PETITION FOR RULEMAKING

Transcription

1 PETITION FOR RULEMAKING TO: Thomas J. Vilsack, Secretary United States Department of Agriculture Jamie L. Whitten Federal Building Room 200-A 1400 Independence Ave., SW Washington, DC Dr. Chester Gipson Deputy Administrator of Animal Care United States Department of Agriculture Jamie L. Whitten Federal Building Room 312-E 1400 Independence Ave., SW Washington, DC Nora Wineland, Director Center for Animal Welfare CC: PETITION: To Amend Regulations on Reporting Requirements from USDA Licensees Regarding Animals Used for Research, Breeding, and Exhibition and to Improve the Accuracy and Ease of Obtaining More Informative Data by the Public SUBMITTED BY: The National Anti-Vivisection Society 53 W. Jackson Blvd., Ste Chicago, IL DATE: December 16, 2014

2 I. Introduction This petition is submitted on behalf of the National Anti-Vivisection Society (NAVS), petitioner, to request that the United States Department of Agriculture ( USDA ), and its Animal and Plant Health Inspection Service ( APHIS ), initiate rulemaking to amend the requirements for recordkeeping and reporting on the use of animals by dealers, exhibitors, research facilities, intermediate handlers and carriers licensed by the USDA under 7 USC 2140 of the Animal Welfare Act. Petitioner requests that the Secretary amend the Animal Welfare Regulations recordkeeping requirements 1 to require more accurate, detailed and useful information in the Animal Welfare Regulations Annual Report. 2 Although current reporting applies to a small fraction of all animals used in research (since mice, rats, birds and cold-blooded animals are exempt from reporting and welfare requirements in the Animal Welfare Act), the reliability of the data that is required is extremely important to any survey on the use of animals in research, testing, teaching and experimentation. Maintaining timely and accurate records is both an obligation on the part of the federal government and a necessity to organizations, such as NAVS, that rely on this information in order to fulfill their mission. A revised system of recordkeeping would not be an undue burden for licensees because the information would be streamlined into a more comprehensive and functional electronic format. This would make reporting easier for licensees and ultimately for parties accessing the information. Additionally, such data would allow more accurate comparisons of animal use in the U.S. to the European Union, so that global trends in animal usage could be determined. II. Interests of the Petitioner The National Anti-Vivisection Society, petitioner, is a non-profit charitable organization that has been working to end the exploitation of animals in research, testing and education since NAVS provides information to supporters, policymakers and members of the general public as part of its mission of educating the public regarding the use and abuse of animals used for research and product testing. NAVS, located in Chicago, Illinois, has supporters throughout the United States who rely on the accuracy of information disseminated by the organization. Petitioner disseminates the information contained in the APHIS Annual Report on its website and uses the information to track trends in the usage of animals over time. This information is also used to prepare teaching materials to be used in presentations to professional organizations and higher education classes on a regular basis. The accuracy and adequacy of APHIS recordkeeping is of great importance to petitioner s credibility in fulfilling its educational mission. 1 7 CFR CFR

3 The use of animals in science is a matter of great concern, not only to the supporters of our organization, but to the general public and those in the scientific community, as the 3 R s (reduction, refinement and replacement of animal use) are implicit in the Animal Welfare Act administered by APHIS and the USDA. 3 Without reliable statistics on where and how animals are used in research, testing, teaching and experimentation, a constructive discussion on how well the 3 R s are being implemented in this country cannot take place. Inadequacies in the current Annual Report of Research Facility form, APHIS Form , do not allow basic data to be collected on how animals are being used in this country. In addition, U.S. government agencies wishing to implement changes to their use of animals, as required under the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM), would benefit from accurate records regarding the number of animals used and how they are used in fulfillment of their own mission. Moreover, non-government organizations that invest in the development and promotion of non-animal alternatives, such as the International Foundation for Ethical Research (funded by NAVS) rely on this data as a measure of success in promoting their efforts. Many other organizations rely on the data APHIS collects on animals used in research, as well. Because APHIS does not collect data on how animals are used in research, confusion and misinformation about animal use are being perpetuated. For example, a 2012 report generated from the APHIS website indicated that the number of dogs used in research, testing, teaching or experimentation is approximately 65,000. Because information about how dogs are used is not collected by APHIS, other animal welfare groups have targeted the largest users of dogs, assuming that they had been harming dogs based on information included in the APHIS report. Conversations by the petitioner with one of these large users of dogs clarified that they do not use animals for experimental purposes, but do perform procedures on dogs from local shelters to help make these dogs adoptable. These procedures include spaying and neutering, teeth and ear cleaning, and nail clipping. The dogs are then released to shelters, and are not harmed. Improving the transparency and accountability in reporting on the use of animals by USDA licensees would eliminate potential confusion. U.S. citizens have the right to petition their government to add, amend or repeal regulations relating to agriculture under the Right to Petition Government Clause of the First Amendment of the United States Constitution, 5 the Administrative Procedure Act 6 and USDA regulations. 7 Under this authority, petitioner submits this petition for rulemaking to the Secretary of the Department of Agriculture ( Secretary ) APHIS Form 7023, Annual Report of Research Facility ( 5 U.S. Const. Amend. I. 6 5 U.S.C. 553(e) 7 7 CFR

4 III. Background on Inadequate Reporting and Transparency The reliability of data on the number of animals used in research and how these animals are being used is important to any survey on the use of animals in research, testing and education. Animal Welfare Regulations recordkeeping requirements on the use of animals for these purposes do not provide sufficient transparency and should be amended to require more accurate, detailed and useful information. An annual report is required to be submitted by USDA licensed dealers, including the number of animals sold, held, leased or exhibited as required by APHIS regulations. 8 Research institutions are also required to submit an annual report including specific information on how the animals are used. 9 Petitioner publishes data on its website that reflects the numbers published by APHIS each year in order to show the decline or increase in the species-specific use of animals over years. This information is broken down by categories established by APHIS in its required rulemaking, including (1) the number of animals that are owned by research institutions but were not being used for any protocols; (2) the number of animals used for non-invasive research; (3) the number of animals used for research causing pain or stress that received analgesics; (4) the number of animals used for research causing pain or stress that did not receive received analgesics to alleviate their suffering; and (5) the total number of individual animals used for research. See Appendix A for the Annual Report Animal Usage by Fiscal Year In 2011, APHIS ceased publication of its Annual Report and instead launched an interactive search site, the Animal Care Information System (ACIS) Search Tool. Data has been difficult to access via this search tool and the tool itself has failed as a means of obtaining accurate information on the use of animals in research due to: inconsistent and/or false results; excessive failures to generate results; excessive time to modify search results; and an interface which has impeded the end user s ability to design a search that will provide the desired results. These shortcomings call into question both the functionality of the site on a programming level and the inadequacy of the information available in the database. As recently as November 4, 2014, a search for an annual report for 2011, done in conjunction with a member of the APHIS staff, yielded clearly erroneous results and multiple listings of a single species of animal. See Appendix B. The recent decision by APHIS to resume publication 10 of the Annual Reports on its website comes as a welcome relief. However working with the available information over the past three 8 9 CFR CFR APHIS, Research Facility Annual Reports 4

5 years has highlighted many deficiencies in the data provided both through the ACIS system and through the published Annual Report. Aside from problems with functionality, there are other major problems with the current reporting system. These problems include how the information is reported to the public and how the information is collected from research institutions licensed by APHIS. Critical data regarding how animals are actually used for research, what type of research they are used for, and their disposition once research has been completed cannot be obtained through the current reporting system. For example, an analysis of the data currently provided fails to clarify whether dogs are being used by a veterinary hospital that is performing spay/neuter services for local animal shelters or whether a medical school is anesthetizing dogs for terminal labs as part of a medical school s anatomy class. 11 Also, the current reporting system uses the category other animals without specifying what animals are included in this category. Various sources have indicated that this category includes ferrets, wild-caught mice, voles and other rodents. It remains unclear whether APHIS currently collects information on the specific species reported as other animals, but it is clear that APHIS does not make this information available publicly. This lack of transparency in reporting on the animals used for research undermines the credibility of APHIS, especially since a vast majority of such research is carried out at least in part with public funds. The lack of transparency gives the impression that the agency is withholding or concealing information from the public by making it unavailable through either the ACIS Search Tool or Annual Reports. Arguments made by proponents of the status quo, that changes to the collection and reporting of animal use data by licensees would constitute an undue burden, are unfounded. The European Union (EU), for example, has been collecting the type of information that petitioner seeks for a number of years. The EU requires all laboratories to submit information (presented in Appendix C) that deals with both the specifics of the animals used and the purpose for which they are being kept. This has been done without placing an undue burden on institutions in the 27 countries required to provide this information, even though these recordkeeping requirements exceed the specifics required by the EU Directive on the Protection of Animals Used for Scientific Purposes. 12 The current EU requirements for the submission of data far exceed those used by the U.S.; they also provide greater accountability and transparency for the public. ( GjzOK9_D2MDJ0MjDzd3V2dDDz93HwCzL29jAyCzYAKIvEo8DYlTrzu6OHibmPgYGBiYWRgaeLk4eLuaWvgYGnGXH6DXAARwNCsP1o_AqAfkArACfE8EK8LihIDc0NMIg0xMAwhVB1g!!/?1dmy&urile=wcm%3apath%3a%2FAPHIS_Content_Library% 2FSA_Our_Focus%2FSA_Animal_Welfare%2FSA_Obtain_Research_Facility_Annual_Report%2F) 11 Kevin Chase, the executive director for the Beagle Freedom Project in Los Angeles, says there are more than 65,000 dogs in medical testing facilities in the United States. [ medical_benefits]. According to USDA statistics, 67,772 dogs were used for research in the U.S. in 2013 but there is no breakdown of how those animals were used for medical testing or veterinary training. 12 Consolidated Commission Implementing Decision 2012/707/EU as corrected by Decision 2014/11/EU ( 5

6 III. Requested Action to Resolve the Problem Petitioner requests that the Secretary amend the Animal Welfare Regulations Recordkeeping requirements 13 to require the collection of more accurate and useful information. Petitioner also requests that more detailed and well-organized information be required for inclusion in the Animal Welfare Regulations Annual Report. 14 This revised system of recordkeeping would not add an undue burden on the licensees because the information would be collected in a streamlined process and reported in a more comprehensive and functional format for the ease of both licensees and the parties accessing the information. Petitioner requests that APHIS replace the current APHIS Form with an entirely new form to be used by research facilities to report their animal use for the Annual Report. Specifically, petitioner requests that APHIS adopt a system of recordkeeping comparable to that already in use by the European Union, which, as a whole, provides an accurate and transparent accounting of how many, what type of animals, and for what specific research, testing and educational purposes the animals are being used. This action is necessitated by: the inability of the agency or the public to obtain accurate and reliable information on the use of animals under the agency s current reporting requirements; the failure of APHIS to require meaningful information from licensees; and the systemic failure of the Animal Care Information System (ACIS) Search Tool to provide accurate, consistent, meaningful or reliable information on the use of animals. Petitioner is proposing the creation and adoption of modified forms that include elements of the EU forms, as well as elements currently required by APHIS. The resulting forms would improve both the utility of the information collected and the transparency of the recordkeeping by APHIS licensees. Petitioner contacted the European Commission to obtain the template used by Member States in the EU to report on animal usage in their country. These reports provide the data that is presented in the European Commission Annual Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union (Appendix C). Petitioner proposes modification of the template 16 to enable reporting of the following: 13 7 CFR CFR APHIS Form 7023, Annual Report of Research Facility (

7 (1) Registration Number assigned to the Research Facility by USDA. (2) Headquarters Research Facility contact information, including the complete name, address and telephone number of the Headquarters Research Facility as registered with USDA. (3) Reporting Facility location where animals were housed or used in actual research, testing, teaching or experimentation, or held for these purposes. (4) Animal Species, presented as a dropdown menu that lists additional species covered by animal welfare regulations. This template also includes a column (4A) to specify the types of animals used if other animal is selected. (5) Number of animals (6) Origin of the animal (7) Genetic status of animal, and (8) Whether animal was used to generated a new genetically-modified line 7

8 (9) Purpose of the experiment and (9A) a Specify other column for further clarification in those instances when Other is selected in column 9. (10) Severity of experiments pertaining to pain inflicted on animal and whether or not pain medication was administered Petitioner has also provided a guide to assist with the completion of this form and is willing to continue to work with and advise the USDA and APHIS on this matter. 17 Petitioner requests that the USDA independently of, or in conjunction with, a more effective ACIS Search Tool use this data to inform the publishing of its Annual Report each year on the APHIS website, consistent with the Annual Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union (Appendix C), including but not limited to: the number of each species of animals used in research; the source from which these animals were acquired (i.e. purpose-bred animals, randomsource animals, animals from shelters, wild-caught animals); the purpose for which they are being used (including but not limited to biological studies of a fundamental nature, research and development of products and devices for human

9 medicine and dentistry and for veterinary medicine, toxicological and other safety evaluations, education and training, etc.); the number of animals used in toxicological and other safety evaluations; the proportion of animals used for studies of diseases; the category of pain/stress under which they fall; the disposition of each animal at the conclusion of the protocol; the name of each registered research institution; and any other information obtained from licensees regarding their use of animals as proposed below. Other countries effectively collect more accurate and comprehensive information without unreasonably burdening licensees who must provide this information. According to the European Commission, The use of laboratory animals is a matter of great public concern. There is a need to reduce the number of animals used in laboratories for experimental and other scientific purposes to the minimum level which is a scientific necessity. Statistics provide information on where and how the animals are currently used. Good reliable statistics serve as a firm basis for constructive discussion on how a reduction can be achieved. They also assist in analysing the effects of the introduction of new alternative methods, as well as indicating trends in the acquisition and use of laboratory animals. 18 Petitioner agrees wholeheartedly with the assertion, above, that Good reliable statistics serve as a firm basis for constructive discussion on how a reduction can be achieved. 19 The petitioner is confident that implementation of revised data collection and reporting on animal use by APHIS has the potential to lead to greater refinement of research procedures, a reduction in the number of animals used, and the replacement of animals with better, more humane methodologies as mandated by the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM). 20 More complete data being published in the Annual Report may also lead to cost- and time-saving benefits because it should result in significantly fewer requests under the Freedom of Information Act (FOIA), which will benefit stakeholders as well as reducing the amount of time needed by APHIS staff to fulfill FOIA requests. In 2013, the USDA FOIA logs for APHIS showed that more than 900 FOIA requests were received by the agency. 21 Many of these 18 European Commission website, Animals used for scientific purposes, introduction Ibid U.S.C. 285l-3 21 USDA, APHIS FOIA logs MjIwNjDwtQswtDBwNnC29_D3DDAw8DIEKIoEKnN0dPUzMfQwMDEwsjAw8XZw8XMwtfQ0MPM2I02- AAzgaENIfrh- 9

10 requests pertained to issues that would have been addressed in a more comprehensive annual reporting process. Petitioner recognizes that the forms used by the European Union contain tracking for animals, such as mice, rats and cold-blooded animals that are not currently required under U.S. law. While we encourage the collection of such data, as it would provide much more clarity on animal use in this country, considering mice, rats, birds and cold-blooded animals are estimated to account for 95% of all animals used in research, we are not specifically making that request in this petition. In addition, there are various pieces of information needed by the EU, a collection of individual countries with their own laws in place, which we have omitted for reporting purposes in the U.S. Petitioner believes that the proposed changes in recordkeeping will significantly improve the quality and quantity of information collected by APHIS from licensees, and will provide greater transparency on the use of animals in research. Further, petitioner believes that the improved collection of information will be invaluable in helping federal government agencies, licensees and the public in developing strategies that help to refine, reduce and replace the use of animals in research, testing and education. Petitioner gratefully recognizes the positive and constructive dialogue that has been established with the professional staff of APHIS and appreciates that the agency has resumed publishing the results of the Annual Report on the APHIS website for the convenience of the public. Nevertheless, the petitioner finds that the information provided is still less than optimal in understanding how animals are used in the U.S. Petitioner is hopeful that the ACIS Search Tool will be able to integrate this proposed new information and provide continuing assistance for the development of customized searches, in addition to providing a published Annual Report generated and approved by APHIS. IV. Conclusion It is clear that the current system of collecting data and reporting is inadequate to accomplish the directives of APHIS to collect and disseminate meaningful information to the public on how many and in what manner animals are used for research, testing and education. The USDA has the authority to initiate rulemaking to fix a broken system. Petitioner has researched and assembled a workable solution to implement the necessary changes. Revising the current system of recordkeeping will serve the interests of all parties, by streamlining data collection, easing the recordkeeping burden of licensees and by providing valuable information to APHIS stakeholders and the public at large. On behalf of the National Anti-Vivisection Society, we offer our continued cooperation and support to the USDA and APHIS in pursuit of these constructive solutions. FqsTd0NEFqCTYxy_Qw83AwNsQqgCfE8EK8LihIDc0wiDTUxEADK5Lvw!!/?1dmy&urile=wcm%3apath%3a%2Faphis_c ontent_library%2fsa_resources%2fsa_laws_and_regulations%2fsa_foia%2fct_foia_logs 10

11 Respectfully submitted, Peggy Cunniff, Executive Director Ian Bucciarelli, J.D., Program Director Marcia Kramer, J.D., Director of Legal Programs Pam Osenkowski, Ph.D., Director of Science Programs National Anti-Vivisection Society 53 W. Jackson Blvd., Suite 1552 Chicago, IL

12 LIST OF APPENDICES A. APHIS Annual Report Animal Usage 2013 B. ACIS Search, November 4, 2014 C. Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union 12

13 Appendix A. APHIS Annual Report Animal Usage

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18 Appendix B. ACIS Search, November 4,

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20 Appendix C. Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union 20

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