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Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce the following hirings and promotions.
Catherine M. Croke, DBA, has been named Director of Product Stewardship and Regulatory Affairs. Dr. Croke is a highly experienced professional with more than three decades of successfully developing and executing product stewardship and regulatory compliance programs within global specialty chemicals and materials companies. She offers clients an exceptionally broad understanding of international product stewardship and sustainability compliance and provides strategic business and technical guidance necessary to achieve business objectives.
Before joining our firms, Dr. Croke was Senior Advocacy and Compliance Manager with Evonik Corporation, Regulatory Affairs Manager for Arkema, Product Safety Manager for IVAX Industries Inc., an Industrial Toxicologist with Sunoco LP, and a Physical Science Technician with the U.S. Department of Agriculture (USDA) Eastern Regional Research Center. She has earned a Doctor of Business Administration degree and holds an MS in Environmental Protection & Safety Management Engineering and a BS in Pharmacology & Toxicology.
Irene M. O’Hara has joined B&C® Consortia Management, L.L.C. (BCCM) as a Consortium Manager. Ms. O’Hara has a decade of experience in association management, including stakeholder engagement, project management, external affairs, and event planning. Her professional network of individuals in government, non-governmental entities, and non-profit associations is an asset to consortia clients, as is her demonstrated excellence in communications and marketing.
Ms. O’Hara’s career prior to joining BCCM included work with the Association of Corporate Counsel, the Institute of Scrap Recycling Industries, the Smithsonian Institution’s Hirshhorn Museum, and the United Nations Association of the National Capital Area (UNA-NCA). She holds a bachelor’s degree in International Relations from Richmond American University London and has experience working with nonprofits, professional associations, and financial services firms.
Karin F. Baron, MSPH, has been promoted to Director of Hazard Communication and International Registration Strategy. Ms. Baron has more than 20 years’ experience developing, implementing, and managing complex chemical regulatory compliance strategies for some of the largest industrial and specialty chemical companies in the world. Her primary areas of practice include navigating the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including classification, labeling, and authoring of compliant safety data sheets (SDS), hazard and risk assessment, industrial hygiene, and environmental health and safety (EHS) programs. She managed assessments for product manufacturers wishing to comply with the food contact materials and cosmetics regulations under the U.S. Food and Drug Administration (FDA) and consumer products under the U.S. Consumer Product Safety Commission (CPSC) and Canada’s Consumer Chemicals and Containers Regulations (CCCR).
Lynn L. Bergeson, Managing Partner of B&C, President of Acta, and President of BCCM, noted “our growing team of experts reflects the diversity of our substantive skill set, our expanding client base, and our commitment to providing our clients with the best and most efficient team of legal, regulatory, and scientific experts available.”
These impressive professionals join B&C, Acta, and BCCM teams that have been recognized for excellence by Chambers USA, U.S. News and World Report, The National Law Review, the Chemical Industries Association (UK), and others. B&C and Acta clients are served by a powerful team of advisors, including eight former senior EPA officials, an extensive scientific staff, including six Ph.D.s, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of chemical regulatory law, science, and policy. For more than 25 years, B&C has offered clients an unparalleled level of excellence in matters relating to the production and use of chemicals, making it the premier Washington, D.C., law firm to provide companies with comprehensive, sophisticated, and business-sensitive Toxic Substance Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) assistance. Acta, B&C’s scientific and regulatory consulting arm with offices in Washington, D.C., Manchester, England, and Brussels, Belgium, provides strategic, comprehensive support for global chemical registration, regulation, and sustained compliance.
Visit the B&C, Acta, and BCCM websites, www.lawbc.com, www.actagroup.com, and www.bc-cm.com, for a wealth of resources to assist companies that make and use chemicals to commercialize their products and maintain a competitive advantage globally.
BRAG was formed in 2013 to give biobased chemical stakeholders the expertise and collective voice necessary to educate legislative and administrative decision-makers during the negotiations occurring at that time regarding reform of the Toxic Substances Control Act (TSCA), and to help its members understand and comply with the application of TSCA to their products and operations. As the only trade group solely focused on addressing the unique challenges that biobased chemicals face under TSCA, BRAG developed strong and compelling advocacy platforms to ensure the robust commercialization and growth of biobased and renewable chemical feedstocks, efforts that will continue to deliver results now that the original goals of BRAG have been realized.
Reviewing the accomplishments and highlights of BRAG’s efforts, these are a few of the standouts:
- TSCA Chemical Data Reporting (CDR): In response to a petition filed by BRAG in 2014, the U.S. Environmental Protection Agency (EPA) issued a final rule in 2016 amending the list of chemical substances that are partially exempt from additional reporting requirements under the CDR rule, including six biodiesel chemicals that are very similar to petroleum-based biodiesel chemicals that are already on the exempt list. This rulemaking was expected to save more than 65 hours, or almost 1.5 weeks of staff time per report, equalizing what had been an uneven regulatory reporting field for biodiesel products.
- Chemical Nomenclature: BRAG led industry efforts to resolve nomenclature rules that caused some complex biobased chemical products designed as greener equivalents to existing chemical products to be considered new chemicals, and thus subject to obtaining a new chemical name and undergoing new chemical notification under TSCA. BRAG and the Biotechnology Innovation Organization (BIO) issued a joint white paper, “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals,” which was presented to EPA in June 2018 and continues to inform EPA as it reviews biobased chemicals. BRAG also led a pilot project to prepare and submit requests for TSCA equivalency determinations of biobased Class 2 chemical substances that are functionally equivalent to another Class 2 chemical.
- Legislative and Agency Engagement: BRAG regularly engaged with federal and state legislators and EPA personnel to educate these stakeholders about biobased interests by: participating in expositions giving biobased producers opportunities to showcase their technology to Hill staffers; submitting comments on proposed rulemakings; and promoting BRAG interests to programs such as the U.S. Department of Agriculture’s (USDA) BioPreferred Program and EPA’s Green Chemistry Awards.
- Input into Industry Standards: Through BRAG, member companies participated in a variety of pertinent standard-setting processes, including reviewing and voting on the American Society for Testing and Materials’ (ASTM) proposed international standard, Standard Terminology for Industrial Biotechnology and ASTM’s proposed Standard Classification for Industrial Microorganisms.
B&C® Consortia Management, L.L.C. (BCCM) is pleased to announce the formation of the Butyl Benzyl Phthalate Consortium. Its mission is to serve the commercial and regulatory interests of butyl benzyl phthalate (BBP) manufacturers, importers, and downstream users; address scientific, regulatory, and product stewardship issues concerning the health, safety, and/or environmental aspects of BBP; and participate in the Toxic Substances Control Act (TSCA) Section 6 risk evaluation initiated by the U.S. Environmental Protection Agency (EPA). Membership in the BBP Consortium is open to manufacturers, importers, processors, and users of BBP and any interested participant in the BBP industry. Parties interested in more information about the Butyl Benzyl Phthalate Consortium should email info@bc-cm.com.
About B&C Consortia Management (BCCM)
BCCM creates and maintains the operational framework for consortia so that members can focus on substantive issues most pertinent to their needs and essential to their success. BCCM is currently engaged with many client organizations working with EPA on a variety of TSCA issues under TSCA Sections 5, 6, and 8. BCCM’s unique business model as an affiliate of Washington, D.C., law firm Bergeson & Campbell (B&C®) gives consortia member company representatives exclusive access to B&C’s deep bench of experts in the law, regulation, science, and policy of TSCA. More information on BCCM can be found at www.bc-cm.com.
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.
The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation." Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6. Industry stakeholder responses to this candidate list proposal and follow up actions with EPA related to risk evaluation work optimally will be conducted under existing or potentially newly formed chemical consortia.
But what if your chemical is not on the list of 20? If you want to protect or even increase your business market advantage, consider inviting your commercial rivals to join an industry advocacy group anyway. This is particularly important if you have a chemical of commercial interest on the TSCA Work Plan Chemicals list.
In today’s regulatory environment, engaging in advocacy opportunities with your company’s competitors makes sense. Consolidating experience, knowledge, and finances allows a company to achieve far more and faster than it could individually. Given that amended TSCA requires EPA to look to the TSCA Work Plan Chemicals to identify chemicals for future prioritization consideration, we know those chemicals will be subject to regulatory scrutiny eventually. So setting up and working under a consortium umbrella now makes sense. Even if your chemical is not yet on the proverbial radar screen, there is benefit of organizing with others early. Groups that wait to organize will deplete valuable limited time to form, leaving less time to engage effectively and comprehensively on EPA’s proposed actions. Organizing industry groups now means reduced cost, greater flexibility, increased time for strategic planning, and less aggravation in the long run.
Beyond prioritization and risk evaluation under Section 6, we also know that EPA anticipates industry group engagement for testing under TSCA Section 4. Within the risk framework rulemakings, EPA expressed repeatedly and clearly that it anticipates TSCA obligations will be shared collaboratively and addressed by consortia groups. Even within a general regulatory advocacy context, in many respects, EPA appropriately prefers working with industry coalitions to save time, obtain greater use and exposure information, and leverage more efficiently its own resources.
Congress explicitly included the concepts of industry consortia as part of amended TSCA legislation under Section 4, as it relates to efforts to reduce animal testing, and Section 26, in anticipation of increased Agency fee payments.
So working under a consortium umbrella makes sense. But before proceeding with group formation, there are some important factors to consider:
- Antitrust Protection: Members of an industry group must consider the need to protect against antitrust concerns. It is reasonable to anticipate that outsiders may be concerned with key competitors working together. It could be perceived as opportunities for dishonest companies to pursue unfair market activities, such as price fixing or monopolization efforts. To address such concerns, industry consortia must be managed in a way that ensures federal antitrust laws are followed. This can be achieved through a third-party management service, which provides administrative structure to the group, including specific meeting agendas and minutes, and competent antitrust counsel at meetings to ensure discussions or exchanges of prohibited information do not occur.
- Regulatory Experience: Today’s regulations are complex. It is nearly impossible for today’s company representatives to have in-depth knowledge of the myriad of regulatory statutes impacting their commercial chemical products. Having easy access to experts to assist the consortium in understanding the regulatory pressures for a specific chemical, as well as insight on strategic approaches, is invaluable.
- Financial Experience: As organizations consider management service providers, they should appreciate that for many regulatory programs, the amount of money to collect and disburse is not insignificant. Under TSCA Section 6, industry consortia will need to collect over $1,000,000 to cover anticipated EPA fees. TSCA Section 4 requires fee payments of about $10,000 to $30,000 -- PLUS costs associated with the specific testing required. Costs under the EPA Endocrine Disruptor Screening Program, while still in hibernation but potentially could progress soon, could be over $1,000,000. A consortium should consider whether its management service provider has the ability to collect and disburse funds needed to cover required industry fees, contract testing, administrative management, and other costs associated with consortium work. In some cases, there may be federal tax implications. As such, it is recommended that consortium financial management be conducted under the auspices of a certified public accountant.
- Sunset Provisions: While details on the why, when, and how of setting up a new industry group is important, companies should also think about the parameters for shutting down the group when its work is completed. A consortium should be maintained only if additional work is needed. Otherwise, there should be an easy option for members to disband when the work is done.
As mentioned, companies should be thinking ahead if chemical products important to them were not on the March 20 list. The new normal is not what you think and going it alone is not smart. The time to prepare for the future of your company’s products is now, and to do that, you will need to coordinate with others in your commercial space.
If you are interested in forming a new consortium, joining an existing B&C® Consortia Management, L.L.C. (BCCM) consortium (see partial list here: http://www.bc-cm.com/affiliate-associations), or need more information on consortia benefits, contact BCCM Vice President Kathleen Roberts, kroberts@bc-cm.com or (202) 833-6581.
“Mighty oaks from little acorns grow” captures perfectly how the ideas from a small but passionate B&C® Consortia Management, L.L.C. (BCCM) group were transformed into an international standard.
Almost a decade ago, in June 2011, a group of stakeholders involved with the production, assessment, and use of nanomaterials convened a workshop in California to share information on existing and emerging measurement strategies and to exchange ideas on expectations for the future. Attendees at the workshop included the California Environmental Protection Agency, the California Department of Toxic Substances Control, the California Air Resources Board, the California Department of Pesticide Regulation, the Office of Environmental Health Hazard Assessment, and the State Water Resources Control Board, each of which supported the need for additional information on the critical issue of measuring nanomaterials in the environment. In response to this request, the initial group of stakeholders formed the Industry Consortium for the Environmental Measurement of Nanomaterials or ICEMN.
Over the course of several years, ICEMN members, which included representatives from industry, academia, and government groups, worked collectively and cooperatively to compile information that would address the challenge of environmental measurement of nanoscale materials and to enhance the state of the science in this regard. In March 2013, a series of articles authored by ICEMN representatives was published in a special issue of Environmental Engineering Science, “Environmental Nanomaterials Reviews,” available at http://online.liebertpub.com/toc/ees/30/3.
The articles were written to be particularly useful for regulatory agencies, especially those at the state level, tasked with addressing the measurement of engineered nanomaterials in the environment. The articles provided a practical guide for regulatory groups and other stakeholders interested in learning about the techniques and issues around nanomaterial measurement in water, air, and soil.
Having achieved its purpose, following the publication of the papers, the ICEMN disbanded. The seed that had been sown by ICEMN -- to educate on the state of the science on environmental measurement of nanomaterials -- slowly but steadily grew. Interest on an international scale was cultivated and scientists from around the globe became engaged, resulting in the newly published International Standard Organization’s (ISO) “Nanotechnologies -- Considerations for the measurement of nano-objects and their aggregates and agglomerates (NOAA) in environmental matrices,” Technical Report 21386 (ISO/TR 21386:2019).
Recognition must be given to Dr. Raymond David, former ICEMN Chair, for his time, passion, and years-long commitment to creating the ISO document and pursuing it through publication. We all owe Dr. David a debt of gratitude for his outstanding contribution to scholarship and stewarding the publication of this essential and groundbreaking achievement.
BCCM is proud of our group’s contribution to the creation of this global effort that will have a long-term and significant positive impact on the nanotechnology world.
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
Please contact Ligia Duarte Botelho if your company is interested in submitting a nomination.
Now more than ever, chemical industry stakeholders with shared business and advocacy interests are urged to consider collaborating on regulatory, testing, and related advocacy opportunities. Two years post-passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act means the U.S. Environmental Protection Agency (EPA) is well underway with implementation of the amended Toxic Substances Control Act (TSCA).
Industry groups that are already established and working efficiently when EPA initiates an action under TSCA will be most successful in nimbly and effectively engaging immediately. Groups that have yet to organize will deplete valuable limited time to form, leaving little time to comment effectively and comprehensively on EPA’s proposed action.
TSCA is by far not the only game in town. Companies should consider the benefits realized when organizing around advocacy and implementation effort pertinent to other regulatory initiatives such as Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data call-ins (DCI), food and drug initiatives pursued by the U.S. Food and Drug Administration, and a wide range of state-specific programs.
This year’s B&C® Consortia Management, L.L.C. (BCCM) forecast highlights our groups’ interests and activities on these and other issues that can and should be addressed under a consortia canopy. While we enjoy sharing our success stories, the goal of the forecast is to highlight the critical importance of leveraging resources by sharing the load through organizing groups of interested stakeholders, to summarize activities pertinent to our existing BCCM consortia, and to encourage you to consider allowing us to help with the formation of a new group to address issues of particular interest.
This mid-year review of B&C® Consortia Management, L.L.C. (BCCM) activities highlights a wide range of advocacy, regulatory, science policy, testing, and communication activities and strategies in which our consortia groups are engaged. As you review the listed activities, we invite you to consider whether your organization would benefit from membership in an existing BCCM consortium, or in the formation of a new group to address issues of particular interest.
Click here to open full PDF report.
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