Regulatory Support & Compliance
Navigate complex chemical regulations with proactive strategies and quality data that meet agency needs.
Manufacturers of chemicals, consumer products, and pharmaceuticals face increasingly complex regulatory landscapes across multiple jurisdictions. Our experts assist with all aspects of regulatory compliance across life cycle stages, from chemical manufacturing to consumer product safety. We engage with clients and regulators early in the process to design strategic data collation, collection, and analysis plans. For existing assessments, our scientists develop scientifically compelling and understandable comments for agency consideration.
Technical Leaders
Heather Lynch, MPH, DABT Principal, Toxicology, Health, and Ecological Science
M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA, Fellow ATS Principal, Toxicology, Health, and Ecological Sciences
Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT Senior Consultant
Claire M. Hamaji, MPH Consultant
Knowledge Share
Proposition 65 Compliance Evaluation for Zinc Alloy Products
Chemical Safety Information Gateway for TSCA Data Reporting
Human Health Risk Characterization of PFAS Chemicals at a Superfund Site
Analysis of Dermal Exposure Assessment in the US Environmental Protection Agency Toxic Substances Control Act Risk Evaluations of Chemical Manufacturing
Reported exposures to respirable crystalline silica during construction tasks and guidance for harmonizing future research
Strategies for Refinement of Occupational Inhalation Exposure Evaluation in the EPA TSCA Risk Evaluation Process
Litigation and Compliance Impacts of Proposed Ethylene Oxide Regulations Based on Flawed Science
Homegrown Produce Consumption Impacted by Contaminated Irrigation Water: An Evaluation of Available Methodologies to Calculate Exposure
Demonstrating the protective effect of a 70-year-old occupational exposure limit against pneumoconiosis caused by mica
Partnerships
With expertise in global environmental health regulatory agencies, including the U.S. EPA and European Chemicals Agency (ECHA), our experts ensure your company is compliant—whether bringing new chemicals to market or demonstrating the safety of existing chemicals and products.
Hazard Assessment and Global Regulatory Support
Our regulatory experts have broad expertise in United States and international programs and regulations pertaining to chemical hazards. This comprehensive regulatory knowledge enables strategic approaches that address multiple jurisdictions simultaneously while reducing duplicative efforts.
U.S. Regulatory Expertise:
- TSCA chemical hazard and toxicity assessment
- Office of Pesticide Programs (OPP) evaluations
- Integrated Risk Information System (IRIS) assessments
- Office of Water criteria and standards
- Multi-program coordination across EPA offices
International Regulatory Expertise:
- REACH registration and evaluation support
- Evaluate and comment on proposals for reclassification under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
- Multi-jurisdictional hazard assessment strategies
- Cross-border regulatory harmonization
Existing Chemical Registration
For existing chemicals, support spans preprioritization through risk management phases, coordinating with consortia or working directly with your company. Our proven track record includes data submissions consistently characterized as “high quality” by EPA, preventing costly issues down the road.
Key Capabilities:
- EPA TSCA test order responses and compliance strategies for single companies or multicompany consortia
- Regulatory comment preparation from preprioritization through risk management
- Customized exposure assessment strategies (occupational, consumer, community, environmental), including:
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- Coordination with laboratories for analytical method development and validation
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- Planning and conduct of occupational hygiene monitoring sampling campaigns
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- Comprehensive statistical analysis, including sophisticated strategies for handling outliers and samples below the analytical limits of detection.
- Independent risk evaluations using the principles of systematic review
New Chemical Registration
Efficient, compliant registrations enable clients to bring new products to market smoothly. We assist clients through all steps of the Section 5 new chemical notification process, from bona fide notices to identifying required toxicity testing and assessing occupational exposures and risk.
Specialized Services:
- Assessment of whether chemicals are defined as new chemicals under Section 5
- Bona fide notice preparation and premanufacture notice (PMN) submissions
- Toxicity testing identification and strategy development
- Occupational exposure assessment and risk evaluation
- Regulatory communication and submission preparation
TSCA Compliance
Integral provides clients with critical strategic support and technical expertise for TSCA Sections 4–6 and 8 and for evolving regulations. Our team has extensive experience with new chemistries as well as existing prioritized chemicals including methylene chloride, perchloroethylene, trichloroethylene, and other substances under EPA evaluation.
FAQs
- 1-bromopropane
- 1,2-dichloropropane
- 1,1-dichloroethylene
- 1,2-dichloroethylene
- 1,4-dioxane
- 1,1,2-trichloroethane
- o-Dichlorobenzene
- Asbestos
- Carbon tetrachloride
- Perchloroethylene
- Trichloroethylene
- Methylene chloride
- Triphenyl phosphate
- Tetrabromobisphenol A
The current administration prioritizes American production and has promised to accelerate new chemical reviews. Moreover, while the administration is re-evaluating the TSCA Section 6 process for risk evaluation, EPA continues work on many of the currently prioritized chemistries, which have existing regulatory deadlines or court-ordered deadlines.
We combine deep regulatory knowledge with technical expertise across toxicology, exposure assessment, industrial hygiene, and product stewardship. Our scientists have direct experience working with EPA, ECHA, FDA, and other agencies, allowing us to anticipate regulatory expectations and develop proactive strategies rather than reactive responses to compliance issues. Under TSCA, EPA has classified our analyses and submissions as high-quality data.
Absolutely. We specialize in responding to agency inquiries and evaluations of existing chemicals and products. We lead technical discussions with agencies and provide ongoing regulatory intelligence to keep your chemistries and products compliant as requirements evolve. Our systematic approach includes independent exposure and risk assessments, and clear communication with regulators to ensure that your chemistries and products are evaluated using the most up-to-date and reliable scientific data and information.