So far we have come up with several possible 'solutions' that our bill would implement. These are:
Animal Use Cap - NJ would have a yearly(?) quota of animals available for research use and institutions would bid for use of these animals. A review board would be created to judge institutions based on certain criteria
More strict universal IACUC standards - currently the penalties for failing an annual IACUC review are not very strong.
Increasing demand for domestically produced primates - it is currently more expensive to purchase a domestically produced primate than it is to purchase an imported one. We could include subsidies for domestic producers or stiffer tarriffs for importers to make domestic producers more competitive
One thing we really need to work on is demonstrating what we find as a "problem" with current policies and practice to convince legislators that our solutions are worthwhile - this is what we should focus on - Kelsey is going to post a link to a government website showing some of the current legislation and I think we should look further into current legislation.
Another strategy is looking up institutions' IACUC policies online - most likely universities - and checking those published policies for inconsistencies and how they mirror the Good Lab Practices publication
This is Brett by the way bfield@eden.rutgers.edu - just in case you lost it
Also, we tentatively agreed to continue meeting face to face each Friday at 10am in the regular classroom. Please let the group know of any objections to this or scheduling conflics and we can figure out another time
The most relevant legislation is the Animal Welfare Act. A link to the outline is: http://www.aphis.usda.gov/animal_welfare/awr.shtml
Parts of particular interest to us would be: *Part 2 subpart C--Research Facilities *Part 3 subpart D--Specifications for the Humane Handling, Care, Treatment, and Transportation of Nonhuman Primates
Another site of interest might be the Animal Law section of the NABR site: http://www.nabr.org/AnimalLaw/index.htm
Something I found through the nabr site under bills introduced during the current congressional session: Legislation Introduced to Treat Non-Human Primates as Prohibited Wildlife under the Lacey Act On January 16, Reps. Eddie Bernice Johnson (D-TX) and Rob Simmons (R-CT) introduced a bill (HR 1329) to amend the Lacey Act amendments of 1981 to include non-human primates as prohibited wildlife. While the text of the bill was not available at press time, the 1981 amendments to the Lacey Act make it illegal to import, export, transport, or trade in fish, wildlife and plants taken or possessed in violation of federal, state or tribal law. The interstate or foreign trade in fish and wildlife taken or possessed in violation of foreign law also is illegal under the Act. Read the full text of HR 1329 (pdf) or check its status.
another resource that might be useful is the Environmental Enrichment for Primates Database: http://www.awionline.org/SearchResultsSite/enrich.aspx
If you have any questions I will try to check the blog but the best way to reach me is by email.
Since institutions are required to document the number of animals acquired and used in approved research activities, we could further examine how this is done and ways to better track those numbers to avoid overuse of primates in the lab.
** Administrative linkage of animal acquisitions in retrospect to IACUC approval numbers is the primary mechanism used to track animal usage in research.
** There is also a simple automated data processing system which alerts an operator and generates a report when a preset percentage has been reached. The report is submitted to an investigator with a request to provide a rationale if they anticipate the number of animals required will exceed the approved number set by IACUC standards
Info from: http://grants.nih.gov/grants/olaw/references/faq_labanimals1997.htm
Conclusion: From my perspective, more strict regulations should be set and a rationale to seek further approval should not even be an option. Once the preset percentage is reached, the institution/facility should be placed on some sort of a close surveillance to avoid them exceeding the preset limit.
Another flaw in the system is that an institution/laboratory facility can choose the number of animals used which is limited to the appropriate number of primates needed to acquire valid results, satisfied by PHS Policy requirement. I believe thatregardless of the number of animals believed to be used in order to obtain valid results, one strict regulation should be implemented and established based on the primate breed used and their reproductive potential.
Animal Welfare Act Overview The major federal law covering chimpanzees and other select nonhuman species in US laboratories is the Animal Welfare Act (AWA). Enacted in 1966, it was amended four times in subsequent decades. (1) Among other things, the law includes: • Minimum animal husbandry and veterinary care requirements • Required annual USDA inspections • Penalties for facilities failing to correct non-complaint items • Required oversight committees (Institutional Animal Care and Use Committee or IACUC). However, provisions such as these and others in the law are riddled with problems. The AWA does not adequately protect chimpanzees and other animals used for research. Even the NIH admits that adherence is “… primarily through voluntary compliance.” (2)
Info obtained from: http://www.releasechimps.org/harm-suffering/myth-of-humane-treatment/animal-welfare-act-overview/
Conclusion: We could have AWA set stricter regulations to protect the use of chimpanzees and other primates for research.
“Some IACUCs are not effectively monitoring research facilities.” The audit stated: “As a result, the facilities are not conducting research in compliance with the AWA or, in some cases, not providing humane conditions for research animals.” (25) The report noted that despite its previous reports highlighting IACUC issues, the number of research facilities cited for violations has steadily increased in recent years. (26) IACUC failures An IACUC review is supposed to be an objective third-party check on the welfare of the animals involved in experiments. However, the potentially biased nature of these committees allows business and scientific interests to compete with concerns for the pain and suffering of the animals. The potential for bias and other flaws in IACUC reviews include: Committees are typically comprised of employees of the facility – often researchers themselves. Since all members are appointed by the facility’s CEO, they could be less likely to support a decision that may conflict with the status quo. • Having researchers make decisions that would restrict the work of their peers could place additional pressure on them to acquiesce. • While one “non-affiliated” member is to represent the concerns of the general public, this member is also chosen by the CEO. If this member opposes a protocol, he or she can be out-voted by the other members. • The chairman has the authority to have only ONE qualified member review a protocol unless a full review has been requested. “That person shall review the activities and has the authority to approve, require modifications, or request a full committee review of the activities.” • The bi-annual evaluations of the facility and animals must include any minority views, (29) but these reports are not publicly accessible unless the facility is federally owned. (30) • If AWA violations at the facility are found, the report of the violation goes on file with the institution. Only if the problem is not corrected is the matter reported to APHIS. If the IACUC is part of a private institution or business, the public does not have access to these internal violation reports. The major loophole: “exemptions” for science While the AWA provides requirements for the care of animals in research, it allows IACUCs and researchers to make “exemptions” as they deem necessary for the needs of the experiment. This may involve such things as keeping an animal in prolonged isolation or withholding food or water for a specified period. The most disturbing of these possible exemptions involves bypassing regulations to minimize an animal’s pain and distress. The AWA allows for the withholding of tranquilizers, anesthesia, analgesia, or euthanasia “when scientifically necessary.” (31) Such exemptions are allowed when “specified by research protocol.” (32)
What is HLS? Huntingdon Life Sciences is the 3rd largest CRO in the world and the largest animal testing facility in all of Europe. HLS has 3 facilities: 2 in England and 1 in the U.S. HLS’s only U.S. site is in New Jersey called the “Princeton Research Center.” How many animals does HLS use? HLS kills approximately 180,000 animals every year, or 500 per day. Average numbers of specific animals are as follows (yearly):
Dogs (2600); Cats (400); Rodents (132,894); Rabbits (5106); Fish (10,300); Birds (7800); Primates (1700); (OUR MAIN FOCUS) other animals (19200). These figures were obtained by averaging out the number of animals listed in USDA reports and other published reports from other overseers and government regulatory agents, over the past few years. Federal Laws: (1) The Laws that protect “lab animals” are limited in the United States. Although the AWA (Animal Welfare Act) is cited to provide legal protection to lab animals, it was not specifically designed for lab animals. Instead the AWA provides minimum protection for all animals, including non-human primates.
Additionally, the AWA merely regulates adequate food, water, housing, exercise, and veterinary care; it places no restrictions whatsoever on what can be done to animals during actual experiments. The following provision ensures this: “Nothing in these rules, regulations, or standards shall affect or interfere with the design, outline, or performance of actual research or experimentation by a research facility as determined by such research facility.” SO RESTRICTIONS REGRADING EXPERIMENTATION SHOULD BE INCLUDED IN OUR BILL. Furthermore, under the Animal Welfare Act rats, mice, birds, fish, and farm animals (which comprise 85-90% of the animals used in “research” are not considered animals and hence are not afforded even the minimal protection of the AWA. WE COULD INCLUDE PROTECTION OF THESE ANIMALS AS WELL BUT OUR MAIN FOCUS WILL BE NON_HUMAN PRIMATES. (2) Beyond the Animal Welfare Act, animals in laboratories are also afforded the “protection” of Institutional Animal Care and Use Committees, or IACUC’s Federal requires Institutional Animal Care and Use Committee (IACUC) to ‘oversee and evaluate all aspects of the institution's animal care and use program,‘. In fact, Federal law requires that only one member of an institution’s IACUC must be an individual not officially affiliated with the institution; no laws exist requiring that any IACUC member not be an animal researcher her/himself. THUS, WE COULD INCLUDE IN OUR BILL THAT MEMBERS OF IACUC SHOULD NOT PREVIOUSLY BEEN OR CURRENTLY BE AN ANIMAL RESEARCHER OR IN AFFILIATION WITH ANY ANIMAL INSTITUTION OR LABORATORY FACILITY OUTSIDE OF WORK-RELATED RESPONSIBILITIES. Who are HLS's customers? HLS is a contract lab and, hence, will test any product on any animal for any reason for any company who has enough money to pay them. However, there are some companies known to be regular customers of HLS. Information on HLS's customers is known largely from documents released during the undercover investigations inside HLS. http://www.insidehls.com/faq.htm CONTAINS OF LIST OF HLS’S CUSTOMERS.
I read the gmails from Dobbs, Long, and Colon and saw the comments by Laguer and Field. I like where you are going with it. If you are putting a bill together to require vaccinations (or whatever), find a legislator that may have an interest in it - doesn't need to be in NJ - this is a federal issue - so you could go to anyone with it. Prepare a cover letter to that/those legislator(s), provide justification of your bill (the backgroung info that I read in your emails), and a proposed bill if you have one. Come as a group to class sometime between9:15 and noon with a hard copy of the above. After speaking with you, you can put it online.
6 comments:
OK Guys here is a recap of our meeting today:
So far we have come up with several possible 'solutions' that our bill would implement. These are:
Animal Use Cap - NJ would have a yearly(?) quota of animals available for research use and institutions would bid for use of these animals. A review board would be created to judge institutions based on certain criteria
More strict universal IACUC standards - currently the penalties for failing an annual IACUC review are not very strong.
Increasing demand for domestically produced primates - it is currently more expensive to purchase a domestically produced primate than it is to purchase an imported one. We could include subsidies for domestic producers or stiffer tarriffs for importers to make domestic producers more competitive
One thing we really need to work on is demonstrating what we find as a "problem" with current policies and practice to convince legislators that our solutions are worthwhile - this is what we should focus on - Kelsey is going to post a link to a government website showing some of the current legislation and I think we should look further into current legislation.
Another strategy is looking up institutions' IACUC policies online - most likely universities - and checking those published policies for inconsistencies and how they mirror the Good Lab Practices publication
This is Brett by the way
bfield@eden.rutgers.edu - just in case you lost it
Also, we tentatively agreed to continue meeting face to face each Friday at 10am in the regular classroom. Please let the group know of any objections to this or scheduling conflics and we can figure out another time
Thanks!
The most relevant legislation is the Animal Welfare Act. A link to the outline is:
http://www.aphis.usda.gov/animal_welfare/awr.shtml
Parts of particular interest to us would be:
*Part 2 subpart C--Research Facilities
*Part 3 subpart D--Specifications for the Humane Handling, Care, Treatment, and Transportation of Nonhuman Primates
Another site of interest might be the Animal Law section of the NABR site:
http://www.nabr.org/AnimalLaw/index.htm
Something I found through the nabr site under bills introduced during the current congressional session:
Legislation Introduced to Treat Non-Human Primates as Prohibited Wildlife under the Lacey Act
On January 16, Reps. Eddie Bernice Johnson (D-TX) and Rob Simmons (R-CT) introduced a bill (HR 1329) to amend the Lacey Act amendments of 1981 to include non-human primates as prohibited wildlife. While the text of the bill was not available at press time, the 1981 amendments to the Lacey Act make it illegal to import, export, transport, or trade in fish, wildlife and plants taken or possessed in violation of federal, state or tribal law. The interstate or foreign trade in fish and wildlife taken or possessed in violation of foreign law also is illegal under the Act.
Read the full text of HR 1329 (pdf) or check its status.
another resource that might be useful is the Environmental Enrichment for Primates Database:
http://www.awionline.org/SearchResultsSite/enrich.aspx
If you have any questions I will try to check the blog but the best way to reach me is by email.
Since institutions are required to document the number of animals acquired and used in approved research activities, we could further examine how this is done and ways to better track those numbers to avoid overuse of primates in the lab.
** Administrative linkage of animal acquisitions in retrospect to IACUC approval numbers is the primary mechanism used to track animal usage in research.
** There is also a simple automated data processing system which alerts an operator and generates a report when a preset percentage has been reached. The report is submitted to an investigator with a request to provide a rationale if they anticipate the number of animals required will exceed the approved number set by IACUC standards
Info from: http://grants.nih.gov/grants/olaw/references/faq_labanimals1997.htm
Conclusion: From my perspective, more strict regulations should be set and a rationale to seek further approval should not even be an option. Once the preset percentage is reached, the institution/facility should be placed on some sort of a close surveillance to avoid them exceeding the preset limit.
Another flaw in the system is that an institution/laboratory facility can choose the number of animals used which is limited to the appropriate number of primates needed to acquire valid results, satisfied by PHS Policy requirement.
I believe thatregardless of the number of animals believed to be used in order to obtain valid results, one strict regulation should be implemented and established based on the primate breed used and their reproductive potential.
Animal Welfare Act Overview
The major federal law covering chimpanzees and other select nonhuman species in US laboratories is the Animal Welfare Act (AWA). Enacted in 1966, it was amended four times in subsequent decades. (1)
Among other things, the law includes:
• Minimum animal husbandry and veterinary care requirements
• Required annual USDA inspections
• Penalties for facilities failing to correct non-complaint items
• Required oversight committees (Institutional Animal Care and Use Committee or IACUC).
However, provisions such as these and others in the law are riddled with problems. The AWA does not adequately protect chimpanzees and other animals used for research. Even the NIH admits that adherence is “… primarily through voluntary compliance.” (2)
Info obtained from: http://www.releasechimps.org/harm-suffering/myth-of-humane-treatment/animal-welfare-act-overview/
Conclusion: We could have AWA set stricter regulations to protect the use of chimpanzees and other primates for research.
“Some IACUCs are not effectively monitoring research facilities.”
The audit stated: “As a result, the facilities are not conducting research in compliance with the AWA or, in some cases, not providing humane conditions for research animals.” (25) The report noted that despite its previous reports highlighting IACUC issues, the number of research facilities cited for violations has steadily increased in recent years. (26)
IACUC failures
An IACUC review is supposed to be an objective third-party check on the welfare of the animals involved in experiments. However, the potentially biased nature of these committees allows business and scientific interests to compete with concerns for the pain and suffering of the animals.
The potential for bias and other flaws in IACUC reviews include:
Committees are typically comprised of employees of the facility – often researchers themselves. Since all members are appointed by the facility’s CEO, they could be less likely to support a decision that may conflict with the status quo.
• Having researchers make decisions that would restrict the work of their peers could place additional pressure on them to acquiesce.
• While one “non-affiliated” member is to represent the concerns of the general public, this member is also chosen by the CEO. If this member opposes a protocol, he or she can be out-voted by the other members.
• The chairman has the authority to have only ONE qualified member review a protocol unless a full review has been requested. “That person shall review the activities and has the authority to approve, require modifications, or request a full committee review of the activities.”
• The bi-annual evaluations of the facility and animals must include any minority views, (29) but these reports are not publicly accessible unless the facility is federally owned. (30)
• If AWA violations at the facility are found, the report of the violation goes on file with the institution. Only if the problem is not corrected is the matter reported to APHIS. If the IACUC is part of a private institution or business, the public does not have access to these internal violation reports.
The major loophole: “exemptions” for science
While the AWA provides requirements for the care of animals in research, it allows IACUCs and researchers to make “exemptions” as they deem necessary for the needs of the experiment. This may involve such things as keeping an animal in prolonged isolation or withholding food or water for a specified period.
The most disturbing of these possible exemptions involves bypassing regulations to minimize an animal’s pain and distress.
The AWA allows for the withholding of tranquilizers, anesthesia, analgesia, or euthanasia “when scientifically necessary.” (31) Such exemptions are allowed when “specified by research protocol.” (32)
What is HLS?
Huntingdon Life Sciences is the 3rd largest CRO in the world and the largest animal testing facility in all of Europe. HLS has 3 facilities: 2 in England and 1 in the U.S.
HLS’s only U.S. site is in New Jersey called the “Princeton Research Center.”
How many animals does HLS use?
HLS kills approximately 180,000 animals every year, or 500 per day. Average numbers of specific animals are as follows (yearly):
Dogs (2600);
Cats (400);
Rodents (132,894);
Rabbits (5106);
Fish (10,300);
Birds (7800);
Primates (1700); (OUR MAIN FOCUS)
other animals (19200).
These figures were obtained by averaging out the number of animals listed in USDA reports and other published reports from other overseers and government regulatory agents, over the past few years.
Federal Laws:
(1) The Laws that protect “lab animals” are limited in the United States. Although the AWA (Animal Welfare Act) is cited to provide legal protection to lab animals, it was not specifically designed for lab animals. Instead the AWA provides minimum protection for all animals, including non-human primates.
Additionally, the AWA merely regulates adequate food, water, housing, exercise, and veterinary care; it places no restrictions whatsoever on what can be done to animals during actual experiments. The following provision ensures this: “Nothing in these rules, regulations, or standards shall affect or interfere with the design, outline, or performance of actual research or experimentation by a research facility as determined by such research facility.”
SO RESTRICTIONS REGRADING EXPERIMENTATION SHOULD BE INCLUDED IN OUR BILL.
Furthermore, under the Animal Welfare Act rats, mice, birds, fish, and farm animals (which comprise 85-90% of the animals used in “research” are not considered animals and hence are not afforded even the minimal protection of the AWA.
WE COULD INCLUDE PROTECTION OF THESE ANIMALS AS WELL BUT OUR MAIN FOCUS WILL BE NON_HUMAN PRIMATES.
(2) Beyond the Animal Welfare Act, animals in laboratories are also afforded the “protection” of Institutional Animal Care and Use Committees, or IACUC’s Federal requires Institutional Animal Care and Use Committee (IACUC) to ‘oversee and evaluate all aspects of the institution's animal care and use program,‘. In fact, Federal law requires that only one member of an institution’s IACUC must be an individual not officially affiliated with the institution; no laws exist requiring that any IACUC member not be an animal researcher her/himself.
THUS, WE COULD INCLUDE IN OUR BILL THAT MEMBERS OF IACUC SHOULD NOT PREVIOUSLY BEEN OR CURRENTLY BE AN ANIMAL RESEARCHER OR IN AFFILIATION WITH ANY ANIMAL INSTITUTION OR LABORATORY FACILITY OUTSIDE OF WORK-RELATED RESPONSIBILITIES.
Who are HLS's customers?
HLS is a contract lab and, hence, will test any product on any animal for any reason for any company who has enough money to pay them. However, there are some companies known to be regular customers of HLS. Information on HLS's customers is known largely from documents released during the undercover investigations inside HLS. http://www.insidehls.com/faq.htm CONTAINS OF LIST OF HLS’S CUSTOMERS.
I read the gmails from Dobbs, Long, and Colon and saw the comments by Laguer and Field. I like where you are going with it. If you are putting a bill together to require vaccinations (or whatever), find a legislator that may have an interest in it - doesn't need to be in NJ - this is a federal issue - so you could go to anyone with it. Prepare a cover letter to that/those legislator(s), provide justification of your bill (the backgroung info that I read in your emails), and a proposed bill if you have one. Come as a group to class sometime between9:15 and noon with a hard copy of the above. After speaking with you, you can put it online.
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