integrated food safety systems: from creation ... - neha cert · fs1103 integrated food safety...

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2011 NEHA AECFS1103 Integrated Food Safety Systems – From Creation to Collaborated Reality with Public Health Partners

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Integrated Food Safety Systems: From Creation to Collaborated Reality with

Public Health PartnersNational Environmental Health Association

Annual Environmental Conferences

June 18, 2011

Timothy Weigner

Director, Development and Integration Branch

U.S. Food & Drug Administration, Office of Regulatory Affairs

Division of Federal-State Relations

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“We will strengthen our collaborations with other public health agencies and leverage the expertise and resources of our colleagues at the international, federal, state, and local levels to ensure effective solutions for the American people.”

Margaret A. Hamburg, M.D.Commissioner of Food and Drugs

FDA Strategic Priorities 2011-2015

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Division of Federal-State Relations (DFSR)

Joseph Reardon

Director

Division of Federal-State Relations (DFSR)

Joseph Reardon

Director

Will Foust, Project OfficerWill Foust, Project OfficerMeghan Anderson,

Public Affairs Specialist

Meghan Anderson,


Timothy Weigner

Branch Director

Development & Integration

Timothy Weigner

Branch Director

Development & Integration

Shuen Chai, RRT Project

Manager

Shuen Chai, RRT Project

Manager

Kelisha Turner, Quality

Systems Manager

Kelisha Turner, Quality

Systems Manager

Lauren Gore, Executive

Assistant

Lauren Gore, Executive

Assistant

Beverly Kent, Senior Federal-

State Relations Specialist

Beverly Kent, Senior Federal-

State Relations Specialist

Wendy Campbell, Project OfficerWendy Campbell, Project Officer

Maya Johnson-Nimo, Contracts Project OfficerMaya Johnson-Nimo, Contracts Project Officer

Anita MacMullanBranch DirectorContracts & GrantsAnita MacMullanBranch DirectorContracts & GrantsMercedes Laddon, Program Specialist SupportMercedes Laddon, Program Specialist Support

Mei-Ying Li, Contracts Project OfficerMei-Ying Li, Contracts Project Officer

Caleb Michaud, Contracts Project OfficerCaleb Michaud, Contracts Project Officer

Matthew Wojtkun,


Matthew Wojtkun,


Anna Finn,

Program Analyst

Anna Finn,

Program Analyst

Ryan Cates,

Management Analyst

Ryan Cates,

Management Analyst

Lori Minor, Office

Automation Assistant

Lori Minor, Office

Automation Assistant

Priscilla Neves, CSOPriscilla Neves, CSO

Ellen Laymon, CSOEllen Laymon, CSO

Guy Delius, CSOGuy Delius, CSO

Travis Goodman, CSOTravis Goodman, CSO

Angela Kohls, CSOAngela Kohls, CSO

Linda Collins, Retail Foods Program LiaisonLinda Collins, Retail Foods Program Liaison

Tressa Madden, CSOTressa Madden, CSO

Catherine McDermott

Branch Director

Public Affairs & Information

Catherine McDermott

Branch Director

Public Affairs & Information

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National Standards

� Manufactured Foods Regulatory

Program Standards (MFRPS)

� Animal Feed Regulatory Program

Standards (under development)

Produce Safety AllianceCommunication with Public

and State Partners

� Meetings/Workshops

� Websites

� Field Management Directive

Information

Sharing/Commissioning

� Food, Feed, and Center for

Tobacco Products (CTP)

Grants/Cooperative

Agreements

� BSE, FERN, Food Safety

Taskforces, Rapid Response

Teams, etc.

Contracts

� Food, Feed, MQSA

� Future Contracts: Egg Inspections,

Menu Labelling

FDA/DFSR Initiatives with State Partners

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Manufactured Food Regulatory Program Standards (MFRPS)

Program Standards

1. Regulatory Foundation

2. Training

3. Inspection Program

4. Inspection Audit Program

5. Food-related Illness and

Outbreaks and Response

6. Compliance and Enforcement

7. Industry and Community Relations

8. Program Resources

9. Program Assessment

10. Laboratory Support

• 10 Standards to establish a uniform foundation for the design and management of state programs responsible for regulating food plants

• Institute a holistic quality assurance and standardization program

• FDA Program-Assessment Validation Audits (PAVAs) conducted at 18, 36, and 60 months

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“If you can't describe what you are doing as a process, you don't know what you're doing.”

W. Edwards Deming

“A great many discrepancies occur merely because they are expected to happen. That expectancy becomes so routine that people spend their time learning how to fix rather than prevent.”

Philip Crosby

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Manufactured Food Regulatory Program Standards (MFRPS)

Currently in 31 programs in 30 States

• 22 through food contracts

• 9 through Rapid Response Team Cooperative Agreements

Development & Implementation:

• Grassroots Meeting: February 2010

• Regional Review Meetings: October 2010 (MD & OK)

• To date: Completed 30 state visits for MFRPS implementation

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Establishing Two-Way MFRPS’ Communication Efforts

• Visits with State programs

– Regional meetings

– Face to face meetings (includes MFRPS orientation, pre- and post-assessment visits)

– FDA Stakeholders at face to face: State reps, DFSR staff, DIBs, DDs, ERCs, State Program Coordinators, Retail Food Specialists

• Monthly conference calls/webcast

– Utilize FoodSHIELD

– Created workgroup on FoodSHIELD for sharing of documents between states and on-line meetings

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Feed Regulatory Program Standards

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45 States = Food Contracts

11,392 Inspections

$9.8 M

FY 2010 State Food Contracts

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36 States = Feed Contracts

5,400 Inspections

$2.5 M

FY 2010 State Feed Contracts

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19 State = Tissue Contracts

260 Inspections

$363k

FY 2010 State Tissue Contracts

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FY 2011 Egg Contract

• Purpose: To conduct inspections of egg layer farms to assess compliance with 21 CFR 118 “The Egg Rule”

• Top 20 egg producing states were targeted for contracting

• Training: DFSR is supporting prospective state contractors to attend the required training

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FY10 Contracts

48 States

147 Contracts

24,445 Inspections

$22.5M

Big Picture and Impact of States on Public Health Protection

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12 States = BSE Grant

$22.5M

FY 2010 BSE Grants

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34 States = FERN Grant

(Radiation, Microbiological, Chemical)

$10M

FY 2010 FERN Grants

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27 States = Food Protection

Taskforce Grant

$200k

FY 2010 Food Protection Taskforce Grants

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Food Protection Taskforce ConferenceProgram Grants

FDA Taskforce Grant

Academia

Law Enforcement

Public Health Officials

Industry

Consumer Groups

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Food Protection Taskforce Websites

• FDA Press Releases

• Food Safety News

• Social Media

• News in other State Taskforces

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9 States = Rapid Response Team

Grant

$4.5M

FY 2010 Rapid Response Team Grants

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• 9 States/10 Districts Participating

– 6 RRTs started in 2008 (CA, FL, MA, MI, MN, NC)

– 3 RRTs started in 2009 (TX, VA, WA)

• 3-year Cooperative Agreement ($500k/year)

• RRT Activities: Collaboration, Communications, Policies/Procedures, Resources/Training

Rapid Response Teams (RRT) develop, implement, exercise, and integrate an all-hazards food and foodborne illness response capability to more rapidly react to potential threats to our food supply. In conjunction with other agencies, FDA district offices, and state emergency operations centers, the RRT’s are another tool to enhance response capabilities.

Rapid Response Teams – Background

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Rapid Response Teams – Project Goals

• Develop Rapid Response Capabilities (including ICS)- Playbook/Best Practices - Metrics - to measure/quantify effectiveness and value

• Improve Program Infrastructure- Implementation of the Manufactured Food Regulatory

Program Standards (MFRPS)

• Strengthened Collaboration– Federal/State/Local– Across programs (health, ag, etc.)– Across initiatives (IFSS, CDC, etc.)

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9 Pilot RRTs Build a Foundation for Rapid Response Capability Development

Develop Measures

5 = FERP incorporated into stateresponse plan; exercised regularly

4 = FERP incorporated into state

response plan3 = Have a plan representing public

health stakeholders2 = Have a plan representing the

individual agency’s responsibility

1 = No plan

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FY10 Grants

39 States

84 Grants

$18.3M

Big Picture and Impact of States on Public Health Protection

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Communication with State Partners

• Sharing/Exchange of Information

• 50-State Conference Calls (quarterly and as needed)

• State workshops

• Dissemination of regulatory or pertinent information through the DFSR Broadcast System

– Recalls, Reportable Food Registry Reports, Weekly Reports

• Commissioning/Credentialing and Confidentiality Agreements

• Activities among FDA Districts and States

• Work-planning, recalls, assignments, outbreaks, facility inventory harmonization

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Food Safety Modernization Act Implementation

• Federal-State Integration

– Deliverable groups:

• Operational Partnerships

• Capacity Building

• Training

– Harmonize work with Partnership for Food Protection (PFP) activities

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FSMA Implementation PlanImplementation

Executive

Committee

Prevention

StandardsDon Kraemer

Dan McChesney

Inspection &

ComplianceBarbara Cassens

Howard Sklamberg

Roberta Wagner

ImportsDavid Elder

Camille Brewer

Leslie Kux

Importer Verification &

VQIP

Domenic Veneziano

Accredited Third- Party

Certification

Charlotte Christin

Lab Accreditation &

Integrated

Consortium/FERN

Tim McGrath

Fees

David Wardrop

Bob Miller

Federal/State

IntegrationJoe Reardon

Tracey Forfa

Reports &

StudiesDavid Dorsey

Dani Schor

Tania Simoncelli

Operational

Partnership

Tim Weigner

Capacity Building

Anita MacMullan

Produce Safety

Regulation

Don Kraemer

Produce Safety

Guidance

Samir Assar

Preventive Controls

Regulation

John Sheehan

Kim Young

Preventive Controls

Guidance

Jenny Scott

Kim Young

Mandatory Recall and

Recall Communications

Cecilia Wolyniak

Food Safety Plan

Review/Component

Inspections

Kathy Gombas

Dave Glasgow

Inspection & Auditor

Fees

Fees Team

Reports to

Congress/Studies

International

Capacity Building

Julie Moss

Task A: Prior Notice

Catherine Lorraine

Task B: Smuggled Food

Tony Taube

Training

Pat AlcockFrequency of

Inspection

Mike Rogers

Administrative

Enforcement Tools

Bill Correll

Safe Food Transport

Mike Kashtock

Food Defense

Jody Menikheim

Contaminants

Mickey Parrish

Terry Proescholdt

Import Certification

Michelle Twarorski

Registration

Amy Barringer

RFR Improvements

Ted Elkin

Implementation Executive CommitteeChief Implementation Manager, Project Management Team

Regulations and Policy

Steering Committee

Strategic Communications

& Outreach Team

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Section 201:

Targeting of Inspection

Resources for Domestic

Facilities, Annual Report

Angela Kohls

Maya Johnson-Nimo

Section 209:

Improving the Training of

State, Local, Territorial,

and Tribal Food Safety

Officers

Tim Weigner

Marybeth Willis

Section 210,

Subsection 1009(f):

Enhancing Food Safety,

Progress and Evaluation

Linda Collins

Travis Goodman

PFP Workgroups:

Performance Measures

PFP Workgroups:

Training

PFP Workgroups:

National Workplan,

National Standards, and

Oversight

Operational Partnerships

Tim Weigner and Travis Goodman

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Operational PartnershipsTim Weigner and Travis Goodman

Section 201:Targeting of Inspection Resources for Domestic Facilities, Annual Report

Scope of Responsibility: “The Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.”

Angela Kohls and Maya Johnson-Nimo

PFP Workgroups:National Workplan National Standards,

and Oversight

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Section 209:Improving the Training of State, Local, Territorial, and Tribal Food Safety Officers

Scope of Responsibility: The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is

authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this Act through the officers and employees of such State, local, territorial, or tribal department or agency.

• Provisions to ensure adequate training of such officers and employees to conduct such

examinations, testing, and investigations

• Provisions regarding reimbursement

Tim Weigner and Marybeth Willis

Operational PartnershipsTim Weigner and Travis Goodman

PFP Workgroups:Training

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Section 210, Subsection 1009(f):

Enhancing Food Safety, Progress and Evaluation

Scope of Responsibility: The Secretary shall measure the status and success of each grant program authorized under the Act. The Secretary shall take the performance of such a grant recipient into account when determining whether to continue funding for such a recipient.

Linda Collins and Travis Goodman

Operational PartnershipsTim Weigner, Travis Goodman

PFP Workgroups:Performance Measures

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Section 205(c)1:Surveillance: Food Safety

Defense Strategy and Implementation

Guy Delius

Shuen Chai

Section 205(c)2:Surveillance: State and Local Capacity Review

Tressa Madden

Caleb Michaud

PFP Workgroups:Policy and Procedures,

Laboratory, and

Information Technology

PFP Workgroups:Emergency Response,

National Standards,

Policy and Procedures, and

Information Technology

Capacity BuildingAnita MacMullan

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Section 205(c)1:

Surveillance: Food Safety Defense Strategy and Implementation

Scope of Responsibility: The Secretary shall develop and implement strategies to leverage and

enhance the food safety and defense capacities of State and local agencies in order to:

• Improve foodborne illness outbreak response and containment• Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of

clinical isolates from clinical laboratories to appropriate State labs, and conducting more

standardized illness outbreak interviews• Strengthen the capacity of State and local agencies to carry out inspections and enforce safety

standards• Improve the effectiveness of Federal, State and local partnerships to coordinate food safety and

defense resources and reduce the incidence of foodborne illness

• Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public

• Strengthen the capacity of State and local agencies to achieve the goals described in section 108.

Guy Delius, Shuen Chai

PFP Workgroups:

Emergency Response, National Standards,

Policy and Procedures, and Information Technology


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Section 205(c)2:Surveillance: State and Local Capacity Review

Scope of Responsibility: The Secretary shall, not later than one year after the date of enactment of the FDA FSMA, complete a review of State and local capacities, and needs for enhancement, which may include:

• A survey with respect to staffing levels and expertise available to perform food safety and defense functions

• Laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities

• Information systems to support data management and sharing of food safety and defense information among State and local agencies with counterparts at the Federal level

• Other State and local activities and needs as determined appropriate by the Secretary.

Tressa Madden and Caleb Michaud


PFP Workgroups:

Policy and Procedures, Laboratory, andInformation Technology

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Training

TrainingPat Alcock and Will Dardick

Section 209:Improving the Training of State, Local, Territorial, and Tribal Food Safety Officers

Scope of Responsibility: The Secretary shall set standards and administer training and educations programs for the employees of State, local, territorial and tribal food safety officials… including programs for:

• Scientific training

• Training to improve the skills of officers and employees authorized to conduct inspections under sections 702/704

• Training to address best practices• Training in administrative process and procedure and integrity issues• Training in appropriate sampling and laboratory analysis methodology

• Training in building enforcement actions following inspections, examinations, testing and investigations.

Pat Alcock and Will Dardick

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Division of Federal State Relations12420 Parklawn Drive, ELEM- 3033, Rockville, MD

301-796-5390

Email: [email protected]

DFSR Website: http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm

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Where Does Your Organization Fit Within the Integrated Food Safety

Systems?

integrated food safety systems: from creation ... - neha cert · fs1103 integrated food safety...

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