FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Summary of Federal-State Meeting:
"Meeting Challenges Together"
Phase II - "Planning the Vision"
Baltimore, Maryland
December 8-11, 1998

EXECUTIVE SUMMARY

A meeting was held in Baltimore, Maryland the week of December 8-11, 1998 with federal, state and local officials to continue work to develop plans for an integrated national food safety system. The meeting, hosted by the Food and Drug Administration, continued the theme MEETING CHALLENGES TOGETHER and focused on follow-up activities from the "50 State meeting" held in Kansas City in September 1998. Representatives from the Centers for Disease Control and Prevention, the USDA's Food Safety Inspection Service and the Cooperative State Research, Education and Extension Service, and the Environmental Protection Agency also participated in this meeting. At the 50 State meeting, attendees had discussed a vision for food safety in the future, identified obstacles and recommended action items, including formation of Work Groups to develop the ideas presented in Kansas City. This week, the participants were asked to suggest ways to overcome obstacles and to identify short and long range goals to make this vision a reality. Over 70 federal, state and local officials were named to six Work Groups and issues were discussed in the following areas: Roles and Responsibilities - Capacity and Resource Needs; Coordinating Outbreak Responses and Investigations; Information Sharing and Data Collection; Communication; Minimum Uniform Standards; and Laboratory Operations and Coordination. The Work Groups elected chairpersons and presented reports on December 11. Each Work Group is working on detailed plans and timelines for proposed projects that will cover a 5-10 year period. The Federal agencies will be considering these plans and funding as we jointly pursue the vision of an integrated food safety system.

A Coordinating Committee, which was recommended at the Kansas City meeting, met on December 10. The Committee is composed of 18 individuals: 5 federal and 13 state and local (6 of whom are Work Group chairs) and includes a broad geographical mix, with representation of agriculture, health and epidemiology disciplines from federal, state and local agencies. The role of the committee will be to set direction, liaison between work groups and agencies, assign tasks, develop a plan based on reports from the Work Groups and to set priorities from Work Group recommendations. The Committee selected a chair and three vice-chairs: Janice Oliver, FDA (chair); and Stuart Richardson, California Department of Health Services, Doug Saunders, Virginia Department of Agriculture and Consumer Services, and Dean Sienko, Ingham County (Michigan) Health Department (vice-chairs).

The Committee selected the vision statement for the Food Safety Initiative's Strategic Plan as the vision for this project. The Committee also recommended that a mission statement be developed for the integrated food safety system. Other topics discussed included planning outreach and public meetings and a timeline for next steps. The Committee presented a report to the Work Groups on December 11.

I. INTRODUCTION

The meeting was opened by Mr. Ralph Stafko, Senior Policy Analyst, U.S. Department of Agriculture (USDA), Food Safety Inspection Service (FSIS). He said that participants at the 50 State meeting in Kansas City had discussed a vision for food safety in the future, identified obstacles and recommended action items. This week, Work Groups have been asked to find ways to overcome these obstacles to make this vision a reality. Mr. Stafko introduced members of the following Work Groups:

• Roles and Responsibilities - Capacity and Resource Needs
• Coordinating Outbreak Responses and Investigations
• Information Sharing and Data Collection
• Communication
• Minimum Uniform Standards
• Laboratory Operations and Coordination

[Note: The list of Work Group participants are included as an attachment]

Ms. Janice Oliver, Mr, Gary Dykstra, Ms. Leslie Kux, and Mr. Joe Levitt from the Food and Drug Administration provided opening remarks to help kickoff this meeting. The Work Groups met from Tuesday, December 8 through Thursday, December 10. Members of the Coordinating Committee also met on Thursday, December 10. On Friday, December 11, the six Work Groups and the Coordinating Committee presented reports to all the participants. Each Work Group is working on detailed plans and timelines for proposed projects that will cover a 5-10 year period. The Federal agencies will be considering these plans and funding as we jointly pursue the vision of an integrated food safety system.

II. WORK GROUP REPORTS

Group 1 - Roles and Responsibilities - Capacity and Resource Needs

Mr. Corby discussed some attributes of an integrated food safety system: uniformity, filling gaps, having confidence in imports, centralized research and data, equal standards and policy and sharing information. He said the only way to have these attributes is to integrate the food safety system.

This Work Group developed a table of food safety activities from production to harvest and identified who has the primary role now. (See Table below)

Mr. Corby presented the same table but with roles for a proposed food safety system.

This Work Group proposed the following activities should be enhanced and improved at federal, state and/ or local levels:

Federal Government

• Risk Assessment
  • Food Safety Concerns
• Research
• Adoption of Standards Uniform Regulations
  Codex
  Lab practices
  Additives / Packaging Approvals
  

State / Local Government

• Inspections Processors / Warehouses (state)
  Retail (Local)
  "Oklahoma Partnership" model (Suggest this model be reviewed to see if could be an applicable model
  
• Complaints
• Issues to be Addressed (Roles to be determined)
• Training ? (certification of inspectors)
• Program Evaluation?
• Imported Foods?
• Lab Support? (Will liaison with the Lab Work Group)
• Funding?
• Implementation?
• Changing roles in the Future? (What happens if a state is not able to carry out a role?)

Work Group Recommendations

• Resource Assessment
• Model Partnerships
• Subcommittees will be formed

Budget: (resources would be needed for the following activities)

1. January / February 1999 Work Group meetings
2. Subcommittee conference calls
3. Information Gathering Resource Assessment (Contract)
   Surveys (Contract)

Roles and Responsibilities Work Group Liaisons

Group #2 - Coordinating Outbreak Responses and Investigations

Co-Chairs:

Jerry Gibson, State Epidemiologist, South Carolina Department of Health Jeff Farrar, Chief, Food Emergency Unit, California Department of Health

This Work Group's initial plan has three major areas:

• Traceback Coordination
• Communication
• Roles, Processes, Evaluations

Sub-Work Group: Traceback Coordination

Five tasks are proposed in this area:

• Develop and test criteria for initiating and prioritizing tracebacks
• Develop/test process for deciding who does tracebacks
• Develop/test process for approaching industry and press during tracebacks
• Recommend how government can promote record-keeping that facilitates tracebacks
• Consider legal issues

How will this work group do its job?

• Need buy-in from stakeholders (federal, state and local representatives)
• the first task will be to do a tabletop multi-state simulatio n
• Assure evaluation of process during multi-state outbreak
• evaluate effectiveness and write report
• Budget: propose 5 in-person meetings

Sub-Work Group: Communication

Effective outbreak response requires that accurate information gets to the people who need it in a timely fashion. Obstacles to effective communication include:

• Information bottlenecks (information flow through a single person who may not always be available)
• Information overload: extraneous, unnecessary, irrelevant information
• Uncertainty about who needs to know what and when
• Inaccurate, incomplete, untimely information

Goal: Develop a model communications plan for coordinating responses to outbreaks, recalls and other situations (e.g., water, chemical, bio-terrorism) that states can utilize to create uniformity and consistency in response and to enhance interaction with other entities (federal agencies, other states, other state agencies, local health departments). This model can stimulate states to develop their own system based on their own administrative structure.

Short-Term Project - Needs Assessment

• Utilize a questionnaire to assess mechanisms already in place for communications
• Questionnaire to determine:
  • Who needs to be notified in each state
  • Notified by what means
  • When do we need to be notified
  • Need to know vs nice to know
  • What information should be sent. Consider a variety of outbreak scenarios
• Recommend pilot project: initial distribution of draft needs assessment in selected states (use states on Work Group)

Timeline: There are questions that need to be addressed. The answers to these questions will help determine the timeline.

• Who will develop the questionnaire for the needs assessment?
• When should the questionnaire be developed?
• Is this subgroup the appropriate work group to develop the questionnaire?
• By when should it be sent out?
• By what means will it be sent?
• To whom?
• When should the network be in place?

Follow-up on the Needs Assessment

Implementation of a basic notification network will be based on questionnaire responses.

• Short-Term: Pilot needs assessment project in selected states
• Intermediate Term: Needs assessment in all states. Develop model communication system
• Long-Term: Look into a intranet and other more sophisticated and elegant options for timely and accurate communications

Budget (resources would be needed for the following activities)

• People to do the needs assessment questionnaire (include support staff)
• Supplies to distribute questionnaire
• Data entry of questionnaire results
• Analysis of questionnaire results
• Develop a rough budget and funding sources for the long-term project

Sub-Work Group: Roles, Process and Evaluation

Objectives

• Identify leadership roles
• identify criteria - need measurable parameters
• Evaluate performance
• Provide feedback

Short-Term Goals (1 Year)

• Outline the process and roles in an outbreak
• Assemble existing documents regarding outbreak response
• Develop a checklist for core criteria for an outbreak response

Long-Term Goals (3 Years)

• Pilot program to evaluate the effectiveness and timeliness of out break activities

Group # 3 - Information Sharing and Data Collection

(Note: this Group changed its name from Data Sharing and Collection)

Co-Chairs:

J. Douglas Park, State Epidemiologist, Michigan Department of Agriculture Judy Lee, Consumer Safety Officer, FDA/CFSAN

This group felt that it should be a "listening post" with the other work groups and needs to hear from the other groups about information sharing and data collection needs. Also requested comments from other Work Groups budget representatives to make sure activities are not redundant.

Assumptions that will affect the goal:

• Funding to pay for all hardware, telecommunications
• The Food Safety Initiative will fund/support these activities
• States are going to buy-in to this enhanced system with a no state fund provision
• There will be continued funding
• Contract procedures for surveys/questionnaires
• Coordinating Committee empowered to "push things through"
• Survey questionnaire is a stand alone

Short-Term Goals

• Propose initial development of FORBIN (Food Oriented Relational Basic information Network)
• Search other National models for information pertaining to federal/state integration computer systems: e.g., LEIN (Law Enforcement Information Network); CLEO
• Obtain data needs from the various work groups that would fit within the following 5 categories: Surveillance
  Complaints
  Entity ID (source)
  Outbreak Information
  Enforcement
• Obtain information from the following short and mid-term projects to determine integration and accessibility levels of performance:
  • FSIS initiative - access to FSIS data bases (e.g. performance based inspection system) by all states
  • CDC mandate from states to develop integrated epidemiology surveinllance system (i.e., CSTE)
  • 2 pilots in the FDA (Dallas District) - in conjunction with the Texas Department of Health (additional funding):
    • to provide training and access to the FDA FACTS system
    • to compare the Texas Department of Health Official Establishment Inventory with the FDA Dallas District Office Official Establishment Inventory
    • Fund MDA pilot Electronic FBD Surveillance System

Contract Needs (On-going list needed for each of the 5 categories of data from state, local and federal governments involved):

• Telecommunications and equipment
• Determine current program applications
• Data needs

Proposed Timeline for the Food Oriented Relational Basic Information Network (FORBIN)

2/5/99	Contract negotiations / specifications
8/1/99	Distribution of survey questionnaire
2/5/00	Telecommunications / equipment report from contractor
3/15/00	Full contractor report
5/1/00	Group recommendations

Budget:

Short-term budget needs:	Funding for meetings Proposed FDA/Texas pilots Proposed Michigan pilots Contracts needed to develop FORBIN
Long-Term (10 years):	Funding for all hardware, software, telecommunication, and contract needs.

Work Group Liaisons

Dennis Baker	- Roles and Responsibilities
Kate Glynn	- Outbreak Coordination
Don Walker	- Communication
Bill Brooks	- Minimum Uniform Standards
Judy Lee	- Laboratory Operations and Coordination (microbiological)
J. D. Warren	- Laboratory Operations and Coordination (chemical)

Group # 4 - Communications

Chair:	Sharon Greenman, Food Protection Coordinator, Seattle County Department of Health (Washington)
Vice-Chair:	Becky Shreeve, Supervisor, Utah Department of Agriculture

Vision: Systems and contacts are in place allowing for both routine and emergency communications to be utilized by all.

Prioritized Work Group Charges

• Propose methods to improve coordination of the current communication systems across local, state and federal agencies.
• Develop a plan for obtaining stakeholder input and outreach efforts for the integrated system concept.
• Identify standardized communications procedures needed for industry and media.
• Propose how to facilitate partnering with industry and consumers, and local, state and federal agencies to optimize resources.

Short-Term Action Items

By 12/31/98

• FDA to give directive to each District Director to survey states regarding relationship, response to requests, inquiries, etc.
• Obtain stakeholders list derived at 50 State Meeting, Kansas City, Missouri.
• Identify existing state/industry working relationships by each FDA district Public Affairs Specialist.

By 1/15/99

• FDA perform an e-mail and fax distribution effectiveness test to see who is on the distribution list; ask for reply to test; lists will be checked annually.

By 1/31/99

• Develop a plan for providing input at annual Governors conference, the Association of Cities, NACCHO (educating politicians about FSI issues).

• AFDO training director to provide nationwide media relations training to state and locals on media relations.

By 2/1/99

• Check with the President's Food Safety Council regarding outcome from their meetings and inform them of our desire to hold more grassroots meetings.

• Develop a plan to identify grassroots groups who might be interested in discussing/ hearing about this concept.

• Solicit op-ed pieces in editorial pages, particularly in local newspapers. Include Web address in piece.

• Obtain infomercial air time on public access television; cable commercials; National Public Radio; banner advertising on the Internet; solicit interviews with local radio, particularly on television morning shows.

• Complete feasibility study on development of an Internet Home Page.

• Work with CSTE to find out what restrictions are in each state regarding the holding of proprietary information.

• Solicit op-ed pieces in editorial pages, particularly in local newspapers.

• Complete feasibility study on development of an Internet Home Page for food safety and link to other food safety pages. A part of the home page, ask for input from readers.

• Review current policy regarding media contacts to determine how much they prohibit interaction with local media.

By 2/28/99

• AFDO requests state and locals to provide heads-up, at minimum, to FDA District Office and USDA prior to initiating a state recall or issuing a press release.

By 3/1/99

• FDA and USDA to invite local governments to subscribe to an e-mail distribution list (List/Serve) for recalls.

By 9/30/99

• Investigate cost of completing a pilot of joint USDA/FDA 24-hour toll-free meat, poultry, and egg Hotline for states and locals.

By 1/1/2000

• Include state and local e-mail addresses on regional FDA e-mail directories - individual names and group lists - state and local officials.

• Establish a working electronic, current Web directory available to all government officials which is constantly updated and includes function and/or expansion of FDA Gold Disk, Eureka System.

• Provide pagers to appropriate officials in each agency.

• Institute annual meetings of local (cities and counties), state and federal officials in each state to discuss the integrated food safety system.

• Bring Internet capability to all state and local governments.

• FDA / USDA to be included in all existing meetings.

• Include academia from Schools of Public Health, food and animal sciences in meetings with states and industry.

Long-Term Action Items (Beyond FY 2000)

• Establish an early warning system, similar to Canadian Incident Tracking System, when potential outbreak information occurs in different locations.

• By 2002, implement systems and contracts for both routine and emergency communications.

• Establish USDA / FDA / CDC 24 hour toll-free Hotline as a single point of contact for state and locals for all issues.

Budget:

Short-Term activities/items that will require resources: Conference calls - 2 per month; Interim calls among group; Meeting - 2/1-5/99 in Dallas; Chair/co-chair meeting(s) with Coordinating Committee; Use of "Meeting Works" type meetings; Fax transmittals; and Express mail documents.

Long-term activities/items that will require resources: Work with CFSAN (cost/year); Pagers (cost/year); Internet capability to all state and local governments; and Annual meetings of local, state and federal officials.

Work Group Liaisons

Al Bugenhagen	- Roles and Responsibilities
Mary Proctor	- Outbreak Coordination
Dave Rodeheaver	- Information Sharing and Data Collection
Roger Holbrook	- Minimum Uniform Standards
Allen Craig	- Laboratory Operations and Coordination

Group # 5 - Minimum Uniform Standards

Chair:	Susan Grayson, Head, Food and Lodging Sanitation Branch, North Carolina Department of Health
Co-Chair:	Charlene Bruce, Director, Food Protection Branch, Mississippi Department of Health

The Work Group selected an acronym: MUST - Minimum Uniform Standards Team. The primary priority for this group is to develop and maintain nationally accepted uniform standards. The first activity will be to develop an overall program standard and then have subcommittees develop inspection and compliance standards for 6-7 programs.

Tentative Sub-Work Groups

• Seafood
• Meat / Poultry
• Retail
• Manufacturing
• Produce
• Milk and Dairy
• ?????

[Note: the first three were selected because some elements may already exist]

Assumptions

• Funding will be available
• Personnel will be available
• Statutes, rules and regulations will need to be changed
• All standards will be science and risk-based, practical and prudent
• All standards developed will have opponents. Not all stakeholders will be able to meet the standard

Short-Term Goals

• By January 15, 1999, draft of general definitions to be used by sub-work groups
• By February 1, 1999, finalize definitions
• By June 1999, establish a review process for the work of the subgroups
• By March 31, 1999, establish and charge the first 3 sub-work groups
• By December 31, 1999, establish and charge all sub-groups

Long-Term Goals

• By January 1, 2001, establish a system to maintain standards (review, update, frequency, other issues to keep the standards up-to-date)

• By January 1, 2001, establish a quality program to assure that regulatory bodies are meeting the standards.

• By January 1, 2002, all standards drafted for review

• By January 1, 2005, all standards accepted

Budget: During the next year, funding is needed for 1 meeting of the work group and for 1 meeting with each subcommittee.

Group # 6 - Laboratory Operations and Coordination

Chair:	William Krueger, Director of Lab Services, Minnesota Department of Agriculture
Co-Chair:	Robert Johnson, Lab Director, FDA/San Francisco District Office

This group reported that it would like to add additional members to the Work Group. Suggested members include representatives from local and veterinary medicine labs and from USDA's Animal Plant Health Inspection Service.

Top Three Work Group Charges:

• Form sub-work groups to develop national standards for labs performing food safety analysis (from farm-to-table). Standards will include equivalency of methods, data, samples, etc.

• Make recommendations on the use of laboratory accreditation bodies, including use of third-party certification agencies, to improve laboratory operations and coordination.

• Propose how local, state and federal agencies could optimize the currently available capacity of government laboratories performing food safety analyses. Propose a mechanism to enhance communications and availability among diverse services. Propose mechanisms to minimize unnecessary duplication and focus research and development efforts.

Activity: Form sub-work groups to develop national standards for labs performing food safety analysis (from farm-to-table). Standards will include equivalency of methods, data, samples, etc.

Short-Term Goal

• Establish a process for national standard development using E. coli 0157:H7 as a model.

• Look at all facets and resolve issues of our laboratory systems at the federal, state and local levels that would enable us to have a fully Integrated Food Safety Laboratory System on this single analyte.

Longer-Term Goals (three phases)

• Develop recommendations, pilot implementation (first year)

• "Turn it on" / full implementation - distribute recommendations and equipment as necessary.

• Validation / evaluation

Sub-Work Group: Sampling, Detection, Isolation and Characterization (SDIC)

Charges:

• sampling, data collection and reporting
• Quality Assurance / Quality Control
• methods, standardization, equivalency
• when considered positive and actionable

Sampling, Detection, Isolation and Characterization (SDIC) Sub-Work Group Members:

Carl Sciacchitano, FDA/ORA/DFS
Joy Wells, CDC
Ann Weber, Montana Department of Health
(5 others to be determined)

Sub-Work Group: PulseNet

Charges:

• DNA fingerprinting
• Quality Assurance / Quality Control
• methods, standardization, equivalency

Barriers:

• Turf issues
• Adequate funding to implement (data systems support equipment, training)
• Lack of information
• Lack of trust
• Legal issues
• Time delays from transport of samples and data between agencies
• Communication
• Different priorities between labs

Sub-Work Group: Expanded Food Safety Analytes

Charge: Compile a list of top 10 additional analytes as priorities for application of the E. coli 0157:H7 model. (These may include: bacteria, viruses, parasites, toxins, pesticides, heavy metals, allergens, or other pathogens of concern).

Expanded Food Safety Analytes Sub-Work Group Members:
Farukh Khambatky, FDA/CFSAN
Mark Lee, California Department of Agriculture
Patrick McCasky, USDA/FSIS

Sub-Work Group: Accreditation

Charges: Make recommendations on the use of laboratory accreditation bodies, including use of third-party certification agencies, to improve laboratory operations and coordination.

• Consolidation of USDA, FDA and EPA accreditation standards

• Develop sub-work group to consult with National Environmental Laboratory Accreditation Conference (NELAC), USDA, FDA and others to tie-in to create a de novo system.

About ORA | Site Map/Index | ORA Search
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

Office of Regulatory Affairs