Producer Informed Consent Form

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-XXXX. 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-XXXX

EXP: XX/20XX

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 Sheep 2024 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 VS Questionnaire and Biologics Phase of the NAHMS Sheep 2024 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 sheep 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 sheep 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 sheep 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 sheep industry. We ask that you provide accurate information regarding your operation’s sheep health and management; however, you may choose to not 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 of questionnaire data and unidentifiable individual findings of biologic data acquired from NAHMS for the benefit of the sheep industry, allied private industries, and other interested groups, but will ensure that the identity of the producer is withheld.

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, gastrointestinal (GI) parasite, and interdigital swab testing to producers who would like to participate. Additionally, serum and DNA collected during the study will be stored in the NAHMS serum and DNA bank to be used for future research. 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 of the questionnaire data and unidentifiable individual findings of biologic results for the benefit of the sheep industry, allied private industries, and other interested groups. Although your information will be kept confidential, you will receive the results of the biological sampling.

By signing this, the NAHMS Agent is pledging APHIS to protect the confidentiality of the participants information

/date

NAHMS Agent

Name: ___________________________________________	Phone number:_______________________
Address:___________________________________________ __________________________________________________	E-mail address:_______________________

By initialing below, the consenting participant is communicating his or her decision to participate or not with biologics testing in this study.

Confidentiality of your data is crucially important to us. Your information will be protected to the full extent of the law, as described above.

	Biologic Sampling – Enteric Microbes	I AGREE to participate	I DO NOT Agree to participate
1.	Producer consents and authorizes the NAHMS Agent or a mutually agreed upon designate to collect 25 fecal samples from sheep. All samples will be tested for Salmonella, Campylobacter, E. coli, and Enterococcus. The Producer will receive results as a positive/negative usually within 4 months of collection. Campylobacter isolates will be investigated for genotypic markers and all the isolates will be stored for future academic research (e.g., genotypic markers of antimicrobial resistance). Future research will be approved by the American Sheep Industry Association.
	Biologic Sampling – GI Parasites
2.	Producer consents and authorizes the Data Collector or a mutually agreed upon designate to collect fecal samples from 6 to 10 sheep to create a composite samples. All composite samples will be submitted for a fecal egg count. A select number of operations will also receive results from a Drenchrite test. Future research will be approved by the American Sheep Industry Association.
	Biologic Sampling – Blood (Serum and DNA) and Interdigital Swabs
3.	Producer consents and authorizes the Data Collector or a mutually agreed upon designate to collect up to 25 blood samples and interdigital swabs from ewes 15 months or older on the operation. Blood sera and DNA will be stored at the National Veterinary Services Laboratory (NVSL) for future testing into areas of concern to the sheep industry. Interdigital swabs will be sent to ARS for testing of foot rot pathogens. The Producer will receive results as a positive/negative for all pathogens tested. Future research on all samples will be approved by the American Sheep Industry Association.

VS Form 21-321

April 2024