USDA 

iiilillll 

United States Department of Agriculture 

Research, Education, and Economics 

Agricultural Research Service 

August30,2007 

Carol Maczka 

Assistant Administrator for Food Defense 

USDA - Food Safety and Inspection Service 

South Building - Room 3130 

Washington, DC 20250 

Re: Non-Funded Cooperative Agreement No. 58-0101-?N-131 between 

USDA/Agricultural Research Service (ARS) and USDA/Food Safety and 

Inspection Servie (FSIS) on Data Sharing 

Dear Dr. Maczka: 

Enclosed please find a fully executed copy of the referenced agreement, signed by Dr. 

Antoinette Betschart for Dr. Edward Knipling, Administrator, Agricultural Research 

Service. 

The ARS Information Staff, Office of Director, has requested that they have an 

opportunity to review any announcement to be made to the public before it is released. 

This should be sent to the attention of Sandy Miller Hays. Her phone number is (301) 

504-1638 and email address is sandy.millerhays@ars.usda.gov. 

If you should have any questions, please feel free to contact me. 

Sincerely, 

BERNADETTE E. GREGOR 

Authorized Departmental Officer 

cc: 

P. Cray, ADODR 

J. Lindsay, NPS 

Administrative and Financial Management 

Extramural Agreements Division 

George Washington Carver Center 

5601 Sunnyside Avenue, Room 3-2168, Beltsville, MD 20705-5110 

Voice: 301-504-1142 Fax: 301-504-1262 E-mail: Bernadette.Greqor@ars.usda.gov 

www.afm.ars.usda.gov/ead/index.htm 

An Equal Opportunity Employer 
COOPERATIVE AGREEMENT 

BETWEEN THE 

UNITED STATES DEPARTMENT OF AGRICULTURE 

AGRICULTURAL RESEARCH SERVICE (ARS) 

AND THE 

UNITED STATES DEPARTMENT OF AGRICULTURE 

FOOD SAFETY AND INSPECTION SERVICE (FSIS) 

ON 

DATA SHARING 

Agreement No. 58-0101-7N-131 

ARTICLE 1 - PURPOSE 

The purpose of this agreement is to specify expectations and requirements related 

to the submission of Salmonella isolates and carcass rinses from the FSIS Pathogen 

Reduction/ HACCP Verification, Baseline, and other programs to ARS for Pulsed 

Field Gel Electrophoresis (PFGE), antimicrobial susceptibility testing and any other 

laboratory subtyping procedures that may be used for inter-laboratory comparisons 

in the future. 

ARTICLE 2 - BACKGROUND 

PulseNet was established in 1998 as a national network of public health and food 

regulatory agencies including state and local health departments and federal 

agencies (Centers for Disease Control and Prevention, CDC; US Department of 

Agriculture/Food Safety and Inspection Service, USDA/FSIS; and the Food and 

Drug Administration, FDA). PulseNet participants perform standardized molecular 

subtyping (or "fingerprinting") of foodborne disease-causing bacteria by PFGE to 

distinguish strains of Escherichia coli O157:H?, Salmonella, or Listeria at the DNA 

level. DNA "fingerprints," or patterns, are submitted electronically to a dynamic 

database to allow for rapid comparison of patterns to detect foodborne disease 

clusters, facilitate early identification of outbreaks, and assist in investigating 

outbreaks through case finding and investigation of potential sources of illness. In 

these ways, PulseNet has become a rapid and effective means of communication 

between public health and food safety regulatory laboratories. As an adjunct to 

PulseNet, the US Department of Agriculture (USDA) ARS established VetNet in 

2004. Results of the analyses from Salmonella and Campylobacter isolates 

submitted to ARS by Animal and Plant Health Inspection Service (APHIS) and FSIS, 

Data Sharing MOA Page 1 of 6 
and ARS Research isolates, are captured in the ARS VetNet database for PFGE. 

The National Antimicrobial Resistance Monitoring System (NARMS) was established 

in 1996 by the FDA, CDC, and USDA (APHIS, ARS, and FSIS) to maintain 

surveillance of antimicrobial resistance patterns in foodborne pathogens including 

Salmonella, generic E. coli (E. coli O157:H? when available), and Campylobacter. 

NARMS is a critical component of an international strategy to maintain the efficacy of 

antimicrobial drugs used in human and veterinary medicine. 

ARTICLE 3 - OBJECTIVES 

By statute, FSIS is responsible for regulating the safety of meat, poultry, and egg 

products. This includes controlling strains of foodborne pathogens in these products 

that are known to cause human illness. The PFGE and antimicrobial resistance 

patterns of isolates obtained from inspected products that FSIS receives from ARS 

provide useful subtype data for evaluating foodborne disease hazards. ARS 

undertakes research in characterizing the development and extent of the zoonotic 

spread of antimicrobial resistant pathogens as part of their Food Safety National 

Research Program for the purpose of exploring and developing mitigation 

strategies. 

I. FSIS Objectives: FSIS has various responsibilities that depend on timely PFGE 

and antimicrobial susceptibility data: 

A. Allocation of Inspection Resources: Spatial and temporal patterns within 

and between establishments provide a critical basis for Risk-Based 

Inspection. These patterns provide insight on those establishments to 

target, and to allocate additional inspection resources. 

B. Foodborne Disease Investigation and Attribution: Linking susceptibility 

patterns and subtyping data on inspected product with strains associated 

with human illness greatly enhances attribution efforts and outbreak 

investigation and management. 

C. Surveillance and Prevention: Timely integration of surveillance data with 

data from other public health partners assists in efforts to reduce the 

number of illnesses and deaths due to outbreaks of foodborne disease. 

D. Risk Management: Each of the above objectives is part of an interrelated 

strategy to strengthen FSIS Risk-Based Inspection. 

11. ARS Objectives: ARS has the following objectives: 

A. Continued receipt of isolates: Receive and characterize zoonotic and 

commensal (where appropriate) isolates from FSIS federally inspected 

slaughter and processing establishments for use in the NARMS and 

VetNet programs to assess relatedness between isolates through 

antimicrobial susceptibility profile and PFGE typing. FSIS isolates may be 

Data Sharing MOA Page 2 of 6 
part of their PR:HACCP, baseline or special projects programs. Study the 

development and movement of resistant isolates throughout the 

slaughter/processing continuum and assess relationships to data 

generated at the farm level. 

B. Continued receipt of rinsates: Receive and isolate zoonotic and 

commensal bacteria from spent rinsates collected by FSIS for use as 

described in (1) above. Currently FSIS only recovers Salmonella as part 

of their HACCP program. Using spent rinsates, ARS recovers 

enterococci, generic E.coli and Campylobacter. 

C. Surveillance, Prevention, and Reporting: Identify trends and disseminate 

information to: public health partners to predict and/or avert outbreaks; 

industry in order to institute mitigation strategies; and guide future 

research. 

ARTICLE 4 - MUTUAL RESPONSIBILITIES 

FSIS and ARS jointly agree to develop and timely disseminate data on PFGE, 

antimicrobial susceptibility testing and any other laboratory subtyping procedures 

that may be used for inter-laboratory comparisons. These data will be used to fulfill 

each Agency's responsibilities and needs. 

FSIS and ARS agree to each designate specific work units that will be responsible 

for interagency interactions. In ARS, the Bacterial Epidemiology and Antimicrobial 

Resistance (BEAR) Research Unit, Athens, GA is responsible for generating 

NARMS and VetNet data, and will be the work unit designated. In FSIS, the Office of 

Public Health Science (OPHS) in Washington, DC will be the work unit designated, 

and OPHS will work with an FSIS liaison who will be located in Athens, GA. 

ARTICLE 5 - FSIS RESPONSIBILITIES 

It is expected that the FSIS will provide ARS, upon isolation or receipt, isolates 

and/or rinsates collected from its PR:HACCP testing program, baseline studies, and 

other programs (if deemed appropriate) by FSIS. Isolate identifiers, such as date, 

product type, and location will be submitted by FSIS to BEAR in order to allow 

subtype data to be merged back into FSIS databases. In this way FSIS will have a 

seamless system that includes subtype data, Sample-ID, form number, product 

class, source, collection date, region, establishment, PR/HACCP set, and serotype -

to assist FSIS in tracing isolates at the plant. These identifier data will be provided 

from FSIS back to ARS as a routine request. If a technical difficulty is encountered 

that does not allow this routine transmission, ARS-BEAR will be immediately 

notified, and the submission will be made as soon as possible. Current needs are 

for timely receipt of Salmonella data. 

ARS anticipates routine/regular requests for PFGE and antimicrobial susceptibility 

Data Sharing MOA Page 3 of 6 
patterns from various offices within FSIS, including OPHS, Human Health Sciences 

Division (for outbreak investigations and disease attribution), the Microbiological 

Analysis and Data Branch, Microbiology Division, OPHS (for surveillance and 

baseline studies); the Data Analysis and Integration Group of the Office of Food 

Defense and Emergency Response (OFDER, for data analysis needs), and the 

Technical Service Center and Headquarters staff in the Office of Policy, Program 

and Employee Development (OPPED; for risk management decisions). ARS 

requires that such requests, including requests for publication, be coordinated 

through the designated FSIS unit for interagency interactions. Requests will be sent 

from FSIS-OPHS through the FSIS liaison located in Athens, GA to the ARS-BEAR. 

In this way requests can be prioritized and coordinated, thus eliminating duplication 

of effort, time, and resources. 

ARTICLE 6 -ARS RESPONSIBILITIES 

It is expected that ARS-BEAR Unit will provide where possible (unless otherwise 

notified) on a routine basis (at least every 30 days following receipt of isolates or 40 

days following receipt of rinsates) PFGE and antimicrobial susceptibility patterns to 

FSIS. Likewise ARS will require a code for masking so that the isolate can be 

seamlessly merged and stored with other FSIS isolates by establishment, sample 

set and sample identification code. If a technical difficulty is encountered that does 

not allow this routine transmission, FSIS-OPHS will be immediately notified, and the 

submission will be made as soon as possible. Current needs are for timely receipt 

of Salmonella data. 

ARS agrees to catalogue and store isolates received from FSIS in a secure 

repository. ARS anticipates that requests for isolates from FSIS may occur. ARSBEAR will make available isolates from the repository to FSIS or a third laboratory; 

however, fulfillment of any request will be based on isolate number requested, time 

involved, anticipated use of isolates (so as not to be in conflict of ARS research) and 

requesting source. ARS-BEAR is not to be considered as a Culture Collection 

resource since it has neither the fiscal or personnel capacity. ARS will not release 

any isolate without prior and written consent/approval of FSIS-OPHS. When and 

where appropriate, ARS may send isolate DNA to collaborators working on projects 

with ARS scientists. A Materials Transfer Agreement (MTA) originating from ARSBEAR, will be submitted and approved by ARS Office of Technology Transfer prior 

to shipment of the isolate. The MTA must state specifically the research objectives 

for isolate use, and how isolates will be disposed of after use. FSIS will be provided 

a copy of the MTA. Use of any FSIS isolate by the collaborator is limited to the 

scope of the MT A. ARS will not release any information concerning the isolate that 

may lead to its source unless deemed appropriate and approved in writing by FSIS. 

In accordance with ARS and FSIS requirements, the receiving laboratory must meet 

at least Biosafety Level 2 status. 

Data Sharing MOA Page 4 of 6 
ARTICLE ?-COLLABORATION AND CLEARANCE 

Pulsed Field Gel Electrophoresis and antimicrobial susceptibility patterns that ARS 

provides to FSIS will not be released publicly until these data are published, unless 

legally obligated to do so, with the exception of distributing PFGE patterns and 

antimicrobial susceptibility patterns to an FSIS-regulated establishment as part of 

their Salmonella set results. ARS and FSIS data published and in the public domain 

may be used without permission. Collaborative projects between FSIS and ARS are 

encouraged and should be pursued in accordance with standard scientific and 

ethical principals of collaboration governing the pursuit of public health and scientific 

advances. The use of Appendix 1 is required for both Agencies' participation in 

collaborative projects. Both ARS and FSIS are required to request clearance for 

abstracts and manuscripts. Clearance must be submitted 45 days in advance of 

submission of abstract/manuscript and each agency agrees to clear the request 

within the 45 day limit at which time the requesting agency may submit the 

abstract/paper. 

Data derived solely by FSIS (without ARS participation) or vice versa may be used 

as necessary. Use of data for internal reports (FSIS and ARS) and routine (quarterly 

and yearly) NARMS and VetNet reports (ARS-BEAR) may be generated as needed. 

Each agency agrees to immediately notify each other when these reports are 

generated and provide copies as soon as available. It should be noted that FSISOPHS routinely participates with ARS-BEAR in generating the NARMS and VetNet 

reports. FSIS is not required to obtain ARS clearance prior to release of individual 

plant-specific data for regulatory purposes. ARS and FSIS agree to keep each other 

informed of specific data analyses and interpretations in order to prevent conflicting 

statements from occurring. 

Data Sharing MOA Page 5 of 6 
ARTICLE 8 - EFFECTIVE DATE 

This agreement will be in effect upon final signature and will continue for a period of 

five years. At such time, the agreement will be reviewed for programmatic relevancy 

and, as mutually agreed, extended for an additional five years. This agreement may 

be modified or discontinued at the request of either party. Each party shall provide 

in writing a 60-day notice in advance of the effective date desired for termination of 

this agreement or any major modification. 

The undersigned approve the terms and conditions of this agreement and represent 

that they have the requisite authority to enter into it. 

Date 

Administrator 

Food Safety and Inspection Service 

United States Department of Agriculture 

~A~~ 

r'Edward B. Knipling 

Administrator 

Agricultural Research Service 

United States Department of Agriculture 

Data Sharing MOA Page 6 of 6 
APPENDIX 1 

ARS-FSIS 

ABSTRACT, PROCEEDINGS, AND MANUSCRIPT PROPOSAL 

NOTE: Clearance by both agencies will occur within 45 days of receipt of this document. 

PART I. Both agencies 

PROPOSED TITLE OF ABSTRACT/PROCEEDINGS/MANUSCRIPT (circle on): 

TARGETED JOURNAL OR MEETING: 

PROPOSED ORDER AND JUSTIFICATION FOR AUTHORSHIP (please indicate 

corresponding author with*): 

NAME JUSTIFICATION/CONTRIBUTIONa,b 

1. 

2. 

3. 

4. 

Add additional names if required. 

a Based upon ARS P&P 152.2 requirements for authorship which includes: 

1. Conception or design or analysis and interpretation of data, or both; and 

2. Drafting the article or revising it for critically important intellectual content; and 

3. Final approval of the version to be published. 

bAll elements of an article critical to the main conclusions must be attributable to at least 

one author. The order of names on a multi-authored article will be decided by the group 

responsible for the research. Participation solely in the collection, supply or 

summarization of data does not justify authorship. 

PART II. ARS Only 

JUSTIFICATION FOR NON-SCIENTIFIC YEAR (SY) AUTHOR (CAT 3-SUPPORT 

SCIENTIST; CAT ?-TECHNICIAN): 

Author No.: 

Author Name: 

Xxxx (name) has met the criteria for authorship on this publication as 

outlined in P&P 152.2 by (circle all that apply): 

Data Sharing MOA Page 1 of 2 
1. Conception or design or analysis and interpretation of data, or both; and 

2. Drafting the article or revising it for critically important intellectual content; and 

3. Final approval of the version to be published. 

Certification by supervisor of non-SY author _______________ 

Certification and approval by RL ___________________ 

Certification and approval* by Area Director:_______________ 

*of ARS non-SY author 

PART Ill. Both agencies 

We are in agreement with the proposal as outlined, including inclusion of the non-SY author. 

(Note: Non-SY author must also sign.) · 

AUTHOR 1:.____________ DATE:_____ 

AUTHOR 2:____________ DATE:_____ 

AUTHOR 3:-------------- DATE:_____ 

AUTHOR4:____________ DATE:_____ 

Add additional authors if necessary. 

PART IV. Attach abstract 

PART V. Clearance signatures 

ARS certifies that this has cleared ARS established clearance procedures: 

ARS-BEAR RL signature and date:.__________________ 

FSIS certifies that this has cleared FSIS established clearance procedures: 

FSIS-OPHS representative signature and date:._______________ 

Data Sharing MOA Page 2 of 2