Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
AWARDS (selective within FDA)
Generic

Diane Ducharme

Alexander,NC

Summary

Accomplished produce safety specialist with over 8 years of experience as a key authority within the U.S. FDA, providing expert policy, scientific, and technical guidance on biological issues related to agricultural production, processing, and handling practices for fresh produce safety. A solid foundation in biological sciences, combined with extensive research experience in both field and laboratory settings, has fostered a successful career focused on advancing knowledge and organizational capabilities. Recognized as an expert-level technical resource, skilled in developing and evaluating programs that align with national public health objectives while effectively engaging diverse audiences. A results-driven leader known for strong leadership abilities, effective communication, technical proficiency, project prioritization, and team collaboration, complemented by a good sense of humor that enhances adaptability in dynamic environments.

Overview

18
18
years of professional experience
1
1
Certification

Work History

Senior Consumer Safety Officer

U. S. Food and Drug Administration
04.2025 - Current
  • Developed and implemented safety training programs for staff and stakeholders, enhancing awareness of new regulations.
  • Collaborated with management to establish policies and improve operational protocols.
  • Established systems to capture workflow data that allows for ongoing analysis.
  • Monitored data to ensuring adherence to standards for ease in on-demand analysis with dashboard creation.
  • Led technical review of curriculums, industry standards, performance standards for produce safety.
  • Identified produce outbreak events that contribute to contamination and utilize root causes and other identified factors to identify ways to educationally aid understanding for compliance actions.
  • Mentored team members on protocols with review of documents for alignment to office policies.
  • Communicated quarterly data-driven analysis and progress to staff and management to provide up to date information.
  • Monitored and analyzed performance metrics, identifying trends and areas for improvement annually.
  • Identified gaps in existing processes and recommended update to process to correct.

Team Lead

U. S. Food and Drug Administration
04.2024 - 03.2025

Led cross-functional teams to enhance operational efficiency and drive project success.

  • Developed training programs for team members, improving skill sets and performance.
  • Implemented process improvements that reduced workflow bottlenecks, increased productivity, and align with annual priorities.
  • Coordinated resource allocation to optimize team output and meet quarterly and annual project deadlines.
  • Mentored junior staff, fostering a collaborative environment and enhancing team capabilities.
  • Oversaw project management initiatives, ensuring timely completion of deliverables.
  • Analyzed data trends to inform strategic decision-making processes.
  • Fostered a culture of continuous improvement through regular feedback and assessments.
  • Coordinated interdepartmental communication to streamline operations and reduce redundancies.

Consumer Safety Officer Project/Business Lead for Special Project: Strategic Engagement for the Integrated Produce Safety Systems Program (IPSSP)

U. S. Food and Drug Administration
04.2023 - 03.2024

Consumer Safety Officer efforts align to 20% of time.

  • Led the development, collection, and interpretation of data regarding the safety of fresh produce and leads the development and evaluation of programs and the implementation of the laws and regulations regarding these food products.
  • Assisted regional experts in organizing, developing and delivery of produce-specific training.
  • Provided the specialized experience of developing policy and regulatory guidelines on the safety of produce and providing scientific and technical guidance related to the safety of fresh produce to internal and external stakeholders.
  • Collaborated with cross-functional teams to identify hazards and improve operational produce safety measures.
  • Led initiatives to enhance facility safety through policy updates and procedural improvements.
  • Facilitated workshops and seminars to promote a culture of safety among employees in the division.
  • Provided expert guidance on risk assessment and mitigation strategies related to food safety issues.
  • Communicated safety performance and progress to management and employees to provide up to date information.
  • Promoted a culture of safety through engaging workshops and training sessions for employees on various topics such as hazard identification, PPE usage, and incident reporting.
  • Streamlined communication protocols among stakeholders, enhancing collaboration on food safety policies.
  • Analyzed data trends to inform strategic decisions regarding fresh produce safety regulations.
  • Collaborated with external partners to advance research initiatives related to produce safety enhancements.
  • Increased team productivity by implementing efficient project management strategies.
  • Led cross-functional teams to successfully complete complex projects on time and within budget.
  • Mentored junior staff members in their professional development pursuits while fostering a supportive learning environment.
  • Implemented data-driven decision-making, enhancing overall business performance and growth.


Project/Business Lead for Special Project: Strategic Engagement for the Integrated Produce Safety Systems Program (IPSSP) for 80% of time

  • Serve as an agency expert and national authority to lead this Special Project that involves a novel and complex, high-profile strategic plan that cuts across all the Agency offices or Centers for the Produce Safety Program.
  • The scope of this project is to visualize, evaluate, formulate, and execute an integrated produce safety system program addressing the current situation, the strategic plan and roadmap for the next 5-10 years, with the incorporation of annual data to allow for risk prioritization.
  • Design the project with an accepted concept paper and project management charter that sets forth the anticipated project teams, timelines and milestones, and outcomes for accomplishments.
  • Manage special projects as co-lead within the OFSS Project Management Structure. Develop and legitimize the project's strategy with objectives, project planning, scope, schedule, and task definitions with co-leads and executive sponsors.
  • Work with the Executive Sponsors, SMEs, Project Team Members to provide overall inputs, support for defined success and scope.
  • Provided expert business understanding of the organization, process, or produce safety offices involvement across the produce safety program.
  • Coordinated with internal food safety partners to develop, review, plan, and execute appropriate food safety outreach sessions and/or training on the project deliverables.
  • Lead the development and collection of data regarding the safety of fresh produce within this project.
  • Resolve conflicting team and SME inputs to remove obstacles through project life cycle.
  • Assist subject matter experts in organizing, developing and delivery of produce-specific data that aligns to the project deliverables.
  • Coordinate and provide approvals to advance each of the four project phases.
  • Provide approval of final outputs and continuing strategy.
  • Monitors of the execution of the pilot produce safety program strategy, as deemed necessary during development.

Consumer Safety Officer

U. S. Food and Drug Administration
04.2022 - 03.2023
  • Coordinated with food safety partners to develop, review, plan, and execute appropriate food safety outreach sessions and/or training for stakeholders.
  • Led the development, collection and interpretation of data regarding the safety of fresh produce and leads the development and evaluation of programs and the implementation of the laws and regulations regarding these food products.
  • Assisted regional experts in organizing, developing and delivery of produce-specific training.
  • Coordinated the education and outreach efforts, compliance response, and work-planning of members of the FDA Produce Safety Network (PSN).
  • Provided the specialized experience of developing policy and regulatory guidelines on the safety of produce and providing scientific and technical guidance related to the safety of fresh produce to internal and external stakeholders.
  • Developed and implemented training programs for staff on safe handling practices.
  • Collaborated with cross-functional teams to address safety concerns within the Fresh Produce Branch.
  • Recognized, documented, and advised on removal of hazards.
  • Collaborated with management to develop site-specific safety policies, ensuring alignment with federal and state requirements.
  • Fostered culture of continuous improvement in safety practices, encouraging innovation and employee feedback.
  • Facilitated cross-departmental safety committees, fostering collaborative approach to workplace safety.
  • Collaborated with management to integrate safety improvements, enhancing overall operational efficiency.
  • Monitored and analyzed safety performance metrics, identifying trends and areas for improvement.
  • Identified gaps in existing compliance processes and recommended updates.
  • Communicated produce safety workflow performance and progress to management and employees to provide up to date information.

Consumer Safety Officer - PSN Team Lead

U. S. Food and Drug Administration
01.2022 - 03.2022
  • Served as an agency expert and national authority on assigned to Produce Safety for education and outreach programs with internal and external stakeholders, external stakeholders, state regulatory agencies and related industry and associations.
  • Served as an authoritative expert to all levels of FDA personnel, other Federal and State (to include tribal) government officials, as well as industry, international, and other stakeholder organizations for guidance and technical advice on the procedures, methods, and resources to assist with implementing new regulations and revising existing regulations on the leafy greens and produce adequacy of proposed policy statements and policy initiatives for the safety of fresh produce, as affected by FSMA.
  • Provided professional leadership and guidance to other Federal, State, and local authorities in carrying out the legislative produce-related food safety objectives of both extending, improving and monitoring existing programs and evaluating public health educational programs in accordance with governing legislative and agency requirements.
  • Coordinated with food safety partners to develop, review, plan, and execute appropriate food safety outreach sessions and/or training for stakeholders.
  • Monitored contract and grant projects to assure that federally funded programs address the needs of FDA produce safety.
  • Organized FDA interactions with cooperative agreement partners for food safety training, education, extension, outreach, and technical assistance.
  • Coordinated education and outreach efforts, compliance response, and work- planning of members of the FDA Produce Safety team.
  • Evaluated effectiveness of public health education planning and programs through a variety of means, including review of project proposals, curriculum and instructional materials, technical and progress reviews, evaluation instruments and discussions.
  • Initiated, planned, conducted and/or participated in national and regional meetings and seminars/conferences for the purpose of gaining support of and advancing national objectives of Produce Safety in relation to Ed/Outreach,
  • Coordinated education and outreach efforts, compliance response, and work-planning of members of the FDA Produce Safety Network (PSN).
  • Communicated with regulatory specialists and other professionals within FDA, other Federal and State (to include tribal) government officials and professional organizations, as well as industry trade organizations, international and other organizations to provide guidance, training and/or updated information on FDA policies and regulations.
  • Led the development, collection and interpretation of data regarding the safety of fresh produce and leads the development and evaluation of programs and the implementation of the laws and regulations regarding these food products.
  • Coordinated food safety partners to develop, review, plan, and execute appropriate food safety outreach sessions and/or training for stakeholders.
  • Assisted regional experts in organizing, developing and delivery of produce-specific training.
  • Served as the principal FDA Center liaison to industry, international organizations, and other organizations on educational issues related to fresh produce.
  • Conducted regular inspections to identify hazards and recommend corrective actions.

Consumer Safety Officer

U. S. Food and Drug Administration
01.2017 - 01.2022
  • Conducted, managed, and coordinated food safety assessments in accordance with the Food Safety Modernization Act (FSMA), Produce Safety Rule (PSR);
  • Served as agency expert and authority on the Food Safety Modernization Act (FSMA)- Produce Safety Rule (PSR) for education and outreach programs.
  • Served as agency expert and national authority on projects for more than one year that include regulatory and compliance matters related to produce safety issues for the Fresh Produce Branch (FPB).
  • Established collaborations to achieve the objectives of current project and grants; expertise with the Cooperative Agreement Program Grants including monitoring, alignment of contract and grant projects with FDA needs, and providing education and technical assistance enabling higher compliance with the PSR.
  • Coordinated with food safety partners to develop, review, plan, and execute appropriate food safety outreach sessions and/or training for stakeholders.
  • Assisted regional experts in organizing, developing and delivery of produce-specific training.
  • Provided leadership for internal FDA offices, other federal (USDA-FAS), international partners, state regulatory and academic, and national industry partners on several teams and projects including Annual Report Team, the Produce Education and Outreach Team, the Biological Soil Amendments of Animal Origins Workshop Team, the Agricultural Water Systems Workshop Team, the Systems Thinking Workshop Team, and the International On-Farm Readiness Review Training Team.
  • Coordinated education and outreach efforts, compliance response, and work-planning of members of the FDA Produce Safety team.
  • Expertise in conducting and directing analysis of highly technical and complex situations related to produce as evidenced by accomplishment of outputs for: Annual Report, Produce Education and Outreach, working with Office of Compliance on egregious conditions and import alert.
  • Provided technical assistance and expertise to state regulatory offices and industry stakeholders in overall and regionally-specific production and handling practices of produce commodities; interpret and implement laws, regulations, and policies applicable to produce operations and food safety.
  • Determined and developed of policy or guidance policies to aide in implementation of the PSR for the states.
  • Consulted with project managers, scientist and FOIA attorneys for resolution of complex or controversial legal or technical issues.
  • Led the development, collection and interpretation of data regarding the safety of fresh produce and leads the development and evaluation of programs and the implementation of the laws and regulations regarding these food products.
  • Evaluated data and reports and preparing decision papers on the safety of fresh produce with extended examples from the field and scientific research.
  • Developed and implemented standard operating procedures (SOPs).
  • Formulated recommendations, resource development, or continued guided discussions for the further development of compliance strategies, policy, and regulatory guidelines.
  • Consulted with FDA and other partners to participate in focused inspection or investigations of outbreaks to provide guidance and direction based upon the PSR and stakeholder experience.

Program Coordinator/Extension Associate

North Carolina State University/NC Cooperative Extension, Department of Horticulture Science and Plants for Human Health Institute
01.2008 - 12.2017
  • Established and provided strategic leadership to a new program at NCSU for fresh produce safety, incorporating good agricultural practices (GAP) and good handling practice (GHP).
  • Collaboratively worked to enhance partnership in agricultural research.
  • Served as NCSU subject matter expert for on-farm agricultural production and produce safety risk analysis.
  • Lead role in strategic outreach and education that includes the facilitation of collaborators, coordination and transparency of efforts, evaluation, and overall administration of projects.
  • Supervisor to team members working on fresh produce education.
  • Provided instructional course development, coordinated delivery and evaluations.
  • Provided technical support and professional leadership with compliance actions (i.e., biological, pesticide, waste and water management, FSMA) necessary to adhere to state and federal laws.
  • Team member on NCSU fresh-cut produce and retail-ready resource development and trainings to industry.
  • Provided integrated expertise in areas of biological production, food safety, postharvest quality, NOP, co-management, waste management, recall, GAP/GHP certification, and food security.
  • Participated in state and association working-groups with leadership for NCSU.

Education

Ph.D. - Horticultural Science; Food Bioprocessing and Nutritional Sciences (Food Science)

NC State University
Raleigh, NC
01.2019

M.S. - Plant Pathology

Clemson University
Clemson, SC
01.1999

B. S. - Environmental Science; Biology

University of NC of Asheville
Asheville, NC
01.1994

Skills

  • Risk assessment methodology
  • Strategic analytical thinking
  • Design effective produce safety training programs
  • Proficient in strategic issue management
  • Collaborative project coordination
  • Strong relationship management

Accomplishments

  • Team lead of seven staff members within the branch of produce safety.
  • Collaborated with team of over 40 in the development of strategic produce program plan (Integrated Produce Safety Program).
  • Received several FDA awards over the years - a highlighted few include FDA Leadership Role in Organizing and developing a on-farm demonstration model; FDA Plain Language Awards - Produce Safety Guidance Fact Sheets and Webpage; FDA group recognition-crosscutting for E. coli O157:H7 Romaine Lettuce Outbreak Incident Group; FDA Group Recognition Award: Crosscutting for Food Traceability Regulation team for superior performance in advancing the publication of the Food Traceability Final Rule
  • Planned and implemented annual program reports through effective analysis of shared data to determine what was learned and set data-driven priorities for the next year.
  • Mentored and trained staff members in methods utilized to achieve the educations and outreach goals for each of the four US regions.

Certification

  • Root Cause Analysis.
  • Instructor Skills Training (IST).
  • Precision Thinking and Problem Solving.
  • Developing Lasting Relationships: Part 1 & 2.
  • Incident Command System Training – FEMA (ICS-100, 200, and 300).
  • Effective Virtual Team Members,
  • Soft Skills Trainings: Active Listening, Personal Accountability, Diversity and Inclusion.
  • Produce Safety Alliance (PSA) Train-the-Trainer & Lead Instructor.
  • Emotional Intelligence.
  • Team Training: The Five Dysfunctions of a Team.
  • Crucial Conversations: Tools for Talking When Stakes are High.

Timeline

Senior Consumer Safety Officer

U. S. Food and Drug Administration
04.2025 - Current

Team Lead

U. S. Food and Drug Administration
04.2024 - 03.2025

Consumer Safety Officer Project/Business Lead for Special Project: Strategic Engagement for the Integrated Produce Safety Systems Program (IPSSP)

U. S. Food and Drug Administration
04.2023 - 03.2024

Consumer Safety Officer

U. S. Food and Drug Administration
04.2022 - 03.2023

Consumer Safety Officer - PSN Team Lead

U. S. Food and Drug Administration
01.2022 - 03.2022

Consumer Safety Officer

U. S. Food and Drug Administration
01.2017 - 01.2022

Program Coordinator/Extension Associate

North Carolina State University/NC Cooperative Extension, Department of Horticulture Science and Plants for Human Health Institute
01.2008 - 12.2017

Ph.D. - Horticultural Science; Food Bioprocessing and Nutritional Sciences (Food Science)

NC State University

M.S. - Plant Pathology

Clemson University

B. S. - Environmental Science; Biology

University of NC of Asheville

AWARDS (selective within FDA)

  • FDA Incentive Award: Teamwork/Collegiality.
  • FDA Group Recognition Award: Crosscutting: Food Traceability Regulation team for superior performance in advancing a New Era of Smarter Food Safety under extraordinary circumstances with the publication of the Food Traceability Final Rule.
  • FDA Incentive Award: Contributions and efforts for virtual Annual Fresh Produce Symposium.
  • FDA Group Award: Produce Safety Annual Report.
  • FDA GROUP RECOGNITION-CROSSCUTTING: E. coli O157:H7 Romaine Lettuce Outbreak Incident Group. For rapid cross-agency collaboration to protect public health by resolving an outbreak of E. coli O157:H7 associated with romaine lettuce.
  • FDA 2019 Plain Language Awards - Produce Safety Guidance Fact Sheets and Webpage- For excellence in addressing the information needs of the farming community and helping them to comply with new food safety regulation.
  • FDA Leadership Role in Organizing and developing On-Farm Demonstration models for delivery.
  • FDA’s Office of Operations/Office of Crisis Management Award for Hurricane Response-For exceptional contributions and outstanding dedication to the agency’s preparedness, response and recovery efforts related to multiple hurricanes.
  • FDA GROUP RECOGNITION-CROSSCUTTING Center for Food Safety and Applied Nutrition For excellence in initiating the inaugural year of the Agency’s first joint collaborative program-specific network.
Diane Ducharme