Input: [ID] 22 [Entry Date] 03/09/2011 at 03:47:16 PM [Affiliation] Self [Organization Name] North Dakota State University [Organization City and State] Fargo, ND [Comments]

Output: Comment 1: The revised guide is an apprpriate standard for the use and care of laboratory animals in research. I suppport its adoption. Comment 2: At least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation is appropriate. I support implementation of such an in inspection.

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] 23 [Entry Date] 03/09/2011 at 04:09:39 PM [Affiliation] Organization [Organization Name] National Association for Biomedical Research [Organization City and State] Washington, DC [Comments]

Output: Comment 1: March 9, 2011 Francis S. Collins, MD, PhD Director, National Institutes of Health Building One, 126 Shannon 1 Center Drive Bethesda, MD 20892 RE: Request for Extension to Comment Period for Proposed Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition Sent via electronic and U.S. Mail Dear Dr. Collins: On behalf of its more than 300 member institutions, many of which are affected Public Health Service (PHS)-assured institutions, the National Association for Biomedical Research (NABR) respectfully requests at least a thirty-day extension to the comment period provided by the NIH Notice, Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, published on February 24, 2011 (76 Federal Register 10379-80). In order for institutions to adequately assess the substantive changes and additions to the Guide for the Care and Use of Laboratory Animals (Guide) and provide meaningful feedback regarding its impact on their animal care and use programs as requested, additional time is needed. The current timeframe set forth in the Notice is insufficient to accurately evaluate the consequences of NIH's potential adoption and implementation of the Eighth Edition of the Guide as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. Furthermore, Executive Order 13563, issued January 18, 2011 (76 Federal Register 3821-23), states that in order to promote participation each agency "shall afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally be at least 60 days." We believe that limiting the public comment period to thirty days is not in keeping with the spirit of OMB's stated intentions to allow for meaningful public input. Therefore, NABR requests that the comment period for the subject Notice be extended at least until April 24, 2011, which would provide a more commonly accepted 60-day comment period. I hope that the NIH will agree to our request to extend the deadline for comments. Thank you for your consideration and please contact me if you have any questions. Sincerely, Frankie L. Trull President National Association for Biomedical 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] 24 [Entry Date] 03/09/2011 at 04:27:03 PM [Affiliation] Self [Comments]

Output: Comment 1: I support adoption of the eighth edition of the "Guide" as currently written. I believe it lays out reasonable guidelines for the use of animals and protects against unjustifiable use of animals. Comment 2: I support the proposed implementation plan as being reasonable and sufficient to ensure proper protection of animals.

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


Input: [ID] 25 [Entry Date] 03/09/2011 at 04:46:09 PM [Affiliation] Self [Comments]

Output: Comment 1: I strongly support the adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. Comment 2: I also support the proposed implementation plan which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012.

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] 26 [Entry Date] 03/09/2011 at 04:51:39 PM [Affiliation] Self [Comments]

Output: Comment 1: Yes. It is an important document for basic biomedical research. Comment 2: Yes, this seems appropiate.

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] 27 [Entry Date] 03/09/2011 at 07:06:38 PM [Affiliation] Self [Comments]

Output: Comment 1: Adoption of the 8th addition of the guide will continue to ensure that animals used in research get the best possible care and provide the best possible model for studies important in understanding human disease processes and potential cures. Comment 2: Indeed the sooner a review is completed with the new guide, the sooner appropriate modifcations to individual programs can be made to remove any detrimental conditions or procedures.

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


Input: [ID] 28 [Entry Date] 03/09/2011 at 09:30:54 PM [Affiliation] Self [Comments]

Output: Comment 1: I strongly support the guidelines proposed in the eighth edition of the Guide for care and use of laboratory 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] 29 [Entry Date] 03/10/2011 at 12:37:32 PM [Affiliation] Organization [Organization Name] Council on Governmental Relations [Organization City and State] Washington DC [Comments]

Output: Comment 1: We are requesting an extension of the deadline for submission of comments in response to the National Institutes of Health request concerning the Proposed Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition. We request an additional 30 days setting the deadline for comments on April 25, 2011. The Council on Governmental Relations (COGR) is an association of 184 research universities and affiliated academic medical centers and research institutes. Our members and the research community generally need more than 30 days to assess the impact of the implementation of the Eighth Edition on the operation of facilities and the conduct of research using animals. The Eighth Edition introduces new standards in a number of areas including aquatic species and sets new standards for the environment, housing and physical plant including new minimum cage requirements for rodents and rabbits. The research community needs sufficient time to assess these standards and their related costs to offer thoughtful and thorough comments to NIH. Additional time will not compromise the care and use of animals used in PHS-supported research because we remain responsible for compliance with the earlier 1996 version of the Guide. The Health Research Extension Act of 1985 requires notice and comment on the policy and we appreciate the opportunity. In the spirit of the call for a "meaningful opportunity to comment" on new regulations articulated in EO 13563, we request an extension of the deadline. Comment 2: See above

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] 30 [Entry Date] 03/10/2011 at 01:09:31 PM [Affiliation] Self [Comments]

Output: Comment 1: I whole heartedly endorse the long-awaited 8th edition of the Guide for the Care and Use of Laboratory 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] 31 [Entry Date] 03/10/2011 at 05:46:00 PM [Affiliation] Self [Comments]

Output: Comment 1: I like the new updates, making it more current and clarifying some ambiguities.

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] 32 [Entry Date] 03/10/2011 at 06:07:34 PM [Affiliation] Self [Organization Name] Oregon health and science university [Comments]

Output: Comment 1: I support adoption

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] 33 [Entry Date] 03/11/2011 at 11:45:39 AM [Affiliation] Organization [Organization Name] Association of American Universities and Association of Public and Land-grant Universities [Organization City and State] Washington, DC [Comments]

Output: Comment 1: March 11, 2011 Patricia Brown, VMD, MS NIH Office of Laboratory Animal Welfare Office of Extramural Research RKL1, Suite 360 6705 Rockledge Drive Bethesda, MD 20892-7982 Dear Dr. Brown: On behalf of the Association for American Universities (AAU) and the Association of Public and Land-grant Universities (APLU), please accept this request for an extension of the deadline for submission of comments in response to the National Institutes of Health notice (FR Doc. 2011–4172) concerning the Proposed Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition ("The Guide"). We request an additional 30 days with a suggested new comment deadline of April 25, 2011. AAU and APLU's combined memberships include most of the major public and private research universities in the United States. We greatly appreciate the opportunity to comment on whether NIH should adopt The Guide, as well as on the proposed implementation plan, and applaud NIH for exploring the potential impact of this policy change. However, in order to provide "insight from institutions on the impact of changes to the Guide on their animal care and use programs" as requested, our members and the research community need more than 30 days. As noted in the Federal Register notice, the Eighth Edition "contains substantive changes and additions from the previous additions." The research community needs sufficient time to assess the consequences of these changes and their related costs in order to offer thoughtful and thorough comments to NIH. Additional time will not compromise the care and use of animals used in PHS-supported research because we remain responsible for compliance with the earlier 1996 version of the Guide. Therefore, we respectfully request that you extend the comment period to April 25, 2011. Thank you for consideration of this request. Sincerely, Respectfully, Robert M. Berdahl President Association of American Universities Peter McPherson President Association of Public and Land-grant Universities

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] 34 [Entry Date] 03/11/2011 at 04:10:33 PM [Affiliation] Self [Organization Name] Oregon Health and Science University [Organization City and State] Portland, OR [Comments]

Output: Comment 1: I support the proposed adoption of the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide) Comment 2: I support the proposed implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition (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] 35 [Entry Date] 03/11/2011 at 04:58:18 PM [Affiliation] Self [Comments]

Output: Comment 1: The guide for the Care and Use of Laboratory Animals Eighth Edition should be adopted as a basis for evaluation of institutional programs across the United States.

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] 36 [Entry Date] 03/11/2011 at 08:02:08 PM [Affiliation] Self [Comments]

Output: Comment 1: YES,adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. Comment 2: YES, require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012.

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] 37 [Entry Date] 03/13/2011 at 12:04:58 PM [Affiliation] Self [Comments]

Output: Comment 1: I have been involved in the care and use of laboratory animals since 1982 = 28 years. My comments with regard to the above question is: NO, the 8th edition of the Guide for the Care and Use of Laboratory Animals should NOT be adopted by OLAW. It was not properly reviewed according to standard Federal government procedures, so we do not know if all aspects of it are even legally defensible. Apparently no one bothered to even try to calculate the costs to the regulated entities of the mandated changes to animal cages (rabbit cages at least) is disingenuous and deceitful. The fact that the Director of NIH had to be the one to insist that proper procedures be followed (after he became aware of the added costs of adopting the 8th edition to just the intramural program - not to mention all the grant recipients) shows how flawed the whole process has been. In the current economy of universal budget cuts, now is NOT the time to require institutions to spend even MORE money to comply with new regulations. Stay with the 7th edition until the 8th edition can be made acceptable to the regulated entities and then only after following all standard Federal review processes, including a public comment period that is not limited to two questions and nothing else, should the 8th edition ever see the light of day again. Do NOT adopt the 8th edition until it can be done correctly, and do NOT adopt it when it increases financial burden on the regulated entities at a time of severe fiscal crisis. Miserable timing. Comment 2: This question assumes that the first question will be answered in the affirmative. This is very poor survey construction. My comment: NO = There should be NO implementation plan until the 8th edition can be re-written to be less burdensome and then properly routed for reviewed according to standard Federal government procedures. Go back to the drawing board, make the 8th edition LESS burdensome rather than MORE burdensome, and then go through the proper procedures to get it accepted by all before even considering adopting it. Do it right or don't do it at all!

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] 38 [Entry Date] 03/13/2011 at 07:43:46 PM [Affiliation] Self [Organization Name] California Institute of Technology [Organization City and State] Pasadena, CA 91105 [Comments]

Output: Comment 1: It is a disappointment that a more thorough revision of the guide was not accomplished, with a eye to reducing paperwork and expense for investigators. Since the research is supported by the public through government agencies and done to benefit the public, reducing the cost of unnecessary compliance would be a win-win situation. Comment 2: Already, some of the requirements for cleanliness and safety, as well as the semiannual program and evaluations, especially for rodent facilities, exceed those for similar facilities used to house or operate on humans. Daily census for rodents far exceeds the human census done only every 10 years.

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


Input: [ID] 39 [Entry Date] 03/14/2011 at 08:44:30 AM [Affiliation] Self [Comments]

Output: Comment 1: Please adopt the new Guide. It is a necessary step forward. Comment 2: Please adopt the new Guide. It is a necessary step forward.

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] 40 [Entry Date] 03/15/2011 at 03:23:27 PM [Affiliation] Self [Organization Name] University of Maryland [Organization City and State] Baltimore, Maryland [Comments]

Output: Comment 1: I request that you DO NOT implement the recently prepared 8th Edition of the "Guide for the Care and Use of Laboratory Animals". In my opinion as a relatively senior biomedical researcher, there are no important deficiencies in the currently used 7th Edition of the Guide. Its continued use fully supports and prioritizes animal welfare, is based upon "best practices", and thus facilitates humane, high-quality biomedical research. The proposed changes to the Guide in the 8th Edition are not supported by any credible scientific data. They are very unlikely to improve the scientific quality of the research, or improve animal welfare. As such the very expensive and complicated proposed changes would impose a large and wholely unjustifiable fiscal and logistical burden on the national research enterprise, with no expected "return on investment". Well intentioned, but VERY BAD POLICY. Comment 2: It is wholely unrealistic to expect the entire research enterprise of the United States to re-tool completely in one year!

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


Input: [ID] 41 [Entry Date] 03/15/2011 at 04:15:05 PM [Affiliation] Self [Comments]

Output: Comment 1: Current 7th edition is adequate for animal welfare and animal research data quality. Precious dollars should be spent on research during this time of budget crisis, so I don't support adoption of 8th edition

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] 42 [Entry Date] 03/15/2011 at 04:23:35 PM [Affiliation] Self [Organization Name] Univ. of Maryland, Baltimore [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: As a University of Maryland, School of Medicine researcher who uses mice and other rodents, I would suggest that implementation of the new 8th Edition of the "Guide for Care and Use of Laboratory Animals" be delayed until our country gets its fiscal act together. My NIH grants have been cut significantly across the board, and implementation of the practices proposed in the 8th Edition will be passed along to the investigators. Implementation of the 8th Edition is something that can be put on the back burner until funding has stabilized and scientists can absorb the additional costs of animal care. Thank you.

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] 43 [Entry Date] 03/17/2011 at 10:50:07 AM [Affiliation] Self [Comments]

Output: Comment 1: I strongly support adoption of the eighth edition of the guide. The Guide has long provided a reasonable set of standards by which ethical research studies using animal models can be performed. Animal models are absolutely crucial to medical and basic research progress. ***** Comment 2: Two areas of the proposed implementation plan require further modification, in my opinion. Both are on pp 30-32 of the draft guide. First, the proposed language would require purchase of "pharmaceutical grade" chemicals for all studies with animals. The intent here is laudable - none of us who work with animals wants to administer poor quality compounds that might contain contaminants that might have undesirable side effects. However, the realities of research has taught us that chemicals that are purified to "pharmaceutical grade" are nearly always much more expensive than simply "analytical grade" or other non-pharmaceutical grade products. The further reality is, for many compounds, there is absolutely no safety risk to the animal. The requirement as currently proposed is backwards. It should be acceptable to use compounds of any reasonable purity unless there is reason to believe, for that specific compound, that to do so might be unsafe for the animals. The result of adopting a "pharmaceutical-grade" requirement will, quite simply, be that for nearly all compounds I will seek exemption to use a lesser quality in my protocols, and will waste a lot of my time and my IACUC's time. The other issue that should be discussed further is the apparent proposal that use of preferred foods as reinforcers should be preferable to the use of very mild food restriction in behavioral protocols. There is a very extensive published literature in the animal learning area that demonstrates quite clearly that these two sources of motivation are not behaviorally equivalent for animals. Mild food deprivation protocols that have no detrimental physiological consequences for the animals are well-understood. There is a large literature that even much more significant food restriction on a permanent basis has health benefits. So, making a default requirement that preferred foods should be used is unreasonable scientifically and will not protect or improve animal health. *****

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] 44 [Entry Date] 03/17/2011 at 04:26:46 PM [Affiliation] Self [Comments]

Output: Comment 1: The Guide should be adopted, but requires revision. It should not be adopted or used in earnest until the revision issue has been put to rest. Comment 2: It is certainly possible to put institutions through a semi-annual under the new "Guide" by March 2012, but there is not sufficient time to ensure compliance particularly in the way of rabbit socialized housing, the essential outlawing of trio mouse mating (and its ramifications for more caging and expanded animal facilities), the intensive training of personnel involved in surgery, and the relocation of rodent surgery procedures from laboratories to dedicated procedure space.

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] 45 [Entry Date] 03/18/2011 at 12:38:20 PM [Affiliation] Organization [Organization Name] National Biodefense Analysis and Countermeasures Center [Organization City and State] Frederick, MD [Comments]

Output: Comment 1: We fully support the adoption of the 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide) by the National Institutes of Health (NIH) and the proposed implementation plan. While the vast majority of the changes to the 8th edition of the Guide provide much needed improvements and clarifications on the standards for research animal care and use programs and facilities, there are a small number of issues that could be misinterpreted by either oversight agencies or research facilities using the Guide as a standard. While most comments apply directly to NIH funded research, a few comments do not but still could result in significant confusion across biomedical research facilities in the United States. These issues are provided as follows: Page 25 Topic: Frequency of Program Review and Facilities Inspections The new Guide states "Program review and facilities inspections should occur at least annually or more often as required (e.g., by the Animal Welfare Act and PHS Policy)." While the Animal Welfare Act and PHS Policy both require semiannual program review and facility inspection, not all research entities, even in the United States, are subject to these regulatory requirements. This will lead to a disparity in requirements for those research entities who utilize the Guide as a guidance document but not the other documents cited. The IACUC is a mechanism of self-regulation and conducting annual reviews of the animal care and use program and facilities is not of a sufficient frequency to identify and resolve program and facility issues in a timely manner. Page 26 Topic: Protocol Review A new requirement for protocol review states that the protocol should include a "method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion." The latter part of this statement is very ambiguous and should be clearly defined as to what constitutes "care" and what are considered "long-lived species." This could easily be interpreted by oversight agencies as the need to establish retirement funds designed to maintain animals in sanctuaries for the remainder of their natural life. While this is currently done for chimpanzees, this would result in a phenomenal increase in the cost for research if the intent of this guidance was to include more commonly used nonhuman primates such as Old World macaques. Page 26 Topic: Protocol Review While the new Guide advises that the responsibility for scientific merit review normally lies outside the IACUC, it states "in the absence of evidence of a formal scientific merit review, the IACUC may consider conducting or requesting such a review (Mann and Prentice 2004)." This statement has considerable implications for programs not utilizing the NIH grant review system and leaves the question of "formal review" open to interpretation by oversight agencies. Clarification should be provided as to whether a formal scientific merit review can be performed internally or if the expectation is that it be performed by an external, independent group of scientists. Pages 59 and 61 Topic: Minimum Space Tables 3.3 and 3.5 The title of the tables prescribing minimum space requirements for rabbits, cats, and dogs (Table 3.3) and nonhuman primates (Table 3.5) changed from "minimum space requirements for individual animals" in the old Guide to "individual space requirements for animals housed in pairs or groups" in the new Guide. While there are some differences in floor space and height requirements, the space requirements are similar in both versions of the Guide. The change with the greatest impact involves the addition of the statement to both tables that states "singly housed animals may require more space per animal than recommended for pair- or group-housed animals." Caging manufacturers have produced cages with dimensions based on the minimum space required for individually housed animals as specified in the 7th edition of the Guide. An implication, and possible expectation, that individually housed animals should now have more space will cause confusion not only to the cage manufacturers on how large to make cages for these species, but could result in all the existing cages in use for these species to now be unusable when housing animals individually, which is often needed due to veterinary care or experimental requirements (e.g., quarantine, infectious disease research). Depending on how this new requirement is interpreted by regulatory agencies, this could have a huge economic impact if new caging must now be procured whenever the single housing of animals is required. Without solid scientific evidence that single housed animals benefit from having larger amounts of space over the stated individual space requirement for group housed animals, this requirement will result in the unnecessary diversion of funds from science and confusion among animal care and use programs. Page 139 Topic: Heating, Ventilation, and Air Conditioning (HVAC) With regard to animal room humidification, the new Guide states "Ideally relative humidity should be maintained within ±10% of set point; however, this may not be achievable under some circumstances." While the Guide recognizes that this may not be achievable, the sentence sets a standard that is unachievable by most all older facilities and many new ones. Even with the caveat, the stated preference of no more than a 10% variation of humidity levels from set point will be used by regulators and oversight agencies as an engineering standard. It should be made clear by regulatory and oversight agencies that this is an unrealistic goal and that as long as humidification levels remain between Guide recommended parameters (i.e., 30-70%), and there are no adverse health effects, that the 10% variation requirement will not be used as a standard when evaluating animal facilities. Comment 2: The implementation plan is reasonable and provides sufficient time for programs to incorporate changes to the Guide.

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


Input: [ID] 46 [Entry Date] 03/19/2011 at 12:15:03 PM [Affiliation] Self [Comments]

Output: Comment 1: i do not believe these standards for lab care of animals are humane at all. you can see the video of the way lab animals are actually kept. those pictures are all over the web on youtube of the abuse to lab animals. i want higher standards. i do not want th eindustry to set standards because they will always want to continue abusing animals. i want humane animal protectors to be brought in to upgrade the standards. the standards are lax and abusive. i think the time to comment should be extended. i would like to have a paper copy sent to me to comment in more detail because i have no access to the lab standards in some obscure book. Comment 2: all use of lab animals should be stopped immediately. i think mice and rats are the only animals i would allow to be used in experiments. no other animal should ever be used. the fact is that there are other testing methods that are more accurate, cheaper and more relevant to people than this stupid use of animals which dates from l500 a.d. it is amazing that just becuase profiteers make money from this disgusting industry that scientific minds continue to allow it to continue. that shows a real problem with scientific minds these days. they have no common sense at all.

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] 47 [Entry Date] 03/22/2011 at 02:50:50 PM [Affiliation] Self [Comments]

Output: Comment 1: I have read the "Guide for the Care and Use of Laboratory Animals" and would like to see the eighth edition adopted. As I am strongly opposed to the use of animals at all in research and testing, it is only decent that scientists do all they can to make lab animals feel as comfortable as possible, and eliminate as much stress and pain as possible. Animals are unwilling participants in research and testing, and don't deserve to suffer like they do. Whenever non-animal resources are available, it is incumbent upon scientists and researchers to use them instead of animals. Comment 2: I support institutions evaluating their compliance to the Guide, and would like to see an evaluation of the personnel's treatment of animals; plus animal conditions such as room temperature, water and food, comfort, room to move around; and safety issues, every 6 months. And wouldn't it be better to have an outside agent do the evaluation for an objective view of all of this?

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] 48 [Entry Date] 03/25/2011 at 08:23:35 AM [Affiliation] Self [Comments]

Output: Comment 1: *REVISED* Comments on Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals Submitted for the record by Roscoe G. Bartlett Member of Congress Sixth District of Maryland I would like to highlight the concerns I have of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals. The University of Maryland, School of Medicine and a small business located in my district, Spring Valley Laboratories, have contacted me regarding the proposed new laboratory guidelines. Addressing the complete set of guidelines Louis DeTolla, V.M.D.,Ph.D.,DACLAM of the University of Maryland, School of Medicine states that, "There are no deficiencies in the currently used 7th Edition of the Guide, so its continued use fully supports animal welfare, best practices, and quality biomedical research. The proposed changes to the Guide in the 8th Edition are not supported by data that demonstrate any improvement in scientific outcome of animal studies or benefits in animal welfare as a result of these changes." Specifically, I am concerned that the costs to academia and small businesses do not justify the negligible benefits to the laboratory animals regarding cage sizes. The additional size requirements (i.e. increasing the height requirement for rabbit cages from 14" to 16") will be very costly to labs and small businesses. For example, the cost to the University of Maryland would be $230,000 to replace existing caging. The impact to Spring Valley Laboratories will be more profound. The dollar cost could be as much as $400,000 but final result of these regulations could drive them out of business. As you grapple with developing new guidelines, please consider the following: 1. The Regulatory Flexibility Act of 1980 (amended in 1996) requires that the rulemaking process include cost/benefit analysis of new regulation to small businesses. In this case, the cage size increases compared to the reductions in the amount of money available for advances in medical research and the cost of jobs; 2. The size of the animal in relation to the newly proposed cage size (for example all rabbits are not the same size); 3. A plan to grant exemptions to the Eight Edition guidelines for institutions and businesses with existing cages which meet the specifications of the Seventh Edition of the Guide for the Care and Use of Laboratory Animals. *** Comment 2: *REVISED* Comments on Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals Submitted for the record by Roscoe G. Bartlett Member of Congress Sixth District of Maryland I would like to highlight the concerns I have of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals. The University of Maryland, School of Medicine and a small business located in my district, Spring Valley Laboratories, have contacted me regarding the proposed new laboratory guidelines. Addressing the complete set of guidelines Louis DeTolla, V.M.D.,Ph.D.,DACLAM of the University of Maryland, School of Medicine states that, "There are no deficiencies in the currently used 7th Edition of the Guide, so its continued use fully supports animal welfare, best practices, and quality biomedical research. The proposed changes to the Guide in the 8th Edition are not supported by data that demonstrate any improvement in scientific outcome of animal studies or benefits in animal welfare as a result of these changes." Specifically, I am concerned that the costs to academia and small businesses do not justify the negligible benefits to the laboratory animals regarding cage sizes. The additional size requirements (i.e. increasing the height requirement for rabbit cages from 14" to 16") will be very costly to labs and small businesses. For example, the cost to the University of Maryland would be $230,000 to replace existing caging. The impact to Spring Valley Laboratories will be more profound. The dollar cost could be as much as $400,000 but final result of these regulations could drive them out of business. As you grapple with developing new guidelines, please consider the following: 1. The Regulatory Flexibility Act of 1980 (amended in 1996) requires that the rulemaking process include cost/benefit analysis of new regulation to small businesses. In this case, the cage size increases compared to the reductions in the amount of money available for advances in medical research and the cost of jobs; 2. The size of the animal in relation to the newly proposed cage size (for example all rabbits are not the same size); 3. A plan to grant exemptions to the Eight Edition guidelines for institutions and businesses with existing cages which meet the specifications of the Seventh Edition of the Guide for the Care and Use of Laboratory 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] 49 [Entry Date] 03/25/2011 at 08:56:18 AM [Affiliation] Organization [Organization Name] University of Maryland [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: The current policies are working and adoption of these new policies will not make a big change. With budget cuts, rises is COLA adoption this policy would increase additional financial strain on the institutions, principal investigators and ultimately the ability to deliver good and usable scientific data. Thus I respectfully, request a postponement of the implementation of this new policy. Comment 2: Under normal conditions, implementation of this proposal would have been ideal. However, it is important to note that many research and organizations are under a continuous pressure of budget cuts imposed by the Federal, state and local governments. Many support personnel have been either laid off or working part time to cope up with these changes. The adoption of the proposed actions will result in additional price raises by the veterinary services at different universities. Ultimately, the PI of NIH funded grants or other types grants will not be able to deliver results with increased charges for animal welfare. The current laws sufficiently address many concerns. Thus, it is important the NIH not adopt this new policy and should not implement at this stage.

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] 50 [Entry Date] 03/25/2011 at 02:28:56 PM [Affiliation] Organization [Organization Name] American Farm Bureau Federation [Organization City and State] Washington, DC [Comments]

Output: Comment 1: American Farm Bureau Federation 600 Maryland Avenue SW Suite 1000W Washington, DC 20024 March 25, 2010 Office of Laboratory Animal Welfare Office of Extramural Research National Institutes of Health RKL1, Suite 360 6705 Rockledge Drive, Bethesda, MD Re: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals As the organization representing the largest number of American livestock, dairy and poultry producers, the American Farm Bureau Federation has a deeply vested interest in ensuring that science-based principles are available to guide the proper care and treatment of animals in agricultural production. We appreciate the opportunity to comment on the proposed adoption and implementation of the January 2011 eighth edition of the Institute for Laboratory Animal Research (ILAR) Guide for the Care and Use of Laboratory Animals (ILAR Guide) as a basis for evaluation of institutional programs receiving Public Health Service support involving animals. After reviewing the updated guide, it has come to our attention that the document has many technical flaws related to agricultural animal care. Farm Bureau opposes the adoption by the National Institutes of Health (NIH) of the ILAR Guide as currently published. As we discussed with NIH representatives on Feb. 1, we agree with numerous scientific experts and animal science researchers that the ILAR Guide is flawed in its ethical position. Many of its elements are inconsistent with scientific recommendations for the care of farm animals. Perhaps most important, strict use of the guide would negatively impact animal care. Scientists that work in the field of large animal welfare have pointed out specific deficiencies in the requirements listed in the ILAR Guide for these animals' needs. Unscientific animal care guidelines pose a threat to animals as well as the producers and researchers responsible for their well-being. We are concerned that the adoption of inaccurate standards by NIH would harm agricultural animals in the care of the Public Health Service, and by precedent, animals in academic research and the private sector. This precedent is not only confusing but potentially dangerous, as it starts down the slippery slope of basing care standards on something other than science. In January 2010, the Federation of Animal Science Societies (FASS) published an updated Guide for the Care and Use of Agricultural Animals in Teaching and Research (Ag Guide). This document was written by 64 professionals with expertise in farm animal care and contains a wealth of substantive technical information about the care of farm animals in teaching or research (agricultural or biomedical). Unlike the ILAR Guide, the Ag Guide contains appropriate, tested and practical protocols for such criteria as sanitation protocols, air temperatures and floor space, to name just a few. All recommendations in the Ag Guide are based upon peer-reviewed research. The Ag Guide is the most scientifically valid, current resource document for agricultural animal care. We strongly urge NIH to adopt and recognize it as the sole reference for farm animal care. Sincerely, Mark Maslyn Executive Director Public Policy

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


Input: [ID] 51 [Entry Date] 03/28/2011 at 09:07:08 AM [Affiliation] Organization [Organization Name] MB Research Labs [Organization City and State] Spinnerstown, PA [Comments]

Output: Comment 1: The Eighth Edition of the Guide has changed the height requirement of rabbit primary enclosures from 14" to 16". Prior to NIH acceptance of the Guide for PHS support, this change should be questioned. The 16" criteria may be suitable for very large rabbits but requiring the height for all animals seems questionable. The use of performance criteria based on animal weight or age should be considered. The economic impact of changing all caging will be significant. We presently inventory approximately 200 rabbit cages which conform to the 14" criteria. Replacing these cages will result in a large financial burden. I suggest that NIH consider instituting performance standards based on animal weight.

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] 52 [Entry Date] 03/29/2011 at 03:18:47 PM [Affiliation] Self [Organization Name] Oregon Health and Science University [Organization City and State] Portland, OR [Comments]

Output: Comment 1: The guide should be adopted. Comment 2: Current requirements are sufficient. No additional regulatory requirements should be imposed on institutions.

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


Input: [ID] 53 [Entry Date] 04/01/2011 at 02:58:44 PM [Affiliation] Organization [Organization Name] Oregon National Primate Research Center [Organization City and State] Beaverton, Oregon [Comments]

Output: Comment 1: We strongly support the adoption of the 8th edition of the Guide for the Care and Use of Laboratory Animals and appreciate the importance of housing animals in cages appropriate for their Psychological, social and Physical needs. In the case of non-human primates we understand and appreciate the need for increased cage height to meet the conformational and behavioral needs of the animals. The recommended cage size for non-human primates in The Guide will make some caging obsolete and will require major engineering changes in animal housing buildings, rooms and cages. This will result in substantial cost without providing a mechanism for re-capturing those costs through granting programs since the G-20 process has been discontinued. Because of these financial constraints, it may not be possible for us to perform a semiannual inspection using the new standards by the recommended date of March 25, 2012.

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] 54 [Entry Date] 04/04/2011 at 12:14:42 PM [Affiliation] Organization [Organization Name] Thomas Jefferson University [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: Expanding the required amount of cage space for housing experimental mice in breeding protocols would have several negative effects that should be considered. First, during these trying economic times not being able to use breeding trios will double an investigator's expense for breeding cages. Also, the use of trios ensures that if one female perishes there is another lactating female who can nurse the pups. This prevents young pups from starving to death. For certain strains it has been published previously that the males help the mother at times by laying on the pups to keep them warm. Also, the removal of a male when a mother has young pups can cause her to cannibalize her litter. If a males is "hopped" between two cages with two females, then one of the female cages will not receive assistance from the male when raising pups. Additionally, if the male is hopped at the wrong time this can result in more eaten litters.

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] 55 [Entry Date] 04/05/2011 at 05:39:11 PM [Affiliation] Self [Comments]

Output: Comment 1: "The use of non-pharmaceutical-grade chemicals or substances should be described and justified in the animal use protocol and be approved by the IACUC" There are many instances when nonpharmaceutical grade compounds or substances may be appropriate and allowances should be made for IACUCs to establish policies governing their use that do not require prior IACUC approval. Specific examples include when a nonpharmaceutical grade compound or substance is used for nonpharmaceutical purposes such as the use of doxycycline to regulate gene expression or the use of sterile PBS as a diluent for research reagents. If efficacy of the compound is not an issue because the compound is not being used therapeutically (eg. antibiotics, anesthetics, etc.) and if proper precautions to ensure sterility, freedom from particulates, and safety of the compounds is a prerequisite, then the use of professional judgment in creating an appropriate policy should be permitted. Blanket statements such as "They should therefore be used, when available, for all animal-related procedures" do not provide the flexibility needed in a diverse research environment. Similarly, the term "animal-related procedures" is vague and open to extreme interpretations (is a necropsy an animal-related procedure? a bath?). All "live animal-related experimental procedures" would offer some better definition. Comment 2: "Single housing of social species should be the exception and justified based on experimental requirements or veterinary-related concerns about animal well-being." It would be very beneficial to readers if the Guide could indicate to which commonly used species this applies - provide examples.

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] 56 [Entry Date] 04/07/2011 at 03:51:19 PM [Affiliation] Self [Comments]

Output: Comment 1: After reading the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, we feel strongly that it should not be adopted as it is, but should be sent back for revision and clarification. While some necessary updates are included, several statements within the Guide are ambiguous and others are not appropriate for the use of species such as rodents and fish. We think that the lack of discussion of species-specific requirements for optimal care and management is a major problem with the Guide as written. If adopted in its present form, the Guide is likely to be interpreted variably by readers at different institutions and increase the regulatory burden on those who work with animals. Of great relevance, it appears that the committee that wrote the Guide included minimal representation from the scientific community who actually use animals in their research. We believe that having a balanced committee is key to having a clear and useful document and that this unbalanced committee structure may underlie the specific issues listed below. 1. Guide page 27-"Experimental and Humane endpoints". We believe that this distinction is false and will be interpreted to mean that some procedures in IACUC-approved documents are inhumane. Before any proposal is submitted by the investigator or approved by an IACUC, alternatives are considered fully. In approved protocols, IACUC-approved experimental and human endpoints are identical. During the course of studies, investigators continually re-evaluate the endpoint criteria necessary to meet the scientific goals and the necessity of any adverse affects that have been previously approved. This change in the Guide may directly hamper research efforts by raising questions about "inhumane" endpoints. 2. Guide page 25-"A clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee." This addition to the Guide does not affect animal welfare, but increases the regulatory burden on investigators. Description of Study Objectives in lay terms is already required (and often difficult); any procedures that are not easily understood can be discussed at committee meeting. If necessary, investigators could be asked for additional clarification for those few cases in which procedures are not clear or adequately justified. 3. Guide page 64-"Social environment"-The concerns raised about social housing apply minimally to mice, rats or fish. Mice, rats and fish should be exempt from these social pairing requirements. The Guide should state that while mice and rats are social animals and single housing is discouraged, they are exempt from the need for provision of scientific justification and review of social housing requirements. Appropriate environmental enrichment for mice and rats is encouraged. 4. Guide pages 29 and 64-Restraint devices. It is unreasonable to broadly apply the information in the physical restraint section, which describes requirements for training and habituation, to laboratory mice, rats and fish. Training and habituation is generally not feasible due to the numbers of animals involved and average length of experiments. Training and habituation should not be required for the restraint of rodents for acute and transient procedures. Only prolonged restraint or restraint used as an experimental stressor for rodents should require description and justification. Listing the restraint methods to be used on the animal study proposal is appropriate in all cases. It should be clarified that animals that fail to adapt should be removed from the study when the failure poses a reasonable risk to the animal or personnel, or adversely affects the animal's health and welfare or study objectives. Finally, fish should be excluded from the physical restraint and training section. 5. Guide page 30-Food and fluid regulation. The requirement that written records of daily food and fluid intake be maintained for individual animals in experiments involving food or fluid restriction should be waived for mice, rats and fish. Measuring intake is virtually impossible for mice or rats unless they are singly housed, which is not recommended elsewhere in the Guide. The IACUC should decide when records are required, unless adverse effects are observed during daily monitoring. 5. Guide page 115-Surgery-"The IACUC, together with the AV, is responsible for determining that personnel performing surgical procedures are appropriately qualified and trained in the procedures (Anderson 2007)." The IACUC should be responsible for supervision. The AV should provide guidance but there will be a potentially adversarial relationship if the AV is also responsible for determining whether personnel are appropriately qualified. 6. Guide page 123-Euthanasia-"Standardized methods of euthanasia that are predictable and controllable should be developed and approved by the AV and IACUC."This is the same issue as in item #5. The IACUC should have the final authority in all areas of euthanasia. 7. Guide page 15: Interinstitutional Collaborations - . "In cases of such collaboration involving animal use (beyond animal transport), the participating institutions should have a formal written understanding…" This creates an unnecessary regulatory burden. OLAW should clarify that the Guide is concerned with animal care and services and not with typical scientific collaborations between investigators at institutions with PHS assurances.

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] 57 [Entry Date] 04/12/2011 at 03:02:49 PM [Affiliation] Self [Comments]

Output: Comment 1: Table 302 on page 57 and the related discussion regarding space requirements for rodent housing are completely inadequate for use as an evaluating tool for rodent research programs for the following reason: The section manages to completely confuse the space requirements for harem breeding or even pair breeding, as there is only a size requirement for a single animal (the dam) with a litter. There is no obvious answer to the question- What is the space requirement for more than one adult with a litter? This is unacceptable, as pair breeding or harem breeding are the primary methods for breeding rodents. This section only creates confusion as to what the appropriate size cage would be for these situations. The size caging that you would end up with for these situations is unreasonable and would create an unreasonable and unsustainable cost for institutions conducting research as breeding programs would take up at least two times their current space, if not more. Their would also be costs associated with new caging required, protocol changes, training requirements exc. I believe the Guide would have to amend this table to correct the issue before it would be usable as an evaluation tool for institutions using rodents for 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] 58 [Entry Date] 04/12/2011 at 06:06:27 PM [Affiliation] Self [Comments]

Output: Comment 1: Chapter 4, pp 114 ...investigator and veterinary staff cannot reach consensus on treatment, the veterinarian must have the authority, delegated by senior administration (see Chapter 2, Institutional Official and Attending Veterinarian) and the IACUC, to treat the animal, remove it from the experiment, institute appropriate measures to relieve severe pain or distress, or perform euthanasia if necessary. This is in direct conflict with 21 CFR 58.33 The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. In addition, 9 CFR 2.31 empowers the IACUC committee to resolve differences in opinion between SD and Veterinarian. It would be a violation of the USDA regulations for the Veterinarian to act unilaterally and intervene against SD opinion, without IACUC consideration and approval. Endpoints and pain/morbidity level plans are a required part of the IACUC protocol approval process. If the Veterinarian is concerned about endpoints or pain management plans, the time to voice those concerns are prior to start of study. Interference can result in biased data and skew endpoints required for FDA decision making and ultimately endanger human health where such endpoints are ignored in favor of animal comfort. Critical data can be lost or obscured under the guise of protecting the test subject. FDA regulations are designed to create studies which per 21 CFR 58.120 reduce bias and per 21 CFR 58.33 capture all data including unanticipated results which may point to future human safety issues thereby saving lives in future clinical trials. The Veterinarian having the authority to act unilaterally without IACUC consideration and approval is unacceptable and violates FFDCA and the regulatory authority of the FDA. Currently the Federal Register Vol 76 March 29, 2011 list April 24, 2011 as the final date for comment. In addition to the problem with the Study Director – Vet conflict there are a number of revisions of cage dimensions which are virtually unavailable in the market making cage sizes obsolete and creating a rather unreasonable financial burden on all research organizations.

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] 59 [Entry Date] 04/13/2011 at 08:21:18 AM [Affiliation] Self [Comments]

Output: Comment 1: The new Guide's "should" level recommendations for behavioral research are alarmingly naive, anthropomorphic, and have no basis in science. For example, the "shoulds" about diet restriction have no basis in science, and they ignore both the well documented health and well-being effects of moderate dietary restriction and the fact that there is no evidence that such regimens produce anything approximating chronic distress. Comment 2: The recommendations about the use of pharmaceutical grade drugs for pharmacology research are not simply cumbersome, they promote bad science. Also of note is the complete absence of any evidence whatsoever that health and welfare of animals have been compromised by the use of research grade drugs (i.e., pure and in a known vehicle that is usually without effects of its own).

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] 60 [Entry Date] 04/13/2011 at 04:51:59 PM [Affiliation] Self [Comments]

Output: Comment 1: I support the use of the 8th edition of the Guide for Animal Care and Use. In general, the revisions in the latest edition are needed and remedy several deficiencies in the previous edition. Comment 2: I believe that the implementation time needs to be extended at least one year. It will be very difficult for institutions to make the changes necessary to be in compliance with the new quidelines by March 31, 2012.

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] 61 [Entry Date] 04/14/2011 at 03:24:55 PM [Affiliation] Organization [Organization Name] Drexel University College of Medicine [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: The eighth edition of the Guide should NOT replace the 1996 edition. The sheer burden of many of the proposed modifications do nothing to increase the care, use and welfare of laboratory animasls and add substantial expenses to both the institution and to the individual investigator. In a time of severely diminishing budgets for research, in a time of substantial cuts to academic institutions, these proposed changes will only further diminish our competitive stance in the healthcare community, will impact on the discovery of new drugs and will further debilitate our younger scientists - all without any derived benefit to the laboratory animals that are so vital - and so adequately cared for under the present guidelines - to our research enterprise. Finally, I wish to comment on the proposed modification on the use of "nonpharmaceutical grade" drugs. THere is virtually no evidence whatsoever, that using pharmaceutical grade drugs would improve animal welfare or science. This is another instance of an attempt to implement a strategy that, on the surface may sound reasonable but, in reality, is completely without benefit to animal welfare. Moreover, the costs incurred are substantial - again, reducing funds available for meaningful research, delaying productivity and increasing the burden of extraneous activity to our investigators. Comment 2: OLAW should require any institutional compliance with the new Guide not sooner than 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] 62 [Entry Date] 04/14/2011 at 04:10:49 PM [Affiliation] Organization [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore, Maryland [Comments]

Output: Comment 1: Adoption of this Guide is unnecessary and amounts to a total waste of precious federal research funds. There are no scientifically valid studies indicating that the health or welfare of the animals would be improved by adoption of the new guidelines. But the new Guide would definitely translate into significantly greater costs (cages!! et al.). A cynic may wonder if this initiative was sponsored by cage manufacturers and alike.... We are supposed to make best use of taxpayers' money, especially in the current fiscal climate. This initiative does the exact opposite. It's simply a terrible idea. Comment 2: Yearly inspections are entirely adequate. Do not fix something that is not broken. Again spoken as a cynic: is this initiative meant to provide jobs for inspectors?? What other purpose could there be?

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] 63 [Entry Date] 04/14/2011 at 04:17:38 PM [Affiliation] Self [Organization Name] University of Maryland, Baltimore [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: This new caging policy for rodents is arbitrarily defined and is not correct according to recent studies. For example, the article given below finds that "The current findings indicate that mouse housing density can be increased 50% to 100% above the current recommendations (as floor area per mouse) with no or few apparent affects on mouse overall wellbeing." The intended guide will result in the following: · 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. Therefore, to increase research costs without justification or scientific validity is a waste of resources, especially in such a budget restricted time. J Am Assoc Lab Anim Sci. 2009 Nov;48(6):740-53. The response of C57BL/6J and BALB/cJ mice to increased housing density. Nicholson A, Malcolm RD, Russ PL, Cough K, Touma C, Palme R, Wiles MV. The Jackson Laboratory, Bar Harbor, Maine, USA. Abstract Increased numbers of mice housed per cage (that is, increased housing density) is seen as 1 way to reduce the costs of conducting biomedical research. Current empirically derived guidelines are based on the area provided per mouse depending on body weight as documented in the Guide for the Care and Use of Laboratory Animals. The current study aimed to provide a more scientific basis for housing density by examining the response of C57BL/6J and BALB/cJ mice to increased housing density from weaning to 5 mo of age, to determine those parameters most useful for future larger-scale studies. A wide range of phenotypic characteristics--including growth rate, body composition, hematology, serum biochemistry, hormone and metabolite measurements, in-cage telemetry, behavior, and cage microenvironment--was examined at various time points. The parameters showing greatest changes were: growth rate, which was significantly reduced in animals at the highest density; adrenal gland size, the proportion of adrenal cortex, and concentration of fecal corticosterone metabolites, all of which were increased at higher densities; and anxiety and barbering, which were more pronounced at higher densities. Cage microenvironment deteriorated with increasing density, but the increases in measured parameters were small, and their biologic impact, if any, was not apparent. The current findings indicate that mouse housing density can be increased 50% to 100% above the current recommendations (as floor area per mouse) with no or few apparent affects on mouse overall wellbeing. However, weight gain, fecal corticosterone metabolite levels, and barbering differed significantly with housing density and therefore are suggested as good measures of the response to alterations in housing. Comment 2: This new caging policy for rodents is arbitrarily defined and is not correct according to recent studies. For example, the article given below finds that "The current findings indicate that mouse housing density can be increased 50% to 100% above the current recommendations (as floor area per mouse) with no or few apparent affects on mouse overall wellbeing." The intended guide will result in the following: · 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. Therefore, to increase research costs without justification or scientific validity is a waste of resources, especially in such a budget restricted time. J Am Assoc Lab Anim Sci. 2009 Nov;48(6):740-53. The response of C57BL/6J and BALB/cJ mice to increased housing density. Nicholson A, Malcolm RD, Russ PL, Cough K, Touma C, Palme R, Wiles MV. The Jackson Laboratory, Bar Harbor, Maine, USA. Abstract Increased numbers of mice housed per cage (that is, increased housing density) is seen as 1 way to reduce the costs of conducting biomedical research. Current empirically derived guidelines are based on the area provided per mouse depending on body weight as documented in the Guide for the Care and Use of Laboratory Animals. The current study aimed to provide a more scientific basis for housing density by examining the response of C57BL/6J and BALB/cJ mice to increased housing density from weaning to 5 mo of age, to determine those parameters most useful for future larger-scale studies. A wide range of phenotypic characteristics--including growth rate, body composition, hematology, serum biochemistry, hormone and metabolite measurements, in-cage telemetry, behavior, and cage microenvironment--was examined at various time points. The parameters showing greatest changes were: growth rate, which was significantly reduced in animals at the highest density; adrenal gland size, the proportion of adrenal cortex, and concentration of fecal corticosterone metabolites, all of which were increased at higher densities; and anxiety and barbering, which were more pronounced at higher densities. Cage microenvironment deteriorated with increasing density, but the increases in measured parameters were small, and their biologic impact, if any, was not apparent. The current findings indicate that mouse housing density can be increased 50% to 100% above the current recommendations (as floor area per mouse) with no or few apparent affects on mouse overall wellbeing. However, weight gain, fecal corticosterone metabolite levels, and barbering differed significantly with housing density and therefore are suggested as good measures of the response to alterations in housing.

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] 64 [Entry Date] 04/14/2011 at 04:21:27 PM [Affiliation] Self [Comments]

Output: Comment 1: I oppose adopting the 8th edition of the Guide, in part because many of the proposed changes that are purported to be for the benefit of the animals are not supported by any scientific evidence. For instance, I am not aware of any evidence to support the changes in rodent housing standards, or of any evidence suggesting that the health or well-being of laboratory rodents is at all compromised by use of the existing (7th edition of the Guide) housing standards. While any consideration of costs should be secondary to the primary concern for animal welfare, it is irresponsible to require costly changes to care that have no demonstrable benefit to the 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] 65 [Entry Date] 04/14/2011 at 04:26:42 PM [Affiliation] Self [Comments]

Output: Comment 1: The new guideline requires an increase in floor spaces for a mouse 25 grams and over (15 sq. in.) and for a female mouse with a litter of pups (51 sq. in.). It is still highly controversial if this increased floor space will increase animal health and wellbeing. However, they represent an unnecessary financial burden on everyone who uses or cares for rodents in research. The money from a typical R01 is not sufficient to pay the cage charges at the current funding level. With the worsening funding environment, I thought that available money should be spent on advancing research, and not on buying new cages for a perceived (but scientifically unproven) increase in animal well being.

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] 66 [Entry Date] 04/14/2011 at 04:29:23 PM [Affiliation] Self [Comments]

Output: Comment 1: There is much concern from the researchers in the department that the changes are expensive and will do nothing to promote the health and well-being of animals.

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


Input: [ID] 67 [Entry Date] 04/14/2011 at 04:52:07 PM [Affiliation] Self [Comments]

Output: Comment 1: Retain the 1996 Guide as is. Restrictive policies on science and innovation should be based on valid scientific evidence. The requirement to use only pharmaceutical grade chemicals for all species is particularly absurd. Comment 2: Retain the 1996 Guide as is. Restrictive policies on science and innovation should be based on valid scientific evidence. The requirement to use only pharmaceutical grade chemicals for all species is particularly absurd.

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] 68 [Entry Date] 04/14/2011 at 04:56:56 PM [Affiliation] Self [Comments]

Output: Comment 1: I would like to express my concern about some of the changes that are planed for this last edition. Space. I am a mouse user and, long story short, these changes will result in being able to hold just 4 mice per cage instead of 5, which results in a considerable increase on the per diem costs and space. As it is mentioned in the document, this particular change is based in recent studies that, at the end of the day, do not prove anything due to the variabilities in those studies. I have being using different strain of mice for over 6 years and I can see that 5 animals do well as long as the cages are changed at the proper time and that, fights rarely occur if you do not try to mix adult animals from different cages. And, if agressivity has to happen, it does not matter if there are 2 or 5 animals housed. If we are to reduce to 4 the animal to house per cage, we will need too many cages to reach a scientifically significative number for our studies and for what? Because it is not that rare that an experimental animal dies during the study and that particular cage is left with 4 instead of 5 animals. Does that mean that my results are influenced by the fact that the animals from the cage with 4 animals had more space and therefore their mental health was better...? I truly think that, to introduce a change with such an impact, you cannot just base it in a possibility, you really need to justify it with real prove. Thanks

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] 69 [Entry Date] 04/14/2011 at 04:59:04 PM [Affiliation] Self [Organization City and State] Richmond VA [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] 70 [Entry Date] 04/14/2011 at 05:07:10 PM [Affiliation] Organization [Organization Name] Columbia University Psychiatry and the NYS Psychiatric Institute [Organization City and State] New York, NY [Comments]

Output: Comment 1: The new guide , if fully adopted by OLAW as policy would have SIGNFICANT SCIENTIFIC and ECONOMIC impact on our research. There has not been sufficient time to completely assess this impact and the space limitations for comments is too restrictive to allow meaningful feedback. For example, at our institution the new space requirements for mouse breeding would require new caging (major expense), or a change from social 'dam' housing (mice) to housing single dams with litter more space. The latter is a significant economic burden. The latter solution forces us to change an important aspect of our experimental design (social parenting) which we believe benefit our mice. Either solution will require more space, which, in turn requires major programmatic changes that may take years to complete. I think I speak for most investigators and our IACUC in strongly recommending that 1) more time be given for the scientific community to evaluate the impact of the guide and provide meaningful feedback. Comment 2: It is unlikely that institutions can implement all of the major changes (the 'musts') outlined by the guide by March 2012. It is recommended that NIH implement instead a 'evaluation period' in which institutions are encouraged to begin using the guide for evaulations and give feedback to NIH. During this time the current guide should be the basis for the official semiannual IACUC evaluation. As stated above, new policies based on the 8th edition would force major changes to experimental design, caging and/or the physical plant. Any implementation deadlines should be set with full consideration of the time needed to make these major changes.

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


Input: [ID] 71 [Entry Date] 04/14/2011 at 05:27:04 PM [Affiliation] Organization [Organization Name] University of Texas at Dallas [Organization City and State] Richardson, TX [Comments]

Output: Comment 1: No valid need exists for adopting the altered guidelines in the 8th edition of the guide for use of laboratory animals. Exacerbating this lack of validation is the fiscal (financial) climate under which research must exist: stringent budgetary and space limitations. With the current political climate, it seems incredible to ask institutions to make vast new expenditures for new animal housing and/or to cut the number of experiments performed to meet arbitrary new requirements. Our own facility is only two years old, and all new caging and equipment was purchased at that time. Are we to throw away this large investment (which should be amortized over a decade or more) and begin anew, at a higher cost to every investigator on the entire campus? Or are we required to increase per diem costs, effectively reducing the yield of every single publicly funded research project? That hardly seems the route to fiscal responsibility both political parties propound currently. Our ACUC strongly recommends against ANY such new regulation. Comment 2: NO to adoption of the new 8th edition! Leave current guidelines in place as they stand; veterinary staff at the local level are more than well qualified to make additional recommendations!

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] 72 [Entry Date] 04/14/2011 at 05:59:40 PM [Affiliation] Self [Comments]

Output: Comment 1: I do not favor adopting new requirements. The requirements of the previous version are sufficient to ensure appropriate care and use of laboratory animals. Comment 2: I do not favor adopting new requirements. The current requirements are sufficient to ensure appropriate care and use of laboratory 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] 73 [Entry Date] 04/14/2011 at 06:01:21 PM [Affiliation] Self [Comments]

Output: Comment 1: I am opposed to the adoption of these standards and particularly those requiring increased space for housing rats and mice. These standards are unnecessary and will divert resources from the actual 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] 74 [Entry Date] 04/14/2011 at 06:03:22 PM [Affiliation] Self [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: I am writing about the changes in the "Guide" regarding husbandry for mice. The requirement it proposes to provide more space per mouse, and per dam and her litter, would be very costly. At my institution, it would increase my costs for the mouse colonies I maintain by at least 25%. That is the equivalent of half a technician's salary, and would make it impossible for me to maintain my research program and research staff at its current size. Across all universities and research institutions in the country, this change alone would result in the loss of thousands of good research jobs and the significant shrinking of programs that use murine models of human diseases. This would in turn undermine the efforts of the NIH to promote translational research, slowing the development of new therapeutics. In a time of diminishing federal research dollars, this is just about the worst thing you could contemplate doing. I urge you to find an alternative (in my opinion, there is nothing wrong with our current approaches to animal husbandry for rats or mice), or at the very least to postpone implimentation of the new regulations until the federal research budget is growing again.

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] 75 [Entry Date] 04/14/2011 at 06:39:26 PM [Affiliation] Self [Comments]

Output: Comment 1: I am VERY STRONGLY OPPOSED to adoption of the 8th edition of the Guide. Most important: there is NO Scientific Evidence that rodents will be SIGNIFICANTLY better off in terms of health and wellbeing with the proposed new caging guidelines. The increassed cost, which is therefore not justfied, will be enormous at a time when funding for research is decreasing. Our entire bioscience research enterprise is already in jeopardy; adoption of these proposed guidelines would further damage the entire enterprise.

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] 76 [Entry Date] 04/14/2011 at 09:45:42 PM [Affiliation] Self [Organization Name] u of maryland dept of orthopaedics, school of medicine [Organization City and State] baltimore, MD [Comments]

Output: Comment 1: The increased space requirements for housing mice and rats would seem to have little scientific backing in the way of proof of improved health and well-being of the animals, yet add substantial increases in cost to house the animals during a time of constricted research funding.

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] 77 [Entry Date] 04/14/2011 at 10:10:11 PM [Affiliation] Organization [Organization Name] University of Hawaii Laboratory Animal Service [Organization City and State] Honolulu, HI [Comments]

Output: Comment 1: This is a significant guidance document which requires more time and space for comment by the public.

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] 78 [Entry Date] 04/15/2011 at 03:13:41 AM [Affiliation] Self [Organization Name] Virginia Commonwealth University [Organization City and State] Richmond, VA [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] 79 [Entry Date] 04/15/2011 at 04:54:50 AM [Affiliation] Organization [Organization Name] MPI Research [Organization City and State] Mattawan, MI [Comments]

Output: Comment 1: I strongly urge the USDA adn OLAW to NOT adopt the newest animal guidelines. The additional expense to our institutions and to the pharmaceutical industry with no real enhancement of animal welfare is just one reason NOT to adopt these guidelines. The additional paperwork burden to the investigator and the institution is yet another. Comment 2: All active researchers are concerned that: (1) the 2011 Guide contains many recommendations that will, in effect, function like regulations, rather than the "guidelines" for the care and use of research animals authorized by the Health Research Extension Act of 1985; (2) there is insufficient scientific evidence for some revisions reflected in the new Guide; and (3) the additional provisions of the 2011 Guide will have a significant economic impact on all PHS-assured institutions as well as the Contract Research Organizations that conduct such research on behalf of pharmaceutical industry sponsors. We do NOT want these guidelines finalized or adopted by the USDA or OLAW.

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] 80 [Entry Date] 04/15/2011 at 06:07:01 AM [Affiliation] Self [Comments]

Output: Comment 1: I am strongly opposed to the recommendations which are not based on good science, are not peer reviewed, and will result in a vast increase in costs without benefit. This is a waste of research money and will have significant effects on the research infrastructure of the USA and further erode the productivity and preeminence of the USA research investment and competitiveness. Comment 2: I am strongly opposed to the recommendations which are not based on good science, are not peer reviewed, and will result in a vast increase in costs without benefit. This is a waste of research money and will have significant effects on the research infrastructure of the USA and further erode the productivity and preeminence of the USA research investment and competitiveness.

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] 81 [Entry Date] 04/15/2011 at 08:07:09 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. 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 been able to promulgate their falsehoods to a sufficiently large number of activists who have lobbied congress successfully to impose regulations that cripple the ability of biomedical researchers to develop cures for diseases that afflict both humans and animals. 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. Several years ago Philip Zimbardo conducted the infamous "Stanford Prison Experiment" which had to be stopped prematurely after only 6 days because of the sadistic abuse of "prisoners" by their "guards". I submit that today's IACUC committees by virtue of the unrestricted powers they have been given, have become the 21st century "guards" and that biomedical researchers have become the "prisoners". Clearly IACUCs are not working as intended and their powers to subject biomedical researchers to their irresponsible whims should be severely curtailed if not completely abolished. Comment 2: I oppose this additional regulation because it adds an unreasonable, disabling burden to institutions that are working for the common good.

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] 82 [Entry Date] 04/15/2011 at 08:48:08 AM [Affiliation] Self [Comments]

Output: Comment 1: I am writing about the changes in the "Guide" regarding husbandry for mice. The requirement it proposes to provide more space per mouse, and per dam and her litter, would be very costly. At my institution, it would increase my costs for the mouse colonies I maintain by at least 25%. Across all universities and research institutions in the country, this change alone would result in the loss of thousands of good research jobs and the significant shrinking of programs that use murine models of human diseases. This would in turn undermine the efforts of the NIH to promote translational research, slowing the development of new therapeutics. In a time of diminishing federal research dollars, this is just about the worst thing you could contemplate doing. I urge you to find an alternative (in my opinion, there is nothing wrong with our current approaches to animal husbandry for rats or mice), or at the very least to postpone implementation of the new regulations until the federal research budget is growing again.

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] 83 [Entry Date] 04/15/2011 at 09:16:14 AM [Affiliation] Self [Comments]

Output: Comment 1: I am opposed to NIH adopting the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. The new rules on rodent housing were apparently largely derived from European housing standards and it is highly controversial if the adoption of these standards will increase animal health and wellbeing. They represent an unnecessary financial burden on everyone who uses or cares for rodents in research. In the current funding environment, available 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] 84 [Entry Date] 04/15/2011 at 09:49:38 AM [Affiliation] Self [Comments]

Output: Comment 1: The proposed schanges, primarily derived from European housing standards, are highly controversial. I am not convinced at all that these standards will increase animal health and wellbeing. They represent an unnecessary financial burden on everyone who uses or cares for rodents in research. In the current funding environment, available money should be spent on advancing research, not buying new cages for a perceived (but scientifically unproven) increase in animal wellbeing. I highly recommend re-evaluating this propsal with a clear mind seriously considering the current situation of our economy!!!!

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