Environmental Regulatory Risk Assessment Leader

Jennifer L. Wingeart

Education

■M.S., Environmental Science and Policy/Environmental Engineering Analysis, Johns Hopkins University, 2014

■B.S., Biology, Minor in Chemistry, Troy State University, 2005

Years of Related Experience

12 Years 7 Months

Executive Summary

Senior leadership and supervisory scope within auspices of environmental policy and regulatory compliance with 12+ years of professional experience supporting; state and federal environmental programs, risk assessments, biotechnology regulations, hazardous materials compliance, and interagency stakeholder engagement. Experienced in developing technical and policy analyses, preparing decision materials for executive leadership, supporting compliance with CERCLA, RCRA, CWA, NEPA, TSCA, FIFRA, and related statutes, and coordinating cross-functional environmental projects across government, research, and regulated-industry settings.

Capabilities Summary

■Regulatory Human Health and Ecological Risk Assessments at Federal, State, and County Levels

■Publications in the Federal Register for Biopesticides in Agricultural Commodities

■Scientific Technical Writing with a focus on risk assessments and regulatory processes

■Acute attention to detail in technical writing/deliverables to meet stringent deadlines

■Budget analysis on multi-million dollar federally funded projects

■Provide technical, regulatory, and programmatic directives

■Excellent time management and multi-tasking expertise at microscale and broadscale spectrums

■Hazard Waste Program Management and Storm Water Quality for State and Federal government

■Program Management for Federal contracting clientele and stakeholders

■Expertise in R&D facilities for site implementation of performance improvement (PI) programs, Correction Action Process (CAP) for new SOPs, Self-Assessment (SA) and Benchmarking (BM) for productivity performance

■Expertise in State and Federal permitting for agriculture, water, and air quality compliance

■Expertise in Tribal Land Management for environmental planning; ESA Phases I-III utilizing ESRI, ArcGIS, AutoCAD

■Industry-leading manufacturing systems certified to ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety)

Professional Experience

Senior Scientist Engineer, Biotechnologies Office (BTO), DARPA (Defense Advanced Research Agency) Strategic Analysis Inc., Arlington, VA, June 2023 – May 2024

■Provided Program Management to novel biotechnologies for DARPA

■Organized and Facilitate Annual Concrete Stakeholder Workshop clientele and agenda

■Organized shipment of biological test articles during research and development Phase I-III utilizing safety protocols and hazardous materials labeling/receiving

■Maintained all program management support documents using FileMaker and BOX databases

■Drafted and Presented Slide-Decks Deliverables to Senior Leadership and Board of Directors

■Researched relevant permitting for DARPA and biotechnology compliance with State and Federal entities (ERDC, EPA, NAVCAC, DoD)

■Facilitate weekly meetings with DARPA stakeholders and agendas for classified research projects

Institutional Animal Care and Use Committee (IACUC) Coordinator, Defense Health Agency; United States Army Medical Research Institute of Infectious Diseases (USAMRIID); USAMRIID Regulated Activities Support Services; Laulima Government Solutions, LLC., Ft. Detrick, Frederick, MD, November 2022 – February 2023 (Contracor)

■Worked with current IACUC functions as well as the federal laws, regulations, policies, and guidelines governing animal care and use in the United States and the DOD in order to complete tasks.

■Became familiar with USAMRIID IACUC animal care and use policies, SOPs, and procedures.

■Performed regulatory tasks based on these animal care and use SOPs, as well as federal and DOD regulations, guidelines, and policies. Applied regulations, policies, and guidelines to IACUC tasks.

■Reviewed animal research proposals and addenda for completeness prior to and after committee review.

■Reviewed all rodent research proposals and addenda to ensure appropriate information, coordination, signature, and proper format prior to IACUC review.

■Reviewed revised animal use proposals to ensure appropriate changes were made IAW the revisions requested by the IACUC. Notified the IACUC Chair of review results within seven days of receipt of revised rodent proposals.

■Reviewed technical reports, grants, presentations, and manuscripts to ensure they met all regulations and requirements for publication. Reviewed submitted reports, grants, publications and presentations for consistency with approved rodent protocols. Submitted to IACUC Chair for review and signature within five business days of receipt.

■Communicated with internal and external customers – oral and written. Prepared written correspondence in accordance with USAMRIID and Army policies. Sent notification of meetings and meeting material to PIs and IACUC members five business days before IACUC subcommittee meeting date.

■Served as an IACUC recorder and prepared IACUC correspondence/reports. Took minutes during IACUC meetings. Prepared revision memos to PIs. Prepared Commander approval memos for proposals and PIs

■Prepared addenda approval memos for PIs. Served as the IACUC recorder for DMR subcommittee meetings and prepared revision memos for PIs. Revision memos should be completed within seven business days of the meeting date.

■Prepared and provided a memorandum (minutes) to the USAMRIID Commander of all IACUC DMR subcommittee meetings to include review of rodent proposals and other IACUC issues.

■Maintained excel spreadsheets of animal use, animal welfare investigations (AWI), and post approval monitoring (PAM). Verified number of animals used, training completion, etc. Tracked completion of AWI and PAM requirements.

■Performed IACUC database entry and prepared necessary reports based on this data. These reports included workload reports, DOD Annual Datacall on Animal Use, AAALACi Annual Report, PHS Annual Assurance report.

■Assisted research staff through the animal proposal development process. Answered customer questions regarding IACUC approval process questions and IACUC policies as needed.

■Reviewed pertinent SOPs for formatting and adherence to USAMRIID SOP requirements.

■Maintained hard copy and electronic files of all regulatory documents.

■Conducted annual review of all rodent animal protocols.

■Scheduled meetings and work with the IACUC Chair to select appropriate IACUC members to sit on the committees and review addenda. IAW the Animal Welfare Regulations, PHS Policy, and DOD Regulations, and based upon guidance from the Chair, selected an appropriate IACUC member to serve as a designated reviewer for rodent addenda and selected appropriate IACUC members to serve on a designated member review subcommittee for review of rodent proposals.

■Prepared official correspondence for the Commander and Deputy Commander when reporting to OLAW and other regulatory bodies.

■Out-processed USAMRIID personnel as needed.

■Formatted proposals for review by the IACUC. Electronically sent out formatted proposals to the IACUC members prior to IACUC meetings as required by the IACUC SOP.

■Contributed data for the quarterly workload assessment within 10 days of quarter’s end.

■Worked with Microsoft Office software, Filemaker Software, and Adobe Acrobat Professional to maintain spreadsheets, prepare correspondence, and perform database entry.

Biologist and Risk Manager, U.S. Environmental Protection Agency (EPA), Office of Chemical Safety Prevention and Pollution (OCSPP), Office of Pesticide Programs (OPP), Biopesticides Pollution and Prevention Division (BPPD), Microbial Pesticides Branch (MPB), Emerging Technologies Branch (ETB), and Risk Assessment Branch (RAB), Washington D.C, October 2014 – May 2022

■Developed short- and long-range environmental program strategies across workgroups, aligning scientific, regulatory, and policy priorities with EPA program goals and senior management direction.

■Developed strategies on various work groups to meet short and long-range goals for applicable programs and assured strategies reflect relevant directions in research, preventive, and clinical approaches as it relates to the scientific area of interest.

■Designed, implemented, and conducted biological scientific surveys/studies or projects to identify and streamline productivity within the division.

■Analyzed study or project implementation procedures for improvement and streamlined procedures within the division and stakeholders.

■Presented findings and deliverables to senior management targeted to address CERCLA, RCRA and other Federal programs

■Routinely prepared written correspondence, which included internal operational plans, performance reports for tracking, pest survey reports, briefing papers, decision memoranda, position papers, and other administrative documents.

■Advised stakeholder engagement and collaborative efforts on technical aspects of EPA laws and regulations.

■Prepared assessments on scientific findings related to product characterization and microbial identity.

■Reviewed physical, biological, and environmental data to support waste management, materials management, environmental standards, regulatory guidance, and risk-based decision-making.

■Drafted Human Health risk assessments regarding biopesticides and new registrations of novel biotechnology products (RNAi).

■Review and evaluate physical, biological, and environmental data to improve waste management and effective materials management processes, regulations, standards and guidance

■Advised and developed new agricultural guidelines with industry stakeholders for waste management and materials management

■Developed briefing materials and reports, advise senior management on exposure assessment issues.

■Represented the Branch at meetings with supervisors and other senior Agency personnel, other government agencies, and non-governmental organizations.

■Examined scientific data and/or pesticide-based studies to produce written reviews and report novel active ingredients to senior leadership.

■Provided technical support and analysis of plant pest risk and invasive weed risk in assessments.

■Provided scientific, technical and analytical support to management, other staff biotechnologists and biological scientists.

■Consulted with fellow experts from the national and international scientific community regarding the criteria and regulation of the release of certain modified organisms into the environment.

■Maintained a continuous self-development by taking part in professional seminars, hands on activities, and by participating in collaborative scientific biotechnology regulatory projects.

■Prepared a variety of authorization documents, risk assessments, reports, and technical analyses on different aspects of biotechnology related to protection of plant health.

■Worked on disciplinary and multi-disciplinary teams related to the risk assessment of pesticides.

■Updating the Endangered Species List based on incoming studies under the Endangered Species Act (ESA)

■Performed statistical analysis of biopesticide exposure data for naturally occurring and genetically engineered microbial pesticides and plant incorporated pesticides (PIPs)

■Experience preparing and reviewing environmental documents for National Environmental Policy Act (NEPA) and other environmental laws, regulations or policy, including experience planning, analyzing impacts, coordinating and executing major components of environmental studies.

Environmental Chemical Safety Scientist, DAP, Inc., (RPM-DoD Contractor) Regulatory & Environmental Affairs, Baltimore, MD, September 2013 – October 2014

■Reported to the Certified Occupational Health Specialist any violation with OSHA and hazards associated with exposure for chemicals used in processing on-site for environmental compliance programs

■Supported environmental compliance across TSCA, FIFRA, FFDCA, SDWA, CERCLA, RCRA, CAA, and CWA, with hands-on experience maintaining regulatory documentation, chemical files, SDS records, and compliance procedures.

■Updated and maintain raw material files with all relevant chemical components.

■Developed technical and policy analyses and documents that support regulatory development and implementation of title V of the Clean Air Act and its regulations found at 40 CFC Parts 70 and 71.

■Supported the operating permits program under Title V of the Clean Air Act.

■Developed written work products to communicate environmental concepts to a variety of stakeholders and establishing professional relationships with environmental groups.

■Coordinated and implemented new data management procedures and performs advanced database management functions for implementation of the Globally Harmonized System (GHS) of chemical classification and reporting.

■Provided technical advice and information on significant analytical methods, sampling techniques, etc., related to specific program areas, functions, or activities.

■Maintained all Safety Data Sheets (HCS 2012) with raw materials and chemical reagents.

■Coordinated with Industrial R&D laboratory on new formulations that are compliant under TSCA.

■Assisted in laboratory procedures to determine; flash point (closed-cup), extrusion rate, melt point, hazardous polymerization (reactivity), VOC content (air particulates).

■Assisted in batch substances additions; plasticizers, surfactants, solvents.

■Compliance and daily routine professional experience with; Toxic Substances Control Act (TSCA ), Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Federal Food, Drug, and Cosmetic Act (FFDCA), Safe Water Drinking Act (SDWA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), Resource Conservation and Recovery Act (RCRA), Clean Air Act (CAA), Clean Water Act (CWA)

■Responsible for all finalized raw material files and accurate data entry into DAP chemical formula management software.

■Implementation of Regulatory Compliance Modules (RCM) 5.0 under the Code of Federal Regulations (CFR, 29,40).

■Implemented DAP’s Regulatory & Environmental Affairs Department Standard Operating Procedures (SOP).

Public Health Laboratory Scientist II: Division of Microbiology Maryland State Health Department, Maryland Department of Health and Mental Hygiene (DHMH), Baltimore, MD, June 2011 - May 2012 (Contractor)

■Microbiologist; responsible for federally funded program under Center for Disease Control (CDC), to collect data and confirm isolates of Haemophilus influenzae, Neisseria meningitides, Listeria monocytogenes, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae and Clostridium difficile.

■Reported directly to MD Infection Control Personnel, CDC, and Johns Hopkins Bloomburg School of Health (Epidemiology).

■Extrapolated data on laboratory animals to confirm positive results of certain isolates of interest in a Biosafety Laboratory, level III (BSL-3); Clostridium botulinum, Bacillus anthracis.

■Performed daily QA/QC maintenance; microbial control plates (subcultures), instrumentation, reagents.

■Presented briefings to; CDC Officials, State and local (country health department) government officials, Professional societies, Public meetings (Annual MD State laboratory training seminar).

■Responsible for final report of isolates (StarLIMS).

■Meticulous record accountability for CDC approval (accession numbers, microbial identification).

■Quantitatively interpret Active Bacterial Core Surveillance bio-statistical data for annual laboratory conference.

■Drafted project reports (quarterly) for bio-statistical surveillance according to State guidelines.

■Briefed the Division Chief monthly on project development and proposed implementations to the special laboratory project.

■Monitored monthly Emerging Infections Program (EIP) funds budget for dissemination for new laboratory purchase orders.

■Managed the annual EIP laboratory budget of over $5,000.

■Certified in Biohazard shipping; Saf-T-Pak, FedEx (ISO: 9001); Responsible for Microbiology Division Chain of Custody (shipping, receiving, documentation) on all isolates in the entire division, including Mycology.

■Used microplate-based colorimetric assays for nitrogen and phosphorus.

Professional Affiliations & Certifications:

■LEEN Yellow Belt (2014)

■American Chemical Society (ACS) # 30723628

■American Society for Microbiology (ASM)

■Weed Science Society of America (WSSA)

■Stormwater Management Certificate (2014)

■DOT/IATA Dangerous Goods (Chain of Custody) 2011

■OSHA- GHS (Chemical Classification, Labeling, SDS) 2014

■HAZCOM (OSHA-HCS) 2012

■Hazardous Waste & Regulatory Certificate (2014)

■Hazardous and Toxic Waste Management Certificate (2014)

■Bioassessment and Water Chemistry Monitor, Alabama Water Watch (AWW, 2005)

■Chemical Hygiene Plan DHMH (2011)

■Method for Quantitative Absorption Spectroscopy (2011)

■CLSI Antimicrobial Susceptibility Testing (AST) Implementations (2012)

■ASM: Rules for Work-up and Reporting (2011)

Publications

Wingeart, Jennifer. “Ilex vomitoria Ait.,” Alabama Herbarium Consortium: Alabama Plant Atlas 30 November 2003: pp. 3of 6. Print.

Wingeart, Jennifer. “Bidens frondosa Linnaeus,” Alabama Herbarium Consortium: Alabama Plant Atlas 30 November 2003: pp. 3 of 5. Print.

Federal Docket Publications available upon request; >68.

Awards

■2019 EPA Scientific Achievement Award Recipient; Bee Vectored Microbial Pesticide Registration Team, OCSPP

■2020 OCSPP-OPP Recognition as Primary Science Reviewer for the New Active Ingredient: Pseudomonas fluorescens strain ACK55

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