Substances that mimic, influence, or interfere with the body’s endocrine system at certain doses, and produce potentially adverse developmental, reproductive, neurological, and/or immune effects in both humans and wildlife, are called endocrine disruptors. These substances can be naturally-occurring or man-made. Endocrine issues have long been the subject of intense regulatory interest and scientific debate. In the last decade, substances that may have endocrine effects have been subject to increased regulatory attention, and companies making or using these substances must stay keenly abreast of the sometimes murky and controversial legal and scientific developments regarding endocrine disruptors.
The Food Quality Protection Act (FQPA), Federal Food, Drug, and Cosmetic Act (FFDCA), and Safe Drinking Water Act (SDWA) each requires the U.S. Environmental Protection Agency (EPA) to screen pesticides, commercial chemicals, and environmental contaminants to determine whether they have endocrine effects in humans and wildlife. EPA’s Endocrine Disruptor Screening Program (EDSP), initiated in 1998, employs a two-tier testing approach: Tier 1 screening is intended to identify substances with potential to interact with estrogen, androgen, or thyroid hormone systems; Tier 2 testing is intended to establish a dose-response relationship for any adverse effects that may have been first identified in the Tier 1 test review. EPA issued the first list of substances (List 1) to be screened under the EDSP in 2009, and the final second list (List 2) in June 2013.
What We Do
B&C professionals routinely advise clients on a full range of endocrine disruptor issues, including registration and assessment. We offer the following expert services:
- Coordinate and oversee test programs to address EDSP Tier 1 and Tier 2 Test Orders,
- Evaluate contract laboratories for compliance with Good Laboratory Practice (GLP) Standards and capabilities in endocrine disruptor screening testing,
- Place, monitor, and evaluate studies conducted in accordance with accepted guidelines and GLP Standards,
- Evaluate existing subchronic, reproductive, and/or developmental toxicity studies to assess potential endocrine disruption,
- Prepare and submit EDSP studies, other scientifically relevant information (OSRI), and dossiers to EPA,
- Assess the impacts of a chemical being identified as an endocrine disruptor,
- Assist in the approval and regulation of chemical products,
- Assist with reporting obligations for new and existing chemicals,
- Assist with labeling and notice requirements,
- Provide management services for companies interested in consortium approach for addressing advocacy needs and testing requirements related to List 1 and List 2 chemicals.
B&C’s scientists, lawyers, and regulatory experts have extensive and specialized expertise with the EDSP. We assist manufacturers, importers, processors, and users of chemicals identified for endocrine screening to respond efficiently to test orders and to minimize business impacts.
James V. Aidala is former Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention (OCSPP)) and has 30 years of experience in both the legislative and executive branch in a variety of senior positions. He offers clients sophisticated interpretation of current EPA policies and helps clients anticipate and plan for evolving federal and state regulation of endocrine disruptors.
Lynn L. Bergeson is an internationally recognized authority on chemical regulatory law and a powerful advocate for clients before EPA, the U.S. Food and Drug Administration (FDA), and other governance and standard-setting bodies. Ms. Bergeson speaks and writes frequently on EPA’s approach to endocrine disruptors and on data sharing, data compensation, and data protection considerations for pesticide registrants engaged in EDSP testing.
Lisa M. Campbell has worked on some of the toughest Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) legal issues of our time, tackling the intersection of pesticide law and public policy, and offers clients decades of experience in addressing pesticide and chemical product approval, defense, and regulatory issues.
Jane S. Vergnes, Ph.D., DABT®, is an experienced leader in global product stewardship as well as a talented research scientist and former scientific study director. Dr. Vergnes brings over 25 years of experience in safety, exposure, and risk assessment of diverse chemicals, including industrial and specialty chemicals, cosmetic ingredients, food ingredients, sunscreen active ingredients, pharmaceutical excipients, antimicrobials, and preservatives, to bear on the screening and assessment of a chemical’s potential for endocrine disruption. Dr. Vergnes leverages her scientific expertise, regulatory knowledge, and business experience to assist clients with development of regulatory compliance strategies that are grounded on sound science yet acknowledge the challenging realities of the global business world.
Lara A. Hall, M.S., a scientist and Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP), has over a decade of experience in monitoring and auditing studies through all phases of testing programs, including test plan development, laboratory inspection and study placement, protocol development, dose selection, in life monitoring, and report and data review for scientific integrity and compliance, budget management, and sponsor updates. Ms. Hall has been closely monitoring the development of testing guidelines, HTP assays, and computational models by EPA (OCSPP) and the Organization for Economic Cooperation and Development (OECD) for the screening and assessment of chemicals for endocrine disruption.
Heather F. Collins, M.S., Regulatory Consultant with B&C, has nearly two decades of regulatory experience with federal and state biocide registrations in the U.S. and Canada. Ms. Collins has developed systems for regulatory compliance, assisted clients with labeling requirements, and analyzed study results to ensure accurate product registration.
Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, is adept at performing exposure-based risk assessments for chemicals of concern, including those listed by EPA in the EDSP, the Office of Environmental Health Hazard Assessment (OEHHA) on the Proposition 65 list, and ECHA on the Substances of Very High Concern (SVHC) list.
BCCM currently manages two groups with chemicals on List 2 — the N-Methylpyrrolidone (NMP) Producers Group, Inc. and the MTBE Consortium. BCCM engages with the groups’ member companies to identify other potential producer or importer companies that should contribute to EDSP testing, outlining how cost shares will be allocated among participating companies and compiling relevant data and studies that can be used in “OSRI” submissions to EPA.