VS 21-204 2021 NAHMS Swine Large Enterprise - 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 0579-0315. 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.
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

OMB Approved
0579-0315
EXP: XX/20XX

2020 NAHMS Swine Large
Enterprise - Informed Consent

Instructions:
Review this page with the producer, answering any questions. Make sure the producer understands that participation is voluntary. After
signatures, give the original to the producer, send one copy to your NAHMS Coordinator, and retain the final copy until instructed.
Background
USDA’s Animal and Plant Health Inspection Service (APHIS) is collecting information on swine health and stewardship through the National
Animal Monitoring System (NAHMS). This information will be used to describe current swine health and stewardship practices, help policymakers
and industry make informed decisions, assist researchers and private enterprise in identifying and focusing on vital issues related to swine
management, and facilitate education of future producers and veterinarians. Participation is voluntary and you may decline to participate. Your
participation is vital and will help APHIS develop swine health and management national estimates. We ask that you provide accurate information
regarding your facility’s swine health and management; however, you retain the right to refuse to answer any or all questions.
Confidentiality
APHIS pledges to keep the information you provide as part of this study confidential and will only use it for statistical purpose. According to the
Confidential Information Protection provisions 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 , and 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.
Every person working for or in cooperation with APHIS on this study has signed. 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 swine 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.
The NAHMS Agent will review this informed consent with you prior to asking for any information in this phase of the study. You are not required to
participate in the study. APHIS will use the information you provide for statistical purposes only.
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 unrelated regulatory action. Additionally, if a NAHMS Agent conducting
this interview on the Producer’s premises observes an animal with signs suspicious of a dangerous, infectious, or exotic disease foreign to the
United States (e.g., foot-and-mouth disease), he or she is required to report this disease to State authorities, in which case further investigation
and possible action may occur which would potentially result in making your participation in a NAHMS study no longer protected. In the unlikely
event of this occurrence, APHIS will continue to protect any of the information provided as part of this study. Again information collected by APHIS
for a NAHMS study may only be used for statistical purposes.
You can obtain these reports and further information from this study by accessing the NAHMS Web site at:
https://www.aphis.usda.gov/nahms
Study Biologics - Not covered by CIPSEA and the confidentiality pledge
APHIS is providing fecal pathogen and oral fluids biologic testing to producers who complete the phase II questionnaire. This portion of the study
is not covered by CIPSEA and the confidentiality pledge does not apply. Even though the confidentiality pledge does not apply to this portion of
the study, APHIS recognizes that the materials you provide and the information generated from these are not regularly provide or shared with
others. APHIS will not have any Personally Identifiable Information on any biologic forms or sample materials so samples cannot be traced to you
or your operation. Individual testing result reports will only have your operations study ID and APHIS staff will mail these results directly to you.

VS Form 21-204
June 2020

1

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

NAHMS Agent

/date

By signing below, the consenting participant is accepting the APHIS confidentiality pledge and is willing to participate in phase II of the study.

Consenting Participant

/date

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

Biologic Sampling – Fecal Pathogens
1.

I AGREE to
participate

I DO NOT
Agree to
participate

____________

___________

____________

____________

Producer consents and authorizes the NAHMS Agent or a mutually agreed upon
designate to collect 30 fecal samples from up to 10 pens containing 20 weeks and older
Finisher pigs. All samples will be tested for Salmonella. The Producer will receive
results as a positive/negative and serotype or speciation, usually within 3 months of
collection.
A subset of these samples will be tested for generic E coli and Enterococcus. These
results will not be returned to the Producer.

Biologic Sampling – Oral Fluids
2.

Producer consents and authorizes the Data Collector or a mutually agreed upon
designate to collect up to 8 oral fluids collections from up to 8 pens containing 20 weeks
and older Finisher pigs. Samples will be tested for Porcine Reproductive & Respiratory
Syndrome (PRRS) antibodies, Swine Influenza Virus (with typing, i.e., H1N1),
Senecavirus A (Seneca Valley Virus) and Coronaviruses (Porcine Epidemic Diarrhea,
Porcine deltacoronavirus and Transmissible Gastroenteritis). Results will be provided to
NAHMS and the Producer within 3 months of collection via logging in with the correct
information at the testing lab website. The remaining oral fluids left over after testing (if
any) will be stored in an oral fluids bank for future research into diseases of concern to
the swine industry.

VS Form 21-204
June 2020

2