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Kenneth Washburn, Ph.D., DABT

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Kenneth Washburn, Ph.D., DABT
Associate of Integral

Kenneth Washburn, Ph.D., DABT

Associate of Integral (207) 800-3818 The Woodlands, TX kwashburn@integral-corp.com

Kenneth Washburn, Ph.D., DABT, has expertise in general toxicology, chemical safety assessment, and regulatory compliance under various chemical control initiatives. He is a board-certified toxicologist and a regulatory affair professional with more than 25 years of experience in academic toxicology and chemistry, the contract research laboratory industry, regulatory consulting services, and the petroleum and specialty chemical industries. In these positions, he has led the development of corporate product stewardship, sustainability, and product safety programs. As a project and group manager, he has a proven track record of delivering results while working with clients, internal stakeholders, trade associations, and government agencies. Dr. Washburn has the tenacity, communication skills, project management experience, budget management skills, and negotiation skills critical to success in the current regulatory environment.

Product Stewardship

Custom Hazard Ranking Tools, Various Locations Created company-specific hazard ranking tools in support of green chemistry initiatives, especially for hydraulic fracturing/oilfield chemicals, and supported these companies with internal sustainability goals and supply chain management. This service included evaluating confidential chemistries/supply chain management for major manufacturers of hydraulic fracturing/oilfield chemicals, while protecting confidential business information, allowing for exchange of technical hazard and toxicology information that was sanitized of proprietary information.
Regulatory Review, Global Interpreted chemical control legislation (REACH, China REACH, and Global GHS) implications for U.S. chemicals companies, as well as for associated trade associations. Developed regulatory reviews for both individual companies and for trade associations supporting the chemicals sector.
Regulatory Analysis, Nationwide Analyzed regulatory impacts, both in cost and timing, for internal stakeholders in order to determine product viability and to optimize and maintain commercialization. This 5-year effort consisted of supporting a surfactant manufacturer in bringing new products to market and providing the necessary regulatory support for existing product lines.
Corporate Regulatory Support, United States and European Union Representing a company with trade associations such as the American Chemistry Council, the European Chemical Industry Council, and the European Wax Federation. This effort involves collaborating with technical, regulatory, and sustainability working groups for hydrocarbon, long-chain alcohols, and surfactants.
Corporate Regulatory Support, Premanufacture Notifications, Nationwide Authored and submitted premanufacture notifications (PMNs) for new chemicals with EPA, and negotiated consent orders and Significant New Use Rules. Supported new chemical registrations for a series of commercial ethoxylated alcohols.
Corporate Regulatory Support, European Union Authored and submitted REACH dossiers and maintaining substance registrations in the European Union. Collected and evaluated human health and ecological toxicity data and prepared the required dossier submissions.
Corporate Regulatory Support, Nationwide Supported U.S. business units with agency-specific compliance audits under EPA TSCA, FDA, Department of Homeland Security, OSHA, and Drug Enforcement Administration regulations, as well as with non-regulatory audits for International Organization for Standardization/Good Laboratory Practice laboratory/toxicology, and American Chemistry Council Responsible Care®.
Stewardship Programs for Industrial Plants, Texas Implemented and optimized a corporate product stewardship program that supported diversified business units encompassing approximately 3,000 products under corporate and various private label agreements, as well as for 4,000 confined refinery streams in three refineries and two lubricant manufacturing plants.
Stewardship Program Legal Support, Nationwide Supported law firms in defending chemical and manufacturing companies subject to enforcement actions by U.S. federal and state agencies, as well as supporting law firms defending companies subject to toxic tort litigation. Performed technical review and regulatory review of enforcement actions and litigation matters for the chemicals and manufacturing sectors.
Stewardship Program Support, Nationwide Supported U.S. companies by authoring and supporting PMNs and managing TSCA registration efforts for new chemicals. Chemistries included automobile battery components, cellulosic fuels, non-petroleum reformates, and phosphate ester-based coolants. These complete registration packages included toxicology testing, new chemicals registrations and supporting the registrations during agency review.
Stewardship Program Support for Compliance Audits, Nationwide Completed facility and systems-compliance audits in support of corporate mergers and acquisitions. These audits were primarily offered to independent chemical manufacturers purchasing new facilities.

Toxicology

Mammalian and Ecological Study Design and Management, Nationwide Designed mammalian and ecological toxicology testing strategies to support multiple product lines with international markets. Identified and qualified non-animal testing (NAT) and in silico and in vitro testing procedures.
Study Design and Management, Nationwide Managed outsourced toxicology studies on behalf of a chemical manufacturer to ensure regulatory compliance and the delivery of studies in a timely and cost-efficient manner. The duration of these studies ranged from days to months.
Exposure Assessment, Nationwide Completed human health risk assessments for new chemicals of concern in modeled operations such as cooling towers, water re-use operations, and de-waxing efforts. These models supported the development of occupational exposure limits for workers and allowed for best practices in protecting the public.
Study Management, Nationwide Managed acute and sub-chronic mammalian toxicology testing for end-use products and managed environmental toxicology testing of refinery streams of an integrated refiner with three independent refineries in the U.S. This testing was completed at contract research organizations and was used to support product registration, environmental permitting efforts, hazard communication development, and litigation response. Authored safety data sheets necessary for highly persistent, bioaccumulative and/or toxic refinery streams.

Chemistry

Regulatory Chemistry, Laboratory Operations, Texas Managed laboratory operations and a professional staff that included chemists, biologists, a pharmacist, a veterinarian, technicians, and technical writers. The large number of studies, of varying length and complexity, required constant time, budget, and resource management.
Regulatory Chemistry, Instrumentation Design, Texas Designed instrumentation for pharmacokinetic studies, acute toxicity testing, and chronic toxicity testing. These toxicokinetic studies included feeding studies, dermal absorption studies, and inhalation studies in various animals ranging from rodents to farm animals.

Roy, C., R. Baker, K. Washburn, and M. Bray. 2003. Aerosolized cidofovir is retained in the respiratory tract and protects mice against intanasal cowpox virus challenge. Antimicrob. Agents Chemother. 47(9):2933–2937.

Washburn, K., K. Donnelly, H. Huebner, R. Burghardt, and L.D. Claxton. 2001. A study of 2,4,6-trinitrotoluene inhibition of benzo[a]pyrene uptake and activation in a microbial mutagenicity assay. Chemosphere 44(8):1703–1709.

Donnelly, K., T. Phillips, A. Onufrock, S. Collie, H. Huebner, and K. Washburn. 1996. Genotoxicity of model and complex mixtures of polycyclic aromatic hydrocarbons. In: Environment Toxicology and Chemistry STP 1306. D.A. Bengton and D.S. Herchel (eds).

Washburn, K., and T.D. Phillips. 1995. Development of a field-practical assay for water-solvated chlorophenols. J. Hazard Mater. 41(2–3):371–381.

Safe, S., K. Washburn, T. Zacharewski, and T.D. Phillips. 1995. Synthesis and characterization of hydroxylated polychlorinated biphenyls (PCBs) identified in human serum. Chemosphere 31(4):3017–3023.

Strobel, F., L Preston, K. Washburn, and D.H. Russell. 1992. Neutral-ion correlation measurements: A novel tandem mass spectrometry data acquisition mode for tandem magnetic sector/reflectron time-of-flight instruments. Analytical Chemistry 64(7):754–762.

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