VS 21-321 Bison 2022 Study - Producer Informed Consent

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0579-0420. The time required to complete this information collection is estimated to average 10 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collected.		OMB Approved 0579-0420 EXP: XX/XXXX
UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES NATIONAL ANIMAL HEALTH MONITORING SYSTEM 2150 CENTRE AVE, BLDG B FORT COLLINS, CO 80526	NAHMS Bison 2022 Study – Producer Informed Consent
Instructions: Thank you for participating and for your support of our programs and U.S. agriculture. If you have any questions, please feel free to call a NAHMS representative at 1-866-907-8190. Please review this form and indicate your willingness to participate in the Biologics Phase of the NAHMS Bison 2022 Study. Your participation is voluntary. You may keep this Producer Informed Consent form for your records. Background USDA’s Animal and Plant Health Inspection Service (APHIS) is collecting information on bison health and stewardship through the National Animal Monitoring System (NAHMS) in partnership with the National Agricultural Statistics Service (NASS). NAHMS studies are voluntary and nonregulatory and, therefore, data and samples collected by APHIS-NAHMS will not be used for regulatory purposes. This information will be used to describe current bison health and management practices, help policymakers and industry make informed decisions, assist researchers and private enterprise in identifying and focusing on vital issues related to bison management, and facilitate education of producers and veterinarians. Participation is voluntary and you may decline to participate. Your participation is vital and will help APHIS develop health and management national estimates in the bison industry. We ask that you provide accurate information regarding your facility’s bison health and management; however, you retain the right to refuse to answer any or all questions. Confidentiality APHIS pledges to keep the survey information you provide confidential and will use it only for statistical purposes. According to the provisions of the Confidential Information Protection and Statistical Efficiency Act of Title V, Subtitle A, Public Law 107-347 (CIPSEA) and other applicable Federal laws, your responses will be kept confidential and will not be disclosed in identifiable form. For more information on how we protect your information, please visit:  https://www.aphis.usda.gov/animal_health/nahms/general/downloads/NAHMS_CIPSEA.pdf. Your information’s security is vitally important to APHIS. Only authorized APHIS employees or those acting on APHIS’s behalf (NAHMS agents) will have access to your individual record data. By law to be an authorized APHIS employee or NAHMS agent, individuals must complete confidentiality training and a confidentiality form which stipulates the requirements for keeping data confidential and the penalties individuals are subject to if identifiable information is released. These penalties stipulate that the individual is subject to a jail term of up to 5 years, a fine of up to $250,000, or both if he or she discloses ANY identifiable information about you or your establishment. Please note that information on a producer’s animals revealed from sources unrelated to this study, such as testing and inspection for movement or sale of animals or tracebacks on testing done at slaughter, may cause regulatory action for reasons separate and distinct from this study. Further, data are protected from cybersecurity threats. Under the Cybersecurity Enhancement Act of 2015, your data will be protected by US Department of Homeland Security (DHS) cybersecurity monitoring. In the event of a cybersecurity incident, and pursuant to any required legal processes, information from these sources may be used to help identify and mitigate the incident. APHIS may publish, or authorize others to publish, the aggregate (summary) findings acquired from NAHMS for the benefit of the bison industry, allied private industries, and other interested groups, but will ensure that the identity of the producer is withheld. APHIS may not publish, or authorize others to publish, individual responses. You are not required to participate in the study. APHIS will use the information you provide for statistical purposes only. Study Biologics – APHIS will safeguard as Confidential Business Information APHIS is providing enteric microbe, fecal parasite, and pasture forage biologic testing to producers who would like to participate. Information collected as part of this phase, the Biologics Phase, will not be covered under CIPSEA. APHIS-NAHMS will keep the information you provide as part of the Biologics Phase confidential and will use it only for statistical purposes. We recognize that the information collected is not typically shared publicly and will consider it as Confidential Business Information (CBI), as defined in the U.S. Code of Federal Regulations (CFR) 19 CFR 201.6. With your information considered as CBI, we will utilize exemption 4 for any Freedom of Information Act (FOIA) (5 U.S. Code 552) requests for your information. Exemption 4 of the FOIA U.S. Code 552 (b) (4) (2012 & Supp,.V 2017) states that “trade secrets and commercial or financial information from a person is privileged or confidential.” Exemption from FOIA prevents your information from being released to the press, the public, or other non-federal government agencies. Exemption 4 of U.S. Code 552 does not exempt CBI from subpoenas from other federal agencies. APHIS will not disclose this information except when required by law. Please visit https://www.justice.gov/oip/foia-guide-2004-edition-exemption-4 for further information. Additionally, the study participant survey will be kept confidential and is considered as CBI, as described above. For both survey data and Biologics Phase data, APHIS will keep the origin of the data confidential by recording the data stored in a secure access-controlled Data Lab specifically used for housing and managing controlled data. Your survey and biologics information will be associated with your unique code number only. APHIS will manage identifying information via a key kept separate from both the survey and biologics data and will destroy the key after the completion of the study. Your responses will be kept confidential and will not be disclosed in identifiable form. APHIS may publish aggregate (summary) findings for the benefit of the bison industry, allied private industries, and other interested groups. APHIS will not publish, or authorize others to publish, individual responses. Although your information will be kept confidential, you will receive the sampling results of the biological sampling. Consent to Biologics Phase By indicating your consent to the opportunity to participate in the Biologics Phase of the NAHMS Bison 2022 Study, you are agreeing to allow USDA-NASS staff to provide the following information to APHIS: your name, address, phone number, email address, inventory, and the biologics sampling that you wish to participate in. This information will allow APHIS-NAHMS to send you biologic sampling kits that can be used to collect the biological samples described below. Consent does not commit you to participating in the Biologics Phase; you are free to accept or decline participation when you receive the biologics sampling kits. Confidentiality of your data is crucially important to us. Your information will be protected to the full extent of the law, as described above. Process of Collection APHIS-NAHMS will provide tools and instructions to you to collect biologic samples (fecal samples and forage samples). If you choose to participate, you will collect fecal samples for fecal parasite testing and enteric microbe testing, and forage samples for pasture forage quality testing. You retain the right to refuse to conduct sampling. Enteric microbe testing You may collect up to 30 fecal samples, depending on your operation size. All samples will be tested for Salmonella, E. coli, and Campylobacter. You will receive results as a positive/negative and serotype or speciation, usually within 4 months of collection. Results of antimicrobial sensitivity profile of detected microbes will follow initial results. These isolates obtained after testing will be stored for future academic research into areas of concern to the bison industry (e.g., genotypic markers of antimicrobial resistance). Fecal parasite testing You may collect up to 30 fecal samples based on your operation size, prior to deworming. The samples will be tested for internal parasites. You will collect post-deworming fecal samples12-30 days after deworming.. If you collect pre-deworming samples you will obtain fecal egg count results and if you collect both pre- and post-deworming samples you will additionally receive fecal egg count reduction test results, which measure the resistance of parasites to dewormers, usually within 4 months of collection. Pasture forage testing You may collect up to one forage sample consisting of specimens from at least 20 locations throughout the pasture area that will be used for winter forage. Results, including analysis for energy, protein, fiber, dry matter, macrominerals, and microminerals, will be returned to you, usually within 2 months of collection.

VS Form 21-321

July 2022