Input: [ID] 85 [Entry Date] 04/15/2011 at 10:25:12 AM [Affiliation] Self [Comments]

Output: Comment 1: The Eighth Edition of the Guide contains substantive changes and additions to the previous edition. The limited opportunity for comment was simply insufficient in terms of both time and substance. A meaningful process for public input should be required. As indicated in the supplementary background information in the subject Federal Register notice, since 1985, the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) has required that institutions receiving PHS support for animal activities base their animal care and use programs on the current edition of the Guide and comply, as applicable, with the Animal Welfare Act (AWA) and other Federal statutes and regulations relating to animal activities. The PHS Policy was authorized by the Health Research Extension Act of 1985 (P.L. 99-158; 42 U.S.C. 289d) and is incorporated by reference in a listing of "several other HHS policies and regulations" that apply to grants for research projects (42 C.F.R. 52.8 and 42 C.F.R. 52a.8). While the Guide itself is not included among the policies and regulations listed, it is specifically and repeatedly referenced in the PHS Policy. The Guide for the Care and Use of Laboratory Animals has been an essential laboratory animal welfare reference document since it was first published in 1963. The 2011 Guide includes new and expanded coverage of the ethics of laboratory animal use; components of effective animal care and use programs (regulations, policies and principles; program management; program oversight; disaster planning and emergency preparedness); housing, environment, and enrichment for terrestrial and aquatic animals; veterinary and clinical care as well as physical plant characteristics. The 2011 edition is over 200 pages, nearly double the length of its predecessor. It contains more than 40 statements about what institutions "must" do, including 29 newly-stated requirements. In addition, there are now approximately 660 recommendations incorporated in the Guide that PHS award seekers "should" do. The 2011 Guide (p. 8) defines "must" statements as "actions that are imperative and mandatory duty requirements." "Should" is said to mean "a strong recommendation for achieving a goal" noting that "individual circumstances might justify an alternative strategy." The current comment process which limits comments to 6,000 characters including spaces and requires comments be submitted by April 24, 2011 is simply insufficient to provide NIH with meaningful comments as to the impact of the Guide on institutional animal care and use programs. Based upon the input we have received from our members, their comments specifically on the recommended minimum cage sizes for rodents housed in groups as well as other provisions would far exceed this limit. When the comments are requested for the Guide under the requirements of OMB Bulletin No. 07-02: Final Bulletin for Agency Good Guidance Practices, no such limits should be in place. A. The new Guide will dramatically increase the cost of research animals. As previously expressed by the Laboratory Animal Breeders Association of North America in comments on the pre-publication version, the new Guide's breeding cage requirements will have a major impact on their businesses. They estimate their total initial capital investment for changes will be $494 million. Their recurring annual operating cost is calculated to be $155 million. These dramatic increases will be passed on in the form of higher research animal prices to their research institution customers, including the NIH intramural program. PHS grants as well as the NIH budget will be affected. B. PHS-assured institutions will incur increased costs for new caging and renovation of facilities. Many, if not most large research-intensive institutions, also breed laboratory rodents in-house. Based on a NABR inquiry, one large NIH grantee indicated the cost of the breeding cage change could range from $3 million to as much as $20 million depending on how the different cage sizes could be accommodated. Another estimated a cost of $6 million for retrofitting existing housing facilities. Some additional NABR member estimates were lower. However, the most common response was that officials simply have not had time to assess the best course of action and what the resulting expenses will be. NABR's concern is that, if even a portion of the more than 1,100 PHS-assured institutions are involved with rodent breeding, the capital investment required to continue their programs could be in the hundreds of millions of dollars. C. The new Guide will increase PHS grant expenses beyond the direct cost of laboratory animals. The cost of rats and mice will certainly increase as breeders pass on the additional cost of meeting the new recommendations for breeding cages. In addition, the per diem charged to principal investigators for animal care by PHS-assured institutions will increase. In order to meet these new recommendations, institutions will either need to change the existing caging systems or increase the number of cages in use, thereby increasing per diem charges. While the cost impact of addressing the many new and revised recommendations is unclear at this time, there are certain to be other costs associated with programmatic changes resulting from the new Guide that will be passed on to the investigators. D. Research capacity will be reduced. In order to comply with new cage sizes, some facilities will have no option but to reduce facility capacity. One member predicts the loss of 20-30% in breeding space capacity. Comment 2: There is insufficient scientific evidence for some revisions reflected in the new Guide. Scientific evidence is lacking for changes in at least one major subject, the "recommended minimum space" for animals by species (Tables 3.2 - 3.6). In the Preface of the 8th Edition, the Committee acknowledges that scientific information is insufficient when it comes to space and housing needs of laboratory species, yet still includes new recommendations that will have significant impact on the research community. While acknowledging that many variables must be considered when housing animals in the laboratory, the new Guide offers no justification from the scientific literature as to why minimum space recommendations have been changed and why specific increases in dimensions were selected. Because the minimum cage sizes are expressed in exact dimensions by species in the Guide, they amount to fixed engineering standards with which PHS-assured institutions must comply. While the 2 inch increase in the height of rabbit cages (Table 3.3) and several changes in non-human primate caging (Table 3.5) are a problem for some NABR members, it is the revision of minimum space for laboratory rodents (Table 3.2) that is causing the greatest concern. For the first time the new Guide indicates recommended space for a "Female + litter" for both rats and mice, specifying a floor area of 51 in2 (330 cm2) for the former housing group and 124 in2 (800 cm2) for the latter. This designation would exclude the current practice of housing rodent pairs (male and female) and trios (one male, 2 females) together continuously for breeding purposes in the standard cage used by most facilities. The new European Directive for the Protection of Animals Used in Scientific Procedures (2010/63/EU) indicates the same floor space requirements, but uses the term "breeding" cages for rodent pair/trio housing, thus permitting the practice of housing breeding pairs and trios in existing cages (See Attachment 1). Because the new Guide will require larger caging for standard breeding practices, PHS-assured institutions and NIH contractors will be faced with the prospect of replacing existing cages for breeding pairs and trios with larger cages. Further complicating the situation is the fact that the 2011 Guide states (p 60-61), "Floor space taken up by food bowls, water containers, litter boxes and enrichment devices (e.g. novel objects, toys, foraging devices) should not be considered part of the floor space." There are significant operational, logistical, physical plant and financial issues associated with these recommendations, which will be commented upon in more detail by individual institutions and commercial laboratory animal breeders. This rodent breeding cage issue was raised in comments on the pre-publication version of the Guide released in June 2010. The final version of the Eighth Edition published in January of this year, only added an asterisk to the title of 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." OLAW currently has a "frequently asked question" published on its website that leads us to believe that the flexibility of institutions to use performance based standards in determining a policy on cage size will be more limited than implied by the language beginning on page 55 of the Guide. The text of that posting appears below: May the IACUC approve deviations from the Guide for rodent (mice and rats) cage density? - OLAW supports the Guide's approach to applying performance standards to achieve specified outcomes, and expects institutions to use the Guide's engineering standards as a baseline. The Guide clearly states that the need for adjustments to the recommendations for primary space enclosures should be made at the institutional level by the Institutional Animal Care and Use Committee (IACUC) and should be based on performance outcomes. The Guide further identifies examples of performance indices to assess adequacy of housing, including health, reproduction, growth, behavior, activity, and use of space (Guide, pages 25-26). IACUC determinations of the need for adjustments in the space recommendations should be based on veterinary considerations or scientific justification relative to the nature of the protocol and its requirements. Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non-animal welfare considerations are not acceptable. IACUC approved deviations from the Guide must be clearly documented and reflect the scientific or veterinary justification relevant to the action. For example, the Guide notes that space allocations should be reviewed and modified as necessary to address individual housing situations and animal needs such as prenatal and postnatal care. One way to address housing for maternally dependent litters of mice and rats is to consider them as single entities with their parent(s) until the pups begin actively moving about the cage, at which point multiple parental/litter groups should then be housed according to housing conditions recommended in the Guide. Adoption of the new Guide as planned by OLAW is likely to have a significant economic impact on PHS-assured institutions. Given the fact that research institutions are already under extreme financial strain and NIH faces the possibility of a significant budget reduction in FY 2011 and beyond, this economic impact must be carefully assessed. Since rats and mice are utilized as a research model by the tens of millions, the proposed change in breeding cage size is likely to have a significant economic impact that may be reasonably anticipated to lead to an annual effect on the economy of $100 million or more and would also materially alter the budgetary impact of NIH grants.

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] 86 [Entry Date] 04/15/2011 at 10:46:43 AM [Affiliation] Organization [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimre, MD [Comments]

Output: Comment 1: I strongly support the need to provide suitable living conditions for animals in our care, but I also believe that the proposed changes will produce only a slight enhancement of animal welfare at an extremely high cost (i.e., the cost/benefit ratio is not favorable). I therefore hope that some of these proposed changes will not be adopted. In particular rules relating to mice that would require no more than 4 adult mice per cage (instead of five), and a rule stating that each female litter would need to be housed individually instead of permitting a second litter to be present prior to weaning.

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] 87 [Entry Date] 04/15/2011 at 10:50:23 AM [Affiliation] Self [Comments]

Output: Comment 1: I am writing to express my opposition to the proposed changes in rodent housing standards outlined in the 8th edition of the Guide for the Care and Use of Laboratory Animals. The new standards will impose an undue hardship on investigators whose research budgets will be reduced by a steep increase in per diem charges. I would urge the National Research Council to commission a scientific study to establish the benefit of these changes on animal welfare before implementing a policy change that will reduce our ability to conduct publically funded science.

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] 88 [Entry Date] 04/15/2011 at 11:12:55 AM [Affiliation] Self [Comments]

Output: Comment 1: No. There has been insufficient time for substantive public comment. Many people are just finding out about this. Some of the proposals are very troublesome. The suggested (I read mandated) increases in rodent cage sizes will cost a fortune to purchase new equipment. I do mouse genetics research and would probably need to reduce my activities by 1/3 to 1/2 to meet the costs of increased housing space, given constraints at my facility. There are many other changes that need serious discussion *****

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] 89 [Entry Date] 04/15/2011 at 11:37:06 AM [Affiliation] Self [Organization City and State] Richmond, Virginia [Comments]

Output: Comment 1: No, I recommend that NIH not adopt the New Guide Comment 2: No, implementation should be delayed until at least 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] 90 [Entry Date] 04/15/2011 at 11:39:47 AM [Affiliation] Self [Comments]

Output: Comment 1: As a scientist who has been working with mouse models for many years, I strongly oppose some of the new regulations proposed by the Guide (8th Edition). For mice, the 8th edition of the Guide requires 15 sq. in. of floor space for a mouse 25 grams and over. A female mouse with a litter of pups requires 51 sq. in. of floor space. Our ventilated mouse rack cages provide 63 sq. in. of floor space. This means: • No more than 4 (not the 5 currently allowed) adult mice per cage – this represents a 20% increase in cages needed over current standards • A female with litter would have to be housed individually, since there would only be 12 sq. in. remaining (63 sq in/cage – 51 sq in for mom with litter) – not "enough" space for a second adult mouse (which needs 15 sq in per these requirements). For a "standard" 2 female, one male breeding cage (which can currently remain together in a single cage as the females deliver pups and nurse them) this represents a >200% increase in cages needed over current standards. I believe these new regulations will no doubt increase unnecessary costs for research and generate huge negative impact on our biomedical research, particularly under the current funding atmosphere. I would also want to add some my personal note. For many years, I am confused by the fact that living expense on those mice in my lab is more than that for any person working in my lab including myself. My monthly animal bill is greater than my mortgage bill for the house where I live. And now, we are told that we did not treat mice well enough and we should offer more. As a human being, I want to stay in a luxury home and work in a luxury lab every day. However, the limiting factor is whether I can afford or not. The question is --- Can NIH afford the increasing costs while maintaining the same productivity? I think the priority for NIH right now should be helping researchers to cut down the costs while maintaining productivity, rather than further increasing their financial responsibility in 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] 91 [Entry Date] 04/15/2011 at 12:33:20 PM [Affiliation] Organization [Organization Name] Univ. of Maryland [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: I believe that the changes to mouse cage housing are unwarranted by any scientific data and represent a new and unreasonable added cost to valuable scientific research. At a time when funding is difficult, these added costs make finding cures and treatments for diseases more difficult. I have bred and cared for mice for over 20 years as a researcher. There is no basis for the increased area demanded by these new regulations.

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] 92 [Entry Date] 04/15/2011 at 12:42:54 PM [Affiliation] Self [Comments]

Output: Comment 1: I acknowledge that the continuing efforts to ensure adequate attention to animal welfare are commendable. However, the proposed changes requiring increased space for housing mice represents an excessive burden on investigators. The new regulations will substantially increase animal care costs (calculated on a per-cage basis) in a time when NIH budgets and, consequently, grant budgets are being slashed. It is also not at all clear that the proposed changes will improve animal health and increase the humaneness of animals used for research. Comment 2: In addition to the added per cage costs, the additional administrative oversight will also add to research costs by necessitating increases in overhead budgets. While this is negotiated by OMB, the costs come from the increasingly strained NIH budget. This means less money for research and more for bureaucracy--another poor decision.

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] 93 [Entry Date] 04/15/2011 at 12:52:47 PM [Affiliation] Self [Comments]

Output: Comment 2: I do not think that the benefits to the animals sufficiently justify the enormous increases in cost and effort required. Specifically the requirement individually house all female mice with litters will require immediate removal of cohabiting females or the male partner upon any birth and will thereby necessitate a large increase in cage number. And is this separation really preferable for - mice which as we know- are social animals? Lastly I think that any policy which requires a large increase in expenditures on animal care must be announced a year before implementation so that at least SOME grants can build this in (not most, but some).

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] 94 [Entry Date] 04/15/2011 at 01:22:17 PM [Affiliation] Self [Organization Name] Boston College [Organization City and State] Chestnut Hill, MA [Comments]

Output: Comment 1: Please DO NOT adopt the eighth edition of the guide. The new rules will hamper animal research on rodents and A & S universities. New rules on survival surgeries, cage sizes, and in particular, the use of pharmaceutical grade drugs will have an extremely negative impact on research. Much neuroscience research depends on research grade drugs to manipulate the brain. Much of neuroscience research requires one survival surgery and one non-survival surgery (cardiac perfusion with formaldehyde). Comment 2: See above. The new rules are much too severe and will deter important health-related 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] 95 [Entry Date] 04/15/2011 at 02:00:53 PM [Affiliation] Self [Comments]

Output: Comment 1: Is is a privilege to use animals in biomedical research, and we strive to provide the highest level of care for research animals. I believe the NIH should NOT adopt the eighth edition of the Guide, since it contains new guidelines for the housing of animals that are highly controversial. These changes, especially for the housing of mice, have not been proven to increase animal health and wellbeing. However, they certainly will induce an unnecessary financial burden on everyone who uses or cares for rodents in research. In the current funding environment, available tax-payer money should be spent on advancing research, not buying new cages for a perceived (but scientifically unproven) increase in animal wellbeing. Comment 2: The NIH should NOT adopt the implementation plan using the eighth edition of the Guide. This edition of the Guide contains new guidelines for the housing of animals that are highly controversial. These changes, especially for the housing of mice, have not been proven to increase animal health and well being and will needlessly waste tax payer money. They certainly will induce an unnecessary financial burden on everyone who uses or cares for rodents in research. In the current funding environment, available tax-payer money should be spent on advancing research, not buying new cages for a perceived (but scientifically unproven) increase in animal wellbeing.

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] 96 [Entry Date] 04/15/2011 at 02:06:06 PM [Affiliation] Organization [Organization Name] Federation of American Societies for Experimental Biology [Organization City and State] Bethesda, MD [Comments]

Output: Comment 1: The Federation of American Societies for Experimental Biology (FASEB) appreciates the opportunity to comment on the National Institutes of Health's (NIH's) acceptance of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide), as solicited by the announcement that appeared in the Federal Register on February 24, 2011. FASEB is a coalition of 23 life science societies representing more than 100,000 biomedical researchers, many of whom are involved in the humane use of animal models in research and education. FASEB strongly supports deferring to the professional judgment of animal care staff in developing performance based standards that provide the best welfare for laboratory animals. Performance based standards are guiding principles that, while describing a desired outcome, provide flexibility in achieving that outcome by granting discretion to those responsible for managing the animal care and use program. Flexibility is important for providing optimal care to laboratory animals and ensuring the integrity of scientific research as it allows researchers, veterinarians, and animal care staff to take into consideration information on the species, individual animal, and research goals that may impact animal care and use. FASEB encourages NIH to follow the suggestions in the Guide and promote performance based standards and professional judgment. Our specific comments concern two points: 1) Should NIH adopt the Guide as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals? and 2) If NIH decides to adopt the eighth edition of the Guide, should NIH use it as the basis for evaluation by March 31, 2012? 1. FASEB recommends that NIH adopt the eighth edition of the Guide as a basis for evaluation of institutional programs receiving or proposing to receive PHS support for activities involving animals with the following caveats: a. FASEB appreciates the importance of housing animals in cages appropriate for their physical, physiologic, and behavioral needs. In evaluating social housing needs for laboratory animals, we, again, strongly encourage NIH to place greater emphasis on performance based standards rather than engineering standards. Engineering standards are prescriptive and provide limited flexibility for implementation. For example, logistical barriers sometimes prevent social housing of animals. Odd numbers of animals needed for a particular experiment would leave one animal not pair-housed. In order to ensure all animals are socially housed, more animals than necessary would be utilized, which is inconsistent with the goal of reducing the number of animals used for research. b. FASEB is particularly concerned about the new cage size requirements for rabbits and rodents. For example, FASEB finds that the change to a two-inch higher cage size for rabbits is especially troublesome. We suggest that the current rabbit cage sizes of 14 inches in height as defined in the 1996 Guide be maintained as opposed to the 16-inch standard in the 2011 Guide unless animals cannot make postural adjustments in the cages. In those cases, performance standards dictate that larger caging should be used. The rationale for increasing the height two inches is unclear, and it is uncertain whether this change would improve the quality of care for laboratory rabbits. Moreover, the current Animal Welfare Act standard is 14 inches in height. In the absence of a clear rationale, congruency between NIH and the United States Department of Agriculture should be maintained. This is consistent with President Obama's Executive Order 13563 and would reduce confusion and maintain efficient work-flow among researchers and institutions. In addition, imposing the new 16-inch standard will render current rabbit caging systems obsolete and necessitate a significant expenditure of funds by research facilities to replace this caging. The resulting expense in both equipment and administrative costs is not balanced by improvements in animal welfare. In a change to rat caging standards, the 2011 Guide now requires that when the weight of paired rats increases to a point that they no longer meet the engineering standards of the Guide, they must be separated or moved to a larger cage. Individually housing these animals would conflict with the guidelines on social housing, yet meeting the new engineering standards set forth in the Guide would require a larger cage size, which is potentially problematic in terms of additional cost. Again, the fiscal constraints that institutions are under due to reduced NIH grant funding and reduced state support may make it difficult for institutions to implement the changes. It is important for NIH to provide clear guidance about what should be done in these cases. In addition, the 2011 Guide spells out specific cage size requirements for female rodents plus their litters, as well as other breeding configurations. Implementing these changes would add huge costs and reduce breeding capacity for many institutions. Again, performance standards should be paramount when evaluating cage spacing requirements. Comment 2: 2. FASEB recommends that: 1) NIH delay the implementation of the Guide, and 2) NIH allow institutions time to develop a comprehensive plan that outlines implementation of new Guide regulations over a predefined period of time, if needed. In order for institutions to implement the changes outlined in the new Guide, a concrete plan must be devised, which may include consultation with experts, hiring new staff, training existing staff, developing new standard operating procedures, and ordering and purchasing caging to meet new social housing and caging requirements. It will take a substantial amount of time to devise this plan, have it approved by the Institutional Animal Care and Use Committee (IACUC), and complete at least one semiannual program and facility evaluation. This process alone could take well over a year. Additionally, the budgetary constraints faced by research institutions and NIH may make it difficult for some institutions to implement the changes recommended in the new Guide by March 31, 2012. Therefore, FASEB recommends that the implementation date be March 31, 2013. For institutions unable to implement all the changes at once in order to be in compliance with the new Guide, FASEB recommends they be allowed to develop and submit a plan to implement the necessary changes over a predefined period of time. This plan, for example, could state that an institution would replace all non-compliant cages over the period of four years (25% per year). As long as the institution meets the milestones outlined in the implementation plan, they would be considered in compliance with IACUC and the Office of Laboratory Animal Welfare. This strategy would allow institutions to prepare better for the financial challenges and infrastructural changes that would need to take place in order to be in compliance with the new Guide. This plan would need to be in place by March 31, 2013. FASEB recognizes that humane animal care and high-quality science go hand-in-hand, and the biomedical researchers represented by FASEB take humane care very seriously. FASEB also appreciates NIH's commitment to providing guidelines that ensure the optimal care and welfare for research animals, and we thank you for this opportunity to provide comments. If you have questions or need additional information, please do not hesitate to contact us.

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] 97 [Entry Date] 04/15/2011 at 03:40:02 PM [Affiliation] Self [Comments]

Output: Comment 1: NIH should not adopt the 8th edition of The Guide. In 2003, an ILAR document was published titled "The Development of Science-based Guidelines for Laboratory Animal Care" that presented the concept of using research and scientific principles to guide our policies on the use and care of animals, with utmost consideration on animal wellbeing. However, the 8th edition of The Guide does not advance the field of animal welfare by inclusion of scientific principles. It introduces policy that is based on philosophical arguments lacking basis on scientific findings. One policy that illustrates this is the new section on "Pharmaceutical Grade" reagents used in animal research (Ch. 2). What this section says is that "pharmaceutical grade" substances should be used, and if they are not used, this has to be justified, including a consideration of grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics. This philosophy is not a new one, however, until now, it has not appeared in a policy document that would have a real impact on research institutions. There are several problems with this addition regarding "Non-Pharmaceutical Grade Chemicals and Other Substances." 1. The term "pharmaceutical grade" is not defined. 2. There are no scientific citations to reinforce this policy. Where is the evidence that non-pharmaceutical grade compounds, whatever they may be, are harming animal welfare or disturbing research results? 3. There is a misconception that this policy is actually part of the Animal Welfare Act. The paragraph cites a reference to USDA 1997b. This citation is a USDA Animal Care Resource Guide (www.aphis.usda.gov/animal_welfare/downloads/policy/policy3.pdf) that is not part of the Animal Welfare Act. It is a policy adopted by USDA to guide interpretation of the Animal Welfare Act, but it is not, in and of itself, part of the Animal Welfare Act. This USDA policy has language about non-pharmaceutical grade substances that is now showing up in The Guide. Again, the problem with this is that it's actually not part of the Animal Welfare Act, so it's not technically a federal law. It's simply the guidance USDA is providing in interpreting the Animal Welfare Act. Other groups could come up with alternative interpretations. Furthermore, this guidance provided by USDA still does nothing to define what is meant by "pharmaceutical grade". 4. The paragraph also cites Wolff et al 2003. This is a FAQ document that was published in Lab Animal in 2003. In the FAQ's specifically question 3 dealt with non-pharmaceutical grade compounds. This FAQ document was written by a group of veterinarians at OLAW. They are providing the argument that the use of non pharmaceutical grade compounds should be justified in an IACUC protocol. However, this response to an FAQ is not official public policy. It represents the opinion of veterinarians at OLAW. 5. The paragraph ends with a citation to NIH 2008. It is suggestive that this policy is part of NIH public policy. However, this is a reference document provided by the NIH to guide NIH internal research programs, and it does not apply to institutions funded by NIH. It is contains essentially the same verbiage found in the FAQ's cited above and the USDA guidance policy. (http://oacu.od.nih.gov/ARAC/documents/Pharmaceutical_Compounds.pdf) It does however provide some definitions, so it is a bit more helpful. A very important note: this document is not part of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. To the best of my knowledge, the term "pharmaceutical grade" does not even appear in the PHS Policy on Humane Care and Use of Laboratory Animals. In fact, this reference to the NIH document appears to have been inadvertently left in the published form of the Guide, as a note in the "Addendum: List of Editorial Changes from the Prepublication Version" of The Guide indicates that this reference was removed from an earlier position in the paragraph: In summary The Guide relating to pharmaceutical grade compounds is misleading and confusing. It does not explain what is meant by pharmaceutical grade compounds, and it also suggests that using non-pharmaceutical grade compounds without justification goes against the Animal Welfare Act and PHS policy, of which it does neither. There has been an emphasis on the application of "science-based" guidelines to develop policies for the care and use of laboratory animals (e.g. see ILAR publication "The Development of Science-based Guidelines for Laboratory Animal Care, National Academies Press 2003). However, this policy on pharmaceutical grade compounds in research is not based on scientific principles, but rather a philosophical argument that, for some reason, non-pharmaceutical grade compounds (whatever that means) are inferior to pharmaceutical grade compounds (whatever they are). If the PHS adopts version 8 of The Guide, this policy will become PHS policy. We still don't even really know what this means. The PI would have to consider grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics. Much of this already gets considered when preparing to administer a reagent to an animal. However, some information may not even be available. Do we have to send out research compounds to a compounding pharmacy or characterization lab? Will the PI have to do these characterizations in house? Does this policy apply to common practices such as administering sucrose in drinking water or using any chemical from Sigma or other reagent suppliers? How will drug dosage be adjusted? What about drug vehicles? Version 8 of The Guide should not be adopted by NIH. If a new version of The Guide is to be adopted, it should be based on scientific principles that will benefit animal welfare, and key terms should be defined. Comment 2: NIH should not adopt the 8th edition of The Guide. If implemented, facilities should not be required to use it in their semiannual inspections prior to March 31, 2015. It will take substantial time and effort to revise internal policies and procedures to meet the recommendation of the 8th edition of The Guide. This would be a multi-year process.

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] 98 [Entry Date] 04/15/2011 at 05:03:43 PM [Affiliation] Self [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore Maryland [Comments]

Output: Comment 1: I do not agree with the proposed changes in cage sizes for rodents, which are highly social species which seek out tactile contact with each other, live in small burrows and are in fact frightened by large open spaces. Increasing the size of the cages will do more to stress the animals than comfort them and could have severe and enduring negative consequences on research relevant to mental health Comment 2: Institutions are already under tremendous scrutiny and reporting demands for their use of animals and no beneficial purpose would be served by additional reporting, this would be a waste of taxpayers dollars.

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] 99 [Entry Date] 04/15/2011 at 05:26:45 PM [Affiliation] Self [Comments]

Output: Comment 1: I spent a couple hours skimming over the 240 pages of the proposed 8th edition of the NIH Guide. Much of the changes are common sense. Some interpretations of the Guide come not from those with the goal of increasing animal welfare but rather with the goal of restricting and ultimately eliminating animal research. As such the vague and subjective wording in the document opens investigators and institutions to frivolous litigation. My other concerns are with requirements that would hinder rather than support animal health and welfare. 1) Of great concern is where the wording of must (defined by the guide as a requirement) is followed by something vague and subjective such as ensure the "well-being" of the animal or "provide a high quality of care and ethical standards" that could expose Universities and investigators to frivolous litigation from groups that would like to entirely eliminate animal research. 2) Under surgery it states that, "Careful monitoring increases the likelihood of successful surgical outcomes. Monitoring includes routine evaluation of anesthetic depth and physiologic functions and conditions, such as body temperature, cardiac and respiratory rates and pattern (Flegal et al. 2009), and blood pressure (Kuhlman 2008), and should be appropriately documented." I completely disagree with this statement. In rodents, successful surgical outcomes are best assured by clean, efficient surgeries that do not require supplemental anesthetic or longer exposure to gas anesthesia than necessary. Not only is it difficult to measure these physiological symptoms in rodents, doing so requires distraction from the surgery that increases anesthetic exposure and encourages breaks from aseptic technique. 3) The new mechanical standards do not appear to allow for a breeder male mouse to stay in the cage with the female and litter and appear to prevent harem breeding in most standard cages; hence they are in conflict with requirements elsewhere in the guide indicated that social animals should not be individually housed. They also state that environmental enrichment (e.g. a paper cup) is to be subtracted from available floor space without taking into consideration that the animal can walk or climb on it or carry it around. The new mechanical standards could greatly restrict research where space is at a premium and will require the employ of personnel who police this. It was better to have standards, e.g. the animal should be able to turn around in its cage and not touch the lid when situated in a normal position. 4) Under food restrictions the guide requires "the least restriction necessary to achieve the scientific objective." This is counter to studies which show rodents are healthier and live longer under food restriction (more than the least necessary to perform a task) than they do under ad libitum schedules. The guide again mandates that the "well-being" of the animals be monitored. This is vague and subjective. In addition, this section is written in a way that could be interpreted as though both food and fluid intake have to be monitored daily even if only one or the other is regimented. This could require a significant increase in personnel effort without increasing the safe monitoring of the health of the animals. 5) "Disaster plans should be established in conjunction with the respon¬sible investigator(s), taking into consideration both the priorities for triaging animal populations and the institutional needs and resources. Animals that cannot be relocated or protected from the consequences of the disaster must be humanely euthanized." This could be interpreted to mean in an impending disaster supporting the unnecessary death of animals and is in conflict with the 3Rs. 6) A good addition in the surgery section is that craniotomy could be considered a minor surgery where most have previously considered it opening a body cavity and classified it as major surgery. This makes sense given how quickly rodents recover from this type of surgery.

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] 100 [Entry Date] 04/15/2011 at 09:43:06 PM [Affiliation] Self [Comments]

Output: Comment 1: I have several comments regarding the proposed guidelines for experimentation on wild/exotic animals. In the field of animal behavior research, guidelines based the biomedical model are often at odds with goals of basic behavioral research. Most animal behavior studies pursue experiments that do not involve intervention commonly performed in biomedical studies (i.e, do not involve pain) or only sets the occasion for natural behaviorl processes, such as predator/prey interactions. Unfortunately most animal behavior research suffers from low funding support; consequently, I argue that guidelines designed for domesticated/lab animals primarily used in biomedical research programs will limit the ability of many scientists to conduct basic animal behavior studies. Using novel species and allowing animals to behave in natural ways under laboratory conditions is fundamental to scientific discovery and it should not be smothered by blanket regulations on animal care and use that increases cost and oversight. Adoption of new policy should be postpone until the impact on animal behavior's unique approach, which is often beyond the knowledge of IACUC members, is fully considered.

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] 101 [Entry Date] 04/16/2011 at 05:53:11 AM [Affiliation] Organization [Organization Name] UNIVERSITY OF CALIFORNIA DAVIS [Organization City and State] SACRAMENTO, CA [Comments]

Output: Comment 1: I do not believe that there is a compelling reason to adopt this new Guide which will cause increased expense and increased paperwork burden with no demonstrated benefit. Comment 2: There are numerous concerns regarding the new Guide. Of particular concern is the requirement to use pharmaceutical-grade chemicals. For the vast majority of academic research projects of the kind supported by NIH, there is no scientific advantage to using pharmaceutical-grade chemicals. There is also no benefit from an animal welfare perspective. However, this requirement will add enormous expense to procure pharmaceutical-grade chemicals that will reduce the availability research funds for other research needs. In addition to the waste of Federal funds, there will also be enormously increased administrative burden procuring such chemicals that will detract from time that could be spent on productive 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] 102 [Entry Date] 04/17/2011 at 12:34:23 AM [Affiliation] Self [Organization Name] Virginia Commonwealth University [Comments]

Output: Comment 1: No--I recommend that NIH not adopt the New Guide. My rationale for this recommendation is based on multiple factors that include: -the financial and administrative cost of complying with new regulations and the resulting disruption in research -the burden of guidance to either use pharmaceutical grade chemicals or to justify not using them, despite a lack of evidence to suggest that pharmaceutical grade chemicals improve animal welfare or science -vague language subject to multiple interpretations on many issues such cage sizes, use of restraint, and use of food restriction Comment 2: Implementation should be delayed until at least March 2015. My rationale for this recommendation is based on my view of the extensive revisions promulgated by the New Guide and the extensive changes in research procedures, administrative procedures and infrastructure that will be required to comply with the 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] 103 [Entry Date] 04/17/2011 at 01:30:23 PM [Affiliation] Self [Comments]

Output: Comment 1: As a PI on several NIH grants that involve the use of non-human primates, I am particularly concerned with the additional regulations imposed by the new Guide. These regulations serve to impair our ability to make scientific decisions based on our experience and knowledge, and the questions we wish to ask. The amount of paperwork required to proceed with our best, experienced judgment presents a considerable burden, and may actually prevent our research from going forward if an unsympathetic or ignorant member of the IACUC decides to stop it. I use many non-pharmaceutical grade chemicals in my efforts to identify a treatment for drug abuse. The list of qualities to consider about these drugs is incompatible with this testing. What harm, for example, has been done in the past by the use of non-pharmaceutical grade compounds whose pharmacokinetics were not well understood?

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] 104 [Entry Date] 04/18/2011 at 12:12:38 AM [Affiliation] Self [Comments]

Output: Comment 1: I do appreciate the thoughtfulness of the revised Guide. My chief concern, however, is that there is a shift in the document to emphasize administrative oversight over basic research. PIs are doing their best to enhance public health by conducting basic research under conditions of decreasing public funding and increased administrative burdens. While the new Guide helps by providing more detail for some animal care issues that have been vague in the past (e.g. cage sizes), some detail will actually have a likely negative impact on research productivity as more research dollars will need to be spent placating IACUC demands that may or may not enhance animal welfare (e.g. "should" for use of pharmaceutical grade compounds) vs. conducting studies that may lead to breakthroughs in understanding diseases relevant to public health. Comment 2: 2012 is too soon for an institution (especially a small institution with minimal IACUC funds) to be able to prepare for implementation of the 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] 105 [Entry Date] 04/18/2011 at 08:36:59 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] 106 [Entry Date] 04/18/2011 at 08:39:03 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] 107 [Entry Date] 04/18/2011 at 08:39:12 AM [Affiliation] Organization [Organization Name] Harvard Medical School [Organization City and State] Boston, MA [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] 108 [Entry Date] 04/18/2011 at 08:39:39 AM [Affiliation] Self [Comments]

Output: Comment 1: This guide should not be adopted. There are several problematic issues including the suggestion that pharmaceutical grade drugs should be used for animal studies. Comment 2: No, this version of the guide should not be used for any evaluation.

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] 109 [Entry Date] 04/18/2011 at 08:47:51 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] 110 [Entry Date] 04/18/2011 at 08:56:09 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] 111 [Entry Date] 04/18/2011 at 08:58:18 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] 112 [Entry Date] 04/18/2011 at 08:59:17 AM [Affiliation] Self [Comments]

Output: Comment 1: The new cage sizes are appropriate. We will not need to change anything in our facility. Having less than 11x11 inches for one rat would mean limiting its movement. Why are we against making welfare for the animals better? I hear that "it will cost much", but since when cost is a factor in welfare of animals? If this is best for the animals, it will also be best for our experiments and we will obtain data that are more relevant and interpretable if the welfare of the animals is appropriate, rather than inappropriate. Comment 2: We already do this in our facility, and tailoring it to the new guide would not be an additional burden. It is no big deal to do this semiannual evaluation, and it actually helps investigators. We find minor infractions and sometimes bigger ones. Why not correct them?

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] 113 [Entry Date] 04/18/2011 at 09:01:46 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.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. 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 significantly increase expenses to the institution and the investigator without really enhancing 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] 114 [Entry Date] 04/18/2011 at 09:18:25 AM [Affiliation] Organization [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore MD [Comments]

Output: Comment 1: Implementation of such a policy will immediately and directly affect our ability to perform research by driving up the cost of research and thereby decreasing the amount that is done. Comment 2: Implementation of such a policy will add extra administrative work and increase the cost of doing 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] 115 [Entry Date] 04/18/2011 at 09:32:46 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] 116 [Entry Date] 04/18/2011 at 09:33:42 AM [Affiliation] Self [Comments]

Output: Comment 1: Response: 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: Response: 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] 117 [Entry Date] 04/18/2011 at 09:34:56 AM [Affiliation] Organization [Organization Name] Primates Incorporated (primatesinc.com) [Organization City and State] Madison, WI [Comments]

Output: Comment 1: Purpose of comment: To discuss and encourage retirement of animals from research by discussing case studies of success stories and methodology from researchers who already are retiring primates and other animals such as cats and dogs under their care Given the fact that several researchers over the years have taken the initiative to plan to retire the primates under their care to sanctuaries, and adopt out dogs and cats involved in non-terminal studies, I am surprised that I could not find a discussion on primate retirement or laboratory animal adoption anywhere in The Guide. I used to be a primate researcher for five years – while I worked there, I discovered how intelligent the rhesus monkeys were. I believe there are enough similarities between monkeys, chimps, and humans, that the monkeys deserve the same respect and accommodations as chimpanzees, including funding for their retirement whenever a retirement scenario arises. I wrote the NIH several years ago about primate retirement and they told me they take primate retirement "very seriously". The reality is that the NIH only takes the retirement of chimpanzees seriously – not all primates. There is funding only for great ape retirement through the CHIMP Act, and inquiring about funding for retiring other primates (or even bringing up the possibility of retiring primates) can be frowned upon by senior management, and employees are easily intimidated and forgo the retirement option. Additionally, a research veterinarian told me that the NIH is using the 3Rs to justify continued re-use of primates over retiring them to reputable sanctuaries; they argue that retiring a monkey goes against the 3Rs. I believe this to be a negative interpretation of the 3Rs and think there needs to be a fourth R added to the 3Rs to avoid future confusion: Reduction, Refinement, Replacement, and Retirement Admittedly, there are some sanctuaries that have had their problems – largely because of underfunding and lack of funding available for animal retirement. If funding is available from the research facility, it is for transportation and to build an enclosure, and the sanctuary is left providing and paying for the lifetime care of the monkeys which could likely cost $5 per day. Additional consideration to providing funding for the first year of care would be a drastic improvement and would ensure the monkeys would receive the quality care, space, and enrichment a sanctuary is supposed to provide. A quality primate sanctuary can be found if it is accredited by The Global Federation of Animal Sanctuaries or The American Sanctuary Association. Given the fact that there are researchers who are taking the initiatives to retire primates under their care, sanctuaries have and will continue to serve as a vital retirement resource. As we continue to discover how smart primates are (e.g. we have recently confirmed Rhesus monkeys are self-aware), we need to start respecting them more by providing them with retirement options after their time in research. If primate researchers are justifying the use of monkeys because of their similarities to humans, shouldn't the monkeys be considered for primate retirement as chimpanzees are? Sanctuary anecdotal evidence suggests abnormal behavior is drastically reduced if not relieved completely when a monkey is retired to a sanctuary with appropriate space, vegetation, social, and enrichment options. Primates who are not able to be rehabilitated through enrichment, social housing, or medication in the laboratory should be given a chance at primate retirement where research procedures are not present and the environment is much more accommodating to producing naturalistic behaviors. The primates with persistent abnormal behavior should not be re-used in studies – and especially not put in invasive terminal studies as a final way to use them. Please consider the brain chemistry involved in abnormal behavior and that using monkeys displaying abnormal behavior in brain chemistry studies should be discouraged and is likely an overlooked variable. The humane option is to treat monkeys with persistent abnormal behavior by giving them a chance at a more spacious, enriching, peaceful, and naturalistic environment. Indeed all primates, are deserving of primate retirement. Please encourage the retirement of primates (or at least discuss retirement as an option) when the primates are not used in terminal studies or need special accommodations. And please extend the CHIMP Act to cover all primates. Thank you for your time and consideration. Comment 2: Please discuss primate retirement as a part of any animal-welfare training classes.

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] 118 [Entry Date] 04/18/2011 at 09:37:29 AM [Affiliation] Self [Organization City and State] Boston MA [Comments]

Output: Comment 1: NO it should not.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] 119 [Entry Date] 04/18/2011 at 09:38:22 AM [Affiliation] Self [Comments]

Output: Comment 1: My understanding is that the new "Guide" will be twice the size of the old guide. I wish to register my opposition to any increases in the regulation of animal research. To expand it further serves little need other than to mollify extremist animal rights groups intent on making biomedical research with animals so cumbersome that it will be nearly impossible to do. I also request that existing regulations be modified so as to reduce the disabling burdens they place upon biomedical researchers who are trying to cure diseases that cause human and animal suffering. Biomedical researchers who use animals in their research are already suffocating in a litany of regulations that range from practical to absurd. Many of these regulations are attributable to animal rights extremists who misrepresent animal research as torture. To move in the direction of abolishing all animal research, they have promulgated falsehoods to a sufficiently large number of activists who have lobbied congress successfully to impose regulations that cripple animal research. As the parent of a child who died from an illness that might have been cured by now had it not been for the ability of extremist animal rightists to prevent the biomedical research needed to cure his and other children's diseases, I greatly resent the implementation of any additional impediments to animal research. More enlightened countries such as Singapore are capable of discerning truth from hyperbole. This is why they are becoming a Mecca for biomedical researchers and we are beginning to see a brain drain from the United States. I have a specific concern regarding Institutional Animal Care and Use Committees (IACUCs). I believe that they are now compromising biomedical research so badly that biomedical researchers spend more time dealing with trivial and often inane demands of IACUCs than they spend preparing grant proposals. Many years ago Philip Zimbardo conducted a psychological experiment in which some students simulated prison guards while others simulated prisoners. The experiment had such disastrous effects that it had to be terminated prematurely, after only 6 days, because of the harm it was doing to the "prisoners". I submit that today's IACUC members are the equivalent of the "guards" and that animal researchers are the equivalent of the "prisoners". I believe that IACUCs are so far out of control that it is only a matter of time before researchers begin to take legal actions against IACUC members who abuse their position on the IACUC causing damage to the careers of biomedical researchers and impairment of research to cure diseases. Therefore I further recommend that any changes in the 8th edition of the "Guide" include a scaling back of the powers of IACUCs. Additionally, there should be a provision added to enable animal researchers to institute research misconduct proceedings against IACUC members whom they believe to be acting improperly. Additionally, explicit warnings should be given to IACUC members that they could be held legally responsible for improper conduct of their role in IACUCs. Comment 2: I oppose any additional regulations that would further hinder instutions conducting biomedical research from squandering scarce financial resources on regulations foisted upon our society by extremist animal rights groups whose ultimate goal is to stop biomedical research using 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] 120 [Entry Date] 04/18/2011 at 09:48:47 AM [Affiliation] Self [Comments]

Output: Comment 1: Please do not adopt this edition of the guide for the care and use of laboratory animals. We are over regulated as it is and this adds an additional unnecessary burden on the investigator. At this point the largest cost in any lab doing animal work is animal husbandry, these measures will further increase that cost and limit what can be done experimentally. At a time when science is falling behind in this country due to the previous administrations lack of funding it seems like a huge burden to further decrease our ability to do our work. Comment 2: Please push back the date to 2015 and gather empirical evidence that these measures would actually benefit anyone.

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] 121 [Entry Date] 04/18/2011 at 10:01:39 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] 122 [Entry Date] 04/18/2011 at 10:07:48 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] 123 [Entry Date] 04/18/2011 at 10:11:51 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] 124 [Entry Date] 04/18/2011 at 10:13:50 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] 125 [Entry Date] 04/18/2011 at 10:19:16 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] 126 [Entry Date] 04/18/2011 at 10:23:26 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] 127 [Entry Date] 04/18/2011 at 10:51:16 AM [Affiliation] Organization [Organization Name] Mount Sinai School of Medicine [Organization City and State] New York, NY [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] 128 [Entry Date] 04/18/2011 at 11:13:06 AM [Affiliation] Self [Organization City and State] Ann Arbor, Michigan [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