Form NAHMS 470 NAHMS 470 On-Farm Monitoring of Antimicrobial Use and Resistance i

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 30 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/XXXX

ON-FARM MONITORING OF
ANTIMICROBIAL USE AND
RESISTANCE IN U.S. BROILER
PRODUCTION – INFORMED CONSENT

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

Instructions to the Data Collector:
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 NAHMS, and retain the final copy at the University of Minnesota.
Background
USDA’s Animal and Plant Health Inspection Service (APHIS) is collecting information on antimicrobial use and resistance in the U.S. broiler industry through the National
Animal Monitoring System (NAHMS). This information will be used to describe current antimicrobial use and resistance, help policymakers and industry make informed
decisions, assist researchers and private enterprise in identifying and focusing on vital issues related to antimicrobial use and resistance, 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 antimicrobial use and
resistance national estimates in the broiler industry. We ask that you provide accurate information regarding your facility’s antimicrobial use; however, you retain the right to
refuse to answer any or all questions.
Confidentiality
APHIS will not apply the Confidential Information Protection provision of Title V, Subtitle A, Public Law 107-347 (CIPSEA) for this information collection. However both
APHIS and the University of Minnesota will keep the information you provide as part of this study confidential and will only use it for statistical purposes. We recognize that
the information collected is not typically shared publicly and will consider it as Commercial Business Information (CBI), as defined in the U.S. Code of Federal Regulations
(CFR) 19 CFR 201.6. 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.” Exception
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. Please see the CBI document provided for more information.
The Data Collector will keep the origin of the data confidential by recording the data stored at the University of Minnesota with the Producer’s unique code number only.
The Data Collector will deliver data to APHIS with no identifying information of any company, complex, or farm. The Data Collector will manage identifying information via a
key kept separate from other data, and will not keep any key after the completion of the study. The Data Collector and all other project personnel acknowledge that the
Producer is providing information and samples that he/she does not customarily share and is providing them with the expectation that they are and will be managed as
Confidential Business Information (CBI) by APHIS and the University of Minnesota.
Once any physical and electronic data that are collected by the data collector are received by NAHMS, they will be stored in the NAHMS laboratory, which is an accesscontrolled environment specifically used for housing and managing controlled data. Your responses will be kept confidential and will not be disclosed in identifiable form.
Maintaining confidentiality and protection of Producer data is important to APHIS. Therefore, no identifying information such as personal or company name, or
contact information, will be transferred from the University of Minnesota to USDA, and no data will be reported in a way that could reveal the identity of a participant. In
reports derived from the data, all results are presented only in aggregated summaries or analyses.
Process of Collection
The University of Minnesota , the “Data Collector”, will provide tools for the Producer to collect survey data at the farm level and litter samples at a single poultry house per
selected farm. The Data Collector and the Producer will participate together in implementing a plan for the Producer to conduct site visits and data collection designed to
monitor the use of antimicrobials and occurrence of antimicrobial resistance in selected bacteria on U.S. broiler farms.
The Producer will assist the Data Collector and APHIS by completing surveys for approximately four (between four and eight,depending on complex enrollment and as
agreed upon by the Data Collector and the Producer) farms per sampled complex on a quarterly basis and, if elected, collecting of litter samples from broiler houses. The
Producer retains the right to refuse to answer any questions or to allow sampling.
Use of Information
All APHIS-NAHMS studies are voluntary and nonregulatory and therefore, data and samples collected by APHIS-NAHMS or the Data Collector will not be used for
regulatory purposes.
APHIS or the University of Minnesota may publish aggregate (summary) findings for the benefit of the poultry industry, allied private industries, and other interested groups.
Neither the Data Collector or APHIS will publish, or authorize others to publish, individual questionnaire responses or sampling results. APHIS or the University of
Minnesota will conduct testing in accordance with the Statement of Work associated with the study, which is available to all participants. APHIS or the University of
Minnesota may perform additional testing, or authorize others to perform additional testing, of samples collected through the study, for the benefit of the poultry industry.
To minimize the collection of producer information, the producer is asked to place an ‘X’ in the appropriate column for each of the following options. The data collector will
subsequently initial each ‘X’ to verify the selection before signing the consent form.
Biologic Sampling by Data Collector for Fecal Pathogens, Antimicrobial Susceptibility, and Antimicrobial
Resistance Genes
Producer consents and authorizes the Data Collector or a mutually agreed upon designate to collect two composite litter
samples from four to eight broiler farms from each enrolled complex each quarter.
All litter samples will be cultured for Salmonella, E. coli, Campylobacter, and Enterococcus at the University of Minnesota.
The Producer will receive results as a positive/negative and serotype or speciation, usually within 3 months of collection.
Salmonella isolates will be serotyped. Campylobacter and Enterococcus isolates will be speciated.
All bacterial isolates will be tested for antimicrobial susceptibility.
UNIVERSITY OF MINNESOTA – DATA COLLECTOR

NAHMS FORM 470
JUN 2021

DATE

PRODUCER ID

I WISH to
participate

I DO NOT WISH to
participate