Training & Certification David Read Dairy & Food Inspection Division Minnesota Dept of Agriculture

Integrated Food Safety System Leverage the participation, expertise, and authorities of federal, state, local, territorial and tribal agencies with food safety responsibilities to work together to ensure a safe food system in the United States

Integrated National Food Safety System Develop standards to ensure consistency Train and certify a highly skilled workforce Work across jurisdictions to ensure protection of the entire food supply from farm to table Create mechanisms for data sharing Ensure use of quality systems Build oversight and accountability What does an integrated food safety system look like? Federal, state, local, tribal and territorial partners working collaboratively to: Establish national standards to ensure consistency across all jurisdictions Develop training and certification to ensure a highly skilled workforce across all jurisdictions and levels of government Work collaboratively to develop national work plans to ensure protection of the entire food supply from farm to table Develop mechanisms (both legal and technological) to share information Create laboratory proficiency programs to ensure consistent and meaningful data Respond quickly and efficiently when problems do occur Federal oversight of the system and accountability at all levels to ensure the safety of the food supply Adequate infrastructure, resources and funding mechanisms to build and sustain the program

Food Safety Modernization Act TITLE II—IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. Sec. 202. Laboratory accreditation for analyses of foods. Sec. 203. Integrated consortium of laboratory networks. Sec. 204. Enhancing tracking and tracing of food and recordkeeping. Sec. 205. Surveillance. Sec. 206. Mandatory recall authority. Sec. 207. Administrative detention of food. Sec. 208. Decontamination and disposal standards and plans. Sec. 209. Improving the training of State, local, territorial, and tribal food safety officials. Sec. 210. Enhancing food safety. Sec. 211. Improving the reportable food registry.

SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS. (a) IMPROVING TRAINING.—Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ‘‘SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL,AND TRIBAL FOOD SAFETY OFFICIALS. ‘‘(a) TRAINING.—The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this Act, including programs for— ‘‘(1) scientific training; ‘‘(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 702 and 704;

‘‘(4) training that addresses best practices; SEC. 209. IMPROVING THE TRAINING OF STATE, LOCALTERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS ‘‘SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL,AND TRIBAL FOOD SAFETY OFFICIALS. ‘‘(3) training to achieve advanced product or process specialization in such inspections; ‘‘(4) training that addresses best practices; ‘‘(5) training in administrative process and procedure and integrity issues; ‘‘(6) training in appropriate sampling and laboratory analysis methodology; and ‘‘(7) training in building enforcement actions following inspections, examinations, testing, and investigations.

SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS ‘‘(b) PARTNERSHIPS WITH STATE AND LOCAL OFFICIALS.— ‘‘(1) IN GENERAL.—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. ‘‘(2) CONTENT.—A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency. ‘‘(3) EFFECT.—Nothing in this subsection shall be construed to limit the authority of the Secretary under section 702.

SEC. 210. ENHANCING FOOD SAFETY (a) Grants To Enhance Food Safety.--Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399) is amended to read as follows: "SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY. "(a) In General.--The Secretary is authorized to make grants to eligible entities to-- "(1) undertake examinations, inspections, and investigations, and related food safety activities under section 702; "(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments; "(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases; "(4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and] "(5) take appropriate action to protect the public health in response to-- "(A) a notification under section 1008, including planning and otherwise preparing to take such action; or "(B) a recall of food under this Act.

National Standards Outcome: Uniform inspectional coverage and sample collection and analysis to enable greater sharing of data to protect public health through: Expansion of Manufactured Food Regulatory Program Standards and Retail Food Regulatory Program Standards Recent release of the Animal Feed Regulatory Program Standards Creating shared data standards to enable exchange of enforcement data among public health and regulatory partners IT interconnectivity between Federal, state, local, tribal, and territorial public health and regulatory partners Implementation of national standards will result in uniform inspectional coverage and sample collection and analysis to enable greater use of each other’s analysis and observations in protecting public health through: Expansion of Manufactured Food Regulatory Program Standards and Retail Food Regulatory Program Standards Creating shared data standards to enable exchange of enforcement data among public health and regulatory partners IT interconnectivity between Federal, state, local, tribal, and territorial public health and regulatory partners

Retail Food Regulatory Program Standards 1. Regulatory Foundation 2. Trained Regulatory Staff 3. Inspection Program based on HACCP 4. Uniform Inspection Program 5. Foodborne Illness Investigation 6. Compliance and Enforcement 7. Industry and Community Relations 8. Program Support and Resources 9. Program Assessment

Manufactured Food Regulatory Program Standards (MFRPS) Regulatory Foundation Training Inspection Program Inspection Audit Program Food-related Illness and Outbreaks and Response Compliance and Enforcement Industry and Community Relations Program Resources Program Assessment Laboratory Support 10 Standards to establish a uniform foundation for the design and management of state programs responsible for regulating food plants Institute a quality assurance and standardization program FDA Program-Assessment Validation Audits (PAVAs) will be conducted at 12, 36, and 60 months

Animal Feed Regulatory Program Standards Standard 1 Regulatory Foundation Standard 2 Training Standard 3 Inspection Program Standard 4 Auditing Standard 5 Feed-Related Illness or Death and Emergency Response Standard 6 Enforcement Program Standard 7 Outreach Activities Standard 8 Planning and Resources Standard 9 Assessment and Improvement Standard 10 Laboratory Services Standard 11 Sampling Program

USDA FSIS Reviews of State Meat Inspection Programs FSIS determines whether each State MPI program is at least equal to the Federal inspection program, and includes evaluation of the following nine components: Statutory Authority and Food Safety Regulations Inspection Product Sampling Staffing and Training Humane Handling Non-Food Safety Consumer Protection Compliance Civil Rights Financial Accountability

2008 50 State Meeting Roles and Responsibilities Workgroup The goal of this group was to identify who would play what roles in the nation’s food protection system in 2013 and to identify the barriers and gaps that might prevent the establishment of such a system.

2008 50 State Meeting Roles and Responsibilities Workgroup Identified the biggest gaps to achieving the ideal 2013 system. This resulted in six items: sharing information/better communication/confidentiality; (2) funding and capacity; (3) qualified staff; (4) uniformity; (5) establish who’s in charge, and (6) length of time to change laws.

2008 50 State Meeting Roles and Responsibilities Workgroup Recommendations Establish an international food protection training center leverage outside funding sources Establish a point person for each element of the food protection plan Create a food protection council Quality systems Standards Metrics (SMART) Adopt or create an interactive information system Communication and data sharing

Partnership for Food Protection Established to implement the recommendations from the 2008 50 – State Workshop. Utilized a workgroup structure to develop and implement procedures, best practices, and other work products that would advance integration. Charged with leading development and implementation of an IFSS. Currently seven workgroups.

2012-2014 Workgroups Information Technology Implementation & Communication Laboratories National Standards National Workplanning Performance Measures Local Engagement National Feed Sampling PETNet now called Animal Feed Net Response & Recall Training & Certification

PFP Workgroups Animal Feed Net: Provide mechanism for information sharing and monitoring between federal and state agencies for animal feed (pets and livestock) related incidents. Implementation & Communications: Develop an implementation plan to facilitate the use of IFSS best practices across federal, state, local, Tribal, and territorial governments. Information Technology: Defining and understanding the requirements for developing an integrated electronic information management backbone, and undertaking technical projects to create an interoperable and integrated national food safety system. Local Area Engagement: To incorporate the Food Safety Modernization Act (FSMA) deliverables that include local agencies with PFP projects and provide specific recommendations for engagement of local agencies within the vision for an IFSS. National Feed Sampling: Develop mechanism for sharing feed collection samples and laboratory data between Federal and State agencies. Response & Recall: Develop response guides and records for event responses. Training & Certification: To provide support for visionary development, best practices, appropriate content and recommendations toward development of an integrated food safety training and certification system.

Produced by: the Partnership for Food Protection National Workplan Workgroup October 2013

Produced by the Partnership for Food Protection National Standards Work Group September 2013

Training and Certification Workgroup Purpose: To assist PFP with the development and implementation of uniform, national standards for training and certification of regulators working in: Retail Foods Manufactured Foods Raw/Unprocessed Foods Feed

Training and Certification Workgroup Charge 1: Create a national training and certification program Establish competencies and certification for all regulatory disciplines Includes retail, manufactured, raw/unprocessed and feed Inspection, laboratory, compliance, epidemiology, etc Start with entry level for inspections (followed by Journey/Technical/Leader) Job task analysis inspection: 120+ tasks already identified at “entry level” Job competencies inspection: 24+ identified at “entry level” FDA consultant conducted JTAs

Training and Certification Workgroup Charge 2: Establish an International Food Protection Training Center Assessed and endorsed the International Food Protection Training Institute (IFPTI)

Training & Certification Workgroup Vision Includes: Goals: Develop & implement a national food safety training system Develop & implement a national certification system

Training & Certification Workgroup Vision Includes: A curriculum development/delivery roadmap Standards and quality assurance built-ins Potential for certifications and accreditations (students/academia/NGO’s) Auditing considerations (federal or third party) Need for funding sources (Centers of Excellence, training institutes, academia, NGO’s)

Training & Certification Workgroup Vision (FDA/ORA-U, 11/09) www.foodshield.org

Integrated Food Safety Training and Certification System Vision Skilled Federal, State, Local, Tribal, and Territorial Food Safety Workforce Center of Excellence (Leadership / Management) Firewall Center of Excellence (Epidemiology) Center of Excellence (Feed) Others Analysts Epidemiologists Investigators Alliance (PCA) Center of Excellence (Food Science/ Technology) Training Companies Local State Tribal Academia Territorial Associations Regulatory Agencies Federal Food Safety Training Institutes and Centers Food Safety Certification Bodies & Centers Training Development/ Administration Certification Development/ Administration Standards and Oversight Training: Advisory Boards Certification: Advisory Boards All Stakeholders

Centers of Excellence Established to develop and provide specific training Composed of experts in defined subject areas Focus primarily on: Journey & Technical levels To provide knowledge and skills in science and technology Management and Leadership Development of middle & upper management staff responsible for policy and people/communication skills Centers will be identified by Federal Agencies such as FDA, USDA, CDC, DHS Funding for COEs will need to come from these same agencies

Food Safety Training Institute Established to serve as the administrative section of the training system Functions to include but not limited to Registration of students Maintenance of training records Coordinating the development and delivery of training Deliver training not currently provided elsewhere Develop trainers

Making the Vision a Reality $7.4 Million per year for 5 years (FDA has entered into Cooperative Agreements/Grants with various Centers of Excellence to develop training and certification programs) Over 70 projects supporting the curriculum framework are in progress Projects include new & revised training courses and development of certifications

Current Grantees International Food Protection Training Institute (IFPTI), Battle Creek, MI Iowa State University (ISU), Ames, IA University of California (UCD), Davis, CA University of Tennessee (UT), Knoxville, TN Auburn University (AU), AL National Environmental Health Association (NEHA), Denver, CO North Carolina State University (NCSU), Raleigh, NC Training being developed and revised will be based on validated Job Task Analyses. Certification Programs will be based on recognized standards.

2010-2012 Projects Training & Certification Work Group Assure that FSMA is covered in the Curriculum Framework Developed a process to identify and prioritize Training and Certification programs needed Develop a process to qualify Job Task Analyses

IFPTI CURICULUM FRAMEWORK

Training & Certification Workgroup Projects  Enlisting the services of the MFRP Alliance for Manufactured Food GMP Investigator JTA and to serve as a Manufactured Food Training Advisory Council

Food Protection Professional Training Development Process

IFPTI Training Process

Desired Results Validate the Curriculum Framework based on completed FDA JTAs Content area - course gap analysis Course content alignment using JTAs Course development to address gaps Provide an understanding of training system development.

Agenda Discuss interrelationship between: Process Job task analyses Competency frameworks Competencies Curriculum frameworks Curriculum Course alignment against JTAs Courses – Using JTA to develop/redevelop

Process Define audience Conduct Job Task Analysis Create competency framework Identify competencies Identify sub competencies Create curriculum framework Map existing courses to curriculum framework Conduct content area-course gap analysis Depth analysis Course alignment with JTAs Course content review Course development/redevelopment

Audience Need to clearly define the audience for which training will be developed. Helps to identify subject matter experts who participate in the JTA process. Outcome of the JTA process is valid for the studied audience.

Conduct approximately 3 years. Job Task Analysis Job - series of tasks. Task - an action designed to contribute a specified end result to the accomplishment of an objective. Conduct approximately 3 years.

Job Task Analysis Defines a job in terms of: Knowledge Skills Abilities Necessary to perform daily tasks. Structured framework that dissects a job Resulting in a report describing a job: Independent of location Across a specified group of people Detailed list of all the tasks

Typically around 10-15 experts Approximately 2.5-3 days DACUM JTA Framework Facilitated workshop Typically around 10-15 experts Approximately 2.5-3 days Systematically identify information about the job Validation of outcome through survey of the larger professional community The acronym DACUM = Develop A Curriculum

FDA JTAs Completed Basic Investigator (New Hires) Certified Professional In Food Safety (CP-FS) (Retail) GMP Food Investigator Import Investigator Low Acid Canned Foods/Acidified Foods Investigator Manufactured Feed GMP Investigator Seafood Investigator Produce Investigator

JTA Report Structure Diagram Job Duty Task Step Knowledge, Skills, abilities, attributes, tools, equipment, resources, etc. (Body of Knowledge)

Eight Primary Duties

DACUM Chart for Manufactured GMP Food Investigators

Use of JTA Reports Identify discrete subject matter topics (content areas) needed to complete tasks. Create specific training on the discrete topic. The knowledge, skills, and abilities of the discrete topics (content areas) add up to the competencies to complete the job. Create a competency framework

Competency Framework Competency framework: Defines ‘excellent’ performance within an organization, sector, or profession. Establishes vision for performance within the profession/defined job. Impact for training: Provides performance expectations to which training should be developed.

Competency Framework Purpose: Identifies desired outcomes or behavior Use: metrics by which competency can be measured. Characteristics: observable & measureable Evaluation: Person meets the competency if she/he can perform to the level of the stated competency.

Competency Framework Components Domains: A broad grouping (category) of knowledge, skills, and abilities (and attributes, behaviors, etc). I.E. Communication, Technical, Leadership, etc. Levels: Subdivision of the profession or job into ranges of expected performance or competence Competencies: Statements of expected performance

Competency Framework Proficiency Levels / Domains Technical Competency   Technical Competency Communication Programmatic Leadership Senior administration Supervisor/ manager Expert Mid-level - expanded test scope - increased test complexity Entry (trainee – 2 years) - limited test scope - limited test complexity

Competency Competency (statements): Single phrase or sentence Written broadly enough to be a complete activity Encompass several areas of knowledge, skills, and abilities (sub competencies) Example: An entry level employee has met a technical competency if he/she can; “Explain laboratory testing methods.”

Competency Framework - Example Proficiency Levels / Domains   Technical Competency Communication Programmatic Leadership Senior administration Anticipate and evaluate resource needs. Distill complex technical information for a variety of audiences. Interact with media organizations regarding sensitive issues. Disseminate the vision, mission, goals, and objectives throughout organization. Strategically prioritize and allocate resources. Collaborate in the development of new program standards. Creating or modifying policy. Establish fee structures. Oversee facility management. Advocate for resources. Establish organizational culture. Leads strategic planning. Promote an integrated food safety system. Supervisor/ manager Assess work performed by experts. Determine if expert’s conclusions are valid. Interpret a compilation of test results and explain the implications. Interact with media organizations regarding non-sensitive issues. Write concise business reports. Conduct conflict resolution and negotiation. Provide clear instructions. Inform senior administration of challenges, opportunities, resource needs, etc. Effectively disseminate information. Produce effectively written and oral inter-personal communications. Assess program performance using data. Suggest new methods. Interpret and apply emerging technologies. Implementing new policies. Ensure compliance with work rules, policies, and practices. Employ program standards relevant to the laboratory. Administer accreditation or certification standards that pertain to the administrative operations. Motivate laboratory professionals. Implement the strategic plan. Advocate for laboratory staff members. Engage in interagency collaboration. Engage in integrated food safety system activities. Expert Troubleshoot problems. Train laboratory professionals. Interpret and describe standard and nonstandard test results. Evaluate data using statistical modeling. Evaluate and implement technologies. Conceptualize and develop novel approaches. Engage in public speaking. Write for publications. Independently interact with peers regarding technical information. Participate in workgroups and. professional organizations. Build collaborations. Write technical reports/documents. Facilitate meetings. Collaborate on applicable grant opportunities. Apply regulatory standards in assessing data and reporting results. Administer accreditation or certification standards that pertain to the laboratory testing operations. Participate in strategic planning. Mentor laboratory professionals. Model professional laboratory behavior. Contribute to professional field. Mid-level - expanded test scope - increased test complexity Apply testing knowledge and skills to similar test methods. Apply knowledge and skills to use similar technologies. Participate in trouble shooting problems. Describe the results in terms of the work performed. Present to peers. Write SOPs. Write in a grammatically correct style. Create data summary reports. Write corrective action reports. Articulate issues. Present information about work performed as evidence in legal proceedings. Describe regulatory programs that the laboratory supports. Explain roles and responsibilities in the quality system. Articulate roles and responsibilities in safety program. Explain the roles and responsibilities of personnel and programs within their laboratory. Initiate problem resolution. Recommend innovative solutions. Recognize and proactively address issues and gaps. Entry (trainee – 2 years) - limited test scope - limited test complexity Explain laboratory testing methods. Perform laboratory tests independently and correctly. Clearly recording observations. Follow written and verbal directions. Seek assistance or clarification when necessary. Discuss laboratory-related issues clearly, logically, and succinctly. Consistently behave in an ethical manner. Pursue professional growth. Assume responsibility and accountability for actions.

Competency Framework- Example Proficiency Levels / Domains   Technical Competency Communication Mid-level - expanded test scope - increased test complexity Apply testing knowledge and skills to similar test methods. Apply knowledge and skills to use similar technologies. Participate in trouble shooting problems. Describe the results in terms of the work performed. Present to peers. Write SOPs. Write in a grammatically correct style. Create data summary reports. Write corrective action reports. Articulate issues. Present information about work performed as evidence in legal proceedings. Entry (trainee – 2 years) - limited test scope - limited test complexity Explain laboratory testing methods. Perform laboratory tests independently and correctly. Clearly recording observations. Follow written and verbal directions. Seek assistance or clarification when necessary. Discuss laboratory-related issues clearly, logically, and succinctly.

Developing a Curriculum Framework Develop competency statements “Independently conduct a feed firm inspection.” Identify knowledge, skills, and abilities needed to perform the competency. Knowledge, skills, and abilities needed BSE Manufacturing processes Basic drugs Manufacturing equipment Federal regulations Medicated feed Etc. Computer skills Research Skills

JTA Report Sample

Means to organize training courses by: Curriculum Framework Means to organize training courses by: Content areas Competency levels entry, journey, technical, leadership Professional tracks for example, unprocessed, manufactured, and retail Specific commodities

Curriculum Framework A platform/system to catalog/organize courses Like a library Courses are like the books – each categorized and in sections (content areas)

Curriculum Framework - Example

Content Areas Content Areas BSE Manufacturing processes Basic drugs Manufacturing equipment Federal regulations Medicated feed Etc. Computer skills Research Skills Content Areas (discrete subject matter topics on which specific training can be developed)

Curriculum Framework - Example Animal Drugs BSE Feed Manufacturing processes Statutes, Regulations, & Ordinances

Mapping Courses to Framework (Examples – not actual courses) Com 2010 Public Speaking Com 2020 Influencing Com 2030 Persuasive writing Com 2040 Interpersonal Skills … Communication Skills

Gap Analysis Identifies content areas that do not have any courses (gaps). Aids in the identification and prioritization of course development needs.

Depth Analysis Examine content areas with existing courses. Review of existing courses to ensure adequate coverage of knowledge, skills, and abilities within the content area. Aids in the identification and prioritization course development/redevelopment.

Creating a Curriculum Curriculum framework allows: Selection of content areas and courses from within those content areas that collectively provide the knowledge, skills, and abilities to perform a job.

Curriculum Definition: Purposeful selection Sequence of courses (or modules) Provide the knowledge, skills, and abilities for an individual to perform their job.

Curriculum – Content Areas - Example GMP Feed Investigator Animal and Public Health Principles Basic Animal Nutrition Basic Feed Ingredients, Processing, and Technology Basic National Incident Management System (NIMS) and Incident Command System (ICS) BSE Awareness Communication Feed Defense Inspections, Compliance, and Enforcement Labeling Prevailing Statutes, Regulations, and Policies Professionalism Safety Sampling

Using JTAs to Align Course Content

Next Steps Develop/refine competency framework Write competencies Validate curriculum framework Identify/prioritize development/redevelopment