Regulatory Consulting Services in the USA
EPA Regulatory Affairs
Regulatory strategies for agrochemicals, home & garden pesticides, biopesticides and biostimulants, antimicrobial products, fertilizers, and consumer/industrial chemicals. Agency liaison, representation, and negotiation, EPA registration package preparation and submission. Consulting support for EPA’s Endocrine Disruptor Screening Program (EDSP) Tier 1 Test Orders and Tier 2 testing insight.
State Registration Management
First-time registration approvals in all 50 states, District of Columbia, and US territories. Annual renewal of product licenses according to individual State schedules and fees. State submission packages (applications, labels, MSDSs, technical data, reports, authorization letters, product summaries).
Data Development / Study Monitoring
Identification of required studies to support registration intent, data gap analysis, placement and monitoring of tests at contract research organizations, review and interpretation of study results, assure compliance with GLP standards.
Toxicology & Chemistry Consultation
A multi-disciplinary team of CSI scientists supports registration activities by providing expert guidance on toxicology, ecotoxicology, product & residue chemistry, environmental fate, and efficacy.
Extensive experience in all aspects of human health and ecological risk assessment. Hazard identification, effects analysis, exposure assessment, risk characterization.
Consumer Product Support
Complete regulatory and compliance support for consumer (household) products and personal care products. CSI specializes in risk assessments and labeling for household and chemicals regulated under the Federal Hazardous Substances Act (FHSA) of the Consumer Product Safety Commission (CPSC). We also provide compliance support for consumer product volatile organice chemical (VOC) regulations (under state and federal regulations including the California Air Resources Board “CARB” and the U.S.E.P.A.), weights and measures regulations (under the Federal Trade Commission) and safety and testing requirements under the Consumer Product Safety Improvement Act of 2008 (CPSIA). We provide safety and testing recommendations and product development guidance to assure compliant products and recall or market withdrawal guidance and support for CPSC related issues. Our capabilities also include work with international equivalents (Health Canada, EU authoritative bodies, etc.). For more information, please visit our Consumer and I&I Products page.
CSI provides comprehensive regulatory support for personal care products in North America and the EU. North American support includes testing, guidance, Canadian notification, risk analysis, ingredient consulting, claims support, and labeling compliance. EU support includes, development of Product Information Files (PIF), Cosmetic Product Safety Reports (CPSR), Notifications through the Cosmetic Products Notification Portal (CPNP), and Responsible Person (RP) services. For more information, please visit our Cosmetics page.
OSHA and GHS Support Including Industrial & Institutional (I&I) Products
CSI provides compliance assistance with the new OSHA GHS regulations including chemical safety and classification, labeling, Safety Data Sheet (SDS) preparation/conversion. We provide advice for workers health and safety issues. Other services include OSHA inspection support including citation remediation and negotiation. For more information, please visit our Consumer and I&I Products page.
Proposition 65 (Prop 65) and other State Regulations
CSI also helps companies avoid and respond to issues with state regulations including California Proposition 65 and the state’s Safer Consumer Products/Green Chemistry Initiative.
Regulatory & Scientific Insights
Advice on emerging regulatory and scientific developments that may impact current and future registrations. Recommend approaches to bring client products into compliance with new regulations.
Task Force Representation / Administration
Client representation on industry trade association consortia. Senior CSI staff serve in administrative and lead technical roles on chemical task forces.