Today as never before, the old adage “there is strength in numbers” rings true. As the U.S. Environmental Protection Agency (EPA) continues to implement the amended Toxic Substances Control Act (TSCA), industry stakeholders are recognizing the immense importance of working within consortia to leverage resources, reduce cost, and increase opportunities for successful results. EPA statements in connection with TSCA implementation have repeatedly reinforced its expectation that industry will work collaboratively and efficiently in consortia in supporting the TSCA Section 6 risk evaluation process for the 20 high-priority chemical substances undergoing evaluation. EPA’s policies for consortia-backed testing under TSCA Section 4 reflect EPA’s belief that when confronted with requirements that are best addressed through shared effort, companies subject to TSCA test rules will opt to work together to complete the testing.
Industry stakeholders are scrambling to understand the obligations for self-identification in response to EPA’s January 27, 2020, notice identifying the “preliminary lists” of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority for risk evaluation for which fees will be charged. See B&C’s February 26, 2020, memorandum on EPA’s February 24, 2020, webinar on the application of the TSCA fees rule to the 20 high-priority chemical substances.
This ongoing effort, and recognition that this process will repeat itself when the next round of chemicals are identified for prioritization, crystalizes the urgent need to form consortia for chemicals of commercial interest now.
The Time to Act Is Now
There is no time like the present. While your chemicals of interest may not be on EPA’s current high-priority list, we know that EPA will be looking to the TSCA Work Plan for future prioritization candidate chemicals. In our view, any chemical on the Work Plan list should have a consortium set up now. Even if your chemical is not on the Work Plan list, it would still be prudent to consider establishing an industry group if one is not already set.
Company representatives looking to form industry groups for chemicals of commercial interest should know that organizing an effective industry consortium takes much more than pulling together a membership roster and e-mail list. We know, as B&C® Consortia Management (BCCM) has been forming and managing chemical consortia for many years. BCCM is now deeply engaged in TSCA chemical consortia and well versed in both consortia management and the law, policy, and science of TSCA and the risk evaluation process. Newly formed groups will need to know TSCA and the legal landscape for antitrust and Federal tax requirements and implement those requirements properly. They must recognize the many challenges in setting up bank accounts that will be used to collect and distribute large sums of money. This work can be particularly tricky if there are non-U.S. companies involved.
A new consortium may need assistance in negotiating reasonable and fair cost allocation strategies among its diverse members, many of which could be of varying sizes and commercial interests. There may be a need for assistance to address what might be a large learning curve in understanding the underlying science of an EPA evaluation or in the development of a testing protocol. And of course, a new consortium must be able to establish and maintain excellent working relationships with EPA staff and leadership and with other stakeholders. Building off the B&C decision tree from the February 26, 2020, memorandum on how to respond to EPA’s January 27, 2020, notice, we also provide a follow-up decision tree that companies should use as they consider consortia management needs; additional resources are available below the graphic
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Why BCCM Is an Unbeatable Choice
BCCM’s unique and decades-long experience is without equal. Our gifted staff has years of experience in setting up and managing consortia of all sizes. We are currently engaged with many client organizations working with EPA on a variety of TSCA issues under TSCA Sections 5, 6, and 8. And perhaps most importantly, BCCM’s unique business model gives our member company representatives exclusive access to Bergeson & Campbell’s (B&C®) deep bench of experts in the law, regulation, science, and policy of TSCA. B&C’s TSCA practice is the largest and most experienced in the country, and its partnership with BCCM makes it a compelling choice to select when considering forming a TSCA consortium.
BCCM, B&C, and Acta Overview
BCCM provides full-service management to more than a dozen separate industry groups with diverse regulatory, legal, and product stewardship interests. Each of these groups requires multi-disciplinary skills, as all companies engage in advocacy initiatives across geographic regions involving domestic and international stakeholders.
BCCM is unique in the services and talents it can offer its clients due to its affiliation with B&C, a Washington, D.C., law firm focusing on chemical control law, regulations, and business matters, and The Acta Group (Acta®), a global regulatory and scientific consulting firm.
BCCM can provide its client groups with immediate access to highly trained, sophisticated attorneys, non-lawyer professionals, and scientists with significant expertise in competition law compliance, regulatory law, data management, data compensation, supply-chain management, and regulatory, legal/policy, and guidance on contract development and related legal matters. The expansive talent pools at BCCM, B&C, and Acta allow for all-inclusive, comprehensive services in management, regulatory, and scientific efforts for a wide range of global chemical management systems and the business and legal issues these systems invite.
The B&C team offers unrivaled access to the premier TSCA practice group in the country. The B&C team includes five former senior EPA officials, an extensive non-lawyer scientific staff, including seven Ph.D.s, and a robust and highly experienced team of lawyers and non-lawyer professionals well versed in all aspects of TSCA law, regulation, policy, and litigation. B&C legal professionals are unparalleled in their understanding of the law and policy of TSCA.
BCCM Services
Regulatory Actions
With its management of several key chemical consortia, BCCM is among the elite management groups with direct, substantive, and ongoing experience working with EPA on TSCA Section 6 risk evaluations under new and old TSCA. Coupled with the B&C team of professionals, our combined professional strengths offer an unmatched powerhouse of TSCA experts. We believe this experience is invaluable and will prove essential in helping new groups navigate ongoing and future TSCA risk evaluation processes. BCCM also manages the TSCA New Chemicals Coalition, which has provided much-needed industry leadership with EPA on new chemical issues under amended TSCA.
BCCM can help ensure any new group’s success by providing the following services:
- Serve as primary liaison with EPA for timely submissions, updates, and associated fee payments required under TSCA;
- Maintain reporting and, if applicable, testing schedules;
- Prepare regulatory submissions, including testing reports, if applicable;
- Coordinate with EPA on any area of concern, potential delay, or other issue that might adversely impact deadlines and work to achieve appropriate relief;
- Network and engage with other industry group(s) on areas of common interest;
- Manage confidential information elicited for supply-chain related issues, including use and exposure information for downstream applications; and
- Assist with development and execution of other strategic or regulatory action plans.
Administrative Services
BCCM’s key management objective is to protect and immunize each consortium’s interests from antitrust concerns, thereby allowing individual members to promote the consortium’s goals. BCCM staff has more than 30 years’ experience in managing and providing antitrust protection to various trade groups.
While antitrust protection is a primary focus, BCCM provides further administrative support services that are necessary for a consortium’s success, including:
- Preparing and submitting relevant government paperwork to establish a consortium;
- Managing the consortium registration in EPA’s Central Data Exchange (CDX);
- Allowing the consortium to use BCCM offices as headquarter address and phone;
- Managing all incoming mail/e-mail and telephone calls to the consortium;
- Coordinating and arranging meetings and/or conference calls at the request of the Board, Work Group, and/or membership and providing antitrust counsel at each;
- Developing and maintaining an e-mail list for internal communications;
- Distributing and revising draft and final minutes for conference calls, web conferences, and meetings, in conjunction with Board members, usually within 48 hours; and
- Leading membership recruitment, as approved by consortium Board and members.
Financial Management Support
BCCM offers financial management support that we believe is second to none. All BCCM consortia clients receive the benefit of our long-established accounting management services, which include the following services:
- Assisting with development and execution of a cost-sharing mechanism for the consortium, based on years of experience for other consortia;
- Executing programs for submission of prorated shares and/or supplemental fees to be paid by new members for expenses already incurred by existing consortium members;
- Invoicing member companies for annual fees, disbursements, and other expenses;
- Remitting payments to contract laboratories, consultants, or other service providers as approved by the membership under contractually agreed-upon conditions and schedules;
- Maintaining consortium funds in a separate bank account, with all interest maintained in the consortium account;
- Collecting member payments and processing accounts payable; and
- Preparing tax filings in all relevant jurisdictions.
All BCCM financial and tax preparation materials are reviewed by a Certified Public Accountant (CPA).
Testing Management Services
If testing or research work is needed, either at EPA’s demand or based on the group’s product stewardship efforts, BCCM can provide the following services to support that effort:
- Contracting and coordinating with technical experts as identified by members;
- Identifying potential candidate contract facilities;
- Placing and monitoring studies, including arrangements of site visits with members and/or consultants;
- Negotiating and maintaining all testing agreements;
- Assisting with protocol review, assessment for conformance with testing guidelines, analytical methodologies, and dose selection;
- Coordinating with laboratory staff on deadlines and communications with members;
- Conducting quality assurance audits to ensure that all regulatory and Good Laboratory Practice (GLP) requirements are met;
- Reviewing reports; and
- Assisting with data compensation issues.
Forming an industry consortium to address TSCA issues -- present and future -- is a critical commercial move. Organizing an industry group means reduced cost, greater flexibility, increased time for strategic planning, and less aggravation in the long run. Finding the right management group for that group could be as important. We invite you to allow BCCM to prepare a consortium formation proposal for your company.
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