the recommendations it received from the National Academy of Sciences.
From a Newsletter published by the Organic Consumers Organization:
Quote:
ALERT: EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN
Send a letter to EPA here!
Forward this alert to friends and colleagues
Note: Concerns about Snopes or other questions are answered here
Friday, November 18, 2005
Public Comment Period for this rule 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 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:
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.
Parental consent forms are not necessary for testing on children who have been neglected or abused.
Chemical studies on any children outside of the U.S. are acceptable.
Send a letter to EPA 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: PDF --- HTML):
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(c) "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.)
Send a letter to EPA here!
Forward this alert to friends and colleagues
Note: Concerns about Snopes or other questions are answered here
Friday, November 18, 2005
Public Comment Period for this rule 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 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:
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.
Parental consent forms are not necessary for testing on children who have been neglected or abused.
Chemical studies on any children outside of the U.S. are acceptable.
Send a letter to EPA 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: PDF --- HTML):
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(c) "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.)
I know that's alot to digest, but what's your opinion on this?
Ladysmokeater
Veteran
Joined: 21 Oct 2005
Age: 47
Gender: Female
Posts: 1,048
Location: North of Atlanta, South of Boston, East of the Mississippi, and West of the Atlantic
19 Nov 2005, 11:24 pm
Sean wrote:
Why can't they just do the testing on prision inmates?
The Human Rights people would just Love that...
Might be an incentive, come to think about it, to not go to prison.
Imagine parents warning their kids...."Billy, now if you break the law and go to prison they will do medical experiements on you and you might end up with a third eye like your good for nothing uncle. I told him not to steal that car....."
But are there things we would WANT tested before its mass marketed?
