ACC Applauds EPA Milestone in Endocrine Disruptor Screening Program
The American Chemical Council (ACC) recognizes the release of the Tier 1 weight-of-evidence (WoE) data review as a significant milestone in EPA's Endocrine Disruptor Screening Program (EDSP).
Weight-of Evidence assessment represents evidence-based approach to risk determination.
The American Chemistry Council’s (ACC) Center for Endocrine Screening and Testing represents a premier scientific, technical, and advocacy resource for the chemical industry on endocrine issues, particularly in the U.S. Environmental Protection Agency’s (EPA) Endocrine Disruptor Screening Program (EDSP). Managed through the self-funded Chemical Products and Technology Division (CPTD), the ACC Center demonstrates effective engagement in each phase of the EDSP through a comprehensive range of activities and services.
ACC’s scientists and regulatory experts have been involved in all aspects of the program’s development since its authorization in 1996. The ACC team’s expertise encompasses all of the technical, policy, and regulatory aspects of the EDSP. When EPA issued its first set of test orders during the first phase of the EDSP in 2009 and 2010, through the Center, experts provided timely and effective response to assist ACC’s panels and member companies.
The EDSP Tier 1 screening is an ambitious testing program that is being implemented under new policies and procedures, utilizing a suite of newly validated—and expensive—test methods. As EPA moves forward in expanding the EDSP beyond pesticide chemicals to substances present in sources of drinking water, many more chemical manufacturers and users may be affected. In anticipation of the second phase of testing, the Center is ideally suited to assist companies and consortia with effective management and response to EPA’s EDSP requirements.
The wide range of services provided by the Center includes the following:
Consortium formation and management through CPTD
Interaction on behalf of members with EPA
Preparation of Requests for Proposal (RFP) and proposal solicitation from contract labs
Scheduling of testing to optimize other scientifically relevant information (OSRI), assay known performance, and limitations of testing protocols
Review OSRI to determine whether one or more EDSP Tier 1 screens can be omitted
Interpretation of test data for individual assays and the overall EDSP Tier 1 battery, as well as submittal to EPA.
ACC’s staff at the Center has a thorough and highly valuable understanding of EPA’s EDSP program. As an internal consulting group, staff members are a resource to serve the chemical industry in meeting EDSP’s unique challenges and requirements. For example, EPA and related global initiatives often require company responses in order to continually modify or improve screening techniques. The ACC staff’s skills and knowledge can assist with this and many other issues through its diverse experience, including:
Participating in International Society of Regulatory Toxicology and Pharmacology (ISRTP) workshops that gather together experts in the field—academics, industry scientists, and government regulatory staff—to analyze and discuss critical elements of the EDSP
Collaborating in a comprehensive review, published in peer reviewed scientific literature, of each EDSP Tier 1 assay, detailing strengths, limitations, pitfalls encountered in analyzing results and providing useful recommendations in order to enhance the interpretation of results
Collaborating on a model approach to conduct a weight of evidence evaluation of individual EDSP Tier 1 screening assays and the Tier 1 battery
Forming a consortia to conduct EDSP Tier 1 screening
Leading consortia activities, including responding to test orders, identifying testing laboratories, contracting and managing testing, interpreting results, and submitting results to the Agency
Evaluating the use of QSAR or other rapid screening assays to replace portions of the current Tier I screening assays
These services, in addition to enhanced advocacy support and strategic planning, underpin a track record of effective response to a range of government initiatives on the endocrine issue, including the EDSP. The Center’s staff members also represent ACC in the Endocrine Policy Forum, and play a significant role in the coalition’s efforts to develop a formal weight-of-evidence framework. Consortia at the Center will be able to draw on this and other experience for the scientific, regulatory, and technical aspects of EPA’s EDSP. Our specialists’ expertise with both endocrine screening and testing and consortia management is unsurpassed as staff members at ACC’s Center for Endocrine Screening and Testing collectively have decades’ worth of invaluable experience.
For further information about the Center, please contact: David Fischer at firstname.lastname@example.org, or (202) 249-6717.
ACC Center for Endocrine Screening and Testing Staff
Richard A. Becker, Ph.D., DABT
Richard A. Becker earned a B.A. in Chemistry from Swarthmore College and a Ph.D. in Pharmacology and Toxicology from the University of California, received post-doctoral training at the University of Toronto and the International Agency for Research on Cancer, and is a Diplomate of the American Board of Toxicology. He was a toxicology study director for NTP and NCI sponsored toxicity studies at SRI International (1985-1987), and then served as a senior scientist with the State of California from 1987 to 1999. His experience in California government included appointments to increasingly important technical and scientific management positions, beginning in Department of Toxic Substances Control, rising first to Deputy Director of Scientific Affairs in the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA), and subsequently to Director of OEHHA by appointment of Governor Wilson. In these positions, he initially conducted and then managed hazard evaluations, exposure assessments and risk characterizations to determine health and environmental threats posed by the exposures to hazardous substances in the environment. Dr. Becker joined ACC in 1999, where he continues to serve as the organization’s senior toxicologist in addressing emerging health risk science issues, including advanced risk assessment techniques, biomonitoring, sensitive subpopulations, endocrine screening and testing and alternative test methods.
Sarah H. Brozena, J.D.
Sarah H. Brozena is a Senior Director in the Regulatory and Technical Affairs Department of ACC in Washington, D.C. She is an advocate on health and chemical regulatory issues affecting ACC member companies, in particular the Toxic Substances Control Act, the endocrine disruption issue, children’s health issues, and biomonitoring. She has extensive experience with EDSP policy, having worked on various aspects of the endocrine issue since the passage of the Food Quality Protection Act in 1996. She began working for ACC in 1990 as legal counsel on environmental matters, in particular on the Clean Water Act, the Safe Drinking Water Act and groundwater issues. She has lectured on the Clean Water Act. She earned her J.D. in 1985 from George Washington University and her B.A., magna cum laude, from the University of Virginia in 1976. She is admitted to the bars of the state of Maryland and the District of Columbia.
Laura A. Brust, J.D.
Laura Brust is Assistant General Counsel at ACC, providing legal support to ACC’s Chemical Products and Technology Division. Laura currently counsels industry groups focused on chlorine chemistry, formaldehyde, hexavalent chromium, and phthalates, among others, and provides legal support to ACC’s chemical assessment and rail transportation programs. Laura joined ACC in 2010. Prior to joining ACC, she practiced environmental law and litigation in Washington, D.C. She received a B.A., with honors, in Political Science from The Johns Hopkins University, an M.A. in Environmental Science and Policy from the Duke University Nicholas School of the Environment, and a J.D., cum laude, from the Duke University School of Law.
Jonathon Busch, MBA
Jon Busch is Director in the Chemical Products &Technology Division of ACC. He joined ACC in 1990. Mr. Busch is manager of a number of ACC Panels, which currently include the Acetone, Acetone EDSP Testing, Alkanolamines, Chelants, Hydrocarbon Solvents, International Hydrocarbon Solvents, Phenol, Propylene Oxide/Propylene Glycol, Sodium Chlorite/Chlorine Dioxide, Specialty Acrylates & Methacrylates, and Substituted Diphenylamines Panels. Mr. Busch additionally assists with selected issues associated with ACC's Reactive/Volatile Chemistry Exposure Study Team of the Antimicrobial Exposure Assessment Task Force. Activities of these self-funded chemical industry groups involve regulatory advocacy, voluntary scientific research, and mandated testing (EDSP, FIFRA,TSCA). Mr. Busch also is an active participant in ACC's newly formed Center for Endocrine Screening and Testing.
Before joining ACC, Mr. Busch was a Senior Associate with ICF-Clement, a health and environmental sciences consulting firm. In this position, he was responsible for a variety of scientific efforts in toxicology, risk and exposure assessment, and environmental auditing. Prior to ICF-Clement, Mr. Busch was Senior Science Analyst with the Cosmetic, Toiletry and Fragrance Association. At this trade association, he was responsible for developing scientific literature reviews on cosmetic ingredients under the Cosmetic Ingredient Review program, and for technical efforts associated with ensuring ingredient and product safety for the cosmetic industry. Mr. Busch received an MBA from George Mason University, where he focused on finance, and a BS in biology from Virginia Polytechnic Institute and State University.
David B. Fischer, M.P.H., J.D.
David B. Fischer is a Senior Director in the Chemical Products and Technology Division of ACC. He leads a practice group within the Division that focuses on flame retardants, solvents, hexavalent chromium, and formaldehyde among other chemicals. Mr. Fischer has been with ACC for 12 years, during which time he has held a number of legal and policy related positions. From 2000 – 2003, Mr. Fischer was Adjunct Professor of Law at the University of Maryland School of Law. He received a B.A. in Biochemistry and Molecular Biology from Northwestern University, an M.P.H. from the University of North Carolina School of Public Health, and a J.D., with honors, from the University of Maryland School of Law, where he focused on environmental law.
William P. Gulledge
Bill Gulledge is a Senior Director of ACC’s Chemical Products and Technology Division. On behalf of its chemical industry members, the Division conducts a wide variety of advocacy programs, manages research and testing projects, and supports voluntary product stewardship programs. He currently manages industry groups focused on innovative technologies, chemical information technology, hydrogen peroxide, hydrogen fluoride, pesticide inerts, endocrine screening, and quality management issues. Prior to re-joining ACC in 2000, Mr. Gulledge worked as an environmental risk management consultant and was a major player in founding and operating two environmental and innovative technology insurance companies. Prior to this, Mr. Gulledge worked in the Environmental Division of ACC where he primarily managed hazardous waste, superfund and air toxics issues. He received a BA in Public Affairs from the American University (AU) in Washington, D.C. and an MS in Environmental Sciences and Engineering from AU/George Washington University.
Angela Lynch, MSPH, Ph.D.
Dr. Lynch joined ACC as Director, within the Chemical Products and Technology Division (CPTD), in November 2013. Dr. Lynch manages numerous chemical specific groups as well as provides scientific support to other chemical groups within CPTD. Prior to joining ACC, Dr. Lynch was a toxicologist for a consulting firm and was responsible for protocol development, study monitoring, reviewing and summarizing both GLP and non-GLP nonclinical toxicology data and human health risk assessment as well as interpreting state, federal and international policy and regulations in the food, pharmaceutical and environmental sciences. She is also an Affiliate Assistant Professor at Roosevelt University College of Pharmacy. Dr. Lynch is a member of the American College of Toxicology, Society of Toxicology, Society of Neuroscience, and Society of Risk Analysis. She serves as a volunteer for the Food and Drug Law Institute Journal Editorial Advisory Board and is currently preparing for the Diplomat, American Board of Toxicology (D.A.B.T.) exam.
Dr. Lynch received her Ph.D. from Rush University in Chicago in pharmacology, with a focus on reproductive, developmental and neurotoxicology. She received her M.S.P.H. from Tulane University in environmental toxicology and her B.A. from the University of Chicago in psychology.
Allison Wisk Starmann, J.D.
Allison Starmann is Assistant General Counsel at ACC, providing legal support to ACC’s Chemical Products and Technology Division. On behalf of its chemical industry members, ACC conducts a wide variety of advocacy programs, manages research projects, and supports voluntary product stewardship programs. Allison currently counsels industry groups focused on nanotechnology, biocides, and flame retardants, among others. Allison joined ACC in 2009. Prior to joining ACC, she worked for the Environmental Protection Agency from 2004 until 2009, serving as Deputy General Counsel and previously as Enforcement Counsel to the Assistant Administrator for Enforcement and Compliance Assurance. Prior to government service, Allison worked as an environmental attorney for a major law firm in both Washington, D.C. and Chicago, Illinois. She received Bachelor of Science and J.D. degrees from the University of Notre Dame.
Emily Tipaldo, M.A.
Emily Tipaldo, Manager of Regulatory & Technical Affairs at ACC, leads the Biobased Chemistry Network and the Retail Subcommittee. She is also responsible for handling green chemistry issues, endocrine issues, and state chemical management legislative and regulatory analysis. Prior to joining the Regulatory & Technical Affairs department, Ms. Tipaldo worked in ACC’s Office of General Counsel and at the U.S. Department of the Treasury. She received a B.A. in American Studies from Mary Washington College, and an M.A. in International Relations, with Distinction, from the University of Westminster, London.
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