BSC Principles & Rules of Engagement
These Principles & Rules of Engagement establish standards for participation in the Botanical Safety Consortium (BSC). All Members of the Steering Committee, Technical Working Groups, and Stakeholder Council acknowledge that they have read, understood, and will abide by these terms. The BSC is convened by HESI and follows HESI bylaws, codes of conduct, and policies.
Background
The Botanical Safety Consortium (BSC) was established in October 2019 by a Memorandum of Understanding between the U.S. Food and Drug Administration (FDA), the National Institute of Environmental Health Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI).
HESI serves as convener and facilitator for the BSC. Funding is provided by an FDA/NIEHS grant via subcontract to HESI, and by charitable contributions from industry members.
Purpose
The BSC brings together scientists from consumer health groups, academia, industry, non-profits, and government to integrate existing safety data with modern toxicology tools for evaluating botanical ingredients. Efforts include chemical characterization of complex botanicals and identification of fit-for-purpose assays (e.g., genotoxicity, hepatotoxicity, developmental and reproductive toxicity, cardiotoxicity, and systemic toxicity). Outcomes include shared methods, case studies, and recommendations to improve clarity and confidence in botanical safety assessments.
Membership
Membership is limited to individuals eligible for the HESI Assembly and entities eligible to become HESI Sponsors or Affiliate Sponsors, as set forth in the HESI bylaws and the BSC Organizational Framework. By joining, members agree to be bound by these documents, as amended.
Who can join
- HESI Assembly-eligible individuals
- HESI Sponsors / Affiliate Sponsors
- 501(c)(6) associations meeting BSC criteria (agreeing to be bound by HESI bylaws “as if” Sponsors)
How to join
- Complete the BSC application form.
- Eligibility reviewed (Steering Committee / staff).
- Private sector: pay applicable fees per Framework.
- Acknowledge compliance with terms of membership.
- Determined it cannot be sold as a dietary supplement (e.g., CBD/THC products),
- Warned consumers not to use for safety reasons (e.g., Kratom), or
- Banned as a dietary supplement (e.g., ephedrine alkaloids).
Role of HESI
HESI is the convener and facilitator of the BSC. In this role HESI: (i) recruits members, (ii) supports scientific program design, execution, evaluation, and implementation per the MOU, and (iii) provides leadership, administration, stakeholder engagement, and communications.
Primary contact: Dr. Michelle Embry • (202) 659-8404 • botanicalsafety@hesiglobal.org
Additional Terms
Term & Termination
Effective 01 March 2020 until the BSC is concluded or superseded by Steering Committee action.
Limitation of Liability
No party is liable for indirect or similar damages. HESI’s maximum liability to any Member is capped at the total fees paid by that Member, per the Organizational Framework.
Confidentiality
Members generally should not share confidential information within BSC activities. If necessary, contact HESI beforehand to arrange protections.
Intellectual Property
Trademarks: BSC marks are owned by HESI and used for BSC purposes.
BSC IP: IP created through BSC work becomes HESI property (subject to federal/subcontract provisions). Filing costs are paid from BSC funds.
Use of Names & Logos
Members may not use BSC/HESI/Member names or logos to promote products or imply endorsement. HESI may list Member names on BSC materials.
BSC Communications
Official statements are issued through HESI. Members need written consent to speak on behalf of BSC and should avoid lobbying or endorsements.
Compliance & Governing Law
Members comply with applicable laws and federal program requirements. Governing law: District of Columbia.
Ethics
The BSC advances public health via open, ethical, multi-sector collaboration. Members commit to:
- Collaboration: respectful, science-focused interaction
- Respect: a safe, collegial environment
- Transparency: publicly accessible, robust resources
- Independence: mission-driven; no policy advocacy
- Integrity: ethical conduct; conflicts disclosed
- Opportunity: equal opportunity and consideration
Antitrust
BSC meetings are not venues for price/market coordination, boycotts, or any activity that violates antitrust/competition laws. Participants must not:
- Discuss prices, pricing policies, or terms of sale
- Divide customers or territories
- Establish blacklists or boycotts
- Coerce adoption of programs/policies
- Resolve problems unique to a single/small group of Members
- Exchange cost/production/marketing data
- Conduct/plan lobbying activities