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 EDSP in 2009, and the final second list (List 2) in June 2013.
As of July 2015, only 52 chemicals had completed Tier 1 review by EPA. EPA has published EDSP weight-of-evidence (WoE) guidance on the criteria and considerations EPA believes to be relevant in identifying candidate chemicals for Tier 2 testing, but no Tier 2 test orders have been announced. The revised List 2, consisting of 109 chemicals for Tier 1 screening, was selected based on EPA's review concerning their possible presence in public drinking water and/or registration review status within EPA, and not because of their potential to interfere with the endocrine systems of humans or other species. The recent release of the Tier 1 WoE assessments and the anticipated release of Tier 2 test guidelines, along with EPA's commitment to further the development of high-throughput (HTP) assays and computational tools, will significantly influence the prioritization of List 2 chemicals in the EDSP and the timing of the List 2 test orders.
How and when EPA assesses chemicals, whether industrial or pesticidal, and determines whether they are considered endocrine disruptors will significantly impact many chemicals and the products in which these chemicals are included. Manufacturers, importers, processors, and users of chemicals identified for screening must decide early on how best to respond, and care will need to be taken to select the most appropriate approach. Recipients of Tier 1 test orders have only 90 days to respond with their action plan, and only 24 months to submit completed test results. Tier 2 testing, if required, will be costly with many scientific, legal, and commercial implications. Managing test orders, data sharing and confidential information, EPA's review process, and the public optics of EDSP is a challenge. Bergeson & Campbell, P.C.'s (B&C®) attorneys, scientists, and regulatory specialists have the business savvy, scientific expertise, policy finesse, and clear understanding of the legal and commercial implications of each potential pathway of compliance to help clients select and execute the appropriate response.
The focus on endocrine disruptors by EPA is matched or arguably exceeded by the European Chemicals Agency (ECHA) and the European Union's (EU) chemical management regulations, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Plant Protection Product Regulation (EC) 1107/2009, and the Biocidal Products Regulation (EU) 528/2012, followed closely by scrutiny from other global regulatory frameworks such as Korea's Act on the Registration and Evaluation, etc. of Chemical Substance (K-REACH). B&C's worldwide consulting affiliate The Acta Group (Acta®), with local staff and affiliates in Manchester, England; Brussels, Belgium; Beijing, China; Seoul, South Korea; and Washington, D.C., among other locations, provides clients with globally-harmonized testing and data strategies for substances identified for endocrine screening under any jurisdiction.
B&C's affiliate B&C® Consortia Management, L.L.C. (BCCM) offers companies wishing to share the cost and administrative burden of responding to EDSP test orders with complete administrative and technical support, including outreach to potential members, placement and monitoring of testing programs, and toxicological expertise. More about BCCM's consortia for responding to EDSP test orders is available online.
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.
Jim 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 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 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 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.
J. Brian Xu, M.D., Ph.D., DABT®, a board-certified toxicologist, has over a decade of experience in toxicology testing and safety/risk assessment of pharmaceuticals, consumer products, cosmetics, agrochemicals, antimicrobials, and industrial and specialty chemicals. He also has hands-on experience assessing for potential endocrine disrupting effects of preservatives, sunscreens, fragrances, and antimicrobials.
Lara 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.
Sheryl Dolan is a product regulatory specialist with nearly 25 years' experience in environmental regulatory consulting. Ms. Dolan addresses regulatory approval and compliance management issues for pesticides and chemicals with industrial, commercial, and consumer applications. Ms. Dolan analyzes and interprets endocrine study results, placing results in context so that clients can make astute regulatory and business decisions.
Kathleen Roberts, Vice President of BCCM, has managed many groups engaged in government-mandated testing programs, such as that outlined in the EDSP. She is experienced in the development of test budgets and cost sharing approaches, identification of management needs, execution of timelines for interim submissions, and preparation of final submissions.
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.
BCCM currently manages two groups with chemicals on List 2 -- the NMP Producers Group and the MTBE Consortium. BCCM engages with the groups' member companies to identify potential other 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.