Input: [ID] 459 [Entry Date] 04/23/2011 at 12:27:16 PM [Affiliation] Self [Comments]

Output: Comment 1: I echo the concerns of my colleagues over the increased regulatory burden caused by the new version, without adequate justification. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. Many of these will result in higher costs to grants and to institutions. Most significantly, Restrictions against using animals in multiple procedures surely increases the number of animals needed. This goes in the wrong direction, in that logic would dictate that it is most ethical to reduce the numbers of animals used in research. Mandatory requirements for new cage sizes for rodent breeding will require large expenditures, which is not adequately justified. In summary, I recommend that the NIH not adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs. Comment 2: Given the concerns outlined above, an opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 460 [Entry Date] 04/23/2011 at 12:42:42 PM [Affiliation] Self [Comments]

Output: Comment 1: This current effort that seems largely driven by the unwarranted notion that somehow dire change is needed, while insufficient evidences are offered supporting this status, is frankly frustrating. Once again, caring scientists who treat animals with the utmost respect are being characterized unfairly in a manner opposite to the evidence. What is missing, it seems to me, is a healthy dose of reasonableness that slips right out the window once bureaucratic mandates come down on the scientific community. Already, decisions about research progress are being made for researchers by veterinarians using simplistic and presumptive rules of thumb regarding pain management, animal housing requirements, feeding restrictions, drug use, and general items of care while the contrary evidence is scoffed at. Why listen to the collected wisdom of researchers who have worked with animals in the very conditions they propose for years when presumptions can be made that seem reasonable based on whether a human being "might" be uncomfortable under similar conditions? How has the value of simply observing animals in the conditions proposed to see if any signs of distress arise been so thoroughly demoted? Mostly, the rapport that doctoral and medical practitioners once had with the veterinary staff, which used to be one of mutual support of the goals related to animal research, seems to be eroding into increasing challenges, terribly long deliberations, and the minutia of paperwork that is already having a significantly diminishing impact on research progress. This seems totally backwards. People within the business of preclinical research who we would all think would want to help promote it, are consistently disrupting it by introducing stronger arm legislation such as what is easily found throughout this document. There are obvious cases during the course of some more invasive research where social housing makes absolutely no sense. When researchers can just explain this, and reasonable people are at the helm, easy accommodations can be made. There are also other obvious cases where certain analgesics will have an interfering effect on, and easily confound, research efforts even in protocols where no evidence for pain or distress have ever arisen... but the mandate precludes reasonableness. In my humble opinion, this is going to destroy the business of saving lives or improving human lives for no good reason. No good evidence for the increased burden this document represents has been put forward, and yet we are supposed to swallow it whole. A huge impact will result on the jobs of my fellow admirable human beings who simply wish to explore the principles of health at a reasonable and permissible cost. Smaller universities will not be able to bear the burden and excellent research programs that train our Americans and bring new minds into the field of biological health will be shut down. Comment 2: Implementing this plan onto the backs of any institution in its current form seems to be a recipe for an unbearable burden for many smaller universities. While it may be a decision worth discussing whether to simply eliminate the smaller players, this will come at a huge cost to progress in the science of medicine. Big institutions are already concerned, at a time when grant funding is becoming increasingly challenging to procure, about the bottom line that defines whether scholarly research should be a part of the program. Shuffling of positions while trying to bear the burden of all the extra paperwork and regulation, and being forced to purchase new housing when evidence that the older housing is insufficient is incredibly weak, and other of the mandated changes are implemented will be an unwarranted slap to institutions that are currently able to contribute to this area.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 461 [Entry Date] 04/23/2011 at 01:18:53 PM [Affiliation] Self [Comments]

Output: Comment 1: My primary reaction is that this would take us a giant step forward toward consuming so much of an investigator's time in compliance, that there will be little time left for actual conduct of the research. As an initial comment, let me state that our IACUC already views every 'should' as a 'must' in the Guide, and that the paperwork and regulatory burden is already much higher than needed with the current Guide. I have made the statement at my institution that there have been enormous increases in paperwork burden and compliance requirements, without a single increase in actual animal welfare. I stand by this statement, and, at my institution, this would hold for the proposed new Guide. There are a number of particulars, a few of which include: Design considerations,which a number of older institutions cannot comply with, but IACUCs will mightily attempt to do so. At my institution, the transition zones between animal housing, animal testing, and student offices are murky, and we had a very long battle with the IACUC over whether personnel must wear booties, with many changes per day and enormous cost, when transition zones are not clear. Many older, smaller facilities, cannot comply with new requirements, which are clearly geared toward very large, centralized facilities. A net effect of the new Guide would be to drive many smaller facilities, and their investigators, out of business. A new mandate for PPE. Availability, training, and choice should be sufficient. Many rodent researchers judge that they do not require much in the way of PPE. Under the guide, all would be required to wear what the IACUC judges. Much more in the way of paperwork requirements, such as a disaster plan, etc. Extension of the requirements to fish; not my issue, but for investigators with a few aquaria, this is hugely burdensome. The issue of 'pharmaceutical grade' chemicals for use in animals. A huge number of investigational drugs are not available in this formulation, and the paperwork requirements for review would be burdensome. Elaboration of requirements for enrichment, food/water restriction, etc. And the list goes on. I strongly urge that the proposed Guide be scrapped, and that a new effort, not piggybacking on earlier versions and adding more restrictions, be initiated. The focus of the new version should be on actually protecting the welfare of animals, WITHOUT adding tons of additional compliance burden which does little for animal welfare. It should also differentiate MUCH more clearly between primates, for which a good bit of the current Guide may be appropriate, and species such as rodents. leaving the differentiation to an IACUC imposes primate-level requirements on rodent researchers. As a final comment, let me give you a single example of the impact of existing guidelines and implementation. For context, I chaired our IACUC for 20 years, and I am at what has recently become a Carnegie I institution. For me, the burden of compliance has already become so great that I just announced that I am discontinuing funding efforts and leaving animal research, and that is only partly as a result of our IACUC's imposition of a three month salary fine upon me for 'unauthorized transport of a rat'. IACUCs already have [and use] the power to make life miserable for researchers and students. The improvement in animal welfare [noted above as negligible], is simply not worth the enormous investment in compliance time and associated aggravations. A likely effect of adoption of the much-expanded Guide would be to drive many researchers out of animal research. Comment 2: I am fine with the notion of semiannual program and facility evaluation, but I am NOT fine with using the proposed revision of the Guide as the basis for that.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 462 [Entry Date] 04/23/2011 at 02:46:19 PM [Affiliation] Self [Organization City and State] Philadelphia, Pa [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 463 [Entry Date] 04/23/2011 at 03:17:25 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 464 [Entry Date] 04/23/2011 at 05:56:40 PM [Affiliation] Self [Comments]

Output: Comment 1: I do not think that NIH should adopt the 8th edition of the Guide because of numerous controversial items and obvious inconsistencies. Additional time is needed to allow for commentary from the scientific community and the resulting editing of the 8th edition that will result from such commentary. Just one example of the problems associated with the 8th edition of the guide are the substantial increase in costs to conduct basic research that will result. These increases will be seen on both the researcher and oversight sides of the overall research enterprise. Given the current global economic climate, oversight committees related to animal research should be trying to identify ways in which research can be done in a less expensive manner while still protecting the health and safety of the animals. Furthermore, many of the proposed changes related to repeated testing and multiple surgical procedures will result in increased animal usage which is absolutely contrary to the mission that many researchers have engaged in for their entire careers (i.e., the attempt of researchers to reduce the number of animals used while still maintaining statistical power for their data analysis). Comment 2: I do not think that the first inspection for which researchers will be accountable to the standards of the 8th edition of the Guide should occur by 3/31/2012. Given that researchers do not have the ability to modify their budgets to accommodate a situation, such as this, that will alter the way in which they conduct research by adding considerable expenses, I believe that if the Guide is adopted, the first inspection utilizing the Guide should not occur for at least 5 years given that the typical duration of an R01 is 5 years.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 465 [Entry Date] 04/23/2011 at 08:38:42 PM [Affiliation] Self [Comments]

Output: Comment 1: I do not approve of the proposed revision of the Guide for the Care and Use of Animals.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 466 [Entry Date] 04/23/2011 at 10:26:19 PM [Affiliation] Self [Comments]

Output: Comment 1: NIH should NOT adopt the eight edition. Comment 2: March 31, 2012 is too soon. I vote to extend it to 2015.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 467 [Entry Date] 04/24/2011 at 12:39:42 AM [Affiliation] Self [Comments]

Output: Comment 1: I do not think it's necessary to change the Guide, Since We don't know if this increase or decrease the health and wellbeing of animals. Also I do not think it is good for the mice and the pups to change cages soon after delivery.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 468 [Entry Date] 04/24/2011 at 10:08:51 AM [Affiliation] Self [Comments]

Output: Comment 1: I do not think it is a good idea to adopt the new Guide as policy governing federally funded research. With the new guidelines there will be an increase in the authority of local Institutional Animal Care and Use Committees, expense of research and paperwork to conduct it. Not all of these recommendations/changes are based on empirical research,they just seem to be a burden to researchers. As a student in an animal research lab this is disheartening. Currently I am learning how to apply behavioral principles in teaching a goldfish to push a soccer ball. Our school did not have an animal lab, but one ambitious professor started a lab at our school with his own money in hopes to demonstrate to the school an animal lab would be a great investment. If the new guidelines were in place, with the increase in the cost of research, this would not have been a possibility. The school is now considering providing funding for such a project! Making the guidelines to begin research too stringent would discourage animal research, which ultimately leads to human research. Have guidelines that reasonable and in the best interest to the animal. Comment 2: I think institutions should have more time to get ready for the changes to the guidelines. At least 3-5 years is enough time to restructure each animal lab's structure to accommodate for attending programs and facility evaluations.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 469 [Entry Date] 04/24/2011 at 10:16:16 AM [Affiliation] Self [Comments]

Output: Comment 1: Areas of concern include: (1) the requirement to use pharmaceutical grade chemicals or justify lack of availability, when there is no clear definition of pharmaceutical grade and when most drugs used for research purposes are not available in clinical preparations (where pharmaceutical grade ratings are typically used) and, even if available, may be produced in preparations inappropriate for research use in laboratory animals; (2) major increases in research costs for inadequately justified increases in cage sizes as well as for the mandate for daily monitoring of both food and fluid of all animals receiving one or the other restriction; (3) restrictions against multiple survival surgeries that are necessary for certain types of empirical research questions (e.g., when conducting surgery to implant a replacement hormone pellet after gonadectomy, mandating the conduct of the 2 surgeries at the same time would result in inappropriate, unphysiologically high hormone levels during the initial post-surgical period). The changes provided in the Guide clearly provide additional constraints to the exercise of scientific and professional judgment of investigators and will add significantly to the paperwork burden of investigators and IACUCs. The new Guide also oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., DEA and OSHA). Comment 2: I concur with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document" as defined by the OMB which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more..." Therefore, a meaningful opportunity to comment is necessary before a decision on Guide adoption and implementation strategy can be made.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 470 [Entry Date] 04/24/2011 at 11:03:16 AM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 471 [Entry Date] 04/24/2011 at 12:01:46 PM [Affiliation] Organization [Organization Name] ASPET [Organization City and State] Bethesda, Maryland [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 472 [Entry Date] 04/24/2011 at 12:21:12 PM [Affiliation] Self [Comments]

Output: Comment 1: Do NOT Adapt. Comment 2: Oppose.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 473 [Entry Date] 04/24/2011 at 03:32:43 PM [Affiliation] Self [Comments]

Output: Comment 1: I could not identify the scientific justification for some of the requirements specified in the new guidelines (e.g., cage sizes, food restriction regimens, etc.). In the absence of a clear rationale for these changes, I recommend that we NOT adopt the guidelines as currently proposed. Comment 2: Given the broad-based nature of the changes being proposed, their associated expense AND the lack of scientific justification, I recommend that we postpone the date by which these guidlines will go into effect. If nothing else, we should try to empirically identify the best practices related to some of the contentious issues in the guidelines and that will take some time.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 474 [Entry Date] 04/24/2011 at 03:38:45 PM [Affiliation] Self [Comments]

Output: Comment 1: I oppose adoption of the 8th edition of the Guide. Additional time is needed to revise the guidelines based on feedback from the scientific community. Implementing the 8th edition of the Guide will substantially increase the costs of conducting basic biomedical research. These increases will result from the more intricate rules and procedures proposed -- MANY OF WHICH DO NOT INCREASE ANIMAL HEALTH AND WELL-BEING -- that both researcher and already overburdened IACUC's will struggle to implement. Given the current global economic climate and the steadily climbing costs of R&D in health care, we SHOULD be determining ways in which animal research can be done more efficiently and inexpensively -- NOT THE OPPOSITE. The current Guide is more than sufficient in terms of ensuring health and well-being of animal subjects. Furthermore, many of the proposed changes related to repeated testing and multiple surgical procedures will result in INCREASED ANIMAL USAGE which is absolutely contrary to efforts to decrease the numbers of animals used in research. Comment 2: If the 8th edition is adopted, institutions and researchers will need at least FIVE YEARS -- not ONE -- to implement and evaluate. Unless Congress is prepared to underwrite the costs of this undertaking using American taxpayer dollars WITHIN THE NEXT YEAR (i.e., to hire more people to engage in oversight, and to support all U.S. NIH-funded researchers with supplements to their grants), it will be an exercise in futility.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 475 [Entry Date] 04/24/2011 at 04:33:44 PM [Affiliation] Organization [Organization Name] Temple University [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 476 [Entry Date] 04/24/2011 at 05:41:14 PM [Affiliation] Self [Organization City and State] Arlington, TX [Comments]

Output: Comment 1: While endorsing the overall intentions of the proposed guidelines for the care of non-human research animals, I recommend retaining the 1996 Guide as PHS policy. The proposed guidelines will unnecessarily increase the difficulty and cost of conducting research using non-human research animals and incorporate some important and potentially costly requirements that are not based upon empirical research (e.g., re. cage size, food and liquid restriction). Comment 2: If the proposed 2011 guidelines are to be implemented as PHS policy, in order to allow ample time for research programs to accommodate the necessary physical plant and equipment changers and expenses, implementation should be delayed until 2015. The current financial limitations and exigencies of many research programs make allowed time beyond 2012 very important.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 477 [Entry Date] 04/24/2011 at 05:41:50 PM [Affiliation] Self [Comments]

Output: Comment 1: There is no need for a new set of rules. This new set will simply require much more time, money and effort to do what is unnessary. There is no evidence that the changes requested will improve the state of the animals. In fine, one gets the feeling that this is all being done to interfere with ongoing research.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 478 [Entry Date] 04/24/2011 at 07:13:33 PM [Affiliation] Self [Organization Name] University of Arkansas for Medical Sciences [Organization City and State] Little Rock, AR [Comments]

Output: Comment 1: With new NIH funding at an all-time low, and existing grants subject to substantial administrative reductions, ANY policy changes that incur new unmet costs must be exhaustively scrutinized, and must meet the HIGHEST STANDARDS of need and justification. A large and quantifiable benefit to animal welfare MUST be shown in order to justify the harm that will inevitably be done to human disease-related research. In the absence of strong scientific justification for such benefit (which is currently lacking), implementation of these proposals should be delayed indefinitely.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 479 [Entry Date] 04/24/2011 at 08:55:22 PM [Affiliation] Self [Organization City and State] Eleva, WI [Comments]

Output: Comment 1: No. Do not adopt the 8th edition of the Guide. Retain the 1996 Guide as PHS policy. Comment 2: If the new policy is adopted (I do not support this), I recommend at least 4 years given the expenses involved with changes imposed by the Guide.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 480 [Entry Date] 04/24/2011 at 09:09:51 PM [Affiliation] Self [Comments]

Output: Comment 1: I received notice that the 8th edition of the "Guide for the Care and Use of Laboratory Animals" was in consideration for adoption as policy only on April 20. When I first saw a copy of the new Guide I thought that it had been thoroughly vetted and was adopted for use. Now I find that not only is it not adopted but, in fact, I had only a few days to respond. My Easter Sunday three-day celebration was seriously interfered with in order to prepare this response to the questions you ask. I have served on an IACUC for a total of 21 years. So I have seen changes that were accepted by the research community in order to better their research. However, there has not been such an upheaval of established procedures in these changes until now. The following are the main points of my response. 1. First, the existing draft of the 8th edition SHOULD NOT be adopted as PHS Policy in the proposed schedule. The proposed changes are so invasive but subtle that more time is needed to thoroughly comprehend the changes by researchers and digest their impact on the research community in the USA. 2. The 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies CONSTRAIN the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. These will add significantly to the cost which grants must pay and to their institutions. This comes at a time when grants are being decreased both in money and numbers. 3. Requirements for new cage sizes for some species (particularly rodent breeding) and for social housing of all species will require large expenditures. Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" are examples of items requiring additional IACUC staffing and researcher effort. We don't as yet know what these requirements are. 4. A major change in the Guide is the introduction of cautions against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries. This echoes a newly introduced caution against animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. These restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral research. 5. Further, the Guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating, "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." Thus for the first time, the Guide appears to want to step into the regulation of agricultural and invertebrate animals. 6. There are imprecise wording in this draft which needs to be straightened out before researchers are sure of the implications of this draft. 7. The Guide under consideration is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." 8. In CONCLUSION, this version of the Guide is not ready for acceptance and SHOULD NOT be accepted. It contains many statements that are not clear for their implementation. Researchers strapped for research funds will be hard pressed to put these rules into use. Comment 2: The date of March 31, 2012 in entirely TOO EARLY. By that time the Guide may not be accepted and if it is, IACUCs will not have time to change their policies.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 481 [Entry Date] 04/24/2011 at 09:50:18 PM [Affiliation] Self [Comments]

Output: Comment 1: I vote against adopting the new Guide as policy. I recommend maintaining adherence to the 1996 Guide. Comment 2: Given the expense of a variety of cage size and housing requirements during this time of great financial difficulty for research institutions, I recommend waiting at least 4 years (e.g., 2015).

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 482 [Entry Date] 04/24/2011 at 10:21:34 PM [Affiliation] Self [Comments]

Output: Comment 1: Do not adopt this "revised" Guide. I know other colleagues will point out specific deficiencies (and there are many), but I would like to make a larger point. I serve on multi-institutional committees, internal committees, etc., and I do have an appreciation for the necessity for rules and policies, but as a practicing scientist in a challenging financial environment, I am also sensitive to "bureaucracy creep". This adds unnecessary burdens to scientific research while yielding little to nothing to benefit animal welfare, which is already at a high standard. This is unnecessary and burdensome and should be rejected. Comment 2: Current procedures and guidelines are adequate. This guide does little to improve on exisiting procedures. This guide should be rejected. (e.g., "leave well enough alone")

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 483 [Entry Date] 04/24/2011 at 11:15:43 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The NIH should NOT adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals. Many of the recommendations contained in the 2011 Guide are not based on empirical scientific evidence (e.g., cage sizes, food & liquid restriction) and would seriously impede or delay progress in scientific research that will benefit the public health. In addition, most recommendations will require significant, costly alterations for institutions and investigators. For example, there is no evidence that pharmaceutical-grade drugs would improve animal welfare. Moreover, research would be impeded because commercially available pharmaceutical-grade formulations are often single concentrations that make it difficult or impossible to manipulate drug dose or to compare different vehicles. Using pharmaceutical-grade drugs will also increase the cost of pharmacological research. Some nonhuman primates live for more than 25 years, and repeated measures are often necessary to answer important research questions using longitudinal designs. Constraints on multiple procedures in animals will make such studies increasingly difficult to complete. Further, repeated surgeries are often necessary to repair or prolong the life of surgically implanted experimental devices. Decreasing the number of manipulations permitted with individual animals will increase the total number of animals used in biomedical research. Paired housing of nonhuman primates, as recommended in the 2011 Guide, would place animals at risk for injury and death. Aggression in response to any surprise (a novel noise, person, pain, etc.) may lead the dominant member of the pair to attack/kill the weaker or more submissive cage mate. Studies that require implantation of any device such as an IV catheter to evaluate medication effectiveness could not be conducted. Further, researchers using nonhuman primates go to great lengths to provide various types of "enrichment" to the animals (i.e., toys, mirrors, food, etc). Comment 2: Implementation of any changes to the 1996 Guide should be delayed for at least five years to allow the NIH to gather scientific evidence to support or to refute the many questionable recommendations proposed in the 2011 Guide update.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 484 [Entry Date] 04/24/2011 at 11:42:11 PM [Affiliation] Self [Comments]

Output: Comment 1: There is not adequate justification for supplanting the 1996 Guide as PHS Policy and that there are numerous problems with the new Guide as federal policy. The 8th edition represents a significant departure from the 7th. Although it includes much new information, it also incorporates new policies in a number of areas. Of particular concern to is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echos a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Although OLAW has published a similar set of statements on its website in recent years, the status as enforceable PHS Policy has been controversial due to their de novo introduction of the topic as an answer to a "Frequently Asked Question," (i.e., no previously published PHS Policy nor the Guide had addressed use of drugs in research). No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of, first, the USDA/APHIS Policy 3, an interpretive rule for use of pharmaceutical grade "medications" to prevent pain/distress in the conduct of research; and second, the NIH policy for its intramural program on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement has made clear that Policy 3 is interpreted to require use of commercially prepared solutions, rather than those prepared by investigators; the first sentence of the new Guide section on this topic is consistent with this view. Yet the NIH policy defines "pharmaceutical grade" drugs as those manufactured according to USP standards, thus accommodating the practice of preparation of drug solutions in the laboratory. Yet even that intramural NIH Policy ignores the fact that the NIDA drug supply program, which has been operating to supply compounds to funded researchers for decades, does not prepare to USP standards, because they are unnecessary for research purposes. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Yet, as with other sections, the contradictions in guidance were not recognized by those who published the 2011 Guide. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify their use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the intrusion of the new Guide into second-guessing scientific and professional judgment of experts in their fields of research. This represents only one of many examples of greater burdens on the IACUC, and by extension staff, imposed by new requirements. Comment 2: I concur with NABR that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 485 [Entry Date] 04/25/2011 at 12:00:40 AM [Affiliation] Self [Comments]

Output: Comment 1: No. These guidelines don't seem to have any scientific rationale, but they will really hamper research by adding a lot of administrative burden that has no benefit to the animals. These guidelines look to me like they are intended to function for the slow strangulation of animal research. Remember that we have options: Many of us can leave the U.S. and work in other countries that are becoming more conducive to research, while the U.S. is steadily making itself a less inviting place.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 486 [Entry Date] 04/25/2011 at 09:06:55 AM [Affiliation] Organization [Organization Name] West Chester University [Organization City and State] West Chester, Pennsylvania [Comments]

Output: Comment 1: I vote AGAINST adoption. The new Guide is nearly twice as long as the 1996 version, and contains a great deal of new policy that promises to significantly increase a) the expense of research, b) the paperwork burden on researchers, and c) the authority of local IACUCs to restrict already peer-reviewed research. And while some of the new recommendations are based on empirical research, many are not (e.g., cage sizes, food and liquid restriction). Although only federally funded research is currently at issue, because the OLAW standards set the compliance agenda for all IACUCs, it is only a matter of time before the more stringent regulatory standards trickle down to even small-scale animal research and teaching programs. Comment 2: Because of the extent and complexity of proposed new requirements if adoped, I recommend at least 4 years (e.g., 2015)for compliance given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 487 [Entry Date] 04/25/2011 at 09:32:04 AM [Affiliation] Self [Comments]

Output: Comment 1: I am AGAINST adoption of the new edition of the Guide for the Care and Use of Laboratory Animals (Guide). My objection stems from a number of new sections added to this version. Of particular concern is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding) and mandatory requirements for social housing of all species (without leeway for practical constraints - animal fighting, illneess, etc.) will require large expenditures of funds to accomplish. In addition, the newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It fails to acknowledge the critical importance of collaborations by chemists with researchers to develop new therapeutic drugs or formulations. It is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Furthermore, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. Even the intramural Policy ignores that the NIDA drug supply program and other standard sources do not prepare to USP standards, as these have more to do with documenting drug manufacture than drug quality. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation. This new regulation is burdensome and expensive without benefit to animal welfare or science. Comment 2: Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. We currently have annual renewals, repeated training sessions, and online continuing eduation. These new policies question professional judgment and add significantly to the paperwork burden for investigators and IACUCs.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 488 [Entry Date] 04/25/2011 at 09:43:30 AM [Affiliation] Self [Comments]

Output: Comment 1: I am writing about the changes in the "Guide" regarding husbandry for mice. The requirement it proposes to provide more space per mouse, and per dam and her litter, would be very costly. Considering the current debate over the budget in Washington this could not come at a worse time.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 489 [Entry Date] 04/25/2011 at 10:10:36 AM [Affiliation] Self [Comments]

Output: Comment 1: There are several problems with the proposal. The most absurd change I find is a requirement to use 'pharmaceutical grade' drugs to animals. There is no evidence that the 'lesser' are harmful, and the pharmaceutical hike up the cost of doing business with little rationale. The whole regulatory process has become absurd...our good judgment is constantly usurped by some regulatory body whose intentions may be good, but whose bureaucratic execution is a nightmare, costing taxpayers much more money than need be and as a result of researcch overhead, making a serious cut in how much research ever gets funded. For what? I can't think of anything that I do today that I didn't do 25 years ago...I just get a boatload of forms to fill out, and everything cost more (oh, and I can't give my animals toys, because they can't be sterilized, or they might harm themselves playing with a ball!). I doubt if the average taxpayer would be in favor of a 'purpose-bred' anything if they knew how much it hikes the cost of animals..and for purposes that still escape me (I'd grant some Class B suppliers were not taking care of the animals...but, there's a true regulatory issue...where was the government on that one?). Instead of more regulatation, the group needs to look at the big picture. At any university, you have smart people. Lord knows, you have enough 'compliance' and 'ethics' programs to choke anyone...yet, despite this 'education', the policy is to trust nobody, and increase cost to the taxpayer in terms of research dollar, both on the grant given, and the grant that was never given because bureacracy on the grant given took money away needlessly. Comment 2: one per year is enough. This reminds me...One reason I came back to grad school was because I was working in a facility for the mentally 'challenged' in MA ...my 'job' was to evaluate the IQ and psychological well-being of the 'resident', and make recommendations for progress over the next year. I'd then go to a meeting with a social worker, education specialist, occupational therapist, physical therapist, and physician where we'd all make our report. These reports were 'required' and the government had funds for these reports which were nearly always the same year after year. But, nothing ever happened. Nearly none of the changes recommended were implemented, because there was no money for that ...just the 'report'.....year after year after year...

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 490 [Entry Date] 04/25/2011 at 10:13:33 AM [Affiliation] Self [Comments]

Output: Comment 1: The new edition guide should be adopted and implemented with no delay. If anything it did not go far enough regarding environmental enrichment for all species, social housing, and run size for NHP. Comment 2: The new edition guide should be adopted and implemented with no delay. If anything it did not go far enough regarding environmental enrichment for all species, social housing, and run size for NHP.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 491 [Entry Date] 04/25/2011 at 11:07:49 AM [Affiliation] Self [Comments]

Output: Comment 1: I am AGAINST the adoption of the new edition of the guide. Comment 2: I concurs with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 492 [Entry Date] 04/25/2011 at 11:13:39 AM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 493 [Entry Date] 04/25/2011 at 11:29:19 AM [Affiliation] Self [Comments]

Output: Comment 1: I do recommend that the NIH adopt the eigth edition of the Guide. Comment 2: I think that this timeline is acceptable as long as IACUC can accept reasonable plans for implementation. Institutions should not be required to immediately implement some of the new requirements, such as the cage requirements for breeding mice.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 494 [Entry Date] 04/25/2011 at 11:39:37 AM [Affiliation] Self [Comments]

Output: Comment 1: Do not adopt the eight edition. It requirements will hamper scientific research with no clear benefit to animal's welfare.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 495 [Entry Date] 04/25/2011 at 11:42:24 AM [Affiliation] Self [Comments]

Output: Comment 1: I vote against the 8th edition of the guide for care of laboratory animals. Comment 2: Were the changes to be accepted, I recommend at least four years delay (2015) for full compliance given that this is a time of great financial difficulty for institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 496 [Entry Date] 04/25/2011 at 11:55:27 AM [Affiliation] Self [Organization Name] West virginia University [Comments]

Output: Comment 1: I have one comment regarding the new Guide and this relates to the avian cage sizing description. It lists 0.8 sq ft per pigeon. Pigeons escape predation by out flying predators. I note that I've seen pigeons housed for 20 years (+) where the caging does not allow normal wing use (e. g. flapping exercise or flight) although the individual housing area exceeds 0.8 sq ft. To me, flapping is a normal behavior of flighted bird species in general, and pigeons in particular. Galliformes do much more running than flying when given the choice, so the guidelines might be more applicable to them. The USDA has a policy for bats that they be exercised in a flight to retain flying ability. While birds seem to retain their flight capabilities a bit more easily than bats, the Guide does little to explicitly address this issue. For example, the new version alludes to quality space, but provides no real guidance in this regard, especially when it is considered that a large number of birds may be used in long-term psychological studies where enrichment and group housing are disallowed for scientific reasons over months or even years. I have personally observed birds moved from smaller to larger cages become more responsive, active and to start flapping as regular exercise when adequate space is provided. For White Carneau pigeons, this is means providing at least 1 area dimension of ~30 inches. In any case, the difference in regulatory treatment between birds (PHS) and bats (USDA) seems like an inherent inconsistency for flighted species.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 497 [Entry Date] 04/25/2011 at 12:24:05 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however, the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 498 [Entry Date] 04/25/2011 at 12:28:10 PM [Affiliation] Self [Comments]

Output: Comment 1: I am against the adoption of the eight edition of the Guide for the Care and Use of Laboratory Animals because its adoption will decrease the scientific impact of research related to the study of the central nervous system. Comment 2: I am against this proposed implementation plan.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 499 [Entry Date] 04/25/2011 at 12:44:40 PM [Affiliation] Self [Comments]

Output: Comment 1: Although it includes much new information, the new Guide also incorporates new policies in a number of areas. Of particular concern is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echoes a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Although OLAW has published a similar set of statements on its website in recent years, the status as enforceable PHS Policy has been controversial due to their de novo introduction of the topic as an answer to a "Frequently Asked Question," (i.e., no previously published PHS Policy nor the Guide had addressed use of drugs in research). No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of, first, the USDA/APHIS Policy 3, an interpretive rule for use of pharmaceutical grade "medications" to prevent pain/distress in the conduct of research; and second, the NIH policy for its intramural program on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement has made clear that Policy 3 is interpreted to require use of commercially prepared solutions, rather than those prepared by investigators; the first sentence of the new Guide section on this topic is consistent with this view. Yet the NIH policy defines "pharmaceutical grade" drugs as those manufactured according to USP standards, thus accommodating the practice of preparation of drug solutions in the laboratory. Yet even that intramural NIH Policy ignores the fact that the NIDA drug supply program, which has been operating to supply compounds to funded researchers for decades, does not prepare to USP standards, because they are unnecessary for research purposes. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Yet, as with other sections, the contradictions in guidance were not recognized by those who published the 2011 Guide. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify their use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the intrusion of the new Guide into second-guessing scientific and professional judgment of experts in their fields of research. This represents only one of many examples of greater burdens on the IACUC, and by extension staff, imposed by new requirements. Comment 2: I concur with NABR that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 500 [Entry Date] 04/25/2011 at 12:58:25 PM [Affiliation] Self [Comments]

Output: Comment 1: The idea that "human-grade" pharmaceuticals be required for animal research is not nessary, nor desirable as such a requirement will hamper, rather than promote research in addition to being expensive. I am all for improving the conditions for husbandry but sometimes keeping animals in single cages is the only way of controlling the study. The same goes for water and/or food restriction. Comment 2: These guidelines should be discussed much more before implementation. Thus, in my view 2012 is way too early.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 501 [Entry Date] 04/25/2011 at 03:02:19 PM [Affiliation] Self [Comments]

Output: Comment 1: This letter is submitted in response to the National Institutes of Health's solicitation of comments concerning the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in the Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). Note that I am a Diplomate of the American College of Laboratory Animal Medicine (ACLAM) and make these comments as an individual. ACLAM is the AVMA-recognized veterinary specialty organization that represents veterinarians certified as Diplomates in laboratory animal medicine. I acknowledges that the Guide is the premier guidance document promoting animal welfare and compliance while supporting the animal-based research community. I do not support adoption of the new Guide in its present form. I is concerned that the new space recommendations for breeding mice are not supported by scientific literature, will have little-to-no measurable benefit on animal welfare, and yet will have a significant financial impact on animal care and use programs. These costs will be passed on to the investigators or will otherwise negatively impact research output. During the pre-publication review period, several organizations including ACLAM commented that minimal cage size requirements for rodents presented in Table 3.2 of the Guide appeared to be adopted from Annex II of the European Directive with a modification. The table in Annex II stipulates that mouse cages should provide 330 cm2 for "breeding," and clarifies breeding "for a monogamous pair (inbred/outbred) or a trio (inbred)." Table 3.2 in the new Guide however, calls for a minimum of 51 in2 (330 cm2) for a female plus litter plus 15 in2 (96.7 cm2) for each additional average sized adult mouse. The clarification language present in Annex II is absent in the Guide. Consequently, standard mouse cages used by facilities throughout the US are not large enough to house some rodent pairs (male and female) and all trios (one male, 2 females) typically maintained together for breeding purposes. If language could somehow be added back to Table 3.2 in the Guide, to allow for mouse trio breeding using existing cage sizes, I would fully endorse NIH's adoption of the Guide. In the final version an asterisk was added to Table 3.2 with the related note: "* The interpretation of this table should take into consideration the performance indices described in the text beginning on page 55." However, this edit lacks the desired clarity since the discussion on performance indices does not provide any examples of trio paradigms and concludes with a statement that reads, "space recommendations presented here….should be considered the minimum for animals housed under conditions commonly found in laboratory animal facilities". Moreover, one "frequently asked question" (FAQ) published on OLAW's website leads us to believe that the flexibility of institutions to use performance based standards to develop and implement a policy to house mice in configurations that result in less space than stipulated in the Guide is limited. Specifically, the FAQ states that, "Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable (http://grants.nih.gov/grants/olaw/faqs.htm#f10). It is important to note the authors of the Guide provide no scientific justification for the increased cage size requirement and, in fact, describe as insufficient, the information that is available to delineate space and housing needs of laboratory species. Contrast this to the significant body of science supporting current breeding densities and paradigms in the US (see references below). By implementing the mouse breeding recommendations in the Guide, PHS-assured institutions will be forced to purchase additional cages or larger cages for breeding pairs and trios, which may require the purchase of additional racks, and in many instances, the construction of additional rooms to accommodate the increases. Bedding costs will increase and the number of males used in breeding programs will also increase because one male can no longer service two females. This last point runs counter to the 3Rs approach to animal welfare. According to data supplied to the National Association for Biomedical Research by the Laboratory Animal Breeders Association initial capital outlay to accommodate these change will cost ~500 million dollars, with annual increased operating expenses of ~150 million dollars. Alternatively, researchers would be forced to scale back breeding populations of mice, thereby limiting research. If the Guide were adopted by the NIH, PHS-assured institutions would be forced to spend hundreds of millions of dollars to fully comply. These costs would be passed on to the investigators in the form of increased charges which would negatively impact their ability to maintain their currently level of productivity. Increasing the cost of doing animal based research without solid scientific evidence that such increases are needed or will benefit animal welfare is not consistent with the NIH's goal "to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research." References J Whitaker, SS Moy, V Godfrey, J Nielsen. Effects of cage size and enrichment on reproductive performance and behavior in C57BL/6Tac mice. Lab Animal, 2009. Laber K, Veatch L, Lopez M, Lathers D. The Impact of Housing Density on Weight Gain, Immune Function, Behavior, and Plasma Corticosterone Levels in BALB/c and C57Bl/6 Mice." JAALAS, 2008. 47(2): 16-23. O'Malley J, Dambrosia JM, Davis JA. Effect of housing density on reproductive parameters and corticosteron levels in nursing mice. J Am Assoc Lab Anim Sci., 2008. Mar;47(2): 9-15. J Whitaker, SS Moy, BR Saville, V Godfrey. The effect of cage size on reproductive performance and behavior of C57BL/6 mice. Lab Animal, 2007 Smith, AL, et al. Effects of housing density and cage floor space on three strains of young adult inbred mice. Comp Med, 2005. Aug 55(4): 368-76. Smith, AL, et al. Effects of housing density and cage floor space on C57BL/6J mice. Comp Med, 2004. Dec 54(6): 656-63. McGlone et al. Floor space needs for laboratory mice: BALB/cJ males or females in solid-bottom cages with bedding. Contemporary Topics, 2001. C. K. Reeb-Whitaker, B. Paigen, W. G. Beamer, R. T. Bronson, G. A. Churchill, I. B. Schweitzer & D. D. Myers. The impact of reduced frequency of cage changes on the health of mice housed in ventilated cages. Laboratory Animals, 2001. (35): 58-73. Eveleigh JR. Murine cage density: cage ammonia levels during the reproductive performance of an inbred strain and two outbred stocks of monogamous breeding pairs of mice. Lab Anim., 1993 Apr; 27(2): 156-60

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 502 [Entry Date] 04/25/2011 at 03:18:44 PM [Affiliation] Self [Comments]

Output: Comment 1: No- NIH should not adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. There is a lack of empirical data to indicate that these new regulations will enhance animal welfare.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 503 [Entry Date] 04/25/2011 at 03:38:56 PM [Affiliation] Self [Comments]

Output: Comment 1: NIH should not adopt the 8th edition of the Guide and should strongly recommend that the Guide, as it now stands, be fully reconsidered. Comment 2: All implementation plans should be stopped until a number of provisions in the new guide can be reconsidered. It should not be adopted in its presnt form.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 504 [Entry Date] 04/25/2011 at 03:47:35 PM [Affiliation] Self [Comments]

Output: Comment 1: This new version of the Guide absolutely should not be adopted. Many changes from the previous version are substantial, prohibitive and completely unjustified. As one example the required use of pharmaceutical grade chemicals is based on nothing, is completely unnecessary, will stifle science, will end careers because of undue burden, and will eventually cost peoples' lives. Additional restrictions on mild food restriction are similarly without reasonable basis and read like they were written by a bureaucrat who doesn't understand the purpose and benefit of basic scientific research. More study and justification are necessary before the new rules in the new Guide are adopted, and frankly they should never be. Comment 2: It seems to me that OLAW should allow a minimum of four more years for institutional compliance with the new Guide to allow for the collection of relevant data (see comment 1).

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 505 [Entry Date] 04/25/2011 at 03:51:15 PM [Affiliation] Organization [Organization Name] University of Utah [Organization City and State] Salt Lake City, UT [Comments]

Output: Comment 1: No it should not. It is not clear what the basis is for the extensive list of revisions made in this Guide. As per the report (NOT-OD-07-016) issued by the working group convened in 2006 to evaluate public comment in reply to the request (NOT-OD-06-011) for such comment on updating the animal welfare standards in the guide. Given the recommendations of that working group (NOT-OD-07-016), the justification for the extensive revisions made in the current Guide is unfounded. In addition to making changes/revisions beyond those put forth by the working group as reflecting the public comment submitted at that time, the new Guide clearly goes beyond the traditional role of the Guide to serve as that--a guide for institutions, verterinarians, and scientific investigators to use to promote animal welfare. Rather, it contains new policies and requirements that will necessitate considerable burdens in terms of financial and paperwork requirements and restrictions on research design and the exercise of scientific judgement on the part of federally supported investigators and institutions. These burdens are being put in place with absolutely no apparent documentation supporting the contention that implementation of such policies will promote animal welfare. Comment 2: First, as noted above, the 8th edition as currently written should NOT be adopted for the reasons noted above. However, if it is adopted, given the considerable financial and paperwork burden it will impose on individual investigators and institutions, the date for required institutional compliance should be NO EARLIER than March, 2015. In the meantime, data supporting the policy revisions to be required should be collected by the NIH to justify the proposed changes.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 506 [Entry Date] 04/25/2011 at 04:35:40 PM [Affiliation] Self [Comments]

Output: Comment 1: As per request, I hereby submit my comments on the proposed Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition First of all, let me state that the Guide for the Care and Use of Laboratory Animals is an excellent document that serves as a very useful resource to use when communicating to the facilities management personnel as to what requirements we have for our animal program. It is concise and effective as a communication tool and has served us well in the past. However, one of the changes in the Guide will cause significant economic hardship to our research program if implemented. Our animal facility has recently purchased a very large number of racks and cages for a recently expanded facility. We have an active mouse breeding program with dozens of different strains of transgenic mice. Many of the mice are difficult to breed because of sub-optimal maternal skills in the breeders. Despite the difficulties in producing sufficient litters of pups from these lines of mice, we have managed to keep our program operating through the careful monitoring of breeding trios. Once pregnancies have been established, we find that fecundity is increased by leaving both mothers with pups together in the same cage until it is time to wean the litters. When one mother exhibits poor/aberrant nursing behavior the other frequently will supply the necessary intervention to properly raise the pups. In the Environment, Housing and Management section of the guide on page 57 TABLE 3.2, Recommended Minimum Space for Commonly Used Laboratory Rodents Housed in Groups states that Female+Litter space requirements are 51 in² floor space per Female+Litter. Therefore, under the new guidelines our rodent cages would need to have 102 in² bottoms to house two litters. Unfortunately our new rodent cages only have 78 in² bottoms which are more than sufficient to house five adult mice. Our animal care staff is very good about performing extra cage changes to prevent any cage sanitation issues, and this SOP is a very important part of our breeding program. I would hate to have a requirement in the guide that would be detrimental to our breeding program by requiring us to house only one litter per cage, but I can't see us purchasing new cage racks and cages just because we are a few square inches short of what has been "suggested" as appropriate in the guide. I am quite certain that there are many other institutions that have the same caging that we use and so this will be a big issue for many facilities. Perhaps the wording could be changed to allow for additional operational controls such as more frequent cage changes be an acceptable alternative? As our accrediting agencies will expect us to adhere to the standards as set forth in the guide, these considerations are very important to us. Comment 2: If the restrictions on minimum space allocation for rodent breeding are addressed as outlined in the comments above, I would have no problem with implementing the guide by March 31, 2012. If the restrictions stand as is, we would be unable to meet this deadline.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 507 [Entry Date] 04/25/2011 at 04:56:16 PM [Affiliation] Organization [Organization Name] University of Utah [Organization City and State] Salt Lake City, UT [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however, the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 508 [Entry Date] 04/25/2011 at 06:26:09 PM [Affiliation] Self [Comments]

Output: Comment 1: I understand that one proposal is to mandate the use of pharmaceutical-grade chemicals ("when available, for all animal-related procedures") and that use of non-pharmaceutical-grade substances would need to be described and justified in IACUC protocols. I wonder if this is advantageous given the limited evidence that using pharmaceutical grade drugs would improve animal welfare or science. In addition adjustment of dose could be problematic since pharmaceutical grade drugs are single concentration formulations.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 509 [Entry Date] 04/26/2011 at 10:48:52 AM [Affiliation] Self [Comments]

Output: Comment 1: Given the many and significant changes in the Guide, I believe it is premature to adopt this 8th edition without more opportunity for consideration, comment and revision. I am a former member of ILAR Council and have served on a variety of ILAR committees, including the committee that produced the 1996 Guide. Accordingly, I have both experience and perspective on this matter. Rather than a set of guidelines, the 8th edition is highly prescriptive with significantly increased directives that will increase the burden on researchers, IACUCs and animal care staff and administration without evidence that animal welfare will be improved. I am very disappointed in this ILAR product, which seems to have ignored the principle of evidence as a basis for moving forward. Comment 2: The changes, directives and significantly increased "should" and "must" in the new Guide make it unreasonable to implement it without further comment and consideration, which will certainly not be completed in a timely and careful way any too soon. In my opinion, because of the many new 'required' changes and including imposition of engineering standards for new cage sizes,the current Guide should be the basis of continuing oversight rather than implementing a flawed and imperfect new Guide.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 510 [Entry Date] 04/26/2011 at 11:11:40 AM [Affiliation] Self [Comments]

Output: Comment 1: I vote against adopting the new guide as policy, and would rather maintain adherence to the 1996 guide. Many of the new proposed guidelines, in my opinion, will increase the expense of already costly research, add to the paperwork burden placed on researchers, and restrict scientific creativity by giving more authority to local IACUCs on already peer-reviewed research. I am dissatisfied with the recommendations that are not empirically based such as cage sizes, food and liquid restrictions. Comment 2: I would recommend at least four years, given the expense of a variety of cage size and housing requirements at a time of great financial difficult for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 511 [Entry Date] 04/26/2011 at 11:12:55 AM [Affiliation] Self [Comments]

Output: Comment 1: Please DO NOT ADOPT this guide until it has been: (1) streamlined and (2) vetted to ensure that it fairly balances the need for protection of laboratory animals with the need to minimize paperwork and burden on research institutions, particularly smaller regional and local Universities. Comment 2: DO NOT require programs to use this updated version until it has been streamlined and represents an IMPROVEMENT over the current Guide. Let's ensure that this is a step forward for all parties rather than adding another chunk of paperwork.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 512 [Entry Date] 04/26/2011 at 11:22:45 AM [Affiliation] Self [Organization Name] Savannah State University [Organization City and State] Savannah, GA [Comments]

Output: Comment 1: I vote against adopting the new Guide as policy. Please maintain adherence to the 1996. Comment 2: I am in favor recommending at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 513 [Entry Date] 04/26/2011 at 11:24:15 AM [Affiliation] Self [Organization Name] California State University, Los Angeles [Organization City and State] Los Angeles, CA [Comments]

Output: Comment 1: I am opposed to adopting the eighth edition of the Guide and recommend retaining the 1996 policy. Comment 2: If adopted I would recommend extended the compliance date to march, 2015.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 514 [Entry Date] 04/26/2011 at 11:27:24 AM [Affiliation] Self [Comments]

Output: Comment 1: It appears to me that the proposed guidelines will markedly increase the cost of research without improving the treatment of animals used in research. I recommend that the 1996 "Care and Use" guide be retained as the basis for evaluation of institutional programs.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 515 [Entry Date] 04/26/2011 at 11:38:49 AM [Affiliation] Self [Comments]

Output: Comment 1: I vote against adopting the new guide as policy. Comment 2: The deadline for full compliance that is proposed in the Federal Register is March 31, 2012. I recommend at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 516 [Entry Date] 04/26/2011 at 11:44:48 AM [Affiliation] Organization [Organization Name] Central Washington Unviersity [Organization City and State] Ellensburg, WA [Comments]

Output: Comment 1: As a scientist I applaud the efforts to maintain the highest levels of care for animals in research. There are a number of specific concerns, however, with the latest version of the Guide. To begin with, the new Guide is nearly twice as long as the 1996 version, and contains a great deal of new policy that promises to significantly increase a) the expense of research, b) the paperwork burden on researchers, and c) the authority of local IACUCs to restrict already peer-reviewed research. And while some of the new recommendations are based on empirical research, many are not (e.g., cage sizes, food and liquid restriction). Although only federally funded research is currently at issue, because the OLAW standards set the compliance agenda for all IACUCs, it is only a matter of time before the more stringent regulatory standards trickle down to even small-scale animal research and teaching programs. It is for these reasons that I vote against adopting the new Guide as policy. Comment 2: I recommend at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 517 [Entry Date] 04/26/2011 at 12:50:57 PM [Affiliation] Self [Comments]

Output: Comment 1: I vote against adopting the eighth edition of the "Guide for Care and Use of Laboratory Animals" as policy. Comment 2: If the 2011 Guide is adopted as PHS policy, I recommend that at the deadline be at least 4 years (2015) for compliance by research institutions to the new policy.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 518 [Entry Date] 04/26/2011 at 01:34:37 PM [Affiliation] Self [Organization Name] OHSU [Organization City and State] Portland, Oregon [Comments]

Output: Comment 1: As this will directly affect the already hard to pay animal costs for biomedical research, more time is needed to obtain quality input as to which guidelines might need to be updated if any. Comment 2: Before a more thorough interaction has taken place with all involved parties, it seems premature to incorporate recommendations as basis of new guidelines. Again, if the end result is simply even higher per diem costs it will harm the public who is benefitting from this research as well as the biomedical researchers and the institutes they work at.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 519 [Entry Date] 04/26/2011 at 01:40:39 PM [Affiliation] Self [Comments]

Output: Comment 1: vote against adopting the new Guide as policy Comment 2: recommend at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 520 [Entry Date] 04/26/2011 at 03:50:00 PM [Affiliation] Self [Comments]

Output: Comment 1: The newly added Guide requirement to use pharmaceutical grade drugs in research involving rodents is neither necessary nor practical, in part, because the definition of "pharmaceutical grade" is not provided. Further and more importantly, appropriate measures (e.g., the use of sterile saline or other vehicles, filtering drug solutions where appropriate, etc.) are already utilized routinely by laboratories, and I am not aware of any data demonstrating that such procedures lead to negative consequences. For this and many other reasons (e.g., including the new requirements for cage sizes), I recommend NOT approving the proposed update of the Guide. Comment 2: This procedure would provide an unnecessary burden on the researchers and institutions. This, I recommend NOT approving this implementation plan.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals